Thomas R. Collins

Disruption of the bacteria in the gut is linked with susceptibility to long COVID-19 syndrome, according to new findings.

While links have been found between the gut’s microbiome and COVID-19, as well as other diseases, this is the first published research to show a link specifically to COVID’s long-term effects, the investigators, based at the Chinese University of Hong Kong, wrote in Gut.

Courtesy Dr. Siew Ng

“To our knowledge, this is the first study to show that altered gut microbiome composition is strongly associated with persistent symptoms in patients with COVID-19 up to 6 months after clearance of SARS-CoV-2 virus,” said Siew Ng, MBBS, PhD, associate director at the university’s Center for Gut Microbiota Research.

At three hospitals, the researchers enrolled 106 patients with COVID-19 from February to August 2020 with stool samples at admission and at 1 month and 6 months after discharge, and compared them with people who did not have COVID, recruited in 2019. The severity of COVID in the enrolled patients was mostly mild to moderate.

At 3 months, 86 of the patients with COVID had post–acute COVID-19 syndrome (PACS) – defined as at least one persistent, otherwise unexplained symptom 4 weeks after clearance of the virus. And 81 patients had PACS at 6 months, most commonly fatigue, poor memory, hair loss, anxiety, and trouble sleeping.

Using stool samples for their analysis, the researchers found that, broadly, the diversity of the types of bacteria, and the abundance of these bacteria, were significantly lower at 6 months for those with PACS, compared with those without PACS and with controls (P < .05 and P < .0001, respectively). Among those with PACS, 28 bacteria species were diminished and 14 were enriched, both at baseline and follow-up. Those patients who had COVID but not PACS showed just 25 alterations of bacteria species at the time of hospital admission, and they all normalized by 6 months.

Having respiratory symptoms at 6 months was linked with higher levels of opportunistic pathogens such as Streptococcus anginosus and S. vestibularis. Neuropsychiatric symptoms and fatigue were associated with nosocomial pathogens that are linked to opportunistic infections, such as Clostridium innocuum and Actinomyces naeslundii (P < .05).

Bacteria known for producing butyrate, a beneficial fatty acid, were significantly depleted in those patients with hair loss. And certain of these bacteria, including Bifidobacterium pseudocatenulatum and Faecalibacterium prausnitzii, had the largest inverse correlations with PACS at 6 months (P < .05), the researchers found.

“Particular gut microbial profiles may indicate heightened susceptibility,” Dr. Ng said.

Although the findings were drawn from patients with earlier strains of the COVID-19 virus, the findings still apply to new variants, including Omicron, since these pose the same problem of persistent disruption of the immune system, Dr. Ng said.

Her group is conducting trials to look at how modulating the microbiome might prevent long COVID and boost antibodies after vaccination in high-risk people, she said.

“Gut microbiota influences the health of the host,” Dr. Ng said. “It provides crucial benefits in the form of immune system development, prevention of infections, nutrient acquisition, and brain and nervous system functionality. Considering the millions of people infected during the ongoing pandemic, our findings are a strong impetus for consideration of microbiota modulation to facilitate timely recovery and reduce the burden of post–acute COVID-19 syndrome.”

Courtesy Dr. John Haran

John Haran, MD, PhD, associate professor of microbiology and physiological systems and emergency medicine at the University of Massachusetts, Worcester, said the research adds to the evidence base on the gut microbiome’s links to COVID, but there was likely be no clinical impact yet. Still, he said the findings linking specific species to specific symptoms was particularly interesting.

“Very early on during hospitalization, [the researchers] saw these differences and correlated out with people who have longer symptoms, and especially different groups of people that have longer symptoms, too,” said Dr. Haran, who has done research on the topic. “It’s very different if you have different symptoms, for example, you keep coughing for months versus you have brain fog and fatigue, or other debilitating symptoms.”

Dr. Haran noted that the findings didn’t identify bacteria types especially linked to COVID, but rather species that have already been found to be associated with a “bad” microbiome. He also pointed out that the patients enrolled in the study were not vaccinated, because vaccines weren’t available at the time. Still, further study to see whether modulation of gut bacteria can be a therapy seems worthwhile.

“Microbiome modulation is pretty safe, and that’s really the next big step that needs to be taken in this,” he said.

For now, the findings don’t give the clinician much new ammunition for treatment.

“We’re not there yet,” he added. “It’s not as if clinicians are going to tell their COVID patients: ‘Go out and buy some kale.’ ”

Eugene Chang, MD, professor of medicine at the University of Chicago, who has studied the gut microbiome and gastrointestinal disease, said it’s “too preliminary” to say whether the findings could lead to a clinical impact. The measures used merely identify the microbes present, but not what they are doing.

“These measures are unlikely to perform well enough to be useful for risk assessment or predicting clinical outcomes,” he said. “That being said, advances in technology are being made where next generations of metrics could be developed and useful as stratifiers and predictors of risk.”

Seeing shifting patterns associated with certain symptoms, he said, is “notable because it suggests that the disturbances of the gut microbiota in PACS are significant.”

But he said it’s important to know whether these changes are a cause of PACS in some way or just an effect of it.

“If causative or contributory – this has to be proven – then ‘microbiota modulation’ would make sense and could be a priority for development,” he said. “If merely an effect, these metrics and better ones to come could be useful as predictors or measures of the patient’s general state of health.”

As seen in his group’s work and other work, he said, “the gut microbiota is highly sensitive to changes in their ecosystem, which is influenced by the health state of the patient.”

Dr. Ng, Dr. Haran, and Dr. Chang reported no relevant disclosures.

This article was updated Jan. 27, 2022.

Disruption of the bacteria in the gut is linked with susceptibility to long COVID-19 syndrome, according to new findings.

While links have been found between the gut’s microbiome and COVID-19, as well as other diseases, this is the first published research to show a link specifically to COVID’s long-term effects, the investigators, based at the Chinese University of Hong Kong, wrote in Gut.

Courtesy Dr. Siew Ng

“To our knowledge, this is the first study to show that altered gut microbiome composition is strongly associated with persistent symptoms in patients with COVID-19 up to 6 months after clearance of SARS-CoV-2 virus,” said Siew Ng, MBBS, PhD, associate director at the university’s Center for Gut Microbiota Research.

At three hospitals, the researchers enrolled 106 patients with COVID-19 from February to August 2020 with stool samples at admission and at 1 month and 6 months after discharge, and compared them with people who did not have COVID, recruited in 2019. The severity of COVID in the enrolled patients was mostly mild to moderate.

At 3 months, 86 of the patients with COVID had post–acute COVID-19 syndrome (PACS) – defined as at least one persistent, otherwise unexplained symptom 4 weeks after clearance of the virus. And 81 patients had PACS at 6 months, most commonly fatigue, poor memory, hair loss, anxiety, and trouble sleeping.

Using stool samples for their analysis, the researchers found that, broadly, the diversity of the types of bacteria, and the abundance of these bacteria, were significantly lower at 6 months for those with PACS, compared with those without PACS and with controls (P < .05 and P < .0001, respectively). Among those with PACS, 28 bacteria species were diminished and 14 were enriched, both at baseline and follow-up. Those patients who had COVID but not PACS showed just 25 alterations of bacteria species at the time of hospital admission, and they all normalized by 6 months.

Having respiratory symptoms at 6 months was linked with higher levels of opportunistic pathogens such as Streptococcus anginosus and S. vestibularis. Neuropsychiatric symptoms and fatigue were associated with nosocomial pathogens that are linked to opportunistic infections, such as Clostridium innocuum and Actinomyces naeslundii (P < .05).

Bacteria known for producing butyrate, a beneficial fatty acid, were significantly depleted in those patients with hair loss. And certain of these bacteria, including Bifidobacterium pseudocatenulatum and Faecalibacterium prausnitzii, had the largest inverse correlations with PACS at 6 months (P < .05), the researchers found.

“Particular gut microbial profiles may indicate heightened susceptibility,” Dr. Ng said.

Although the findings were drawn from patients with earlier strains of the COVID-19 virus, the findings still apply to new variants, including Omicron, since these pose the same problem of persistent disruption of the immune system, Dr. Ng said.

Her group is conducting trials to look at how modulating the microbiome might prevent long COVID and boost antibodies after vaccination in high-risk people, she said.

“Gut microbiota influences the health of the host,” Dr. Ng said. “It provides crucial benefits in the form of immune system development, prevention of infections, nutrient acquisition, and brain and nervous system functionality. Considering the millions of people infected during the ongoing pandemic, our findings are a strong impetus for consideration of microbiota modulation to facilitate timely recovery and reduce the burden of post–acute COVID-19 syndrome.”

Courtesy Dr. John Haran

John Haran, MD, PhD, associate professor of microbiology and physiological systems and emergency medicine at the University of Massachusetts, Worcester, said the research adds to the evidence base on the gut microbiome’s links to COVID, but there was likely be no clinical impact yet. Still, he said the findings linking specific species to specific symptoms was particularly interesting.

“Very early on during hospitalization, [the researchers] saw these differences and correlated out with people who have longer symptoms, and especially different groups of people that have longer symptoms, too,” said Dr. Haran, who has done research on the topic. “It’s very different if you have different symptoms, for example, you keep coughing for months versus you have brain fog and fatigue, or other debilitating symptoms.”

Dr. Haran noted that the findings didn’t identify bacteria types especially linked to COVID, but rather species that have already been found to be associated with a “bad” microbiome. He also pointed out that the patients enrolled in the study were not vaccinated, because vaccines weren’t available at the time. Still, further study to see whether modulation of gut bacteria can be a therapy seems worthwhile.

“Microbiome modulation is pretty safe, and that’s really the next big step that needs to be taken in this,” he said.

For now, the findings don’t give the clinician much new ammunition for treatment.

“We’re not there yet,” he added. “It’s not as if clinicians are going to tell their COVID patients: ‘Go out and buy some kale.’ ”

Eugene Chang, MD, professor of medicine at the University of Chicago, who has studied the gut microbiome and gastrointestinal disease, said it’s “too preliminary” to say whether the findings could lead to a clinical impact. The measures used merely identify the microbes present, but not what they are doing.

“These measures are unlikely to perform well enough to be useful for risk assessment or predicting clinical outcomes,” he said. “That being said, advances in technology are being made where next generations of metrics could be developed and useful as stratifiers and predictors of risk.”

Seeing shifting patterns associated with certain symptoms, he said, is “notable because it suggests that the disturbances of the gut microbiota in PACS are significant.”

But he said it’s important to know whether these changes are a cause of PACS in some way or just an effect of it.

“If causative or contributory – this has to be proven – then ‘microbiota modulation’ would make sense and could be a priority for development,” he said. “If merely an effect, these metrics and better ones to come could be useful as predictors or measures of the patient’s general state of health.”

As seen in his group’s work and other work, he said, “the gut microbiota is highly sensitive to changes in their ecosystem, which is influenced by the health state of the patient.”

Dr. Ng, Dr. Haran, and Dr. Chang reported no relevant disclosures.

This article was updated Jan. 27, 2022.

Disruption of the bacteria in the gut is linked with susceptibility to long COVID-19 syndrome, according to new findings.

While links have been found between the gut’s microbiome and COVID-19, as well as other diseases, this is the first published research to show a link specifically to COVID’s long-term effects, the investigators, based at the Chinese University of Hong Kong, wrote in Gut.

Courtesy Dr. Siew Ng

“To our knowledge, this is the first study to show that altered gut microbiome composition is strongly associated with persistent symptoms in patients with COVID-19 up to 6 months after clearance of SARS-CoV-2 virus,” said Siew Ng, MBBS, PhD, associate director at the university’s Center for Gut Microbiota Research.

At three hospitals, the researchers enrolled 106 patients with COVID-19 from February to August 2020 with stool samples at admission and at 1 month and 6 months after discharge, and compared them with people who did not have COVID, recruited in 2019. The severity of COVID in the enrolled patients was mostly mild to moderate.

At 3 months, 86 of the patients with COVID had post–acute COVID-19 syndrome (PACS) – defined as at least one persistent, otherwise unexplained symptom 4 weeks after clearance of the virus. And 81 patients had PACS at 6 months, most commonly fatigue, poor memory, hair loss, anxiety, and trouble sleeping.

Using stool samples for their analysis, the researchers found that, broadly, the diversity of the types of bacteria, and the abundance of these bacteria, were significantly lower at 6 months for those with PACS, compared with those without PACS and with controls (P < .05 and P < .0001, respectively). Among those with PACS, 28 bacteria species were diminished and 14 were enriched, both at baseline and follow-up. Those patients who had COVID but not PACS showed just 25 alterations of bacteria species at the time of hospital admission, and they all normalized by 6 months.

Having respiratory symptoms at 6 months was linked with higher levels of opportunistic pathogens such as Streptococcus anginosus and S. vestibularis. Neuropsychiatric symptoms and fatigue were associated with nosocomial pathogens that are linked to opportunistic infections, such as Clostridium innocuum and Actinomyces naeslundii (P < .05).

Bacteria known for producing butyrate, a beneficial fatty acid, were significantly depleted in those patients with hair loss. And certain of these bacteria, including Bifidobacterium pseudocatenulatum and Faecalibacterium prausnitzii, had the largest inverse correlations with PACS at 6 months (P < .05), the researchers found.

“Particular gut microbial profiles may indicate heightened susceptibility,” Dr. Ng said.

Although the findings were drawn from patients with earlier strains of the COVID-19 virus, the findings still apply to new variants, including Omicron, since these pose the same problem of persistent disruption of the immune system, Dr. Ng said.

Her group is conducting trials to look at how modulating the microbiome might prevent long COVID and boost antibodies after vaccination in high-risk people, she said.

“Gut microbiota influences the health of the host,” Dr. Ng said. “It provides crucial benefits in the form of immune system development, prevention of infections, nutrient acquisition, and brain and nervous system functionality. Considering the millions of people infected during the ongoing pandemic, our findings are a strong impetus for consideration of microbiota modulation to facilitate timely recovery and reduce the burden of post–acute COVID-19 syndrome.”

Courtesy Dr. John Haran

John Haran, MD, PhD, associate professor of microbiology and physiological systems and emergency medicine at the University of Massachusetts, Worcester, said the research adds to the evidence base on the gut microbiome’s links to COVID, but there was likely be no clinical impact yet. Still, he said the findings linking specific species to specific symptoms was particularly interesting.

“Very early on during hospitalization, [the researchers] saw these differences and correlated out with people who have longer symptoms, and especially different groups of people that have longer symptoms, too,” said Dr. Haran, who has done research on the topic. “It’s very different if you have different symptoms, for example, you keep coughing for months versus you have brain fog and fatigue, or other debilitating symptoms.”

Dr. Haran noted that the findings didn’t identify bacteria types especially linked to COVID, but rather species that have already been found to be associated with a “bad” microbiome. He also pointed out that the patients enrolled in the study were not vaccinated, because vaccines weren’t available at the time. Still, further study to see whether modulation of gut bacteria can be a therapy seems worthwhile.

“Microbiome modulation is pretty safe, and that’s really the next big step that needs to be taken in this,” he said.

For now, the findings don’t give the clinician much new ammunition for treatment.

“We’re not there yet,” he added. “It’s not as if clinicians are going to tell their COVID patients: ‘Go out and buy some kale.’ ”

Eugene Chang, MD, professor of medicine at the University of Chicago, who has studied the gut microbiome and gastrointestinal disease, said it’s “too preliminary” to say whether the findings could lead to a clinical impact. The measures used merely identify the microbes present, but not what they are doing.

“These measures are unlikely to perform well enough to be useful for risk assessment or predicting clinical outcomes,” he said. “That being said, advances in technology are being made where next generations of metrics could be developed and useful as stratifiers and predictors of risk.”

Seeing shifting patterns associated with certain symptoms, he said, is “notable because it suggests that the disturbances of the gut microbiota in PACS are significant.”

But he said it’s important to know whether these changes are a cause of PACS in some way or just an effect of it.

“If causative or contributory – this has to be proven – then ‘microbiota modulation’ would make sense and could be a priority for development,” he said. “If merely an effect, these metrics and better ones to come could be useful as predictors or measures of the patient’s general state of health.”

As seen in his group’s work and other work, he said, “the gut microbiota is highly sensitive to changes in their ecosystem, which is influenced by the health state of the patient.”

Dr. Ng, Dr. Haran, and Dr. Chang reported no relevant disclosures.

This article was updated Jan. 27, 2022.

Drinking more than three cups of caffeinated coffee a day is associated with less liver stiffness, according to an analysis of a nationally representative survey, which was recently published in Clinical Gastroenterology and Hepatology.

amenic181/Getty Images

The study is likely the most rigorous look to date on the benefits of coffee on liver health in the U.S. It was based on data from the National Health and Nutrition Examination Survey (NHANES), in which participants were asked about what they eat and drink. Crucially, in 2017, NHANES began to include elastography (FibroScan), of participants’ liver stiffness, not because of suspected problems with the liver but as across-the-board evaluations of all participants.

“Because it’s an unselected population for FibroScan and because of the detail, the granularity, the richness of the information from the nutritional surveys that they do, this is the closest we’re ever going to get to a linkage between what people are eating or drinking and the health of their liver, absent a longitudinal study where we set out to follow people for many, many years,” said Elliot Tapper, MD, assistant professor of gastroenterology at the University of Michigan, Ann Arbor, and the study’s senior author.

Researchers examined data from about 4,500 patients who had participated in the NHANES study in 2017-2018. The participants were aged 20 years or older, with an average age of 48; 73% were overweight, about the national average.

The researchers found no association between coffee consumption and controlled attenuation parameter (CAP), a measure of fatty liver. But they found a link between coffee and liver stiffness.

Those who drank more than three cups of coffee daily had a liver stiffness measure (LSM) that was 0.9 kilopascals (kPa) lower than others (P = .03). Drinking more than three cups a day also was found to be protective against an LSM of 9.5 kPa or higher, the threshold for advanced liver fibrosis (OR, 0.4; P = .05). Decaffeinated coffee was not found to be associated with LSM.

Caffeine is an antagonist to adenosine receptors in the liver cell that, if blocked, stops the production of scar tissue, according to the researchers. But when they looked at estimated caffeine consumption, calculated through the detailed, trained interviews performed by nutritionists, there was no association with liver stiffness. That said, Dr. Tapper noted that this could be due to the imperfection of making those estimations.

“If we had to hypothesize about a mechanism, it would most likely be caffeine, and the reason we couldn’t see that here is because these are estimated milligrams of caffeine per coffee – but the way that we brew coffee, and the beans that we’re using, are so highly variable it just can’t be captured in this kind of database,” he said.

He said the data will be reassuring to clinicians who suggest coffee-drinking to patients.

“There are hepatologists around the world who are actively recommending coffee – they’ll feel empowered by these data,” he said. “I would still like to see more robust longitudinal data before I start spending our precious time counseling patients about coffee. There are many other data-driven interventions for the management of liver disease that we should be focusing our time on.”

Moreover, he said that the data will be important for patients who are particularly interested in natural remedies.

“For patients who are very interested in a natural supplement, to feel like they’re taking an active role in the health of their liver, I will tell them to avoid carbohydrates and increase their exercise – and that it is OK to add coffee to their daily routine.”

A study based on a UK database found that coffee was associated with protection against chronic liver disease, but the association was seen for both caffeinated and decaffeinated drinks, noted Nathan Davies, PhD, professor of biochemistry at the Institute of the Liver and Digestive Health at the University College London.

Dr. Davies, a registered nutritionist who has studied coffee’s effects on the liver, said that while including elastography in the Michigan study is interesting, it “does not necessarily by itself add greatly” to the evidence base.

The outcomes from both studies do suggest a positive effect for coffee, but he said it’s important to remember that liver disease develops over years and decades.

“Looking at a snapshot moment does not necessarily reflect an individual’s behavior during the onset and development of their condition,” he said. “As such, there are a number of behavioral and nutritional factors that could be contributing to the observed effect over a period of years.”

He pointed out that while different coffee and brewing types affect the amount of caffeine in a cup, all cups of coffee in this study were treated the same way. He noted there was no apparent dose-dependent effect, which would have been expected if there is an active ingredient that affects liver stiffness.

“In general, my advice is to improve diet, take more exercise, and reduce alcohol consumption, which is likely to be more effective in preventing liver disease – and its progression – than drinking an extra cup of coffee,” Dr. Davies said. “That being said, for patients at increased risk for liver disease who currently drink three cups or more of coffee daily, it may be prudent for them to continue because this level of consumption might be actively lowering their chances of developing more serious disease.”

Dr. Tapper has done consulting for Novartis, Axcella and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has unrestricted research grants from Gilead and Valeant. The remaining authors disclose no conflicts. Dr. Davies reported no relevant disclosures.

Drinking more than three cups of caffeinated coffee a day is associated with less liver stiffness, according to an analysis of a nationally representative survey, which was recently published in Clinical Gastroenterology and Hepatology.

amenic181/Getty Images

The study is likely the most rigorous look to date on the benefits of coffee on liver health in the U.S. It was based on data from the National Health and Nutrition Examination Survey (NHANES), in which participants were asked about what they eat and drink. Crucially, in 2017, NHANES began to include elastography (FibroScan), of participants’ liver stiffness, not because of suspected problems with the liver but as across-the-board evaluations of all participants.

“Because it’s an unselected population for FibroScan and because of the detail, the granularity, the richness of the information from the nutritional surveys that they do, this is the closest we’re ever going to get to a linkage between what people are eating or drinking and the health of their liver, absent a longitudinal study where we set out to follow people for many, many years,” said Elliot Tapper, MD, assistant professor of gastroenterology at the University of Michigan, Ann Arbor, and the study’s senior author.

Researchers examined data from about 4,500 patients who had participated in the NHANES study in 2017-2018. The participants were aged 20 years or older, with an average age of 48; 73% were overweight, about the national average.

The researchers found no association between coffee consumption and controlled attenuation parameter (CAP), a measure of fatty liver. But they found a link between coffee and liver stiffness.

Those who drank more than three cups of coffee daily had a liver stiffness measure (LSM) that was 0.9 kilopascals (kPa) lower than others (P = .03). Drinking more than three cups a day also was found to be protective against an LSM of 9.5 kPa or higher, the threshold for advanced liver fibrosis (OR, 0.4; P = .05). Decaffeinated coffee was not found to be associated with LSM.

Caffeine is an antagonist to adenosine receptors in the liver cell that, if blocked, stops the production of scar tissue, according to the researchers. But when they looked at estimated caffeine consumption, calculated through the detailed, trained interviews performed by nutritionists, there was no association with liver stiffness. That said, Dr. Tapper noted that this could be due to the imperfection of making those estimations.

“If we had to hypothesize about a mechanism, it would most likely be caffeine, and the reason we couldn’t see that here is because these are estimated milligrams of caffeine per coffee – but the way that we brew coffee, and the beans that we’re using, are so highly variable it just can’t be captured in this kind of database,” he said.

He said the data will be reassuring to clinicians who suggest coffee-drinking to patients.

“There are hepatologists around the world who are actively recommending coffee – they’ll feel empowered by these data,” he said. “I would still like to see more robust longitudinal data before I start spending our precious time counseling patients about coffee. There are many other data-driven interventions for the management of liver disease that we should be focusing our time on.”

Moreover, he said that the data will be important for patients who are particularly interested in natural remedies.

“For patients who are very interested in a natural supplement, to feel like they’re taking an active role in the health of their liver, I will tell them to avoid carbohydrates and increase their exercise – and that it is OK to add coffee to their daily routine.”

A study based on a UK database found that coffee was associated with protection against chronic liver disease, but the association was seen for both caffeinated and decaffeinated drinks, noted Nathan Davies, PhD, professor of biochemistry at the Institute of the Liver and Digestive Health at the University College London.

Dr. Davies, a registered nutritionist who has studied coffee’s effects on the liver, said that while including elastography in the Michigan study is interesting, it “does not necessarily by itself add greatly” to the evidence base.

The outcomes from both studies do suggest a positive effect for coffee, but he said it’s important to remember that liver disease develops over years and decades.

“Looking at a snapshot moment does not necessarily reflect an individual’s behavior during the onset and development of their condition,” he said. “As such, there are a number of behavioral and nutritional factors that could be contributing to the observed effect over a period of years.”

He pointed out that while different coffee and brewing types affect the amount of caffeine in a cup, all cups of coffee in this study were treated the same way. He noted there was no apparent dose-dependent effect, which would have been expected if there is an active ingredient that affects liver stiffness.

“In general, my advice is to improve diet, take more exercise, and reduce alcohol consumption, which is likely to be more effective in preventing liver disease – and its progression – than drinking an extra cup of coffee,” Dr. Davies said. “That being said, for patients at increased risk for liver disease who currently drink three cups or more of coffee daily, it may be prudent for them to continue because this level of consumption might be actively lowering their chances of developing more serious disease.”

Dr. Tapper has done consulting for Novartis, Axcella and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has unrestricted research grants from Gilead and Valeant. The remaining authors disclose no conflicts. Dr. Davies reported no relevant disclosures.

Drinking more than three cups of caffeinated coffee a day is associated with less liver stiffness, according to an analysis of a nationally representative survey, which was recently published in Clinical Gastroenterology and Hepatology.

amenic181/Getty Images

The study is likely the most rigorous look to date on the benefits of coffee on liver health in the U.S. It was based on data from the National Health and Nutrition Examination Survey (NHANES), in which participants were asked about what they eat and drink. Crucially, in 2017, NHANES began to include elastography (FibroScan), of participants’ liver stiffness, not because of suspected problems with the liver but as across-the-board evaluations of all participants.

“Because it’s an unselected population for FibroScan and because of the detail, the granularity, the richness of the information from the nutritional surveys that they do, this is the closest we’re ever going to get to a linkage between what people are eating or drinking and the health of their liver, absent a longitudinal study where we set out to follow people for many, many years,” said Elliot Tapper, MD, assistant professor of gastroenterology at the University of Michigan, Ann Arbor, and the study’s senior author.

Researchers examined data from about 4,500 patients who had participated in the NHANES study in 2017-2018. The participants were aged 20 years or older, with an average age of 48; 73% were overweight, about the national average.

The researchers found no association between coffee consumption and controlled attenuation parameter (CAP), a measure of fatty liver. But they found a link between coffee and liver stiffness.

Those who drank more than three cups of coffee daily had a liver stiffness measure (LSM) that was 0.9 kilopascals (kPa) lower than others (P = .03). Drinking more than three cups a day also was found to be protective against an LSM of 9.5 kPa or higher, the threshold for advanced liver fibrosis (OR, 0.4; P = .05). Decaffeinated coffee was not found to be associated with LSM.

Caffeine is an antagonist to adenosine receptors in the liver cell that, if blocked, stops the production of scar tissue, according to the researchers. But when they looked at estimated caffeine consumption, calculated through the detailed, trained interviews performed by nutritionists, there was no association with liver stiffness. That said, Dr. Tapper noted that this could be due to the imperfection of making those estimations.

“If we had to hypothesize about a mechanism, it would most likely be caffeine, and the reason we couldn’t see that here is because these are estimated milligrams of caffeine per coffee – but the way that we brew coffee, and the beans that we’re using, are so highly variable it just can’t be captured in this kind of database,” he said.

He said the data will be reassuring to clinicians who suggest coffee-drinking to patients.

“There are hepatologists around the world who are actively recommending coffee – they’ll feel empowered by these data,” he said. “I would still like to see more robust longitudinal data before I start spending our precious time counseling patients about coffee. There are many other data-driven interventions for the management of liver disease that we should be focusing our time on.”

Moreover, he said that the data will be important for patients who are particularly interested in natural remedies.

“For patients who are very interested in a natural supplement, to feel like they’re taking an active role in the health of their liver, I will tell them to avoid carbohydrates and increase their exercise – and that it is OK to add coffee to their daily routine.”

A study based on a UK database found that coffee was associated with protection against chronic liver disease, but the association was seen for both caffeinated and decaffeinated drinks, noted Nathan Davies, PhD, professor of biochemistry at the Institute of the Liver and Digestive Health at the University College London.

Dr. Davies, a registered nutritionist who has studied coffee’s effects on the liver, said that while including elastography in the Michigan study is interesting, it “does not necessarily by itself add greatly” to the evidence base.

The outcomes from both studies do suggest a positive effect for coffee, but he said it’s important to remember that liver disease develops over years and decades.

“Looking at a snapshot moment does not necessarily reflect an individual’s behavior during the onset and development of their condition,” he said. “As such, there are a number of behavioral and nutritional factors that could be contributing to the observed effect over a period of years.”

He pointed out that while different coffee and brewing types affect the amount of caffeine in a cup, all cups of coffee in this study were treated the same way. He noted there was no apparent dose-dependent effect, which would have been expected if there is an active ingredient that affects liver stiffness.

“In general, my advice is to improve diet, take more exercise, and reduce alcohol consumption, which is likely to be more effective in preventing liver disease – and its progression – than drinking an extra cup of coffee,” Dr. Davies said. “That being said, for patients at increased risk for liver disease who currently drink three cups or more of coffee daily, it may be prudent for them to continue because this level of consumption might be actively lowering their chances of developing more serious disease.”

Dr. Tapper has done consulting for Novartis, Axcella and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has unrestricted research grants from Gilead and Valeant. The remaining authors disclose no conflicts. Dr. Davies reported no relevant disclosures.

Annual health care costs for patients with psoriatic arthritis rose over recent 5-year periods across all categories of resource use to a significantly greater extent than among patients with psoriasis only or those without any psoriatic disease diagnoses, according to commercial insurance claims data.

Thinkstock Photos

Using an IBM MarketScan Commercial Database, researchers examined claims data for 208,434 patients with psoriasis, 47,274 with PsA, and 255,708 controls who had neither psoriasis nor PsA. Controls were matched for age and sex. Those with RA, ankylosing spondylitis, Crohn’s disease, or ulcerative colitis were excluded.

The investigators examined data for 2009-2020, following patients for 5 years within that period. They looked at hospitalizations, outpatient and pharmacy services, lab services, and office visits, Steven Peterson, director of market access for rheumatology at Janssen Pharmaceuticals, said in his presentation of the data at the Pan American League of Associations for Rheumatology 2021 annual meeting, held recently as a virtual event.

The research was also published online May 2, 2021, in Clinical Rheumatology.

Big differences between the groups were seen in the first year, when the average health care costs for the PsA group were $28,322, about half of which was outpatient drug costs. That compared with $12,039 for the psoriasis group and $6,672 for the control group.

The differences tended to widen over time. By the fifth year, average costs for the PsA group were $34,290, nearly 60% of which were drug costs. That compared with $12,877 for the psoriasis group and $8,569 for the control group. In each year examined, outpatient drug costs accounted for less than half of the expenses for the psoriasis group and about a quarter for the control group.

Researchers found that the PsA group needed 28.7 prescriptions per person per year, compared with 17.0 and 12.7 in the psoriasis and control groups, respectively, Mr. Peterson said. He also noted that patients with PsA and psoriasis tended to have higher rates of hypertension, depression, and anxiety.

“The cost and resource utilization disparity between these patient groups demonstrates the high remaining unmet medical need for patients with psoriasis and psoriatic arthritis,” Mr. Peterson said during the virtual proceedings.

Do findings reflect treatment advances?

Elaine Husni, MD, MPH, director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic, where she studies health outcomes in PsA, said the findings are helpful in pointing to a trend across a large sample. But she added it’s important to remember that the increasing costs could reflect recent advances in PsA treatment, which include costly biologic drugs.

“There’s a ton more treatments for psoriasis and psoriatic arthritis than there were even just 5 years ago,” she said in an interview. She was not involved in the research.

Dr. Husni would like to see a more detailed look at the costs, from the categories of expenses to the patients who are incurring the highest costs.  

“Is it just a couple of percent of really sick patients that are driving the psoriatic arthritis group?” she wondered.

She also pointed out that PsA is going to be more expensive by its very nature. PsA tends to develop 3-10 years after psoriasis, adding to the costs for someone who already has psoriasis and at a time when they are older and likely have higher health care costs because of comorbidities that develop with age.

Dr. Husni said she does think about treatment costs, in that a less expensive first-line drug might be more appropriate than going straight to a more expensive biologic, especially because they also tend to be safer. She said it’s not just a simple question of curbing costs.

“Is there a way that we can personalize medicine?” she asked. “Is there a way that we can be more accurate about which people may need the more expensive drugs, and which patients may need the less expensive drugs? Are we getting better at monitoring so we can avoid high-cost events?”

Mr. Peterson is an employee of Janssen Pharmaceuticals. Dr. Husni reported serving as a consultant to AbbVie, Amgen, Bristol-Myers Squibb, UCB, Novartis, Lilly, and Pfizer.

* Update, 9/28/21: The headline and parts of this story were updated to better reflect the study on which it reports.

A version of this article first appeared on Medscape.com.

Annual health care costs for patients with psoriatic arthritis rose over recent 5-year periods across all categories of resource use to a significantly greater extent than among patients with psoriasis only or those without any psoriatic disease diagnoses, according to commercial insurance claims data.

Thinkstock Photos

Using an IBM MarketScan Commercial Database, researchers examined claims data for 208,434 patients with psoriasis, 47,274 with PsA, and 255,708 controls who had neither psoriasis nor PsA. Controls were matched for age and sex. Those with RA, ankylosing spondylitis, Crohn’s disease, or ulcerative colitis were excluded.

The investigators examined data for 2009-2020, following patients for 5 years within that period. They looked at hospitalizations, outpatient and pharmacy services, lab services, and office visits, Steven Peterson, director of market access for rheumatology at Janssen Pharmaceuticals, said in his presentation of the data at the Pan American League of Associations for Rheumatology 2021 annual meeting, held recently as a virtual event.

The research was also published online May 2, 2021, in Clinical Rheumatology.

Big differences between the groups were seen in the first year, when the average health care costs for the PsA group were $28,322, about half of which was outpatient drug costs. That compared with $12,039 for the psoriasis group and $6,672 for the control group.

The differences tended to widen over time. By the fifth year, average costs for the PsA group were $34,290, nearly 60% of which were drug costs. That compared with $12,877 for the psoriasis group and $8,569 for the control group. In each year examined, outpatient drug costs accounted for less than half of the expenses for the psoriasis group and about a quarter for the control group.

Researchers found that the PsA group needed 28.7 prescriptions per person per year, compared with 17.0 and 12.7 in the psoriasis and control groups, respectively, Mr. Peterson said. He also noted that patients with PsA and psoriasis tended to have higher rates of hypertension, depression, and anxiety.

“The cost and resource utilization disparity between these patient groups demonstrates the high remaining unmet medical need for patients with psoriasis and psoriatic arthritis,” Mr. Peterson said during the virtual proceedings.

Do findings reflect treatment advances?

Elaine Husni, MD, MPH, director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic, where she studies health outcomes in PsA, said the findings are helpful in pointing to a trend across a large sample. But she added it’s important to remember that the increasing costs could reflect recent advances in PsA treatment, which include costly biologic drugs.

“There’s a ton more treatments for psoriasis and psoriatic arthritis than there were even just 5 years ago,” she said in an interview. She was not involved in the research.

Dr. Husni would like to see a more detailed look at the costs, from the categories of expenses to the patients who are incurring the highest costs.  

“Is it just a couple of percent of really sick patients that are driving the psoriatic arthritis group?” she wondered.

She also pointed out that PsA is going to be more expensive by its very nature. PsA tends to develop 3-10 years after psoriasis, adding to the costs for someone who already has psoriasis and at a time when they are older and likely have higher health care costs because of comorbidities that develop with age.

Dr. Husni said she does think about treatment costs, in that a less expensive first-line drug might be more appropriate than going straight to a more expensive biologic, especially because they also tend to be safer. She said it’s not just a simple question of curbing costs.

“Is there a way that we can personalize medicine?” she asked. “Is there a way that we can be more accurate about which people may need the more expensive drugs, and which patients may need the less expensive drugs? Are we getting better at monitoring so we can avoid high-cost events?”

Mr. Peterson is an employee of Janssen Pharmaceuticals. Dr. Husni reported serving as a consultant to AbbVie, Amgen, Bristol-Myers Squibb, UCB, Novartis, Lilly, and Pfizer.

* Update, 9/28/21: The headline and parts of this story were updated to better reflect the study on which it reports.

A version of this article first appeared on Medscape.com.

Annual health care costs for patients with psoriatic arthritis rose over recent 5-year periods across all categories of resource use to a significantly greater extent than among patients with psoriasis only or those without any psoriatic disease diagnoses, according to commercial insurance claims data.

Thinkstock Photos

Using an IBM MarketScan Commercial Database, researchers examined claims data for 208,434 patients with psoriasis, 47,274 with PsA, and 255,708 controls who had neither psoriasis nor PsA. Controls were matched for age and sex. Those with RA, ankylosing spondylitis, Crohn’s disease, or ulcerative colitis were excluded.

The investigators examined data for 2009-2020, following patients for 5 years within that period. They looked at hospitalizations, outpatient and pharmacy services, lab services, and office visits, Steven Peterson, director of market access for rheumatology at Janssen Pharmaceuticals, said in his presentation of the data at the Pan American League of Associations for Rheumatology 2021 annual meeting, held recently as a virtual event.

The research was also published online May 2, 2021, in Clinical Rheumatology.

Big differences between the groups were seen in the first year, when the average health care costs for the PsA group were $28,322, about half of which was outpatient drug costs. That compared with $12,039 for the psoriasis group and $6,672 for the control group.

The differences tended to widen over time. By the fifth year, average costs for the PsA group were $34,290, nearly 60% of which were drug costs. That compared with $12,877 for the psoriasis group and $8,569 for the control group. In each year examined, outpatient drug costs accounted for less than half of the expenses for the psoriasis group and about a quarter for the control group.

Researchers found that the PsA group needed 28.7 prescriptions per person per year, compared with 17.0 and 12.7 in the psoriasis and control groups, respectively, Mr. Peterson said. He also noted that patients with PsA and psoriasis tended to have higher rates of hypertension, depression, and anxiety.

“The cost and resource utilization disparity between these patient groups demonstrates the high remaining unmet medical need for patients with psoriasis and psoriatic arthritis,” Mr. Peterson said during the virtual proceedings.

Do findings reflect treatment advances?

Elaine Husni, MD, MPH, director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic, where she studies health outcomes in PsA, said the findings are helpful in pointing to a trend across a large sample. But she added it’s important to remember that the increasing costs could reflect recent advances in PsA treatment, which include costly biologic drugs.

“There’s a ton more treatments for psoriasis and psoriatic arthritis than there were even just 5 years ago,” she said in an interview. She was not involved in the research.

Dr. Husni would like to see a more detailed look at the costs, from the categories of expenses to the patients who are incurring the highest costs.  

“Is it just a couple of percent of really sick patients that are driving the psoriatic arthritis group?” she wondered.

She also pointed out that PsA is going to be more expensive by its very nature. PsA tends to develop 3-10 years after psoriasis, adding to the costs for someone who already has psoriasis and at a time when they are older and likely have higher health care costs because of comorbidities that develop with age.

Dr. Husni said she does think about treatment costs, in that a less expensive first-line drug might be more appropriate than going straight to a more expensive biologic, especially because they also tend to be safer. She said it’s not just a simple question of curbing costs.

“Is there a way that we can personalize medicine?” she asked. “Is there a way that we can be more accurate about which people may need the more expensive drugs, and which patients may need the less expensive drugs? Are we getting better at monitoring so we can avoid high-cost events?”

Mr. Peterson is an employee of Janssen Pharmaceuticals. Dr. Husni reported serving as a consultant to AbbVie, Amgen, Bristol-Myers Squibb, UCB, Novartis, Lilly, and Pfizer.

* Update, 9/28/21: The headline and parts of this story were updated to better reflect the study on which it reports.

A version of this article first appeared on Medscape.com.

With the approval by the Food and Drug Administration of the calcineurin inhibitor voclosporin (Lupkynis) in January and belimumab (Benlysta) a month before that, clinicians now have new options for treating lupus nephritis in combination with a background immunosuppressive agent, such as mycophenolate mofetil.

But which combination should clinicians choose?

Brad Rovin, MD, a nephrologist with the Ohio State University Wexner Medical Center, Columbus, who worked on the phase 3 voclosprin trial, pointed to that drug’s fast reduction in proteinuria in a session of the Pan American League of Associations for Rheumatology (PANLAR) 2021 Annual Meeting. That effect on proteinuria is likely due to its effect on podocytes, special epithelial cells that cover the outside of capillaries in the kidney, he said.

These crucial cells have an elaborate cytoskeleton that is stabilized by the protein synaptopodin, which can be subject to harm from calcineurin. But because voclosporin blocks calcineurin, synaptopodin is protected, which consequently protects podocytes and the kidney, Dr. Rovin said.

“There’s a lot of data in the nephrology literature that suggests as you lose podocytes, you actually can develop glomerular sclerosis and loss of renal function,” he said. “In fact, if you lose a critical number of podocytes, then no matter what you do, the kidney is likely to progress to end-stage kidney disease.

“The way I think about it now is, what else do these drugs add? And this idea of preserving the histology of the kidney is really important, and this can be done with voclosporin,” Dr. Rovin said.

Belimumab is also hailed as an effective tool, particularly for the prevention of flares. In the trial leading to its approval), just under 16% of patients experienced a renal-related event or death over 2 years, compared with 28% of the group that received placebo. Those receiving belimumab had a 50% greater chance of reaching the primary efficacy renal response, which was defined as a ratio of urinary protein to creatinine of 0.7 or less, an estimated glomerular filtration rate that was no worse than 20% below the pre-flare value or at least 60 mL/min per 1.73 m², and no use of rescue therapy for treatment failure.

The endpoints in the belimumab lupus nephritis trial were “quite rigorous,” Richard A. Furie, MD, said in the same session at the meeting. Patients with class V lupus nephritis were included in the trial, although disease of this severity is known to be particularly difficult to treat, he noted.

“There’s little question that our patients with lupus nephritis will benefit from such a therapeutic approach” with belimumab and mycophenolate, said Dr. Furie, professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, in Hempstead, N.Y. “But regardless of which combination clinicians use, we are making advances, and that means better outcomes for our patients with lupus and lupus nephritis.”

Graciela Alarcon, MD, MPH, professor emeritus of medicine at the University of Alabama at Birmingham, who moderated the discussion, said there is no sure answer regarding the best choice for clinicians.

“As long as there’s no head-to-head comparison between the two new compounds, I don’t think that the question can be answered,” she said.

Indeed, the answer for many clinicians might be that for certain patients, dual therapy isn’t necessary, Dr. Furie said.

“The fundamental question, before we choose the second drug, is whether a second drug should be chosen,” he said. “There’s a lot of people in the community who are just sticking to the old-fashioned algorithm and that is just choosing one drug, like mycophenolate. ... Others might pick a second drug, but not until they see that mycophenolate is not doing an effective job.”

All agreed that the response rates are still not optimal for patients with lupus nephritis, even with these new combinations – they are still only in the 30%-40% range.

“We haven’t really boosted the response rate to where we want it to be, at least as measured by our current measurements and composite renal response,” Dr. Rovin said.

With voclosporin’s protective effects and belimumab’s flare prevention, the two could potentially be used together at some point, he suggested.

“I think these two drugs show us the possibility that we might use them together and get rid of the older drugs, and really minimize the older drugs and then use them on a longer-term basis to preserve kidney function, as well as keep the lupus in check,” he said.

A version of this article first appeared on Medscape.com.

With the approval by the Food and Drug Administration of the calcineurin inhibitor voclosporin (Lupkynis) in January and belimumab (Benlysta) a month before that, clinicians now have new options for treating lupus nephritis in combination with a background immunosuppressive agent, such as mycophenolate mofetil.

But which combination should clinicians choose?

Brad Rovin, MD, a nephrologist with the Ohio State University Wexner Medical Center, Columbus, who worked on the phase 3 voclosprin trial, pointed to that drug’s fast reduction in proteinuria in a session of the Pan American League of Associations for Rheumatology (PANLAR) 2021 Annual Meeting. That effect on proteinuria is likely due to its effect on podocytes, special epithelial cells that cover the outside of capillaries in the kidney, he said.

These crucial cells have an elaborate cytoskeleton that is stabilized by the protein synaptopodin, which can be subject to harm from calcineurin. But because voclosporin blocks calcineurin, synaptopodin is protected, which consequently protects podocytes and the kidney, Dr. Rovin said.

“There’s a lot of data in the nephrology literature that suggests as you lose podocytes, you actually can develop glomerular sclerosis and loss of renal function,” he said. “In fact, if you lose a critical number of podocytes, then no matter what you do, the kidney is likely to progress to end-stage kidney disease.

“The way I think about it now is, what else do these drugs add? And this idea of preserving the histology of the kidney is really important, and this can be done with voclosporin,” Dr. Rovin said.

Belimumab is also hailed as an effective tool, particularly for the prevention of flares. In the trial leading to its approval), just under 16% of patients experienced a renal-related event or death over 2 years, compared with 28% of the group that received placebo. Those receiving belimumab had a 50% greater chance of reaching the primary efficacy renal response, which was defined as a ratio of urinary protein to creatinine of 0.7 or less, an estimated glomerular filtration rate that was no worse than 20% below the pre-flare value or at least 60 mL/min per 1.73 m², and no use of rescue therapy for treatment failure.

The endpoints in the belimumab lupus nephritis trial were “quite rigorous,” Richard A. Furie, MD, said in the same session at the meeting. Patients with class V lupus nephritis were included in the trial, although disease of this severity is known to be particularly difficult to treat, he noted.

“There’s little question that our patients with lupus nephritis will benefit from such a therapeutic approach” with belimumab and mycophenolate, said Dr. Furie, professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, in Hempstead, N.Y. “But regardless of which combination clinicians use, we are making advances, and that means better outcomes for our patients with lupus and lupus nephritis.”

Graciela Alarcon, MD, MPH, professor emeritus of medicine at the University of Alabama at Birmingham, who moderated the discussion, said there is no sure answer regarding the best choice for clinicians.

“As long as there’s no head-to-head comparison between the two new compounds, I don’t think that the question can be answered,” she said.

Indeed, the answer for many clinicians might be that for certain patients, dual therapy isn’t necessary, Dr. Furie said.

“The fundamental question, before we choose the second drug, is whether a second drug should be chosen,” he said. “There’s a lot of people in the community who are just sticking to the old-fashioned algorithm and that is just choosing one drug, like mycophenolate. ... Others might pick a second drug, but not until they see that mycophenolate is not doing an effective job.”

All agreed that the response rates are still not optimal for patients with lupus nephritis, even with these new combinations – they are still only in the 30%-40% range.

“We haven’t really boosted the response rate to where we want it to be, at least as measured by our current measurements and composite renal response,” Dr. Rovin said.

With voclosporin’s protective effects and belimumab’s flare prevention, the two could potentially be used together at some point, he suggested.

“I think these two drugs show us the possibility that we might use them together and get rid of the older drugs, and really minimize the older drugs and then use them on a longer-term basis to preserve kidney function, as well as keep the lupus in check,” he said.

A version of this article first appeared on Medscape.com.

With the approval by the Food and Drug Administration of the calcineurin inhibitor voclosporin (Lupkynis) in January and belimumab (Benlysta) a month before that, clinicians now have new options for treating lupus nephritis in combination with a background immunosuppressive agent, such as mycophenolate mofetil.

But which combination should clinicians choose?

Brad Rovin, MD, a nephrologist with the Ohio State University Wexner Medical Center, Columbus, who worked on the phase 3 voclosprin trial, pointed to that drug’s fast reduction in proteinuria in a session of the Pan American League of Associations for Rheumatology (PANLAR) 2021 Annual Meeting. That effect on proteinuria is likely due to its effect on podocytes, special epithelial cells that cover the outside of capillaries in the kidney, he said.

These crucial cells have an elaborate cytoskeleton that is stabilized by the protein synaptopodin, which can be subject to harm from calcineurin. But because voclosporin blocks calcineurin, synaptopodin is protected, which consequently protects podocytes and the kidney, Dr. Rovin said.

“There’s a lot of data in the nephrology literature that suggests as you lose podocytes, you actually can develop glomerular sclerosis and loss of renal function,” he said. “In fact, if you lose a critical number of podocytes, then no matter what you do, the kidney is likely to progress to end-stage kidney disease.

“The way I think about it now is, what else do these drugs add? And this idea of preserving the histology of the kidney is really important, and this can be done with voclosporin,” Dr. Rovin said.

Belimumab is also hailed as an effective tool, particularly for the prevention of flares. In the trial leading to its approval), just under 16% of patients experienced a renal-related event or death over 2 years, compared with 28% of the group that received placebo. Those receiving belimumab had a 50% greater chance of reaching the primary efficacy renal response, which was defined as a ratio of urinary protein to creatinine of 0.7 or less, an estimated glomerular filtration rate that was no worse than 20% below the pre-flare value or at least 60 mL/min per 1.73 m², and no use of rescue therapy for treatment failure.

The endpoints in the belimumab lupus nephritis trial were “quite rigorous,” Richard A. Furie, MD, said in the same session at the meeting. Patients with class V lupus nephritis were included in the trial, although disease of this severity is known to be particularly difficult to treat, he noted.

“There’s little question that our patients with lupus nephritis will benefit from such a therapeutic approach” with belimumab and mycophenolate, said Dr. Furie, professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, in Hempstead, N.Y. “But regardless of which combination clinicians use, we are making advances, and that means better outcomes for our patients with lupus and lupus nephritis.”

Graciela Alarcon, MD, MPH, professor emeritus of medicine at the University of Alabama at Birmingham, who moderated the discussion, said there is no sure answer regarding the best choice for clinicians.

“As long as there’s no head-to-head comparison between the two new compounds, I don’t think that the question can be answered,” she said.

Indeed, the answer for many clinicians might be that for certain patients, dual therapy isn’t necessary, Dr. Furie said.

“The fundamental question, before we choose the second drug, is whether a second drug should be chosen,” he said. “There’s a lot of people in the community who are just sticking to the old-fashioned algorithm and that is just choosing one drug, like mycophenolate. ... Others might pick a second drug, but not until they see that mycophenolate is not doing an effective job.”

All agreed that the response rates are still not optimal for patients with lupus nephritis, even with these new combinations – they are still only in the 30%-40% range.

“We haven’t really boosted the response rate to where we want it to be, at least as measured by our current measurements and composite renal response,” Dr. Rovin said.

With voclosporin’s protective effects and belimumab’s flare prevention, the two could potentially be used together at some point, he suggested.

“I think these two drugs show us the possibility that we might use them together and get rid of the older drugs, and really minimize the older drugs and then use them on a longer-term basis to preserve kidney function, as well as keep the lupus in check,” he said.

A version of this article first appeared on Medscape.com.

New efforts – including the development of drugs that target mitochondrial pathways and others that target androgen receptors selectively – are underway for treating sarcopenia in rheumatic diseases, but so far the results have been mixed, an expert said at the Pan American League of Associations for Rheumatology (PANLAR) 2021 Annual Meeting, held recently as a virtual event.

Addressing the problem of reduced muscle mass – experienced by many patients with rheumatic diseases, owing in part to the processes of inflammation and to pain interfering with exercise – is bound to help with outcomes, inasmuch as lean mass and fat mass are linked with disability and early mortality, said Joshua Baker, MD, associate professor of medicine at the University of Pennsylvania, Philadelphia.

Elamipretide, which works by stabilizing mitochondrial pathways that are disrupted in people with sarcopenia, in particular those with mitochondrial disorders, might be the most promising of the therapies being developed. In a study published last year, patients with mitochondrial myopathy experienced significant improvement in gait speed, fatigue, and physical function after 4 weeks, Dr. Baker said.

It’s “an interesting and exciting approach that we need to see more studies about in the future,” he said.

Studies of selective androgen receptor modulators (SARMs), which are similar to anabolic steroids but only target certain androgen receptors so as to prevent side effects, have been a letdown, Dr. Baker said. The idea with SARMs is to enhance growth of certain tissue, such as muscle, without causing side effects in other tissues. Previous trials found that although this approach increased muscle mass, it didn’t produce improvements in measures of physical function.

A myostatin/activin type II receptor blocker, bimagrumab, was recently found to boost lean mass but without improvement in physical function or gait speed.

Still, the focus on improving sarcopenia is an encouraging development, Dr. Baker said.

“New therapies are in the pipeline, and let’s be optimistic and hope that in the future we’ll have lots of options for these patients,” he said.

For now, resistance training remains the best way to tackle the problem. However, the need to have access to trainers, equipment, and gyms, as well as the presence of comorbidities, can make exercise difficult, he said. In addition, routine nutritional supplements, such as with vitamin D, have not been found to improve outcomes, he noted.

The sheer number of people with sarcopenia should make the search for better inventions a priority, suggested Maria Lorena Brance, MD, PhD, professor of medicine at the National University of Rosario, Argentina.

“Prevalence of sarcopenia is very high in autoimmune disease, with representation between 20% and 30%, depending on the pathology,” she said. “So it’s very important to study the presence of sarcopenia.”

Identifying the problem – by first noticing symptoms and then confirming with tests of muscle strength, such as grip tests – would be a big step, the panelists said. Dr. Baker said that among patients with obesity, sarcopenia is more likely to be overlooked, because such patients might not be weak in an absolute sense but might be weak relative to their size.

Dr. Brance said that it’s important to differentiate the value of vitamin D for someone with normal levels in comparison with someone who has a deficiency. Although evidence does not support the use of vitamin D supplements across the board, supplements have been shown to be helpful for patients with low vitamin D levels, she said.

Xavier Ricardo, MD, PhD, professor at Federal University of Rio Grande, Brazil, suggested that sarcopenia may differ from what meets the eye. At his hospital, researchers are studying sarcopenia in patients with systemic sclerosis and have found that in about 20% to 25% of patients, it is present in levels similar to those that occur in patients with rheumatoid arthritis. Researchers are now examining tissue from biopsies to see whether there are differences between the two conditions in the processes of muscle wasting.

“So far, we’re a little bit surprised,” he said. “We expected to have more sarcopenia in these patients, because they do look more frail, more cachexic sometimes.”

Dr. Baker has received consulting fees from Bristol-Myers Squibb, Burns-White, and Gilead. Dr. Ricardo has received consulting fees, speaker fees, or both from AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer, Roche, and UCB. Dr. Brance has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

New efforts – including the development of drugs that target mitochondrial pathways and others that target androgen receptors selectively – are underway for treating sarcopenia in rheumatic diseases, but so far the results have been mixed, an expert said at the Pan American League of Associations for Rheumatology (PANLAR) 2021 Annual Meeting, held recently as a virtual event.

Addressing the problem of reduced muscle mass – experienced by many patients with rheumatic diseases, owing in part to the processes of inflammation and to pain interfering with exercise – is bound to help with outcomes, inasmuch as lean mass and fat mass are linked with disability and early mortality, said Joshua Baker, MD, associate professor of medicine at the University of Pennsylvania, Philadelphia.

Elamipretide, which works by stabilizing mitochondrial pathways that are disrupted in people with sarcopenia, in particular those with mitochondrial disorders, might be the most promising of the therapies being developed. In a study published last year, patients with mitochondrial myopathy experienced significant improvement in gait speed, fatigue, and physical function after 4 weeks, Dr. Baker said.

It’s “an interesting and exciting approach that we need to see more studies about in the future,” he said.

Studies of selective androgen receptor modulators (SARMs), which are similar to anabolic steroids but only target certain androgen receptors so as to prevent side effects, have been a letdown, Dr. Baker said. The idea with SARMs is to enhance growth of certain tissue, such as muscle, without causing side effects in other tissues. Previous trials found that although this approach increased muscle mass, it didn’t produce improvements in measures of physical function.

A myostatin/activin type II receptor blocker, bimagrumab, was recently found to boost lean mass but without improvement in physical function or gait speed.

Still, the focus on improving sarcopenia is an encouraging development, Dr. Baker said.

“New therapies are in the pipeline, and let’s be optimistic and hope that in the future we’ll have lots of options for these patients,” he said.

For now, resistance training remains the best way to tackle the problem. However, the need to have access to trainers, equipment, and gyms, as well as the presence of comorbidities, can make exercise difficult, he said. In addition, routine nutritional supplements, such as with vitamin D, have not been found to improve outcomes, he noted.

The sheer number of people with sarcopenia should make the search for better inventions a priority, suggested Maria Lorena Brance, MD, PhD, professor of medicine at the National University of Rosario, Argentina.

“Prevalence of sarcopenia is very high in autoimmune disease, with representation between 20% and 30%, depending on the pathology,” she said. “So it’s very important to study the presence of sarcopenia.”

Identifying the problem – by first noticing symptoms and then confirming with tests of muscle strength, such as grip tests – would be a big step, the panelists said. Dr. Baker said that among patients with obesity, sarcopenia is more likely to be overlooked, because such patients might not be weak in an absolute sense but might be weak relative to their size.

Dr. Brance said that it’s important to differentiate the value of vitamin D for someone with normal levels in comparison with someone who has a deficiency. Although evidence does not support the use of vitamin D supplements across the board, supplements have been shown to be helpful for patients with low vitamin D levels, she said.

Xavier Ricardo, MD, PhD, professor at Federal University of Rio Grande, Brazil, suggested that sarcopenia may differ from what meets the eye. At his hospital, researchers are studying sarcopenia in patients with systemic sclerosis and have found that in about 20% to 25% of patients, it is present in levels similar to those that occur in patients with rheumatoid arthritis. Researchers are now examining tissue from biopsies to see whether there are differences between the two conditions in the processes of muscle wasting.

“So far, we’re a little bit surprised,” he said. “We expected to have more sarcopenia in these patients, because they do look more frail, more cachexic sometimes.”

Dr. Baker has received consulting fees from Bristol-Myers Squibb, Burns-White, and Gilead. Dr. Ricardo has received consulting fees, speaker fees, or both from AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer, Roche, and UCB. Dr. Brance has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

New efforts – including the development of drugs that target mitochondrial pathways and others that target androgen receptors selectively – are underway for treating sarcopenia in rheumatic diseases, but so far the results have been mixed, an expert said at the Pan American League of Associations for Rheumatology (PANLAR) 2021 Annual Meeting, held recently as a virtual event.

Addressing the problem of reduced muscle mass – experienced by many patients with rheumatic diseases, owing in part to the processes of inflammation and to pain interfering with exercise – is bound to help with outcomes, inasmuch as lean mass and fat mass are linked with disability and early mortality, said Joshua Baker, MD, associate professor of medicine at the University of Pennsylvania, Philadelphia.

Elamipretide, which works by stabilizing mitochondrial pathways that are disrupted in people with sarcopenia, in particular those with mitochondrial disorders, might be the most promising of the therapies being developed. In a study published last year, patients with mitochondrial myopathy experienced significant improvement in gait speed, fatigue, and physical function after 4 weeks, Dr. Baker said.

It’s “an interesting and exciting approach that we need to see more studies about in the future,” he said.

Studies of selective androgen receptor modulators (SARMs), which are similar to anabolic steroids but only target certain androgen receptors so as to prevent side effects, have been a letdown, Dr. Baker said. The idea with SARMs is to enhance growth of certain tissue, such as muscle, without causing side effects in other tissues. Previous trials found that although this approach increased muscle mass, it didn’t produce improvements in measures of physical function.

A myostatin/activin type II receptor blocker, bimagrumab, was recently found to boost lean mass but without improvement in physical function or gait speed.

Still, the focus on improving sarcopenia is an encouraging development, Dr. Baker said.

“New therapies are in the pipeline, and let’s be optimistic and hope that in the future we’ll have lots of options for these patients,” he said.

For now, resistance training remains the best way to tackle the problem. However, the need to have access to trainers, equipment, and gyms, as well as the presence of comorbidities, can make exercise difficult, he said. In addition, routine nutritional supplements, such as with vitamin D, have not been found to improve outcomes, he noted.

The sheer number of people with sarcopenia should make the search for better inventions a priority, suggested Maria Lorena Brance, MD, PhD, professor of medicine at the National University of Rosario, Argentina.

“Prevalence of sarcopenia is very high in autoimmune disease, with representation between 20% and 30%, depending on the pathology,” she said. “So it’s very important to study the presence of sarcopenia.”

Identifying the problem – by first noticing symptoms and then confirming with tests of muscle strength, such as grip tests – would be a big step, the panelists said. Dr. Baker said that among patients with obesity, sarcopenia is more likely to be overlooked, because such patients might not be weak in an absolute sense but might be weak relative to their size.

Dr. Brance said that it’s important to differentiate the value of vitamin D for someone with normal levels in comparison with someone who has a deficiency. Although evidence does not support the use of vitamin D supplements across the board, supplements have been shown to be helpful for patients with low vitamin D levels, she said.

Xavier Ricardo, MD, PhD, professor at Federal University of Rio Grande, Brazil, suggested that sarcopenia may differ from what meets the eye. At his hospital, researchers are studying sarcopenia in patients with systemic sclerosis and have found that in about 20% to 25% of patients, it is present in levels similar to those that occur in patients with rheumatoid arthritis. Researchers are now examining tissue from biopsies to see whether there are differences between the two conditions in the processes of muscle wasting.

“So far, we’re a little bit surprised,” he said. “We expected to have more sarcopenia in these patients, because they do look more frail, more cachexic sometimes.”

Dr. Baker has received consulting fees from Bristol-Myers Squibb, Burns-White, and Gilead. Dr. Ricardo has received consulting fees, speaker fees, or both from AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer, Roche, and UCB. Dr. Brance has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A third dose of a COVID-19 vaccine can boost antibody levels in people who previously received a solid organ transplant and had an unsatisfactory response to their first two mRNA shots, according to data from a newly published 30-patient case series.

All of those with low titers before the third dose had high titers after receiving the additional shot, but only about 33% of those with negative initial responses had detectable antibodies after the third dose, according to the paper, published in Annals of Internal Medicine.

Researchers at Johns Hopkins, Baltimore, who keep a COVID-19 vaccine registry, perform antibody tests on all registry subjects and inform them of their results. Registry participants were asked to inform the research team if they received a third dose, and, the research team tracked the immune responses of those who did.

The participants in this case series had low antibody levels and received a third dose of the vaccine on their own between March 20 and May 10 of 2021.
 

Third dose results

In this cases series – thought to be the first to look at third vaccine shots in this type of patient group – all six of those who had low antibody titers before the third dose had high-positive titers after the third dose.

Of the 24 individuals who had negative antibody titers before the third dose, just 6 had high titers after the third dose.

Two of the participants had low-positive titers, and 16 were negative.

“Several of those boosted very nicely into ranges seen, using these assays, in healthy persons,” said William Werbel, MD, a fellow in infectious disease at Johns Hopkins Medicine, Baltimore, who helped lead the study. Those with negative levels, even if they responded, tended to have lower titers, he said.

“The benefits at least from an antibody perspective were not the same for everybody and so this is obviously something that needs to be considered when thinking about selecting patients” for a COVID-19 prevention strategy, he said.

Reactions to the vaccine were low to moderate, such as some arm pain and fatigue.

“Showing that something is safe in that special, vulnerable population is important,” Dr. Werbel said. “We’re all wanting to make sure that we’re doing no harm.”

Dr. Werbel noted that there was no pattern in the small series based on the organ transplanted or in the vaccines used. As their third shot, 15 of the patients received the Johnson & Johnson vaccine; 9 received Moderna; and 6 received Pfizer-BioNTech.
 

Welcome news, but larger studies needed

“To think that a third dose could confer protection for a significant number of people is of course extremely welcome news,” said Christian Larsen, MD, DPhil, professor of surgery in the transplantation division at Emory University, Atlanta, who was not involved in the study. “It’s the easiest conceivable next intervention.”

He added, “We just want studies to confirm that – larger studies.”

Dr. Werbel stressed the importance of looking at third doses in these patients in a more controlled fashion in a randomized trial, to more carefully monitor safety and how patients fare when starting with one type of vaccine and switching to another, for example.

Richard Wender, MD, chair of family medicine and community health at the University of Pennsylvania, Philadelphia, said the findings are a reminder that there is still a lot that is unknown about COVID-19 and vaccination.

“We still don’t know who will or will not benefit from a third dose,” he said. “And our knowledge is evolving.  For example, a recent study suggested that people with previous infection and who are vaccinated may have better and longer protection than people with vaccination alone. We’re still learning.”

He added that specialists, not primary care clinicians, should be relied upon to respond to this emerging vaccination data. Primary care doctors are very busy in other ways – such as in getting children caught up on vaccinations and helping adults return to managing their chronic diseases, Dr. Wender noted.

“Their focus needs to be on helping to overcome hesitancy, mistrust, lack of information, or antivaccination sentiment to help more people feel comfortable being vaccinated – this is a lot of work and needs constant focus. In short, primary care clinicians need to focus chiefly on the unvaccinated,” he said.

“Monitoring immunization recommendations for unique at-risk populations should be the chief responsibility of teams providing subspecialty care, [such as for] transplant patients, people with chronic kidney disease, cancer patients, and people with other chronic illnesses.  This will allow primary care clinicians to tackle their many complex jobs.”
 

Possible solutions for those with low antibody responses

Dr. Larsen said that those with ongoing low antibody responses might still have other immune responses, such as a T-cell response. Such patients also could consider changing their vaccine type, he said.

“At the more significant intervention level, there may be circumstances where one could change the immunosuppressive drugs in a controlled way that might allow a better response,” suggested Dr. Larsen. “That’s obviously going to be something that requires a lot more thought and careful study.”

Dr. Werbel said that other options might need to be considered for those having no response following a third dose. One possibility is trying a vaccine with an adjuvant, such as the Novavax version, which might be more widely available soon.

“If you’re given a third dose of a very immunogenic vaccine – something that should work – and you just have no antibody development, it seems relatively unlikely that doing the same thing again is going to help you from that perspective, and for all we know might expose you to more risk,” Dr. Werbel noted.
 

Participant details

None of the 30 patients were thought to have ever had COVID-19. On average, patients had received their transplant 4.5 years before their original vaccination. In 25 patients, maintenance immunosuppression included tacrolimus or cyclosporine along with mycophenolate. Corticosteroids were also used for 24 patients, sirolimus was used for one patient, and belatacept was used for another patient.

Fifty-seven percent of patients had received the Pfizer/BioNTech vaccine originally, and 43% the Moderna vaccine. Most of the patients were kidney recipients, with two heart, three liver, one lung, one pancreas and one kidney-pancreas.

Dr. Werbel, Dr. Wender, and Dr. Larsen reported no relevant disclosures.

A third dose of a COVID-19 vaccine can boost antibody levels in people who previously received a solid organ transplant and had an unsatisfactory response to their first two mRNA shots, according to data from a newly published 30-patient case series.

All of those with low titers before the third dose had high titers after receiving the additional shot, but only about 33% of those with negative initial responses had detectable antibodies after the third dose, according to the paper, published in Annals of Internal Medicine.

Researchers at Johns Hopkins, Baltimore, who keep a COVID-19 vaccine registry, perform antibody tests on all registry subjects and inform them of their results. Registry participants were asked to inform the research team if they received a third dose, and, the research team tracked the immune responses of those who did.

The participants in this case series had low antibody levels and received a third dose of the vaccine on their own between March 20 and May 10 of 2021.
 

Third dose results

In this cases series – thought to be the first to look at third vaccine shots in this type of patient group – all six of those who had low antibody titers before the third dose had high-positive titers after the third dose.

Of the 24 individuals who had negative antibody titers before the third dose, just 6 had high titers after the third dose.

Two of the participants had low-positive titers, and 16 were negative.

“Several of those boosted very nicely into ranges seen, using these assays, in healthy persons,” said William Werbel, MD, a fellow in infectious disease at Johns Hopkins Medicine, Baltimore, who helped lead the study. Those with negative levels, even if they responded, tended to have lower titers, he said.

“The benefits at least from an antibody perspective were not the same for everybody and so this is obviously something that needs to be considered when thinking about selecting patients” for a COVID-19 prevention strategy, he said.

Reactions to the vaccine were low to moderate, such as some arm pain and fatigue.

“Showing that something is safe in that special, vulnerable population is important,” Dr. Werbel said. “We’re all wanting to make sure that we’re doing no harm.”

Dr. Werbel noted that there was no pattern in the small series based on the organ transplanted or in the vaccines used. As their third shot, 15 of the patients received the Johnson & Johnson vaccine; 9 received Moderna; and 6 received Pfizer-BioNTech.
 

Welcome news, but larger studies needed

“To think that a third dose could confer protection for a significant number of people is of course extremely welcome news,” said Christian Larsen, MD, DPhil, professor of surgery in the transplantation division at Emory University, Atlanta, who was not involved in the study. “It’s the easiest conceivable next intervention.”

He added, “We just want studies to confirm that – larger studies.”

Dr. Werbel stressed the importance of looking at third doses in these patients in a more controlled fashion in a randomized trial, to more carefully monitor safety and how patients fare when starting with one type of vaccine and switching to another, for example.

Richard Wender, MD, chair of family medicine and community health at the University of Pennsylvania, Philadelphia, said the findings are a reminder that there is still a lot that is unknown about COVID-19 and vaccination.

“We still don’t know who will or will not benefit from a third dose,” he said. “And our knowledge is evolving.  For example, a recent study suggested that people with previous infection and who are vaccinated may have better and longer protection than people with vaccination alone. We’re still learning.”

He added that specialists, not primary care clinicians, should be relied upon to respond to this emerging vaccination data. Primary care doctors are very busy in other ways – such as in getting children caught up on vaccinations and helping adults return to managing their chronic diseases, Dr. Wender noted.

“Their focus needs to be on helping to overcome hesitancy, mistrust, lack of information, or antivaccination sentiment to help more people feel comfortable being vaccinated – this is a lot of work and needs constant focus. In short, primary care clinicians need to focus chiefly on the unvaccinated,” he said.

“Monitoring immunization recommendations for unique at-risk populations should be the chief responsibility of teams providing subspecialty care, [such as for] transplant patients, people with chronic kidney disease, cancer patients, and people with other chronic illnesses.  This will allow primary care clinicians to tackle their many complex jobs.”
 

Possible solutions for those with low antibody responses

Dr. Larsen said that those with ongoing low antibody responses might still have other immune responses, such as a T-cell response. Such patients also could consider changing their vaccine type, he said.

“At the more significant intervention level, there may be circumstances where one could change the immunosuppressive drugs in a controlled way that might allow a better response,” suggested Dr. Larsen. “That’s obviously going to be something that requires a lot more thought and careful study.”

Dr. Werbel said that other options might need to be considered for those having no response following a third dose. One possibility is trying a vaccine with an adjuvant, such as the Novavax version, which might be more widely available soon.

“If you’re given a third dose of a very immunogenic vaccine – something that should work – and you just have no antibody development, it seems relatively unlikely that doing the same thing again is going to help you from that perspective, and for all we know might expose you to more risk,” Dr. Werbel noted.
 

Participant details

None of the 30 patients were thought to have ever had COVID-19. On average, patients had received their transplant 4.5 years before their original vaccination. In 25 patients, maintenance immunosuppression included tacrolimus or cyclosporine along with mycophenolate. Corticosteroids were also used for 24 patients, sirolimus was used for one patient, and belatacept was used for another patient.

Fifty-seven percent of patients had received the Pfizer/BioNTech vaccine originally, and 43% the Moderna vaccine. Most of the patients were kidney recipients, with two heart, three liver, one lung, one pancreas and one kidney-pancreas.

Dr. Werbel, Dr. Wender, and Dr. Larsen reported no relevant disclosures.

A third dose of a COVID-19 vaccine can boost antibody levels in people who previously received a solid organ transplant and had an unsatisfactory response to their first two mRNA shots, according to data from a newly published 30-patient case series.

All of those with low titers before the third dose had high titers after receiving the additional shot, but only about 33% of those with negative initial responses had detectable antibodies after the third dose, according to the paper, published in Annals of Internal Medicine.

Researchers at Johns Hopkins, Baltimore, who keep a COVID-19 vaccine registry, perform antibody tests on all registry subjects and inform them of their results. Registry participants were asked to inform the research team if they received a third dose, and, the research team tracked the immune responses of those who did.

The participants in this case series had low antibody levels and received a third dose of the vaccine on their own between March 20 and May 10 of 2021.
 

Third dose results

In this cases series – thought to be the first to look at third vaccine shots in this type of patient group – all six of those who had low antibody titers before the third dose had high-positive titers after the third dose.

Of the 24 individuals who had negative antibody titers before the third dose, just 6 had high titers after the third dose.

Two of the participants had low-positive titers, and 16 were negative.

“Several of those boosted very nicely into ranges seen, using these assays, in healthy persons,” said William Werbel, MD, a fellow in infectious disease at Johns Hopkins Medicine, Baltimore, who helped lead the study. Those with negative levels, even if they responded, tended to have lower titers, he said.

“The benefits at least from an antibody perspective were not the same for everybody and so this is obviously something that needs to be considered when thinking about selecting patients” for a COVID-19 prevention strategy, he said.

Reactions to the vaccine were low to moderate, such as some arm pain and fatigue.

“Showing that something is safe in that special, vulnerable population is important,” Dr. Werbel said. “We’re all wanting to make sure that we’re doing no harm.”

Dr. Werbel noted that there was no pattern in the small series based on the organ transplanted or in the vaccines used. As their third shot, 15 of the patients received the Johnson & Johnson vaccine; 9 received Moderna; and 6 received Pfizer-BioNTech.
 

Welcome news, but larger studies needed

“To think that a third dose could confer protection for a significant number of people is of course extremely welcome news,” said Christian Larsen, MD, DPhil, professor of surgery in the transplantation division at Emory University, Atlanta, who was not involved in the study. “It’s the easiest conceivable next intervention.”

He added, “We just want studies to confirm that – larger studies.”

Dr. Werbel stressed the importance of looking at third doses in these patients in a more controlled fashion in a randomized trial, to more carefully monitor safety and how patients fare when starting with one type of vaccine and switching to another, for example.

Richard Wender, MD, chair of family medicine and community health at the University of Pennsylvania, Philadelphia, said the findings are a reminder that there is still a lot that is unknown about COVID-19 and vaccination.

“We still don’t know who will or will not benefit from a third dose,” he said. “And our knowledge is evolving.  For example, a recent study suggested that people with previous infection and who are vaccinated may have better and longer protection than people with vaccination alone. We’re still learning.”

He added that specialists, not primary care clinicians, should be relied upon to respond to this emerging vaccination data. Primary care doctors are very busy in other ways – such as in getting children caught up on vaccinations and helping adults return to managing their chronic diseases, Dr. Wender noted.

“Their focus needs to be on helping to overcome hesitancy, mistrust, lack of information, or antivaccination sentiment to help more people feel comfortable being vaccinated – this is a lot of work and needs constant focus. In short, primary care clinicians need to focus chiefly on the unvaccinated,” he said.

“Monitoring immunization recommendations for unique at-risk populations should be the chief responsibility of teams providing subspecialty care, [such as for] transplant patients, people with chronic kidney disease, cancer patients, and people with other chronic illnesses.  This will allow primary care clinicians to tackle their many complex jobs.”
 

Possible solutions for those with low antibody responses

Dr. Larsen said that those with ongoing low antibody responses might still have other immune responses, such as a T-cell response. Such patients also could consider changing their vaccine type, he said.

“At the more significant intervention level, there may be circumstances where one could change the immunosuppressive drugs in a controlled way that might allow a better response,” suggested Dr. Larsen. “That’s obviously going to be something that requires a lot more thought and careful study.”

Dr. Werbel said that other options might need to be considered for those having no response following a third dose. One possibility is trying a vaccine with an adjuvant, such as the Novavax version, which might be more widely available soon.

“If you’re given a third dose of a very immunogenic vaccine – something that should work – and you just have no antibody development, it seems relatively unlikely that doing the same thing again is going to help you from that perspective, and for all we know might expose you to more risk,” Dr. Werbel noted.
 

Participant details

None of the 30 patients were thought to have ever had COVID-19. On average, patients had received their transplant 4.5 years before their original vaccination. In 25 patients, maintenance immunosuppression included tacrolimus or cyclosporine along with mycophenolate. Corticosteroids were also used for 24 patients, sirolimus was used for one patient, and belatacept was used for another patient.

Fifty-seven percent of patients had received the Pfizer/BioNTech vaccine originally, and 43% the Moderna vaccine. Most of the patients were kidney recipients, with two heart, three liver, one lung, one pancreas and one kidney-pancreas.

Dr. Werbel, Dr. Wender, and Dr. Larsen reported no relevant disclosures.

Imagine a hospitalist, part of a group with 35 hospitalists, is in her second year of practice and is caring for a 55-year-old woman with a history of congestive heart failure and cirrhosis from hepatitis C due to heroin use. The patient was hospitalized with acute back pain and found to have vertebral osteomyelitis confirmed on MRI.

The hospitalist calls a surgeon to get a biopsy so that antibiotic therapy can be chosen. The surgeon says it’s the second time the patient has been hospitalized for this condition, and asks, “Why do you need me to see this patient?” He says the hospitalist should just give IV antibiotics and consult infectious disease.

The hospitalist says, “The patient needs this biopsy. I’ll just call your chair.”

In the course of a busy day, conflicts arise all the time in the hospital – between clinicians, between patients and clinicians, and as internal battles when clinicians face uncertain situations. There are ways to make these conflicts less tense and more in tune with patient care, panelists said recently during a session at SHM Converge, the annual conference of the Society of Hospital Medicine.

In the case of vertebral osteomyelitis, for instance, the hospitalist was using a “position-based” strategy to deal with the conflict with the surgeon – she came in knowing she wanted a biopsy – rather than an “interest-based” strategy, or what is in the patient’s interest, said Patrick Rendon, MD, FHM, assistant professor in the hospital medicine division at the University of New Mexico, Albuquerque.

A version of this article first appeared on Medscape.com.

Imagine a hospitalist, part of a group with 35 hospitalists, is in her second year of practice and is caring for a 55-year-old woman with a history of congestive heart failure and cirrhosis from hepatitis C due to heroin use. The patient was hospitalized with acute back pain and found to have vertebral osteomyelitis confirmed on MRI.

The hospitalist calls a surgeon to get a biopsy so that antibiotic therapy can be chosen. The surgeon says it’s the second time the patient has been hospitalized for this condition, and asks, “Why do you need me to see this patient?” He says the hospitalist should just give IV antibiotics and consult infectious disease.

The hospitalist says, “The patient needs this biopsy. I’ll just call your chair.”

In the course of a busy day, conflicts arise all the time in the hospital – between clinicians, between patients and clinicians, and as internal battles when clinicians face uncertain situations. There are ways to make these conflicts less tense and more in tune with patient care, panelists said recently during a session at SHM Converge, the annual conference of the Society of Hospital Medicine.

In the case of vertebral osteomyelitis, for instance, the hospitalist was using a “position-based” strategy to deal with the conflict with the surgeon – she came in knowing she wanted a biopsy – rather than an “interest-based” strategy, or what is in the patient’s interest, said Patrick Rendon, MD, FHM, assistant professor in the hospital medicine division at the University of New Mexico, Albuquerque.

A version of this article first appeared on Medscape.com.

Imagine a hospitalist, part of a group with 35 hospitalists, is in her second year of practice and is caring for a 55-year-old woman with a history of congestive heart failure and cirrhosis from hepatitis C due to heroin use. The patient was hospitalized with acute back pain and found to have vertebral osteomyelitis confirmed on MRI.

The hospitalist calls a surgeon to get a biopsy so that antibiotic therapy can be chosen. The surgeon says it’s the second time the patient has been hospitalized for this condition, and asks, “Why do you need me to see this patient?” He says the hospitalist should just give IV antibiotics and consult infectious disease.

The hospitalist says, “The patient needs this biopsy. I’ll just call your chair.”

In the course of a busy day, conflicts arise all the time in the hospital – between clinicians, between patients and clinicians, and as internal battles when clinicians face uncertain situations. There are ways to make these conflicts less tense and more in tune with patient care, panelists said recently during a session at SHM Converge, the annual conference of the Society of Hospital Medicine.

In the case of vertebral osteomyelitis, for instance, the hospitalist was using a “position-based” strategy to deal with the conflict with the surgeon – she came in knowing she wanted a biopsy – rather than an “interest-based” strategy, or what is in the patient’s interest, said Patrick Rendon, MD, FHM, assistant professor in the hospital medicine division at the University of New Mexico, Albuquerque.

A version of this article first appeared on Medscape.com.

When Marisha Burden, MD, division head of hospital medicine at the University of Colorado at Denver, Aurora, would go to medical conferences, it seemed as if very few women were giving talks. She wondered if she could be wrong.

“I started doing my own assessments at every conference I would go to, just to make sure I wasn’t biased in my own belief system,” she said in a session at SHM Converge 2021, the annual conference of the Society of Hospital Medicine.

She wasn’t wrong.

In 2015, only 35% of all speakers at the SHM annual conference were women, and only 23% of the plenary speakers were women. In the years after that, when the society put out open calls for speakers, the numbers of women who spoke increased substantially, to 47% overall and 45% of plenary speakers.

The results – part of the SPEAK UP study Dr. Burden led in 2020 – show how gender disparity can be improved with a systematic process that is designed to improve it. The results of the study also showed that as the percentages of female speakers increased, the attendee ratings of the sessions did, too.

“You can do these things, and the quality of your conference doesn’t get negatively impacted – and in this case, actually improved,” Dr. Burden said.

That study marked progress toward leveling a traditionally uneven playing field when it comes to men and women in medicine, and the panelists in the session called on the field to use a variety of tools and strategies to continue toward something closer to equality.

Sara Spilseth, MD, MBA, chief of staff at Regions Hospital, in St. Paul, Minn., said it’s well established that although almost 50% of medical school students are women, the percentage shrinks each step from faculty to full professor to dean – of which only 16% are women. She referred to what’s known as the “leaky pipe.”

In what Dr. Spilseth said was one of her favorite studies, researchers in 2015 found that only 13% of clinical department leaders at the top 50 U.S. medical schools were women – they were outnumbered by the percentage of department leaders with mustaches, at 19%, even though mustaches are dwindling in popularity.

“Why does this exist? Why did we end up like this?” Part of the problem is a “respect gap,” she said, pointing to a study on the tendency of women to use the formal title of “doctor” when introducing male colleagues, whereas men who introduce women use that title less than half the time.

The COVID-19 pandemic has only made these disparities worse. Women are responsible for childcare much more frequently than men, Dr. Burden said, although the pandemic has brought caregiving duties to the forefront.

Dr. Spilseth said mentoring can help women navigate the workplace so as to help overcome these disparities. At Regions, the mentoring program is robust.

“Even before a new hire steps foot in the hospital, we have established them with a mentor,” she said. Sponsoring – the “ability of someone with political capital to use it to help colleagues” – can also help boost women’s careers, she said.

Her hospital also has a Women in Medicine Cooperative, which provides a way for women to talk about common struggles and to network.

Flexible work opportunities – working in transitional care units, being a physician advisor, and doing research – can all help boost a career as well, Dr. Spilseth said.

She said that at the University of Colorado, leaders set out to reach salary equity in a year and a half – and “it was a painful, painful process.” They found that different people held different beliefs about how people were paid, which led to a lot of unnecessary stress as they tried to construct a fairer system.

“On the back end of having done that, while it was a rough year and half, it has saved so much time – and I think built a culture of trust and transparency,” she said.

Recruiting in a more thoughtful way can also have a big impact, Dr. Spilseth said. The manner in which people are told about opportunities could exclude people without intending to.

“Are you casting a wide net?” she asked.

Adia Ross, MD, MHA, chief medical officer at Duke Regional Hospital, Durham, N.C., said that even in the face of obvious disparities, women can take steps on their own to boost their careers. She encouraged taking on “stretch assignments,” a project or task that is a bit beyond one’s current comfort level or level of experience or knowledge. “It can be a little scary, and sometimes there are bumps along the way,” she said.

All of these measures, though incremental, are the way to make bigger change, she said. “We want to take small steps but big strides forward.”

A version of this article first appeared on Medscape.com.

When Marisha Burden, MD, division head of hospital medicine at the University of Colorado at Denver, Aurora, would go to medical conferences, it seemed as if very few women were giving talks. She wondered if she could be wrong.

“I started doing my own assessments at every conference I would go to, just to make sure I wasn’t biased in my own belief system,” she said in a session at SHM Converge 2021, the annual conference of the Society of Hospital Medicine.

She wasn’t wrong.

In 2015, only 35% of all speakers at the SHM annual conference were women, and only 23% of the plenary speakers were women. In the years after that, when the society put out open calls for speakers, the numbers of women who spoke increased substantially, to 47% overall and 45% of plenary speakers.

The results – part of the SPEAK UP study Dr. Burden led in 2020 – show how gender disparity can be improved with a systematic process that is designed to improve it. The results of the study also showed that as the percentages of female speakers increased, the attendee ratings of the sessions did, too.

“You can do these things, and the quality of your conference doesn’t get negatively impacted – and in this case, actually improved,” Dr. Burden said.

That study marked progress toward leveling a traditionally uneven playing field when it comes to men and women in medicine, and the panelists in the session called on the field to use a variety of tools and strategies to continue toward something closer to equality.

Sara Spilseth, MD, MBA, chief of staff at Regions Hospital, in St. Paul, Minn., said it’s well established that although almost 50% of medical school students are women, the percentage shrinks each step from faculty to full professor to dean – of which only 16% are women. She referred to what’s known as the “leaky pipe.”

In what Dr. Spilseth said was one of her favorite studies, researchers in 2015 found that only 13% of clinical department leaders at the top 50 U.S. medical schools were women – they were outnumbered by the percentage of department leaders with mustaches, at 19%, even though mustaches are dwindling in popularity.

“Why does this exist? Why did we end up like this?” Part of the problem is a “respect gap,” she said, pointing to a study on the tendency of women to use the formal title of “doctor” when introducing male colleagues, whereas men who introduce women use that title less than half the time.

The COVID-19 pandemic has only made these disparities worse. Women are responsible for childcare much more frequently than men, Dr. Burden said, although the pandemic has brought caregiving duties to the forefront.

Dr. Spilseth said mentoring can help women navigate the workplace so as to help overcome these disparities. At Regions, the mentoring program is robust.

“Even before a new hire steps foot in the hospital, we have established them with a mentor,” she said. Sponsoring – the “ability of someone with political capital to use it to help colleagues” – can also help boost women’s careers, she said.

Her hospital also has a Women in Medicine Cooperative, which provides a way for women to talk about common struggles and to network.

Flexible work opportunities – working in transitional care units, being a physician advisor, and doing research – can all help boost a career as well, Dr. Spilseth said.

She said that at the University of Colorado, leaders set out to reach salary equity in a year and a half – and “it was a painful, painful process.” They found that different people held different beliefs about how people were paid, which led to a lot of unnecessary stress as they tried to construct a fairer system.

“On the back end of having done that, while it was a rough year and half, it has saved so much time – and I think built a culture of trust and transparency,” she said.

Recruiting in a more thoughtful way can also have a big impact, Dr. Spilseth said. The manner in which people are told about opportunities could exclude people without intending to.

“Are you casting a wide net?” she asked.

Adia Ross, MD, MHA, chief medical officer at Duke Regional Hospital, Durham, N.C., said that even in the face of obvious disparities, women can take steps on their own to boost their careers. She encouraged taking on “stretch assignments,” a project or task that is a bit beyond one’s current comfort level or level of experience or knowledge. “It can be a little scary, and sometimes there are bumps along the way,” she said.

All of these measures, though incremental, are the way to make bigger change, she said. “We want to take small steps but big strides forward.”

A version of this article first appeared on Medscape.com.

When Marisha Burden, MD, division head of hospital medicine at the University of Colorado at Denver, Aurora, would go to medical conferences, it seemed as if very few women were giving talks. She wondered if she could be wrong.

“I started doing my own assessments at every conference I would go to, just to make sure I wasn’t biased in my own belief system,” she said in a session at SHM Converge 2021, the annual conference of the Society of Hospital Medicine.

She wasn’t wrong.

In 2015, only 35% of all speakers at the SHM annual conference were women, and only 23% of the plenary speakers were women. In the years after that, when the society put out open calls for speakers, the numbers of women who spoke increased substantially, to 47% overall and 45% of plenary speakers.

The results – part of the SPEAK UP study Dr. Burden led in 2020 – show how gender disparity can be improved with a systematic process that is designed to improve it. The results of the study also showed that as the percentages of female speakers increased, the attendee ratings of the sessions did, too.

“You can do these things, and the quality of your conference doesn’t get negatively impacted – and in this case, actually improved,” Dr. Burden said.

That study marked progress toward leveling a traditionally uneven playing field when it comes to men and women in medicine, and the panelists in the session called on the field to use a variety of tools and strategies to continue toward something closer to equality.

Sara Spilseth, MD, MBA, chief of staff at Regions Hospital, in St. Paul, Minn., said it’s well established that although almost 50% of medical school students are women, the percentage shrinks each step from faculty to full professor to dean – of which only 16% are women. She referred to what’s known as the “leaky pipe.”

In what Dr. Spilseth said was one of her favorite studies, researchers in 2015 found that only 13% of clinical department leaders at the top 50 U.S. medical schools were women – they were outnumbered by the percentage of department leaders with mustaches, at 19%, even though mustaches are dwindling in popularity.

“Why does this exist? Why did we end up like this?” Part of the problem is a “respect gap,” she said, pointing to a study on the tendency of women to use the formal title of “doctor” when introducing male colleagues, whereas men who introduce women use that title less than half the time.

The COVID-19 pandemic has only made these disparities worse. Women are responsible for childcare much more frequently than men, Dr. Burden said, although the pandemic has brought caregiving duties to the forefront.

Dr. Spilseth said mentoring can help women navigate the workplace so as to help overcome these disparities. At Regions, the mentoring program is robust.

“Even before a new hire steps foot in the hospital, we have established them with a mentor,” she said. Sponsoring – the “ability of someone with political capital to use it to help colleagues” – can also help boost women’s careers, she said.

Her hospital also has a Women in Medicine Cooperative, which provides a way for women to talk about common struggles and to network.

Flexible work opportunities – working in transitional care units, being a physician advisor, and doing research – can all help boost a career as well, Dr. Spilseth said.

She said that at the University of Colorado, leaders set out to reach salary equity in a year and a half – and “it was a painful, painful process.” They found that different people held different beliefs about how people were paid, which led to a lot of unnecessary stress as they tried to construct a fairer system.

“On the back end of having done that, while it was a rough year and half, it has saved so much time – and I think built a culture of trust and transparency,” she said.

Recruiting in a more thoughtful way can also have a big impact, Dr. Spilseth said. The manner in which people are told about opportunities could exclude people without intending to.

“Are you casting a wide net?” she asked.

Adia Ross, MD, MHA, chief medical officer at Duke Regional Hospital, Durham, N.C., said that even in the face of obvious disparities, women can take steps on their own to boost their careers. She encouraged taking on “stretch assignments,” a project or task that is a bit beyond one’s current comfort level or level of experience or knowledge. “It can be a little scary, and sometimes there are bumps along the way,” she said.

All of these measures, though incremental, are the way to make bigger change, she said. “We want to take small steps but big strides forward.”

A version of this article first appeared on Medscape.com.

With intensive care units stretched to their limits – and beyond – during the COVID-19 pandemic, hospitalists became more central than ever in orchestrating the response.

At SHM Converge, the annual conference of the Society of Hospital Medicine, two hospitalists shared how their teams helped to develop new critical care units and strategies for best managing and allocating care to COVID patients in the ICU.

“The pandemic has been a selective pressure on us as a specialty,” said Jason Stein, MD, SFHM, a full-time clinical hospitalist at Roper Hospital, a 332-bed facility in Charleston, S.C.

Dr. Stein explained how hospitalists at Roper helped create the Progressive Care Unit – a negative-pressure unit with 12 high-flow oxygen beds overseen by a hospital medicine team, with the help of a respiratory therapist, pharmacist, and nurses. Patients in this unit had escalating acuity – quickly increasing oxygen needs – or deescalating acuity, such as ICU transfers, Dr. Stein said. Cardiac catheterization space was converted for the unit, which was intended to preserve beds in the hospital ICU for patients needing mechanical ventilation or vasoactive medication.

Interdisciplinary rounds – to assess oxygen and inflammatory marker trends, and run through a COVID care checklist – took place every day at 10 a.m.

“Consistency was the key,” Dr. Stein said.

At Weill Cornell Medical Center in New York, hospitalists helped build the COVID Recovery Unit, which was dedicated to the care of patients coming out of the ICU, said Vishwas Anand Singh, MD, MS, FHM, cochief of hospital medicine at New York Presbyterian–Lower Manhattan Hospital.

“The pandemic created an unprecedented need for critical care, and post-ICU care,” Dr. Singh said. “After extubation, patients remain very complicated and they have unique needs.”

The 30-bed COVID Recovery Unit – converted from a behavioral health unit – was designed to meet those needs. It was staffed by one lead hospitalist, 3 hospitalist physicians, 3 advanced practitioners, about 12 nurses and a neurologist, psychiatrist, and neuropsychologist.

The idea was to integrate medical care with careful attention to rehab and neuropsychological needs, Dr. Singh said. To be in the unit, patients had to be medically stable but with ongoing medical and rehabilitation needs and able to tolerate about half an hour of physical or occupational therapy each day.

The space was set up so that patients could interact with each other as well as staff, and this ability to share their experiences of trauma and recovery “led to an improved sense of psychological well-being and to healing,” according to Dr. Singh. Group therapy and meditation were also held several times a week.

“All this together, we thought we were really meeting the need for a lot of these patients from medical to psychosocial,” he said.

New York Presbyterian––Lower Manhattan Hospital also established a program called ICU Outreach to give hospitalists a “bird’s eye view” of the ICU in order to help move patients from unit to unit for optimized care. One hospitalist acted as a bridge between the ICU, the floors, and the emergency room.

The hospitalist on duty touched based with the ICU each day at 10 a.m., assessed the available beds, compiled a list of patients being discharged, met with all of the hospitalists and individual teams in inpatient and emergency services, and compiled a list of “watchers” – the sickest patients who needed help being managed.

The broad perspective was important, Dr. Singh said.

“We quickly found that each individual team or provider only knew the patients they were caring for, and the ICU Outreach person knew the whole big picture and could put the pieces together,” he said. “They could answer who was next in line for a bed, who benefited from a goals of care discussion, who could be managed on the floor with assistance. And this bridge, having this person fill this role, allowed the intensivists to focus on the patients they had in the unit.”
 

Palliative care and patient flow

Dr. Singh also described how hospitalists played an important role in palliative care for COVID patients. The hospital medicine team offered hospitalist palliative care services, which included COVIDtalk, a course on communicating about end of life, which helped to expand the pool of palliative care providers. Those trained were taught that these difficult conversations had to be honest and clear, with the goals of care addressed very early in the admission, should a patient decompensate soon after arrival.

A palliative “rapid response team” included a virtual hospitalist, a palliative care nurse practitioner, and a virtual psychiatrist – a team available 24 hours a day to have longer conversations so that clinicians could better tend to their patients when the in-person palliative care service was stretched thin, or at off hours like the middle of the night.

These innovations not only helped serve patients and families better, but also gave hospitalists training and experience in palliative care.

At Roper Hospital, Dr. Stein explained how hospitalists helped improve management of COVID patient flow. Depending on the time of day and the staffing on duty, there could be considerable confusion about where patients should go after the ED, or the COVID progressive unit, or the floor.

Hospitalists helped develop hospitalwide algorithms for escalating and deescalating acuity, Dr. Stein said, providing a “shared mental model for where a patient should go.”

“There are many ways hospitalists can and did rise to meet the unique demands of COVID,” Dr. Singh said, “whether it was innovating a new unit or service or work flow or leading a multidisciplinary team to extend or support other services that may have been strained.”
 

With intensive care units stretched to their limits – and beyond – during the COVID-19 pandemic, hospitalists became more central than ever in orchestrating the response.

At SHM Converge, the annual conference of the Society of Hospital Medicine, two hospitalists shared how their teams helped to develop new critical care units and strategies for best managing and allocating care to COVID patients in the ICU.

“The pandemic has been a selective pressure on us as a specialty,” said Jason Stein, MD, SFHM, a full-time clinical hospitalist at Roper Hospital, a 332-bed facility in Charleston, S.C.

Dr. Stein explained how hospitalists at Roper helped create the Progressive Care Unit – a negative-pressure unit with 12 high-flow oxygen beds overseen by a hospital medicine team, with the help of a respiratory therapist, pharmacist, and nurses. Patients in this unit had escalating acuity – quickly increasing oxygen needs – or deescalating acuity, such as ICU transfers, Dr. Stein said. Cardiac catheterization space was converted for the unit, which was intended to preserve beds in the hospital ICU for patients needing mechanical ventilation or vasoactive medication.

Interdisciplinary rounds – to assess oxygen and inflammatory marker trends, and run through a COVID care checklist – took place every day at 10 a.m.

“Consistency was the key,” Dr. Stein said.

At Weill Cornell Medical Center in New York, hospitalists helped build the COVID Recovery Unit, which was dedicated to the care of patients coming out of the ICU, said Vishwas Anand Singh, MD, MS, FHM, cochief of hospital medicine at New York Presbyterian–Lower Manhattan Hospital.

“The pandemic created an unprecedented need for critical care, and post-ICU care,” Dr. Singh said. “After extubation, patients remain very complicated and they have unique needs.”

The 30-bed COVID Recovery Unit – converted from a behavioral health unit – was designed to meet those needs. It was staffed by one lead hospitalist, 3 hospitalist physicians, 3 advanced practitioners, about 12 nurses and a neurologist, psychiatrist, and neuropsychologist.

The idea was to integrate medical care with careful attention to rehab and neuropsychological needs, Dr. Singh said. To be in the unit, patients had to be medically stable but with ongoing medical and rehabilitation needs and able to tolerate about half an hour of physical or occupational therapy each day.

The space was set up so that patients could interact with each other as well as staff, and this ability to share their experiences of trauma and recovery “led to an improved sense of psychological well-being and to healing,” according to Dr. Singh. Group therapy and meditation were also held several times a week.

“All this together, we thought we were really meeting the need for a lot of these patients from medical to psychosocial,” he said.

New York Presbyterian––Lower Manhattan Hospital also established a program called ICU Outreach to give hospitalists a “bird’s eye view” of the ICU in order to help move patients from unit to unit for optimized care. One hospitalist acted as a bridge between the ICU, the floors, and the emergency room.

The hospitalist on duty touched based with the ICU each day at 10 a.m., assessed the available beds, compiled a list of patients being discharged, met with all of the hospitalists and individual teams in inpatient and emergency services, and compiled a list of “watchers” – the sickest patients who needed help being managed.

The broad perspective was important, Dr. Singh said.

“We quickly found that each individual team or provider only knew the patients they were caring for, and the ICU Outreach person knew the whole big picture and could put the pieces together,” he said. “They could answer who was next in line for a bed, who benefited from a goals of care discussion, who could be managed on the floor with assistance. And this bridge, having this person fill this role, allowed the intensivists to focus on the patients they had in the unit.”
 

Palliative care and patient flow

Dr. Singh also described how hospitalists played an important role in palliative care for COVID patients. The hospital medicine team offered hospitalist palliative care services, which included COVIDtalk, a course on communicating about end of life, which helped to expand the pool of palliative care providers. Those trained were taught that these difficult conversations had to be honest and clear, with the goals of care addressed very early in the admission, should a patient decompensate soon after arrival.

A palliative “rapid response team” included a virtual hospitalist, a palliative care nurse practitioner, and a virtual psychiatrist – a team available 24 hours a day to have longer conversations so that clinicians could better tend to their patients when the in-person palliative care service was stretched thin, or at off hours like the middle of the night.

These innovations not only helped serve patients and families better, but also gave hospitalists training and experience in palliative care.

At Roper Hospital, Dr. Stein explained how hospitalists helped improve management of COVID patient flow. Depending on the time of day and the staffing on duty, there could be considerable confusion about where patients should go after the ED, or the COVID progressive unit, or the floor.

Hospitalists helped develop hospitalwide algorithms for escalating and deescalating acuity, Dr. Stein said, providing a “shared mental model for where a patient should go.”

“There are many ways hospitalists can and did rise to meet the unique demands of COVID,” Dr. Singh said, “whether it was innovating a new unit or service or work flow or leading a multidisciplinary team to extend or support other services that may have been strained.”
 

With intensive care units stretched to their limits – and beyond – during the COVID-19 pandemic, hospitalists became more central than ever in orchestrating the response.

At SHM Converge, the annual conference of the Society of Hospital Medicine, two hospitalists shared how their teams helped to develop new critical care units and strategies for best managing and allocating care to COVID patients in the ICU.

“The pandemic has been a selective pressure on us as a specialty,” said Jason Stein, MD, SFHM, a full-time clinical hospitalist at Roper Hospital, a 332-bed facility in Charleston, S.C.

Dr. Stein explained how hospitalists at Roper helped create the Progressive Care Unit – a negative-pressure unit with 12 high-flow oxygen beds overseen by a hospital medicine team, with the help of a respiratory therapist, pharmacist, and nurses. Patients in this unit had escalating acuity – quickly increasing oxygen needs – or deescalating acuity, such as ICU transfers, Dr. Stein said. Cardiac catheterization space was converted for the unit, which was intended to preserve beds in the hospital ICU for patients needing mechanical ventilation or vasoactive medication.

Interdisciplinary rounds – to assess oxygen and inflammatory marker trends, and run through a COVID care checklist – took place every day at 10 a.m.

“Consistency was the key,” Dr. Stein said.

At Weill Cornell Medical Center in New York, hospitalists helped build the COVID Recovery Unit, which was dedicated to the care of patients coming out of the ICU, said Vishwas Anand Singh, MD, MS, FHM, cochief of hospital medicine at New York Presbyterian–Lower Manhattan Hospital.

“The pandemic created an unprecedented need for critical care, and post-ICU care,” Dr. Singh said. “After extubation, patients remain very complicated and they have unique needs.”

The 30-bed COVID Recovery Unit – converted from a behavioral health unit – was designed to meet those needs. It was staffed by one lead hospitalist, 3 hospitalist physicians, 3 advanced practitioners, about 12 nurses and a neurologist, psychiatrist, and neuropsychologist.

The idea was to integrate medical care with careful attention to rehab and neuropsychological needs, Dr. Singh said. To be in the unit, patients had to be medically stable but with ongoing medical and rehabilitation needs and able to tolerate about half an hour of physical or occupational therapy each day.

The space was set up so that patients could interact with each other as well as staff, and this ability to share their experiences of trauma and recovery “led to an improved sense of psychological well-being and to healing,” according to Dr. Singh. Group therapy and meditation were also held several times a week.

“All this together, we thought we were really meeting the need for a lot of these patients from medical to psychosocial,” he said.

New York Presbyterian––Lower Manhattan Hospital also established a program called ICU Outreach to give hospitalists a “bird’s eye view” of the ICU in order to help move patients from unit to unit for optimized care. One hospitalist acted as a bridge between the ICU, the floors, and the emergency room.

The hospitalist on duty touched based with the ICU each day at 10 a.m., assessed the available beds, compiled a list of patients being discharged, met with all of the hospitalists and individual teams in inpatient and emergency services, and compiled a list of “watchers” – the sickest patients who needed help being managed.

The broad perspective was important, Dr. Singh said.

“We quickly found that each individual team or provider only knew the patients they were caring for, and the ICU Outreach person knew the whole big picture and could put the pieces together,” he said. “They could answer who was next in line for a bed, who benefited from a goals of care discussion, who could be managed on the floor with assistance. And this bridge, having this person fill this role, allowed the intensivists to focus on the patients they had in the unit.”
 

Palliative care and patient flow

Dr. Singh also described how hospitalists played an important role in palliative care for COVID patients. The hospital medicine team offered hospitalist palliative care services, which included COVIDtalk, a course on communicating about end of life, which helped to expand the pool of palliative care providers. Those trained were taught that these difficult conversations had to be honest and clear, with the goals of care addressed very early in the admission, should a patient decompensate soon after arrival.

A palliative “rapid response team” included a virtual hospitalist, a palliative care nurse practitioner, and a virtual psychiatrist – a team available 24 hours a day to have longer conversations so that clinicians could better tend to their patients when the in-person palliative care service was stretched thin, or at off hours like the middle of the night.

These innovations not only helped serve patients and families better, but also gave hospitalists training and experience in palliative care.

At Roper Hospital, Dr. Stein explained how hospitalists helped improve management of COVID patient flow. Depending on the time of day and the staffing on duty, there could be considerable confusion about where patients should go after the ED, or the COVID progressive unit, or the floor.

Hospitalists helped develop hospitalwide algorithms for escalating and deescalating acuity, Dr. Stein said, providing a “shared mental model for where a patient should go.”

“There are many ways hospitalists can and did rise to meet the unique demands of COVID,” Dr. Singh said, “whether it was innovating a new unit or service or work flow or leading a multidisciplinary team to extend or support other services that may have been strained.”
 

Two experts scoured the medical journals for the practice-changing research most relevant to hospital medicine in 2020 at a recent session at SHM Converge, the annual conference of the Society of Hospital Medicine.

The presenters chose findings they considered either practice changing or practice confirming, and in areas over which hospitalists have at least some control. Here is what they highlighted:
 

IV iron administration before hospital discharge

In a randomized double-blind, placebo-controlled trial across 121 centers in Europe, South America, and Singapore, 1,108 patients hospitalized with acute heart failure and iron deficiency were randomized to receive intravenous ferric carboxymaltose or placebo, with a first dose before discharge and a second at 6 weeks.

Those in the intravenous iron group had a significant reduction in hospitalizations for heart failure up to 52 weeks after randomization, but there was no significant reduction in deaths because of heart failure. There was no difference in serious adverse events.

Anthony Breu, MD, assistant professor of medicine at Harvard Medical School, Boston, said the findings should alter hospitalist practice.

“In patients hospitalized with acute heart failure and left ventricular ejection fraction of less than 50%, check iron studies and start IV iron prior to discharge if they have iron deficiency, with or without anemia,” he said.
 

Apixaban versus dalteparin for venous thromboembolism in cancer

This noninferiority trial involved 1,155 adults with cancer who had symptomatic or incidental acute proximal deep vein thrombosis or pulmonary embolism. The patients were randomized to receive oral apixaban or subcutaneous dalteparin for 6 months.

Patients in the apixaban group had a significantly lower rate of recurrent venous thromboembolism (P = .09), with no increase in major bleeds, Dr. Breu said. He noted that those with brain cancer and leukemia were excluded.

“In patients with cancer and acute venous thromboembolism, consider apixaban as your first-line treatment, with some caveats,” he said.
 

Clinical decision rule for penicillin allergy

With fewer than 10% of patients who report a penicillin allergy actually testing positive on a standard allergy test, a simpler way to predict an allergy would help clinicians, said Shoshana Herzig, MD, MPH, associate professor of medicine at Harvard Medical School.

A 622-patient cohort that had undergone penicillin allergy testing was used to identify factors that could help predict an allergy. A scoring system called PEN-FAST was developed based on five factors – a penicillin allergy reported by the patient, 5 years or less since the last reaction (2 points); anaphylaxis or angioedema, or severe cutaneous adverse reaction (2 points); and treatment being required for the reaction (1 point).

Researchers, after validation at three sites, found that a score below a threshold identified a group that had a 96% negative predictive value for penicillin allergy skin testing.

“A PEN-FAST score of less than 3 can be used to identify patients with reported penicillin allergy who can likely proceed safely to oral challenge,” Dr. Herzig said. She said the findings would benefit from validation in an inpatient setting.
 

Prehydration before contrast-enhanced computed tomography in CKD

Previous studies have found that omitting prehydration was noninferior to volume expansion with isotonic saline, and this trial looked at omission versus sodium bicarbonate hydration.

Participants were 523 adults with stage 3 chronic kidney disease who were getting elective outpatient CT with contrast. They were randomized to either no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate an hour before CT.

Researchers found that postcontrast acute kidney injury was rare even in this high-risk patient population overall, and that withholding prehydration was noninferior to prehydration with sodium bicarbonate, Dr. Herzig said.
 

Gabapentin for alcohol use disorder in those with alcohol withdrawal symptoms

Dr. Breu noted that only about one in five patients with alcohol use disorder receive medications to help preserve abstinence or to reduce drinking, and many medications target cravings but not symptoms of withdrawal.

In a double-blind, randomized, placebo-controlled trial at a single academic outpatient medical center in South Carolina, 90 patients were randomized to receive titrated gabapentin or placebo for 16 weeks.

Researchers found that, among those with abstinence of at least 2 days, gabapentin reduced the number of days of heavy drinking and the days of any drinking, especially in those with high symptoms of withdrawal.

“In patients with alcohol use disorder and high alcohol withdrawal symptoms, consider gabapentin to help reduce heavy drinking or maintain abstinence,” Dr. Breu said.
 

Hospitalist continuity of care and patient outcomes

In a retrospective study examining all medical admissions of Medicare patients with a 3- to 6-day length of stay, and in which all general medical care was provided by hospitalists, researchers examined the effects of continuity of care. Nearly 115,000 patient stays were included in the study, which covered 229 Texas hospitals.

The stays were grouped into quartiles of continuity of care, based on the number of hospitalists involved in a patient’s stay. Greater continuity was associated with lower 30-day mortality, with a linear relationship between the two. Researchers also found costs to be lower as continuity increased.

“Efforts by hospitals and hospitalist groups to promote working schedules with more continuity,” Dr. Herzig said, “could lead to improved postdischarge outcomes.”


 

Two experts scoured the medical journals for the practice-changing research most relevant to hospital medicine in 2020 at a recent session at SHM Converge, the annual conference of the Society of Hospital Medicine.

The presenters chose findings they considered either practice changing or practice confirming, and in areas over which hospitalists have at least some control. Here is what they highlighted:
 

IV iron administration before hospital discharge

In a randomized double-blind, placebo-controlled trial across 121 centers in Europe, South America, and Singapore, 1,108 patients hospitalized with acute heart failure and iron deficiency were randomized to receive intravenous ferric carboxymaltose or placebo, with a first dose before discharge and a second at 6 weeks.

Those in the intravenous iron group had a significant reduction in hospitalizations for heart failure up to 52 weeks after randomization, but there was no significant reduction in deaths because of heart failure. There was no difference in serious adverse events.

Anthony Breu, MD, assistant professor of medicine at Harvard Medical School, Boston, said the findings should alter hospitalist practice.

“In patients hospitalized with acute heart failure and left ventricular ejection fraction of less than 50%, check iron studies and start IV iron prior to discharge if they have iron deficiency, with or without anemia,” he said.
 

Apixaban versus dalteparin for venous thromboembolism in cancer

This noninferiority trial involved 1,155 adults with cancer who had symptomatic or incidental acute proximal deep vein thrombosis or pulmonary embolism. The patients were randomized to receive oral apixaban or subcutaneous dalteparin for 6 months.

Patients in the apixaban group had a significantly lower rate of recurrent venous thromboembolism (P = .09), with no increase in major bleeds, Dr. Breu said. He noted that those with brain cancer and leukemia were excluded.

“In patients with cancer and acute venous thromboembolism, consider apixaban as your first-line treatment, with some caveats,” he said.
 

Clinical decision rule for penicillin allergy

With fewer than 10% of patients who report a penicillin allergy actually testing positive on a standard allergy test, a simpler way to predict an allergy would help clinicians, said Shoshana Herzig, MD, MPH, associate professor of medicine at Harvard Medical School.

A 622-patient cohort that had undergone penicillin allergy testing was used to identify factors that could help predict an allergy. A scoring system called PEN-FAST was developed based on five factors – a penicillin allergy reported by the patient, 5 years or less since the last reaction (2 points); anaphylaxis or angioedema, or severe cutaneous adverse reaction (2 points); and treatment being required for the reaction (1 point).

Researchers, after validation at three sites, found that a score below a threshold identified a group that had a 96% negative predictive value for penicillin allergy skin testing.

“A PEN-FAST score of less than 3 can be used to identify patients with reported penicillin allergy who can likely proceed safely to oral challenge,” Dr. Herzig said. She said the findings would benefit from validation in an inpatient setting.
 

Prehydration before contrast-enhanced computed tomography in CKD

Previous studies have found that omitting prehydration was noninferior to volume expansion with isotonic saline, and this trial looked at omission versus sodium bicarbonate hydration.

Participants were 523 adults with stage 3 chronic kidney disease who were getting elective outpatient CT with contrast. They were randomized to either no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate an hour before CT.

Researchers found that postcontrast acute kidney injury was rare even in this high-risk patient population overall, and that withholding prehydration was noninferior to prehydration with sodium bicarbonate, Dr. Herzig said.
 

Gabapentin for alcohol use disorder in those with alcohol withdrawal symptoms

Dr. Breu noted that only about one in five patients with alcohol use disorder receive medications to help preserve abstinence or to reduce drinking, and many medications target cravings but not symptoms of withdrawal.

In a double-blind, randomized, placebo-controlled trial at a single academic outpatient medical center in South Carolina, 90 patients were randomized to receive titrated gabapentin or placebo for 16 weeks.

Researchers found that, among those with abstinence of at least 2 days, gabapentin reduced the number of days of heavy drinking and the days of any drinking, especially in those with high symptoms of withdrawal.

“In patients with alcohol use disorder and high alcohol withdrawal symptoms, consider gabapentin to help reduce heavy drinking or maintain abstinence,” Dr. Breu said.
 

Hospitalist continuity of care and patient outcomes

In a retrospective study examining all medical admissions of Medicare patients with a 3- to 6-day length of stay, and in which all general medical care was provided by hospitalists, researchers examined the effects of continuity of care. Nearly 115,000 patient stays were included in the study, which covered 229 Texas hospitals.

The stays were grouped into quartiles of continuity of care, based on the number of hospitalists involved in a patient’s stay. Greater continuity was associated with lower 30-day mortality, with a linear relationship between the two. Researchers also found costs to be lower as continuity increased.

“Efforts by hospitals and hospitalist groups to promote working schedules with more continuity,” Dr. Herzig said, “could lead to improved postdischarge outcomes.”


 

Two experts scoured the medical journals for the practice-changing research most relevant to hospital medicine in 2020 at a recent session at SHM Converge, the annual conference of the Society of Hospital Medicine.

The presenters chose findings they considered either practice changing or practice confirming, and in areas over which hospitalists have at least some control. Here is what they highlighted:
 

IV iron administration before hospital discharge

In a randomized double-blind, placebo-controlled trial across 121 centers in Europe, South America, and Singapore, 1,108 patients hospitalized with acute heart failure and iron deficiency were randomized to receive intravenous ferric carboxymaltose or placebo, with a first dose before discharge and a second at 6 weeks.

Those in the intravenous iron group had a significant reduction in hospitalizations for heart failure up to 52 weeks after randomization, but there was no significant reduction in deaths because of heart failure. There was no difference in serious adverse events.

Anthony Breu, MD, assistant professor of medicine at Harvard Medical School, Boston, said the findings should alter hospitalist practice.

“In patients hospitalized with acute heart failure and left ventricular ejection fraction of less than 50%, check iron studies and start IV iron prior to discharge if they have iron deficiency, with or without anemia,” he said.
 

Apixaban versus dalteparin for venous thromboembolism in cancer

This noninferiority trial involved 1,155 adults with cancer who had symptomatic or incidental acute proximal deep vein thrombosis or pulmonary embolism. The patients were randomized to receive oral apixaban or subcutaneous dalteparin for 6 months.

Patients in the apixaban group had a significantly lower rate of recurrent venous thromboembolism (P = .09), with no increase in major bleeds, Dr. Breu said. He noted that those with brain cancer and leukemia were excluded.

“In patients with cancer and acute venous thromboembolism, consider apixaban as your first-line treatment, with some caveats,” he said.
 

Clinical decision rule for penicillin allergy

With fewer than 10% of patients who report a penicillin allergy actually testing positive on a standard allergy test, a simpler way to predict an allergy would help clinicians, said Shoshana Herzig, MD, MPH, associate professor of medicine at Harvard Medical School.

A 622-patient cohort that had undergone penicillin allergy testing was used to identify factors that could help predict an allergy. A scoring system called PEN-FAST was developed based on five factors – a penicillin allergy reported by the patient, 5 years or less since the last reaction (2 points); anaphylaxis or angioedema, or severe cutaneous adverse reaction (2 points); and treatment being required for the reaction (1 point).

Researchers, after validation at three sites, found that a score below a threshold identified a group that had a 96% negative predictive value for penicillin allergy skin testing.

“A PEN-FAST score of less than 3 can be used to identify patients with reported penicillin allergy who can likely proceed safely to oral challenge,” Dr. Herzig said. She said the findings would benefit from validation in an inpatient setting.
 

Prehydration before contrast-enhanced computed tomography in CKD

Previous studies have found that omitting prehydration was noninferior to volume expansion with isotonic saline, and this trial looked at omission versus sodium bicarbonate hydration.

Participants were 523 adults with stage 3 chronic kidney disease who were getting elective outpatient CT with contrast. They were randomized to either no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate an hour before CT.

Researchers found that postcontrast acute kidney injury was rare even in this high-risk patient population overall, and that withholding prehydration was noninferior to prehydration with sodium bicarbonate, Dr. Herzig said.
 

Gabapentin for alcohol use disorder in those with alcohol withdrawal symptoms

Dr. Breu noted that only about one in five patients with alcohol use disorder receive medications to help preserve abstinence or to reduce drinking, and many medications target cravings but not symptoms of withdrawal.

In a double-blind, randomized, placebo-controlled trial at a single academic outpatient medical center in South Carolina, 90 patients were randomized to receive titrated gabapentin or placebo for 16 weeks.

Researchers found that, among those with abstinence of at least 2 days, gabapentin reduced the number of days of heavy drinking and the days of any drinking, especially in those with high symptoms of withdrawal.

“In patients with alcohol use disorder and high alcohol withdrawal symptoms, consider gabapentin to help reduce heavy drinking or maintain abstinence,” Dr. Breu said.
 

Hospitalist continuity of care and patient outcomes

In a retrospective study examining all medical admissions of Medicare patients with a 3- to 6-day length of stay, and in which all general medical care was provided by hospitalists, researchers examined the effects of continuity of care. Nearly 115,000 patient stays were included in the study, which covered 229 Texas hospitals.

The stays were grouped into quartiles of continuity of care, based on the number of hospitalists involved in a patient’s stay. Greater continuity was associated with lower 30-day mortality, with a linear relationship between the two. Researchers also found costs to be lower as continuity increased.

“Efforts by hospitals and hospitalist groups to promote working schedules with more continuity,” Dr. Herzig said, “could lead to improved postdischarge outcomes.”