Maureen Salamon

Across the United States, an explosive growth in recreational facilities boasting trampolines coincides with alarming growth in trampoline-related injuries in children, including those to the spine, according to new research.

Among youths, the risk for trampoline park–related fractures is about three times higher than for home-based trampoline fractures, said study author Serena Freiman, MD, of Washington University, St. Louis.

Recreational sports facilities with trampolines “pose a public health hazard,” Dr. Freiman said during a presentation at the virtual American Academy of Pediatrics 2020 National Conference.

“There aren’t any set regulations for these parks, so the American Society for Testing and Materials released a set of standards, but only Michigan and Arizona enforced those,” Dr. Freiman explained.

“Hopefully, since we’re showing a significant increased risk of injuries, the federal government will enforce regulations throughout the United States,” she said in an interview.

The first trampoline park in the United States opened in 2004, Dr. Freiman said. By 2018, there were more than 800 recreational facilities with trampolines across the country. This rapid growth coincided with a 45% increase in ED visits for trampoline-related injuries, from 61,509 in 2014 to more than 89,000 in 2017.

“There’s been exponential growth since their founding,” she said, “and with that we’ve also seen an exponential growth in injuries, whereas home injuries [from trampolines] remained stable during that time period.”

To assess the rates of trampoline-related injuries, Dr. Freiman and colleague analyzed data from the National Electronic Injury Surveillance System (NEISS). They included all patients whose records include a code for trampoline injury and who presented to a hospital ED between 1998 and 2017. They compared home trampoline injuries with those sustained at recreational facilities.

During the study period, more than 1.37 million patients presented to the ED for trampoline-related injuries. Of those, 125,473 occurred at recreational facilities, and 1.22 million occurred at home. Injuries at trampoline parks increased 90-fold between 2004 and 2017 (0.04 per 10,000 ED visits in 2004 to 0.9 per 10,000 in 2017), with 69% of those injuries occurring between 2012 and 2017.

Home-based trampoline injuries dropped during the study period, from 2.8 per 10,000 ED visits in 2014 to 1.6 in 2017.

Patients injured at trampoline facilities tended to present at large hospitals, Dr. Freiman noted, likely because of these parks being located in more populated regions.

The type of injury differed between locations. Severe injuries, such as spine fractures, occurred three times as often at trampoline parks than at home (2.7% vs. 0.9%; P = .016).

Internal organ injuries occurred more frequently on home-based trampolines (20.1% vs. 2.3% ; P < .001), whereas strains and sprains were more common at trampoline parks (32% vs. 51%; P < .001).

“Since home trampolines are often off the ground, I would speculate that you’re more likely to hit the edge of the trampoline or fall from it,” she said, “whereas at recreational sports facilities, there are often multiple jumpers, and you’re not falling off ― you’re falling in general or colliding with other jumpers.”

The authors noted that lower-extremity fractures occurred more often in trampoline parks (35.6% home vs. 51.7% parks; P < .0001), and upper-extremity fractures were more prevalent from home trampolines (60.2% vs. 42.5%; P < .0001). Also, a larger proportion of trampoline park injuries occurred among adolescents and young adults aged 15-34 years in comparison with home-based injuries (28.2% vs. 13.6%). No race or gender differences were noted.

Dr. Freiman noted one possible study limitation. The NEISS data only included patients tagged as being injured on trampolines, so “it may be incomplete,” she said. “Also, anyone presenting to their personal physician or urgent care centers weren’t included, so there’s likely an underestimation of cases.

“We hope people gain a better understanding of risks associated with these facilities and dive further into research and [to] identify areas that can be improved within these facilities,” Dr. Freiman added.

To drive home the importance of caution, physicians should relay data about trampoline injuries to parents and children, said Amber Hardeman, MD, MPH, MBA, of Tulane University, New Orleans.

Because most injuries at trampoline parks occur among people aged 15-34 years, Dr. Hardeman said, babysitters or parents may also “be indulging as well” when they take their young charges there to jump.

“They need to understand how to set a good example and teach kids proper safety precautions, such as not jumping too close together or maybe not doing things like splits,” she said.

Dr. Hardeman said in an interview that “there’s a lot of truth” to the study’s conclusion that recreational sports facilities with trampolines pose a public health hazard. Additional research should focus on what types of safety measures trampoline parks may be taking. Such measures could include increased padding, hiring more staff, or placing firmer limits on how many people can jump in each area at a time.

“Some centers don’t have as much padding around as others, and some allow multiple children to jump in the same area at the same time,” she said. “What exact scenarios are kids encountering more so than being on a trampoline at home?

“Trampoline centers are exciting and fun, but they are a hazard, and the fact that such an aggregate population being impacted by increasing numbers shows it’s definitely an issue right now,” Dr. Hardeman added.

Dr. Freiman and Dr. Hardeman have disclosed no relevant financial relationships.

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

Across the United States, an explosive growth in recreational facilities boasting trampolines coincides with alarming growth in trampoline-related injuries in children, including those to the spine, according to new research.

Among youths, the risk for trampoline park–related fractures is about three times higher than for home-based trampoline fractures, said study author Serena Freiman, MD, of Washington University, St. Louis.

Recreational sports facilities with trampolines “pose a public health hazard,” Dr. Freiman said during a presentation at the virtual American Academy of Pediatrics 2020 National Conference.

“There aren’t any set regulations for these parks, so the American Society for Testing and Materials released a set of standards, but only Michigan and Arizona enforced those,” Dr. Freiman explained.

“Hopefully, since we’re showing a significant increased risk of injuries, the federal government will enforce regulations throughout the United States,” she said in an interview.

The first trampoline park in the United States opened in 2004, Dr. Freiman said. By 2018, there were more than 800 recreational facilities with trampolines across the country. This rapid growth coincided with a 45% increase in ED visits for trampoline-related injuries, from 61,509 in 2014 to more than 89,000 in 2017.

“There’s been exponential growth since their founding,” she said, “and with that we’ve also seen an exponential growth in injuries, whereas home injuries [from trampolines] remained stable during that time period.”

To assess the rates of trampoline-related injuries, Dr. Freiman and colleague analyzed data from the National Electronic Injury Surveillance System (NEISS). They included all patients whose records include a code for trampoline injury and who presented to a hospital ED between 1998 and 2017. They compared home trampoline injuries with those sustained at recreational facilities.

During the study period, more than 1.37 million patients presented to the ED for trampoline-related injuries. Of those, 125,473 occurred at recreational facilities, and 1.22 million occurred at home. Injuries at trampoline parks increased 90-fold between 2004 and 2017 (0.04 per 10,000 ED visits in 2004 to 0.9 per 10,000 in 2017), with 69% of those injuries occurring between 2012 and 2017.

Home-based trampoline injuries dropped during the study period, from 2.8 per 10,000 ED visits in 2014 to 1.6 in 2017.

Patients injured at trampoline facilities tended to present at large hospitals, Dr. Freiman noted, likely because of these parks being located in more populated regions.

The type of injury differed between locations. Severe injuries, such as spine fractures, occurred three times as often at trampoline parks than at home (2.7% vs. 0.9%; P = .016).

Internal organ injuries occurred more frequently on home-based trampolines (20.1% vs. 2.3% ; P < .001), whereas strains and sprains were more common at trampoline parks (32% vs. 51%; P < .001).

“Since home trampolines are often off the ground, I would speculate that you’re more likely to hit the edge of the trampoline or fall from it,” she said, “whereas at recreational sports facilities, there are often multiple jumpers, and you’re not falling off ― you’re falling in general or colliding with other jumpers.”

The authors noted that lower-extremity fractures occurred more often in trampoline parks (35.6% home vs. 51.7% parks; P < .0001), and upper-extremity fractures were more prevalent from home trampolines (60.2% vs. 42.5%; P < .0001). Also, a larger proportion of trampoline park injuries occurred among adolescents and young adults aged 15-34 years in comparison with home-based injuries (28.2% vs. 13.6%). No race or gender differences were noted.

Dr. Freiman noted one possible study limitation. The NEISS data only included patients tagged as being injured on trampolines, so “it may be incomplete,” she said. “Also, anyone presenting to their personal physician or urgent care centers weren’t included, so there’s likely an underestimation of cases.

“We hope people gain a better understanding of risks associated with these facilities and dive further into research and [to] identify areas that can be improved within these facilities,” Dr. Freiman added.

To drive home the importance of caution, physicians should relay data about trampoline injuries to parents and children, said Amber Hardeman, MD, MPH, MBA, of Tulane University, New Orleans.

Because most injuries at trampoline parks occur among people aged 15-34 years, Dr. Hardeman said, babysitters or parents may also “be indulging as well” when they take their young charges there to jump.

“They need to understand how to set a good example and teach kids proper safety precautions, such as not jumping too close together or maybe not doing things like splits,” she said.

Dr. Hardeman said in an interview that “there’s a lot of truth” to the study’s conclusion that recreational sports facilities with trampolines pose a public health hazard. Additional research should focus on what types of safety measures trampoline parks may be taking. Such measures could include increased padding, hiring more staff, or placing firmer limits on how many people can jump in each area at a time.

“Some centers don’t have as much padding around as others, and some allow multiple children to jump in the same area at the same time,” she said. “What exact scenarios are kids encountering more so than being on a trampoline at home?

“Trampoline centers are exciting and fun, but they are a hazard, and the fact that such an aggregate population being impacted by increasing numbers shows it’s definitely an issue right now,” Dr. Hardeman added.

Dr. Freiman and Dr. Hardeman have disclosed no relevant financial relationships.

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

Across the United States, an explosive growth in recreational facilities boasting trampolines coincides with alarming growth in trampoline-related injuries in children, including those to the spine, according to new research.

Among youths, the risk for trampoline park–related fractures is about three times higher than for home-based trampoline fractures, said study author Serena Freiman, MD, of Washington University, St. Louis.

Recreational sports facilities with trampolines “pose a public health hazard,” Dr. Freiman said during a presentation at the virtual American Academy of Pediatrics 2020 National Conference.

“There aren’t any set regulations for these parks, so the American Society for Testing and Materials released a set of standards, but only Michigan and Arizona enforced those,” Dr. Freiman explained.

“Hopefully, since we’re showing a significant increased risk of injuries, the federal government will enforce regulations throughout the United States,” she said in an interview.

The first trampoline park in the United States opened in 2004, Dr. Freiman said. By 2018, there were more than 800 recreational facilities with trampolines across the country. This rapid growth coincided with a 45% increase in ED visits for trampoline-related injuries, from 61,509 in 2014 to more than 89,000 in 2017.

“There’s been exponential growth since their founding,” she said, “and with that we’ve also seen an exponential growth in injuries, whereas home injuries [from trampolines] remained stable during that time period.”

To assess the rates of trampoline-related injuries, Dr. Freiman and colleague analyzed data from the National Electronic Injury Surveillance System (NEISS). They included all patients whose records include a code for trampoline injury and who presented to a hospital ED between 1998 and 2017. They compared home trampoline injuries with those sustained at recreational facilities.

During the study period, more than 1.37 million patients presented to the ED for trampoline-related injuries. Of those, 125,473 occurred at recreational facilities, and 1.22 million occurred at home. Injuries at trampoline parks increased 90-fold between 2004 and 2017 (0.04 per 10,000 ED visits in 2004 to 0.9 per 10,000 in 2017), with 69% of those injuries occurring between 2012 and 2017.

Home-based trampoline injuries dropped during the study period, from 2.8 per 10,000 ED visits in 2014 to 1.6 in 2017.

Patients injured at trampoline facilities tended to present at large hospitals, Dr. Freiman noted, likely because of these parks being located in more populated regions.

The type of injury differed between locations. Severe injuries, such as spine fractures, occurred three times as often at trampoline parks than at home (2.7% vs. 0.9%; P = .016).

Internal organ injuries occurred more frequently on home-based trampolines (20.1% vs. 2.3% ; P < .001), whereas strains and sprains were more common at trampoline parks (32% vs. 51%; P < .001).

“Since home trampolines are often off the ground, I would speculate that you’re more likely to hit the edge of the trampoline or fall from it,” she said, “whereas at recreational sports facilities, there are often multiple jumpers, and you’re not falling off ― you’re falling in general or colliding with other jumpers.”

The authors noted that lower-extremity fractures occurred more often in trampoline parks (35.6% home vs. 51.7% parks; P < .0001), and upper-extremity fractures were more prevalent from home trampolines (60.2% vs. 42.5%; P < .0001). Also, a larger proportion of trampoline park injuries occurred among adolescents and young adults aged 15-34 years in comparison with home-based injuries (28.2% vs. 13.6%). No race or gender differences were noted.

Dr. Freiman noted one possible study limitation. The NEISS data only included patients tagged as being injured on trampolines, so “it may be incomplete,” she said. “Also, anyone presenting to their personal physician or urgent care centers weren’t included, so there’s likely an underestimation of cases.

“We hope people gain a better understanding of risks associated with these facilities and dive further into research and [to] identify areas that can be improved within these facilities,” Dr. Freiman added.

To drive home the importance of caution, physicians should relay data about trampoline injuries to parents and children, said Amber Hardeman, MD, MPH, MBA, of Tulane University, New Orleans.

Because most injuries at trampoline parks occur among people aged 15-34 years, Dr. Hardeman said, babysitters or parents may also “be indulging as well” when they take their young charges there to jump.

“They need to understand how to set a good example and teach kids proper safety precautions, such as not jumping too close together or maybe not doing things like splits,” she said.

Dr. Hardeman said in an interview that “there’s a lot of truth” to the study’s conclusion that recreational sports facilities with trampolines pose a public health hazard. Additional research should focus on what types of safety measures trampoline parks may be taking. Such measures could include increased padding, hiring more staff, or placing firmer limits on how many people can jump in each area at a time.

“Some centers don’t have as much padding around as others, and some allow multiple children to jump in the same area at the same time,” she said. “What exact scenarios are kids encountering more so than being on a trampoline at home?

“Trampoline centers are exciting and fun, but they are a hazard, and the fact that such an aggregate population being impacted by increasing numbers shows it’s definitely an issue right now,” Dr. Hardeman added.

Dr. Freiman and Dr. Hardeman have disclosed no relevant financial relationships.

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

Concussions resulting from assaults and sports may not be entirely similar in children and youth, researchers report. For example, more than twice as many children who experience assault-related concussions report declines in school grades, compared with those with sports-related concussions.

The researchers also saw trends suggesting there are clinically meaningful differences between the groups in terms of longer periods before return to school, symptom resolution, and full physician clearance after injury. Patients with assault-related concussion were also less likely to be referred to specialists and to receive initial visio-vestibular testing.

The research, conducted over a 2-year period with 124 children and adolescents aged 8-18 years, stands out by focusing on lesser-understood outcomes of concussions related to assault, said study author Margaret Means, MD, of Children’s Hospital of Philadelphia.

“From my standpoint as a pediatrician and training to be a pediatric neurologist, I want to make sure I come into each patient encounter with as much understanding as I can and to treat all the associated factors adequately,” Dr. Means said.

“It’s so important to recognize that one disease process, as we categorize it, such as concussion, doesn’t mean all your patients are going to have the same needs or outcomes,” Dr. Means said in an interview. “We focus a lot on sports-related concussion, and that’s very important, but unless we recognize [that] a child who presents to the emergency department after assault could have a concussion, they are much less likely to be screened for certain concussion aspects.”

The research was presented at the virtual American Academy of Pediatrics National Conference.

Dr. Means and her colleagues undertook a retrospective chart review comparing 62 patients with assault-related concussions to the same number with sports- and recreation-related concussion between 2012 and 2014.

Patients with assault-related concussion were more likely to be Black, publicly insured, and to initially present to the emergency department. Markedly fewer patients with assault-related concussions received visio-vestibular testing at their first visit, compared with sports concussion patients (25% vs. 75%; P < .001).

Although the total number of reported physical, cognitive, emotional, and sleep symptoms didn’t differ between the groups during their recovery period, patients with assault-related concussions reported drops in school grades more than twice as often as those youths with sports concussion (47% vs. 20%; P = .012).

“The decline in grades in this group suggests it takes longer for children to become asymptomatic from concussion related to an assault,” Dr. Means explained. “We need to investigate that further to hopefully address that difference and help kids to not experience that decline in grades.”

Clinically meaningful but not statistically significant differences were revealed in the rate of specialist referral for those with assault-related vs. sports-related concussions (53% vs. 40%; P = .086). Patients with assault-related concussions also tended to take longer to return to school than patients with sports-related concussions (11 days vs. 8 days; P = .252); to experience symptom resolution (13.5 days vs. 11.5 days; P = .389); and to receive full physician clearance (35 days vs. 24 days; P = .332).

“With a child experiencing interpersonal assault, obviously there are a lot of different factors that need to be addressed in terms of the emotional and physical response to the trauma,” Dr. Means said. “But in terms of to-dos – and I’d love for the medical community to recognize this more readily – maybe we could develop some type of screening tool for the population experiencing assault so we might be more aware they’ve also experienced concussion.

“As a clinician, it’s important to understand research like this so you see some nuances to how each patient experiences this,” she added, “and tailor your approach to them for the best treatment and outcomes.”

Carrie Esopenko, PhD, of Rutgers University in Newark, N.J., agreed with Dr. Means that focusing on youth concussions that are not the result of sports has been largely neglected.

“We haven’t really realized concussion is occurring more on a milder scale of abusive head injuries,” said Dr. Esopenko, who conducts research on intimate partner violence but wasn’t involved in the new study.

“Head injury is the key phrase in sports right now, and I think we’re just starting to realize how prevalent the issue is in interpersonal and intimate partner violence,” Dr. Esopenko said in an interview.

“Clinicians need to do a full concussion battery on kids coming in and be aware these symptoms can be treated similarly even if they’re from a different mechanism,” she added. “It’s still the same organ impacted. These kids are still struggling, even though they’re not injured on a sports field.”

Dr. Means and Dr. Esopenko have disclosed no relevant financial relationships.

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

Concussions resulting from assaults and sports may not be entirely similar in children and youth, researchers report. For example, more than twice as many children who experience assault-related concussions report declines in school grades, compared with those with sports-related concussions.

The researchers also saw trends suggesting there are clinically meaningful differences between the groups in terms of longer periods before return to school, symptom resolution, and full physician clearance after injury. Patients with assault-related concussion were also less likely to be referred to specialists and to receive initial visio-vestibular testing.

The research, conducted over a 2-year period with 124 children and adolescents aged 8-18 years, stands out by focusing on lesser-understood outcomes of concussions related to assault, said study author Margaret Means, MD, of Children’s Hospital of Philadelphia.

“From my standpoint as a pediatrician and training to be a pediatric neurologist, I want to make sure I come into each patient encounter with as much understanding as I can and to treat all the associated factors adequately,” Dr. Means said.

“It’s so important to recognize that one disease process, as we categorize it, such as concussion, doesn’t mean all your patients are going to have the same needs or outcomes,” Dr. Means said in an interview. “We focus a lot on sports-related concussion, and that’s very important, but unless we recognize [that] a child who presents to the emergency department after assault could have a concussion, they are much less likely to be screened for certain concussion aspects.”

The research was presented at the virtual American Academy of Pediatrics National Conference.

Dr. Means and her colleagues undertook a retrospective chart review comparing 62 patients with assault-related concussions to the same number with sports- and recreation-related concussion between 2012 and 2014.

Patients with assault-related concussion were more likely to be Black, publicly insured, and to initially present to the emergency department. Markedly fewer patients with assault-related concussions received visio-vestibular testing at their first visit, compared with sports concussion patients (25% vs. 75%; P < .001).

Although the total number of reported physical, cognitive, emotional, and sleep symptoms didn’t differ between the groups during their recovery period, patients with assault-related concussions reported drops in school grades more than twice as often as those youths with sports concussion (47% vs. 20%; P = .012).

“The decline in grades in this group suggests it takes longer for children to become asymptomatic from concussion related to an assault,” Dr. Means explained. “We need to investigate that further to hopefully address that difference and help kids to not experience that decline in grades.”

Clinically meaningful but not statistically significant differences were revealed in the rate of specialist referral for those with assault-related vs. sports-related concussions (53% vs. 40%; P = .086). Patients with assault-related concussions also tended to take longer to return to school than patients with sports-related concussions (11 days vs. 8 days; P = .252); to experience symptom resolution (13.5 days vs. 11.5 days; P = .389); and to receive full physician clearance (35 days vs. 24 days; P = .332).

“With a child experiencing interpersonal assault, obviously there are a lot of different factors that need to be addressed in terms of the emotional and physical response to the trauma,” Dr. Means said. “But in terms of to-dos – and I’d love for the medical community to recognize this more readily – maybe we could develop some type of screening tool for the population experiencing assault so we might be more aware they’ve also experienced concussion.

“As a clinician, it’s important to understand research like this so you see some nuances to how each patient experiences this,” she added, “and tailor your approach to them for the best treatment and outcomes.”

Carrie Esopenko, PhD, of Rutgers University in Newark, N.J., agreed with Dr. Means that focusing on youth concussions that are not the result of sports has been largely neglected.

“We haven’t really realized concussion is occurring more on a milder scale of abusive head injuries,” said Dr. Esopenko, who conducts research on intimate partner violence but wasn’t involved in the new study.

“Head injury is the key phrase in sports right now, and I think we’re just starting to realize how prevalent the issue is in interpersonal and intimate partner violence,” Dr. Esopenko said in an interview.

“Clinicians need to do a full concussion battery on kids coming in and be aware these symptoms can be treated similarly even if they’re from a different mechanism,” she added. “It’s still the same organ impacted. These kids are still struggling, even though they’re not injured on a sports field.”

Dr. Means and Dr. Esopenko have disclosed no relevant financial relationships.

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

Concussions resulting from assaults and sports may not be entirely similar in children and youth, researchers report. For example, more than twice as many children who experience assault-related concussions report declines in school grades, compared with those with sports-related concussions.

The researchers also saw trends suggesting there are clinically meaningful differences between the groups in terms of longer periods before return to school, symptom resolution, and full physician clearance after injury. Patients with assault-related concussion were also less likely to be referred to specialists and to receive initial visio-vestibular testing.

The research, conducted over a 2-year period with 124 children and adolescents aged 8-18 years, stands out by focusing on lesser-understood outcomes of concussions related to assault, said study author Margaret Means, MD, of Children’s Hospital of Philadelphia.

“From my standpoint as a pediatrician and training to be a pediatric neurologist, I want to make sure I come into each patient encounter with as much understanding as I can and to treat all the associated factors adequately,” Dr. Means said.

“It’s so important to recognize that one disease process, as we categorize it, such as concussion, doesn’t mean all your patients are going to have the same needs or outcomes,” Dr. Means said in an interview. “We focus a lot on sports-related concussion, and that’s very important, but unless we recognize [that] a child who presents to the emergency department after assault could have a concussion, they are much less likely to be screened for certain concussion aspects.”

The research was presented at the virtual American Academy of Pediatrics National Conference.

Dr. Means and her colleagues undertook a retrospective chart review comparing 62 patients with assault-related concussions to the same number with sports- and recreation-related concussion between 2012 and 2014.

Patients with assault-related concussion were more likely to be Black, publicly insured, and to initially present to the emergency department. Markedly fewer patients with assault-related concussions received visio-vestibular testing at their first visit, compared with sports concussion patients (25% vs. 75%; P < .001).

Although the total number of reported physical, cognitive, emotional, and sleep symptoms didn’t differ between the groups during their recovery period, patients with assault-related concussions reported drops in school grades more than twice as often as those youths with sports concussion (47% vs. 20%; P = .012).

“The decline in grades in this group suggests it takes longer for children to become asymptomatic from concussion related to an assault,” Dr. Means explained. “We need to investigate that further to hopefully address that difference and help kids to not experience that decline in grades.”

Clinically meaningful but not statistically significant differences were revealed in the rate of specialist referral for those with assault-related vs. sports-related concussions (53% vs. 40%; P = .086). Patients with assault-related concussions also tended to take longer to return to school than patients with sports-related concussions (11 days vs. 8 days; P = .252); to experience symptom resolution (13.5 days vs. 11.5 days; P = .389); and to receive full physician clearance (35 days vs. 24 days; P = .332).

“With a child experiencing interpersonal assault, obviously there are a lot of different factors that need to be addressed in terms of the emotional and physical response to the trauma,” Dr. Means said. “But in terms of to-dos – and I’d love for the medical community to recognize this more readily – maybe we could develop some type of screening tool for the population experiencing assault so we might be more aware they’ve also experienced concussion.

“As a clinician, it’s important to understand research like this so you see some nuances to how each patient experiences this,” she added, “and tailor your approach to them for the best treatment and outcomes.”

Carrie Esopenko, PhD, of Rutgers University in Newark, N.J., agreed with Dr. Means that focusing on youth concussions that are not the result of sports has been largely neglected.

“We haven’t really realized concussion is occurring more on a milder scale of abusive head injuries,” said Dr. Esopenko, who conducts research on intimate partner violence but wasn’t involved in the new study.

“Head injury is the key phrase in sports right now, and I think we’re just starting to realize how prevalent the issue is in interpersonal and intimate partner violence,” Dr. Esopenko said in an interview.

“Clinicians need to do a full concussion battery on kids coming in and be aware these symptoms can be treated similarly even if they’re from a different mechanism,” she added. “It’s still the same organ impacted. These kids are still struggling, even though they’re not injured on a sports field.”

Dr. Means and Dr. Esopenko have disclosed no relevant financial relationships.

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

“I worry that vaccines are going to be sold like magic powder that we sprinkle across the land and make the virus go away,” Paul Offit, MD, said at the virtual American Academy of Pediatrics (AAP) 2020 National Conference. “That’s not true.”

Even after effective vaccines for SARS-CoV-2 are in widespread use, wearing masks will still be advisable to prevent COVID-19, according to Dr. Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

“I think we can get a vaccine that’s 75%-80% effective at preventing mild to moderate disease, but that means one of every four people can still get moderate to severe disease,” Dr. Offit continued.

And that’s if there is high uptake of the vaccine, which may not be the case. Recent polls have suggested there is considerable concern about the pending vaccines.

“It’s somewhat understandable,” Dr. Offitt acknowledged, especially given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. Before COVID-19, the fastest vaccine ever developed was for mumps, he said, with the virus isolated in 1963 and a commercial product available in 1967.
 

Addressing hesitancy in clinics

In a wide-ranging livestream plenary presentation, Dr. Offit, coinventor of a rotavirus vaccine, shed light on SARS-CoV-2 vaccine development and his impressions of vaccine hesitancy among patients and families. He also offered advice for how to reassure those skeptical of the safety and efficacy of any SARS-COV-2 vaccine, given the accelerated development process.

With more than 180 different vaccines in various stages of investigation, Dr. Offit called the effort to develop COVID-19 vaccines “unprecedented.” Part of that is a result of governments relieving pharmaceutical companies of much of the typical financial risk – which often climbs to hundreds of millions of dollars – by underwriting the costs of vaccine development to battle the pandemic-inducing virus, he said.

But this very swiftness is also stoking antivaccine sentiment. Dr. Offit, part of vaccine advisory groups for the National Institutes of Health and U.S. Food and Drug Administration, cited recent research reporting nearly half of American adults definitely or probably would not get a COVID-19 vaccine if it were available today.

“One way you convince skeptics is with data presented in a clear, compassionate, and compelling way,” he said.

“The other group is vaccine cynics, who are basically conspiracy theorists who believe pharmaceutical companies control the world, the government, the medical establishment. I think there’s no talking them down from this.”

Numerous strategies are being used in COVID-19 vaccine development, he noted, including messenger RNA, DNA, viral vectors, purified protein, and whole killed virus. Dr. Offit believes any candidates approved for distribution will likely be in the range of 75% effective at preventing mild to moderate symptoms.

But clinicians should be ready to face immediate questions of safety. “Even if this vaccination is given to 20,000 [trial participants] safely, that’s not 20 million,” Dr. Offit said. “Anyone could reasonably ask questions about if it causes rare, serious side effects.

“The good news is, there are systems in place,” such as adverse event reporting systems, to identify rare events, even those that occur in one in a million vaccine recipients. Reminding patients of that continued surveillance can be reassuring.

Another reassuring point is that COVID-19 vaccine trial participants have included people from many diverse populations, he said. But children, notably absent so far, should be added to trials immediately, Dr. Offit contends.

“This is going to be important when you consider strategies to get children universally back into school,” he said, which is a “critical issue” from both learning and wellness standpoints. “It breaks my heart that we’ve been unable to do this when other countries have.”
 

Transparency will be paramount

While presenting data transparently to patients is key in helping them accept COVID-19 vaccination, Dr. Offit said, he also believes “telling stories” can be just as effective, if not more so. When the varicella vaccine was approved in 1995, he said, the “uptake the first few years was pretty miserable” until public service messaging emphasized that some children die from chickenpox.

“Fear works,” he said. “You always worry about pushback of something being oversold, but hopefully we’re scared enough about this virus” to convince people that vaccination is wise. “I do think personal stories carry weight on both sides,” Dr. Offit said.

Mark Sawyer, MD, of University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, California, said Offit’s presentation offered important takeaways for clinicians about how to broach the topic of COVID-19 vaccination with patients and families.

“We need to communicate clearly and transparently to patients about what we do and don’t know” about the vaccines, Dr. Sawyer said in an interview. “We will know if they have common side effects, but we will not know about very rare side effects until we have used the vaccines for a while.

“We will know how well the vaccine works over the short-term, but we won’t know over the long term,” added Dr. Sawyer, a member of the AAP Committee on Infectious Diseases.

“We can reassure the community that SARS-CoV-2 vaccines are being evaluated in trials in the same way and with the same thoroughness as other vaccines have been,” he said. “That should give people confidence that shortcuts are not being taken with regard to safety and effectiveness evaluations.”

Dr. Offit and Dr. Sawyer have disclosed no relevant financial relationships.
 

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

“I worry that vaccines are going to be sold like magic powder that we sprinkle across the land and make the virus go away,” Paul Offit, MD, said at the virtual American Academy of Pediatrics (AAP) 2020 National Conference. “That’s not true.”

Even after effective vaccines for SARS-CoV-2 are in widespread use, wearing masks will still be advisable to prevent COVID-19, according to Dr. Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

“I think we can get a vaccine that’s 75%-80% effective at preventing mild to moderate disease, but that means one of every four people can still get moderate to severe disease,” Dr. Offit continued.

And that’s if there is high uptake of the vaccine, which may not be the case. Recent polls have suggested there is considerable concern about the pending vaccines.

“It’s somewhat understandable,” Dr. Offitt acknowledged, especially given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. Before COVID-19, the fastest vaccine ever developed was for mumps, he said, with the virus isolated in 1963 and a commercial product available in 1967.
 

Addressing hesitancy in clinics

In a wide-ranging livestream plenary presentation, Dr. Offit, coinventor of a rotavirus vaccine, shed light on SARS-CoV-2 vaccine development and his impressions of vaccine hesitancy among patients and families. He also offered advice for how to reassure those skeptical of the safety and efficacy of any SARS-COV-2 vaccine, given the accelerated development process.

With more than 180 different vaccines in various stages of investigation, Dr. Offit called the effort to develop COVID-19 vaccines “unprecedented.” Part of that is a result of governments relieving pharmaceutical companies of much of the typical financial risk – which often climbs to hundreds of millions of dollars – by underwriting the costs of vaccine development to battle the pandemic-inducing virus, he said.

But this very swiftness is also stoking antivaccine sentiment. Dr. Offit, part of vaccine advisory groups for the National Institutes of Health and U.S. Food and Drug Administration, cited recent research reporting nearly half of American adults definitely or probably would not get a COVID-19 vaccine if it were available today.

“One way you convince skeptics is with data presented in a clear, compassionate, and compelling way,” he said.

“The other group is vaccine cynics, who are basically conspiracy theorists who believe pharmaceutical companies control the world, the government, the medical establishment. I think there’s no talking them down from this.”

Numerous strategies are being used in COVID-19 vaccine development, he noted, including messenger RNA, DNA, viral vectors, purified protein, and whole killed virus. Dr. Offit believes any candidates approved for distribution will likely be in the range of 75% effective at preventing mild to moderate symptoms.

But clinicians should be ready to face immediate questions of safety. “Even if this vaccination is given to 20,000 [trial participants] safely, that’s not 20 million,” Dr. Offit said. “Anyone could reasonably ask questions about if it causes rare, serious side effects.

“The good news is, there are systems in place,” such as adverse event reporting systems, to identify rare events, even those that occur in one in a million vaccine recipients. Reminding patients of that continued surveillance can be reassuring.

Another reassuring point is that COVID-19 vaccine trial participants have included people from many diverse populations, he said. But children, notably absent so far, should be added to trials immediately, Dr. Offit contends.

“This is going to be important when you consider strategies to get children universally back into school,” he said, which is a “critical issue” from both learning and wellness standpoints. “It breaks my heart that we’ve been unable to do this when other countries have.”
 

Transparency will be paramount

While presenting data transparently to patients is key in helping them accept COVID-19 vaccination, Dr. Offit said, he also believes “telling stories” can be just as effective, if not more so. When the varicella vaccine was approved in 1995, he said, the “uptake the first few years was pretty miserable” until public service messaging emphasized that some children die from chickenpox.

“Fear works,” he said. “You always worry about pushback of something being oversold, but hopefully we’re scared enough about this virus” to convince people that vaccination is wise. “I do think personal stories carry weight on both sides,” Dr. Offit said.

Mark Sawyer, MD, of University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, California, said Offit’s presentation offered important takeaways for clinicians about how to broach the topic of COVID-19 vaccination with patients and families.

“We need to communicate clearly and transparently to patients about what we do and don’t know” about the vaccines, Dr. Sawyer said in an interview. “We will know if they have common side effects, but we will not know about very rare side effects until we have used the vaccines for a while.

“We will know how well the vaccine works over the short-term, but we won’t know over the long term,” added Dr. Sawyer, a member of the AAP Committee on Infectious Diseases.

“We can reassure the community that SARS-CoV-2 vaccines are being evaluated in trials in the same way and with the same thoroughness as other vaccines have been,” he said. “That should give people confidence that shortcuts are not being taken with regard to safety and effectiveness evaluations.”

Dr. Offit and Dr. Sawyer have disclosed no relevant financial relationships.
 

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

“I worry that vaccines are going to be sold like magic powder that we sprinkle across the land and make the virus go away,” Paul Offit, MD, said at the virtual American Academy of Pediatrics (AAP) 2020 National Conference. “That’s not true.”

Even after effective vaccines for SARS-CoV-2 are in widespread use, wearing masks will still be advisable to prevent COVID-19, according to Dr. Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

“I think we can get a vaccine that’s 75%-80% effective at preventing mild to moderate disease, but that means one of every four people can still get moderate to severe disease,” Dr. Offit continued.

And that’s if there is high uptake of the vaccine, which may not be the case. Recent polls have suggested there is considerable concern about the pending vaccines.

“It’s somewhat understandable,” Dr. Offitt acknowledged, especially given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. Before COVID-19, the fastest vaccine ever developed was for mumps, he said, with the virus isolated in 1963 and a commercial product available in 1967.
 

Addressing hesitancy in clinics

In a wide-ranging livestream plenary presentation, Dr. Offit, coinventor of a rotavirus vaccine, shed light on SARS-CoV-2 vaccine development and his impressions of vaccine hesitancy among patients and families. He also offered advice for how to reassure those skeptical of the safety and efficacy of any SARS-COV-2 vaccine, given the accelerated development process.

With more than 180 different vaccines in various stages of investigation, Dr. Offit called the effort to develop COVID-19 vaccines “unprecedented.” Part of that is a result of governments relieving pharmaceutical companies of much of the typical financial risk – which often climbs to hundreds of millions of dollars – by underwriting the costs of vaccine development to battle the pandemic-inducing virus, he said.

But this very swiftness is also stoking antivaccine sentiment. Dr. Offit, part of vaccine advisory groups for the National Institutes of Health and U.S. Food and Drug Administration, cited recent research reporting nearly half of American adults definitely or probably would not get a COVID-19 vaccine if it were available today.

“One way you convince skeptics is with data presented in a clear, compassionate, and compelling way,” he said.

“The other group is vaccine cynics, who are basically conspiracy theorists who believe pharmaceutical companies control the world, the government, the medical establishment. I think there’s no talking them down from this.”

Numerous strategies are being used in COVID-19 vaccine development, he noted, including messenger RNA, DNA, viral vectors, purified protein, and whole killed virus. Dr. Offit believes any candidates approved for distribution will likely be in the range of 75% effective at preventing mild to moderate symptoms.

But clinicians should be ready to face immediate questions of safety. “Even if this vaccination is given to 20,000 [trial participants] safely, that’s not 20 million,” Dr. Offit said. “Anyone could reasonably ask questions about if it causes rare, serious side effects.

“The good news is, there are systems in place,” such as adverse event reporting systems, to identify rare events, even those that occur in one in a million vaccine recipients. Reminding patients of that continued surveillance can be reassuring.

Another reassuring point is that COVID-19 vaccine trial participants have included people from many diverse populations, he said. But children, notably absent so far, should be added to trials immediately, Dr. Offit contends.

“This is going to be important when you consider strategies to get children universally back into school,” he said, which is a “critical issue” from both learning and wellness standpoints. “It breaks my heart that we’ve been unable to do this when other countries have.”
 

Transparency will be paramount

While presenting data transparently to patients is key in helping them accept COVID-19 vaccination, Dr. Offit said, he also believes “telling stories” can be just as effective, if not more so. When the varicella vaccine was approved in 1995, he said, the “uptake the first few years was pretty miserable” until public service messaging emphasized that some children die from chickenpox.

“Fear works,” he said. “You always worry about pushback of something being oversold, but hopefully we’re scared enough about this virus” to convince people that vaccination is wise. “I do think personal stories carry weight on both sides,” Dr. Offit said.

Mark Sawyer, MD, of University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, California, said Offit’s presentation offered important takeaways for clinicians about how to broach the topic of COVID-19 vaccination with patients and families.

“We need to communicate clearly and transparently to patients about what we do and don’t know” about the vaccines, Dr. Sawyer said in an interview. “We will know if they have common side effects, but we will not know about very rare side effects until we have used the vaccines for a while.

“We will know how well the vaccine works over the short-term, but we won’t know over the long term,” added Dr. Sawyer, a member of the AAP Committee on Infectious Diseases.

“We can reassure the community that SARS-CoV-2 vaccines are being evaluated in trials in the same way and with the same thoroughness as other vaccines have been,” he said. “That should give people confidence that shortcuts are not being taken with regard to safety and effectiveness evaluations.”

Dr. Offit and Dr. Sawyer have disclosed no relevant financial relationships.
 

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

Pediatric fractures dropped by 2.5-fold during the early months of the COVID-19 pandemic, but more breaks happened at home and on bicycles, and younger kids were more affected, new research indicates.

The study of 1,745 patients also found that those with distal radius torus fractures were more likely to receive a Velcro splint during the pandemic. Experts said this key trend points toward widespread shifts to streamline treatment, which should persist after the pandemic.

“We expected to see a drop in fracture volume, but what was a bit unexpected was the proportional rise in at-home injuries, which we weren’t immediately aware of,” said senior author Apurva Shah, MD, MBA, of Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania in Philadelphia.

“As time went on, it became more apparent that trampoline and bicycle injuries were on the rise, but at the beginning of the pandemic, we didn’t intuitively expect that,” he added.

“Whenever there’s a major shift in how the world is working, we want to understand how that impacts child safety,” Dr. Shah said in an interview. “The message to get out to parents is that it’s obviously difficult to supervise kids while working from home” during the pandemic “and that supervision obviously is not always working as well as intended.”

Joshua T. Bram, a medical student, presented the study at the virtual American Academy of Pediatrics (AAP) 2020 National Conference.

Dr. Bram, Dr. Shah, and colleagues compared patients with acute fractures who presented at CHOP between March and April 2020 with those who presented during the same months in 2018 and 2019.

Overall, the number of patients with pediatric fractures who presented to CHOP fell to an average of just under 10 per day, compared with more than 22 per day in prior years (P < .001). In addition, the age of the patients fell from an average of 9.4 years to 7.5 years (P < .001), with fewer adolescents affected in 2020.

“I think when you cancel a 14-year-old’s baseball season” because of the pandemic, “unfortunately, that lost outdoor time might be substituted with time on a screen,” he explained. “But canceling a 6-year-old’s soccer season might mean substituting that with more time outside on bikes or on a trampoline.”

As noted, because of the pandemic, a higher proportion of pediatric fractures occurred at home (57.8% vs. 32.5%; P < .001) or on bicycles (18.3% vs. 8.2%; P < .001), but there were fewer organized sports–related (7.2% vs. 26.0%; P < .001) or playground-related injuries (5.2% vs. 9.0%; P < .001).

In the study period this year, the researchers saw no increase in the amount of time between injury and presentation. However, data suggest that, in more recent months, “kids are presenting with fractures late, with sometimes great consequences,” Dr. Shah said.

“What has changed is that a lot of adults have lost their jobs, and as a consequence, a lot of children have lost their access to private insurance,” he said. “But fracture is really a major injury, and this is a reminder for pediatricians and primary care physicians to recognize that families are going through these changes and that delays in care can really be detrimental to children.”
 

Velcro splints more common

A potential upside to shifts seen during the pandemic, Dr. Shah said, is the finding that distal radius torus fractures were more likely to be treated with a Velcro splint than in previous years (44.2% vs. 25.9%; P = .010).

“This is hitting on something important – that sometimes it’s crisis that forces us as physicians to evolve,” he said. “This is something I think is here to stay.

“Although research had already been there suggesting a close equivalent between splints and casting, culturally, a lot of surgeons hadn’t made that shift when historically the gold standard had been casting,” Dr. Shah added. “But with the pandemic, the shift to minimize contact with the health care system to keep families safe in their COVID bubble helped [usage of] splints take off.

“I suspect – and we’ll only know when we’re on the other side of this – when physicians see good results in splints in their own patients, they’re going to adopt those strategies more permanently,” he said.

Benjamin Shore, MD, MPH, of Boston Children’s Hospital, agreed with Dr. Shah’s prediction that fracture care will be more streamlined after the pandemic. Dr. Shore, who wasn’t involved in the study, said not only are more orthopedic providers treating patients with Velcro splints and bivalve casts, but they are also monitoring patients via telehealth.

“All of these are great examples of innovation, and one of the unique parts of the pandemic is it created a lot of rapid change across healthcare because it caused us to scrutinize the ways we practice and make a change,” Dr. Shore said in an interview.

“It wasn’t a very fancy study, but it’s very important in terms of demonstrating a change in practice,” Dr. Shore said. “The research here basically validated what many of us are seeing and hopefully will help us in future pandemics – which hopefully won’t happen – to tell families what to be proactive about.”

Dr. Shah and Dr. Shore agreed that, because fewer fractures are occurring in kids during the pandemic, there is an opportunity to redeploy orthopedic providers to other clinical areas on the basis of volume and need.

Dr. Shah and Dr. Shore have disclosed no relevant financial relationships.
 

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

Pediatric fractures dropped by 2.5-fold during the early months of the COVID-19 pandemic, but more breaks happened at home and on bicycles, and younger kids were more affected, new research indicates.

The study of 1,745 patients also found that those with distal radius torus fractures were more likely to receive a Velcro splint during the pandemic. Experts said this key trend points toward widespread shifts to streamline treatment, which should persist after the pandemic.

“We expected to see a drop in fracture volume, but what was a bit unexpected was the proportional rise in at-home injuries, which we weren’t immediately aware of,” said senior author Apurva Shah, MD, MBA, of Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania in Philadelphia.

“As time went on, it became more apparent that trampoline and bicycle injuries were on the rise, but at the beginning of the pandemic, we didn’t intuitively expect that,” he added.

“Whenever there’s a major shift in how the world is working, we want to understand how that impacts child safety,” Dr. Shah said in an interview. “The message to get out to parents is that it’s obviously difficult to supervise kids while working from home” during the pandemic “and that supervision obviously is not always working as well as intended.”

Joshua T. Bram, a medical student, presented the study at the virtual American Academy of Pediatrics (AAP) 2020 National Conference.

Dr. Bram, Dr. Shah, and colleagues compared patients with acute fractures who presented at CHOP between March and April 2020 with those who presented during the same months in 2018 and 2019.

Overall, the number of patients with pediatric fractures who presented to CHOP fell to an average of just under 10 per day, compared with more than 22 per day in prior years (P < .001). In addition, the age of the patients fell from an average of 9.4 years to 7.5 years (P < .001), with fewer adolescents affected in 2020.

“I think when you cancel a 14-year-old’s baseball season” because of the pandemic, “unfortunately, that lost outdoor time might be substituted with time on a screen,” he explained. “But canceling a 6-year-old’s soccer season might mean substituting that with more time outside on bikes or on a trampoline.”

As noted, because of the pandemic, a higher proportion of pediatric fractures occurred at home (57.8% vs. 32.5%; P < .001) or on bicycles (18.3% vs. 8.2%; P < .001), but there were fewer organized sports–related (7.2% vs. 26.0%; P < .001) or playground-related injuries (5.2% vs. 9.0%; P < .001).

In the study period this year, the researchers saw no increase in the amount of time between injury and presentation. However, data suggest that, in more recent months, “kids are presenting with fractures late, with sometimes great consequences,” Dr. Shah said.

“What has changed is that a lot of adults have lost their jobs, and as a consequence, a lot of children have lost their access to private insurance,” he said. “But fracture is really a major injury, and this is a reminder for pediatricians and primary care physicians to recognize that families are going through these changes and that delays in care can really be detrimental to children.”
 

Velcro splints more common

A potential upside to shifts seen during the pandemic, Dr. Shah said, is the finding that distal radius torus fractures were more likely to be treated with a Velcro splint than in previous years (44.2% vs. 25.9%; P = .010).

“This is hitting on something important – that sometimes it’s crisis that forces us as physicians to evolve,” he said. “This is something I think is here to stay.

“Although research had already been there suggesting a close equivalent between splints and casting, culturally, a lot of surgeons hadn’t made that shift when historically the gold standard had been casting,” Dr. Shah added. “But with the pandemic, the shift to minimize contact with the health care system to keep families safe in their COVID bubble helped [usage of] splints take off.

“I suspect – and we’ll only know when we’re on the other side of this – when physicians see good results in splints in their own patients, they’re going to adopt those strategies more permanently,” he said.

Benjamin Shore, MD, MPH, of Boston Children’s Hospital, agreed with Dr. Shah’s prediction that fracture care will be more streamlined after the pandemic. Dr. Shore, who wasn’t involved in the study, said not only are more orthopedic providers treating patients with Velcro splints and bivalve casts, but they are also monitoring patients via telehealth.

“All of these are great examples of innovation, and one of the unique parts of the pandemic is it created a lot of rapid change across healthcare because it caused us to scrutinize the ways we practice and make a change,” Dr. Shore said in an interview.

“It wasn’t a very fancy study, but it’s very important in terms of demonstrating a change in practice,” Dr. Shore said. “The research here basically validated what many of us are seeing and hopefully will help us in future pandemics – which hopefully won’t happen – to tell families what to be proactive about.”

Dr. Shah and Dr. Shore agreed that, because fewer fractures are occurring in kids during the pandemic, there is an opportunity to redeploy orthopedic providers to other clinical areas on the basis of volume and need.

Dr. Shah and Dr. Shore have disclosed no relevant financial relationships.
 

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

Pediatric fractures dropped by 2.5-fold during the early months of the COVID-19 pandemic, but more breaks happened at home and on bicycles, and younger kids were more affected, new research indicates.

The study of 1,745 patients also found that those with distal radius torus fractures were more likely to receive a Velcro splint during the pandemic. Experts said this key trend points toward widespread shifts to streamline treatment, which should persist after the pandemic.

“We expected to see a drop in fracture volume, but what was a bit unexpected was the proportional rise in at-home injuries, which we weren’t immediately aware of,” said senior author Apurva Shah, MD, MBA, of Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania in Philadelphia.

“As time went on, it became more apparent that trampoline and bicycle injuries were on the rise, but at the beginning of the pandemic, we didn’t intuitively expect that,” he added.

“Whenever there’s a major shift in how the world is working, we want to understand how that impacts child safety,” Dr. Shah said in an interview. “The message to get out to parents is that it’s obviously difficult to supervise kids while working from home” during the pandemic “and that supervision obviously is not always working as well as intended.”

Joshua T. Bram, a medical student, presented the study at the virtual American Academy of Pediatrics (AAP) 2020 National Conference.

Dr. Bram, Dr. Shah, and colleagues compared patients with acute fractures who presented at CHOP between March and April 2020 with those who presented during the same months in 2018 and 2019.

Overall, the number of patients with pediatric fractures who presented to CHOP fell to an average of just under 10 per day, compared with more than 22 per day in prior years (P < .001). In addition, the age of the patients fell from an average of 9.4 years to 7.5 years (P < .001), with fewer adolescents affected in 2020.

“I think when you cancel a 14-year-old’s baseball season” because of the pandemic, “unfortunately, that lost outdoor time might be substituted with time on a screen,” he explained. “But canceling a 6-year-old’s soccer season might mean substituting that with more time outside on bikes or on a trampoline.”

As noted, because of the pandemic, a higher proportion of pediatric fractures occurred at home (57.8% vs. 32.5%; P < .001) or on bicycles (18.3% vs. 8.2%; P < .001), but there were fewer organized sports–related (7.2% vs. 26.0%; P < .001) or playground-related injuries (5.2% vs. 9.0%; P < .001).

In the study period this year, the researchers saw no increase in the amount of time between injury and presentation. However, data suggest that, in more recent months, “kids are presenting with fractures late, with sometimes great consequences,” Dr. Shah said.

“What has changed is that a lot of adults have lost their jobs, and as a consequence, a lot of children have lost their access to private insurance,” he said. “But fracture is really a major injury, and this is a reminder for pediatricians and primary care physicians to recognize that families are going through these changes and that delays in care can really be detrimental to children.”
 

Velcro splints more common

A potential upside to shifts seen during the pandemic, Dr. Shah said, is the finding that distal radius torus fractures were more likely to be treated with a Velcro splint than in previous years (44.2% vs. 25.9%; P = .010).

“This is hitting on something important – that sometimes it’s crisis that forces us as physicians to evolve,” he said. “This is something I think is here to stay.

“Although research had already been there suggesting a close equivalent between splints and casting, culturally, a lot of surgeons hadn’t made that shift when historically the gold standard had been casting,” Dr. Shah added. “But with the pandemic, the shift to minimize contact with the health care system to keep families safe in their COVID bubble helped [usage of] splints take off.

“I suspect – and we’ll only know when we’re on the other side of this – when physicians see good results in splints in their own patients, they’re going to adopt those strategies more permanently,” he said.

Benjamin Shore, MD, MPH, of Boston Children’s Hospital, agreed with Dr. Shah’s prediction that fracture care will be more streamlined after the pandemic. Dr. Shore, who wasn’t involved in the study, said not only are more orthopedic providers treating patients with Velcro splints and bivalve casts, but they are also monitoring patients via telehealth.

“All of these are great examples of innovation, and one of the unique parts of the pandemic is it created a lot of rapid change across healthcare because it caused us to scrutinize the ways we practice and make a change,” Dr. Shore said in an interview.

“It wasn’t a very fancy study, but it’s very important in terms of demonstrating a change in practice,” Dr. Shore said. “The research here basically validated what many of us are seeing and hopefully will help us in future pandemics – which hopefully won’t happen – to tell families what to be proactive about.”

Dr. Shah and Dr. Shore agreed that, because fewer fractures are occurring in kids during the pandemic, there is an opportunity to redeploy orthopedic providers to other clinical areas on the basis of volume and need.

Dr. Shah and Dr. Shore have disclosed no relevant financial relationships.
 

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

Conventional chest x-rays combined with artificial intelligence (AI) can identify lung damage from COVID-19 and differentiate coronavirus patients from other patients, improving triage efforts, new research suggests.

The AI tool – developed by Jason Fleischer, PhD, and graduate student Mohammad Tariqul Islam, both from Princeton (N.J.) University – can distinguish COVID-19 patients from those with pneumonia or normal lung tissue with an accuracy of more than 95%.

“We were able to separate the COVID-19 patients with very high fidelity,” Dr. Fleischer said in an interview. “If you give me an x-ray now, I can say with very high confidence whether a patient has COVID-19.”

The diagnostic tool pinpoints patterns on x-ray images that are too subtle for even trained experts to notice. The precision of CT scanning is similar to that of the AI tool, but CT costs much more and has other disadvantages, said Dr. Fleischer, who presented his findings at the virtual European Respiratory Society International Congress 2020.

“CT is more expensive and uses higher doses of radiation,” he said. “Another big thing is that not everyone has tomography facilities – including a lot of rural places and developing countries – so you need something that’s on the spot.”

With machine learning, Dr. Fleischer analyzed 2,300 x-ray images: 1,018 “normal” images from patients who had neither pneumonia nor COVID-19, 1,011 from patients with pneumonia, and 271 from patients with COVID-19.

The AI tool uses a neural network to refine the number and type of lung features being tracked. A UMAP (Uniform Manifold Approximation and Projection) clustering algorithm then looks for similarities and differences in those images, he explained.

“We, as users, knew which type each x-ray was – normal, pneumonia positive, or COVID-19 positive – but the network did not,” he added.

Clinicians have observed two basic types of lung problems in COVID-19 patients: pneumonia that fills lung air sacs with fluid and dangerously low blood-oxygen levels despite nearly normal breathing patterns. Because treatment can vary according to type, it would be beneficial to quickly distinguish between them, Dr. Fleischer said.

The AI tool showed that there is a distinct difference in chest x-rays from pneumonia-positive patients and healthy people, he said. It also demonstrated two distinct clusters of COVID-19–positive chest x-rays: those that looked like pneumonia and those with a more normal presentation.

The fact that “the AI system recognizes something unique in chest x-rays from COVID-19–positive patients” indicates that the computer is able to identify visual markers for coronavirus, he explained. “We currently do not know what these markers are.”

Dr. Fleischer said his goal is not to replace physician decision-making, but to supplement it.

“I’m uncomfortable with having computers make the final decision,” he said. “They often have a narrow focus, whereas doctors have the big picture in mind.”

This AI tool is “very interesting,” especially in the context of expanding AI applications in various specialties, said Thierry Fumeaux, MD, from Nyon (Switzerland) Hospital. Some physicians currently disagree on whether a chest x-ray or CT scan is the better tool to help diagnose COVID-19.

“It seems better than the human eye and brain” to pinpoint COVID-19 lung damage, “so it’s very attractive as a technology,” Dr. Fumeaux said in an interview.

And AI can be used to supplement the efforts of busy and fatigued clinicians who might be stretched thin by large caseloads. “I cannot read 200 chest x-rays in a day, but a computer can do that in 2 minutes,” he said.

But Dr. Fumeaux offered a caveat: “Pattern recognition is promising, but at the moment I’m not aware of papers showing that, by using AI, you’re changing anything in the outcome of a patient.”

Ideally, Dr. Fleischer said he hopes that AI will soon be able to accurately indicate which treatments are most effective for individual COVID-19 patients. And the technology might eventually be used to help with treatment decisions for patients with asthma or chronic obstructive pulmonary disease, he noted.

But he needs more data before results indicate whether a COVID-19 patient would benefit from ventilator support, for example, and the tool can be used more widely. To contribute data or collaborate with Dr. Fleischer’s efforts, contact him.

“Machine learning is all about data, so you can find these correlations,” he said. “It would be nice to be able to use it to reassure a worried patient that their prognosis is good; to say that most of the people with symptoms like yours will be just fine.”

Dr. Fleischer and Dr. Fumeaux have declared no relevant financial relationships.

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

Conventional chest x-rays combined with artificial intelligence (AI) can identify lung damage from COVID-19 and differentiate coronavirus patients from other patients, improving triage efforts, new research suggests.

The AI tool – developed by Jason Fleischer, PhD, and graduate student Mohammad Tariqul Islam, both from Princeton (N.J.) University – can distinguish COVID-19 patients from those with pneumonia or normal lung tissue with an accuracy of more than 95%.

“We were able to separate the COVID-19 patients with very high fidelity,” Dr. Fleischer said in an interview. “If you give me an x-ray now, I can say with very high confidence whether a patient has COVID-19.”

The diagnostic tool pinpoints patterns on x-ray images that are too subtle for even trained experts to notice. The precision of CT scanning is similar to that of the AI tool, but CT costs much more and has other disadvantages, said Dr. Fleischer, who presented his findings at the virtual European Respiratory Society International Congress 2020.

“CT is more expensive and uses higher doses of radiation,” he said. “Another big thing is that not everyone has tomography facilities – including a lot of rural places and developing countries – so you need something that’s on the spot.”

With machine learning, Dr. Fleischer analyzed 2,300 x-ray images: 1,018 “normal” images from patients who had neither pneumonia nor COVID-19, 1,011 from patients with pneumonia, and 271 from patients with COVID-19.

The AI tool uses a neural network to refine the number and type of lung features being tracked. A UMAP (Uniform Manifold Approximation and Projection) clustering algorithm then looks for similarities and differences in those images, he explained.

“We, as users, knew which type each x-ray was – normal, pneumonia positive, or COVID-19 positive – but the network did not,” he added.

Clinicians have observed two basic types of lung problems in COVID-19 patients: pneumonia that fills lung air sacs with fluid and dangerously low blood-oxygen levels despite nearly normal breathing patterns. Because treatment can vary according to type, it would be beneficial to quickly distinguish between them, Dr. Fleischer said.

The AI tool showed that there is a distinct difference in chest x-rays from pneumonia-positive patients and healthy people, he said. It also demonstrated two distinct clusters of COVID-19–positive chest x-rays: those that looked like pneumonia and those with a more normal presentation.

The fact that “the AI system recognizes something unique in chest x-rays from COVID-19–positive patients” indicates that the computer is able to identify visual markers for coronavirus, he explained. “We currently do not know what these markers are.”

Dr. Fleischer said his goal is not to replace physician decision-making, but to supplement it.

“I’m uncomfortable with having computers make the final decision,” he said. “They often have a narrow focus, whereas doctors have the big picture in mind.”

This AI tool is “very interesting,” especially in the context of expanding AI applications in various specialties, said Thierry Fumeaux, MD, from Nyon (Switzerland) Hospital. Some physicians currently disagree on whether a chest x-ray or CT scan is the better tool to help diagnose COVID-19.

“It seems better than the human eye and brain” to pinpoint COVID-19 lung damage, “so it’s very attractive as a technology,” Dr. Fumeaux said in an interview.

And AI can be used to supplement the efforts of busy and fatigued clinicians who might be stretched thin by large caseloads. “I cannot read 200 chest x-rays in a day, but a computer can do that in 2 minutes,” he said.

But Dr. Fumeaux offered a caveat: “Pattern recognition is promising, but at the moment I’m not aware of papers showing that, by using AI, you’re changing anything in the outcome of a patient.”

Ideally, Dr. Fleischer said he hopes that AI will soon be able to accurately indicate which treatments are most effective for individual COVID-19 patients. And the technology might eventually be used to help with treatment decisions for patients with asthma or chronic obstructive pulmonary disease, he noted.

But he needs more data before results indicate whether a COVID-19 patient would benefit from ventilator support, for example, and the tool can be used more widely. To contribute data or collaborate with Dr. Fleischer’s efforts, contact him.

“Machine learning is all about data, so you can find these correlations,” he said. “It would be nice to be able to use it to reassure a worried patient that their prognosis is good; to say that most of the people with symptoms like yours will be just fine.”

Dr. Fleischer and Dr. Fumeaux have declared no relevant financial relationships.

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

Conventional chest x-rays combined with artificial intelligence (AI) can identify lung damage from COVID-19 and differentiate coronavirus patients from other patients, improving triage efforts, new research suggests.

The AI tool – developed by Jason Fleischer, PhD, and graduate student Mohammad Tariqul Islam, both from Princeton (N.J.) University – can distinguish COVID-19 patients from those with pneumonia or normal lung tissue with an accuracy of more than 95%.

“We were able to separate the COVID-19 patients with very high fidelity,” Dr. Fleischer said in an interview. “If you give me an x-ray now, I can say with very high confidence whether a patient has COVID-19.”

The diagnostic tool pinpoints patterns on x-ray images that are too subtle for even trained experts to notice. The precision of CT scanning is similar to that of the AI tool, but CT costs much more and has other disadvantages, said Dr. Fleischer, who presented his findings at the virtual European Respiratory Society International Congress 2020.

“CT is more expensive and uses higher doses of radiation,” he said. “Another big thing is that not everyone has tomography facilities – including a lot of rural places and developing countries – so you need something that’s on the spot.”

With machine learning, Dr. Fleischer analyzed 2,300 x-ray images: 1,018 “normal” images from patients who had neither pneumonia nor COVID-19, 1,011 from patients with pneumonia, and 271 from patients with COVID-19.

The AI tool uses a neural network to refine the number and type of lung features being tracked. A UMAP (Uniform Manifold Approximation and Projection) clustering algorithm then looks for similarities and differences in those images, he explained.

“We, as users, knew which type each x-ray was – normal, pneumonia positive, or COVID-19 positive – but the network did not,” he added.

Clinicians have observed two basic types of lung problems in COVID-19 patients: pneumonia that fills lung air sacs with fluid and dangerously low blood-oxygen levels despite nearly normal breathing patterns. Because treatment can vary according to type, it would be beneficial to quickly distinguish between them, Dr. Fleischer said.

The AI tool showed that there is a distinct difference in chest x-rays from pneumonia-positive patients and healthy people, he said. It also demonstrated two distinct clusters of COVID-19–positive chest x-rays: those that looked like pneumonia and those with a more normal presentation.

The fact that “the AI system recognizes something unique in chest x-rays from COVID-19–positive patients” indicates that the computer is able to identify visual markers for coronavirus, he explained. “We currently do not know what these markers are.”

Dr. Fleischer said his goal is not to replace physician decision-making, but to supplement it.

“I’m uncomfortable with having computers make the final decision,” he said. “They often have a narrow focus, whereas doctors have the big picture in mind.”

This AI tool is “very interesting,” especially in the context of expanding AI applications in various specialties, said Thierry Fumeaux, MD, from Nyon (Switzerland) Hospital. Some physicians currently disagree on whether a chest x-ray or CT scan is the better tool to help diagnose COVID-19.

“It seems better than the human eye and brain” to pinpoint COVID-19 lung damage, “so it’s very attractive as a technology,” Dr. Fumeaux said in an interview.

And AI can be used to supplement the efforts of busy and fatigued clinicians who might be stretched thin by large caseloads. “I cannot read 200 chest x-rays in a day, but a computer can do that in 2 minutes,” he said.

But Dr. Fumeaux offered a caveat: “Pattern recognition is promising, but at the moment I’m not aware of papers showing that, by using AI, you’re changing anything in the outcome of a patient.”

Ideally, Dr. Fleischer said he hopes that AI will soon be able to accurately indicate which treatments are most effective for individual COVID-19 patients. And the technology might eventually be used to help with treatment decisions for patients with asthma or chronic obstructive pulmonary disease, he noted.

But he needs more data before results indicate whether a COVID-19 patient would benefit from ventilator support, for example, and the tool can be used more widely. To contribute data or collaborate with Dr. Fleischer’s efforts, contact him.

“Machine learning is all about data, so you can find these correlations,” he said. “It would be nice to be able to use it to reassure a worried patient that their prognosis is good; to say that most of the people with symptoms like yours will be just fine.”

Dr. Fleischer and Dr. Fumeaux have declared no relevant financial relationships.

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

Upadacitinib (Rinvoq) improves joint and skin symptoms in patients with psoriatic arthritis for whom at least one other disease-modifying antirheumatic drug (DMARD) didn’t work or wasn’t well tolerated, a pair of phase 3 trials suggests.

“In psoriatic arthritis patients, there’s still a high proportion of patients who do not respond to traditional, nonbiologic DMARDs, so there’s room for improvement,” said Marina Magrey, MD, from the MetroHealth Medical Center, Case Western Reserve University School of Medicine, in Cleveland.

She and her colleagues evaluated the JAK inhibitor, already approved for rheumatoid arthritis in the United States, in the SELECT-PsA 1 and SELECT-PsA 2 trials, which followed more than 2,300 patients with psoriatic arthritis for an average of 6-10 years.

No safety signals emerged for upadacitinib in either trial that weren’t already seen in patients with rheumatoid arthritis, the investigators report, although a lower dose appeared to prompt fewer adverse events.

The research adds upadacitinib “to the armamentarium of medications we have against psoriatic arthritis,” said Dr. Magrey, who is a SELECT-PsA 1 investigator.

“The advantage of this medication is it’s available orally, so the convenience is there. It will enable both patients and physicians to choose from efficacious medications,” she told Medscape Medical News.

Mitchel L. Zoler/MDedge News

The team was “pleasantly surprised by the magnitude and rapidity of effect” of upadacitinib in study participants, said Philip Mease, MD, from the Swedish Medical Center and the University of Washington in Seattle, who is lead investigator for SELECT-PsA 2.

“It’s important to be able to understand if there’s adequate effectiveness in patients who’ve already been around the block several times with other treatments,” Dr. Mease told Medscape Medical News. “This trial demonstrated there was a high degree of effectiveness in each of the clinical domains” of psoriatic arthritis.

Results from both studies were presented at the virtual European League Against Rheumatism 2020 Congress.
 

SELECT-PsA 1

In SELECT-PsA 1, upadacitinib was compared with adalimumab and placebo in 1705 patients who previously had an inadequate response or intolerance to at least one nonbiologic DMARD. Participants were randomized to receive upadacitinib – 15 mg or 30 mg once daily – adalimumab 40 mg every other week, or placebo.

The primary endpoint was an improvement of at least 20% (ACR20) at week 12.

Secondary endpoints included change in Health Assessment Questionnaire Disability Index (HAQ-DI) score and change in patient assessment of pain on a numeric rating scale from baseline to week 12, achievement of ACR50 and ACR70 at week 12, and achievement of ACR20 at week 2.

Treatment-related adverse events were reported out to week 24 for patients who received at least one dose of upadacitinib.

Improvement in musculoskeletal symptoms, psoriasis, pain, physical function, and fatigue were seen by week 2 in both upadacitinib groups. At week 12, both doses of upadacitinib were noninferior to adalimumab for the achievement of ACR20 (P < .001), and the 30-mg dose was superior to adalimumab (P < .001).

More patients in the upadacitinib groups than in the placebo group met the stringent criteria for disease control, which included the achievement of minimal disease activity, ACR50, and ACR70.

The difference in effectiveness between the two doses of upadacitinib was small, but “there were relatively more adverse events,” such as infections, in the 30-mg group, Dr. Magrey reported, “so 15 mg seems like it will be the dose to go toward FDA approval.”
 

SELECT-PsA 2

SELECT-PsA 2 compared upadacitinib – 15 mg or 30 mg once daily – with placebo in 641 patients who previously had an inadequate response or intolerance to one or more biologic DMARDs.

The primary endpoint was the achievement of ACR20 at week 12.

Among the many secondary endpoints were a 75% improvement in Psoriasis Area and Severity Index score (PASI 75) at week 16, change in Self-Assessment of Psoriasis Symptoms (SAPS) score from baseline to week 16, the achievement of minimal disease activity at week 24, the achievement of ACR50 and ACR70 at week 12, and the achievement of ACR20 at week 2.

Adverse events were reported for patients who received at least one dose of upadacitinib.

At week 12, ACR20 was achieved by significantly more patients in the 15 mg and 30 mg upadacitinib groups than in the placebo group (56.9% vs. 63.8% vs. 24.1%; P < .0001), as was ACR50 (31.8% vs. 37.6% vs. 4.1%; P < .0001) and ACR70 (8.5% vs. 16.5% vs. 0.5%; P < .0001). In addition, all secondary endpoints were significantly better with upadacitinib than with placebo.

Rates of adverse events were similar in the 15 mg upadacitinib and placebo groups, but the rate was higher in the 30 mg upadacitinib group, including for herpes zoster.

“I was pleasantly surprised by the overall safety profile,” Dr. Mease said. “Yes, you need to pay attention to the potential for infection, but rates of serious infection were very low.”

“We didn’t see opportunistic infections occurring, and the overall adverse-events profile was one where we could be pretty reassuring with patients when introducing the medication and mechanism of action,” he added.

Upadacitinib appears to have significantly improved PASI scores in both trials, which is surprising, said Christopher Ritchlin, MD, from the University of Rochester Medical Center in New York.

“I think the data indicate that upadacitinib is a viable drug for treatment of psoriatic arthritis,” he told Medscape Medical News. “I don’t think it’s going to be tested in psoriasis, but for those with psoriatic arthritis and those whose burden of psoriasis is not particularly elevated, this drug looks like it might be very helpful to practicing physicians and their patients.”

Dr. Ritchlin added that he hopes future research will address whether upadacitinib is effective for axial disease in psoriatic arthritis, which wasn’t measured in these trials.

“I don’t see this as a weakness” of the current research, he said, but “having some spinal measures would be helpful. It’s something additional we’d like to know.”

Both trials were funded by AbbVie. Dr. Magrey reports financial relationships with Amgen, AbbVie, UCB Pharma, Novartis, Eli Lilly, Pfizer, and Janssen. Dr. Mease reports financial relationships with Abbott, Amgen, Biogen, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB, Genentech, and Janssen. Dr. Ritchlin has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.




 

Upadacitinib (Rinvoq) improves joint and skin symptoms in patients with psoriatic arthritis for whom at least one other disease-modifying antirheumatic drug (DMARD) didn’t work or wasn’t well tolerated, a pair of phase 3 trials suggests.

“In psoriatic arthritis patients, there’s still a high proportion of patients who do not respond to traditional, nonbiologic DMARDs, so there’s room for improvement,” said Marina Magrey, MD, from the MetroHealth Medical Center, Case Western Reserve University School of Medicine, in Cleveland.

She and her colleagues evaluated the JAK inhibitor, already approved for rheumatoid arthritis in the United States, in the SELECT-PsA 1 and SELECT-PsA 2 trials, which followed more than 2,300 patients with psoriatic arthritis for an average of 6-10 years.

No safety signals emerged for upadacitinib in either trial that weren’t already seen in patients with rheumatoid arthritis, the investigators report, although a lower dose appeared to prompt fewer adverse events.

The research adds upadacitinib “to the armamentarium of medications we have against psoriatic arthritis,” said Dr. Magrey, who is a SELECT-PsA 1 investigator.

“The advantage of this medication is it’s available orally, so the convenience is there. It will enable both patients and physicians to choose from efficacious medications,” she told Medscape Medical News.

Mitchel L. Zoler/MDedge News

The team was “pleasantly surprised by the magnitude and rapidity of effect” of upadacitinib in study participants, said Philip Mease, MD, from the Swedish Medical Center and the University of Washington in Seattle, who is lead investigator for SELECT-PsA 2.

“It’s important to be able to understand if there’s adequate effectiveness in patients who’ve already been around the block several times with other treatments,” Dr. Mease told Medscape Medical News. “This trial demonstrated there was a high degree of effectiveness in each of the clinical domains” of psoriatic arthritis.

Results from both studies were presented at the virtual European League Against Rheumatism 2020 Congress.
 

SELECT-PsA 1

In SELECT-PsA 1, upadacitinib was compared with adalimumab and placebo in 1705 patients who previously had an inadequate response or intolerance to at least one nonbiologic DMARD. Participants were randomized to receive upadacitinib – 15 mg or 30 mg once daily – adalimumab 40 mg every other week, or placebo.

The primary endpoint was an improvement of at least 20% (ACR20) at week 12.

Secondary endpoints included change in Health Assessment Questionnaire Disability Index (HAQ-DI) score and change in patient assessment of pain on a numeric rating scale from baseline to week 12, achievement of ACR50 and ACR70 at week 12, and achievement of ACR20 at week 2.

Treatment-related adverse events were reported out to week 24 for patients who received at least one dose of upadacitinib.

Improvement in musculoskeletal symptoms, psoriasis, pain, physical function, and fatigue were seen by week 2 in both upadacitinib groups. At week 12, both doses of upadacitinib were noninferior to adalimumab for the achievement of ACR20 (P < .001), and the 30-mg dose was superior to adalimumab (P < .001).

More patients in the upadacitinib groups than in the placebo group met the stringent criteria for disease control, which included the achievement of minimal disease activity, ACR50, and ACR70.

The difference in effectiveness between the two doses of upadacitinib was small, but “there were relatively more adverse events,” such as infections, in the 30-mg group, Dr. Magrey reported, “so 15 mg seems like it will be the dose to go toward FDA approval.”
 

SELECT-PsA 2

SELECT-PsA 2 compared upadacitinib – 15 mg or 30 mg once daily – with placebo in 641 patients who previously had an inadequate response or intolerance to one or more biologic DMARDs.

The primary endpoint was the achievement of ACR20 at week 12.

Among the many secondary endpoints were a 75% improvement in Psoriasis Area and Severity Index score (PASI 75) at week 16, change in Self-Assessment of Psoriasis Symptoms (SAPS) score from baseline to week 16, the achievement of minimal disease activity at week 24, the achievement of ACR50 and ACR70 at week 12, and the achievement of ACR20 at week 2.

Adverse events were reported for patients who received at least one dose of upadacitinib.

At week 12, ACR20 was achieved by significantly more patients in the 15 mg and 30 mg upadacitinib groups than in the placebo group (56.9% vs. 63.8% vs. 24.1%; P < .0001), as was ACR50 (31.8% vs. 37.6% vs. 4.1%; P < .0001) and ACR70 (8.5% vs. 16.5% vs. 0.5%; P < .0001). In addition, all secondary endpoints were significantly better with upadacitinib than with placebo.

Rates of adverse events were similar in the 15 mg upadacitinib and placebo groups, but the rate was higher in the 30 mg upadacitinib group, including for herpes zoster.

“I was pleasantly surprised by the overall safety profile,” Dr. Mease said. “Yes, you need to pay attention to the potential for infection, but rates of serious infection were very low.”

“We didn’t see opportunistic infections occurring, and the overall adverse-events profile was one where we could be pretty reassuring with patients when introducing the medication and mechanism of action,” he added.

Upadacitinib appears to have significantly improved PASI scores in both trials, which is surprising, said Christopher Ritchlin, MD, from the University of Rochester Medical Center in New York.

“I think the data indicate that upadacitinib is a viable drug for treatment of psoriatic arthritis,” he told Medscape Medical News. “I don’t think it’s going to be tested in psoriasis, but for those with psoriatic arthritis and those whose burden of psoriasis is not particularly elevated, this drug looks like it might be very helpful to practicing physicians and their patients.”

Dr. Ritchlin added that he hopes future research will address whether upadacitinib is effective for axial disease in psoriatic arthritis, which wasn’t measured in these trials.

“I don’t see this as a weakness” of the current research, he said, but “having some spinal measures would be helpful. It’s something additional we’d like to know.”

Both trials were funded by AbbVie. Dr. Magrey reports financial relationships with Amgen, AbbVie, UCB Pharma, Novartis, Eli Lilly, Pfizer, and Janssen. Dr. Mease reports financial relationships with Abbott, Amgen, Biogen, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB, Genentech, and Janssen. Dr. Ritchlin has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.




 

Upadacitinib (Rinvoq) improves joint and skin symptoms in patients with psoriatic arthritis for whom at least one other disease-modifying antirheumatic drug (DMARD) didn’t work or wasn’t well tolerated, a pair of phase 3 trials suggests.

“In psoriatic arthritis patients, there’s still a high proportion of patients who do not respond to traditional, nonbiologic DMARDs, so there’s room for improvement,” said Marina Magrey, MD, from the MetroHealth Medical Center, Case Western Reserve University School of Medicine, in Cleveland.

She and her colleagues evaluated the JAK inhibitor, already approved for rheumatoid arthritis in the United States, in the SELECT-PsA 1 and SELECT-PsA 2 trials, which followed more than 2,300 patients with psoriatic arthritis for an average of 6-10 years.

No safety signals emerged for upadacitinib in either trial that weren’t already seen in patients with rheumatoid arthritis, the investigators report, although a lower dose appeared to prompt fewer adverse events.

The research adds upadacitinib “to the armamentarium of medications we have against psoriatic arthritis,” said Dr. Magrey, who is a SELECT-PsA 1 investigator.

“The advantage of this medication is it’s available orally, so the convenience is there. It will enable both patients and physicians to choose from efficacious medications,” she told Medscape Medical News.

Mitchel L. Zoler/MDedge News

The team was “pleasantly surprised by the magnitude and rapidity of effect” of upadacitinib in study participants, said Philip Mease, MD, from the Swedish Medical Center and the University of Washington in Seattle, who is lead investigator for SELECT-PsA 2.

“It’s important to be able to understand if there’s adequate effectiveness in patients who’ve already been around the block several times with other treatments,” Dr. Mease told Medscape Medical News. “This trial demonstrated there was a high degree of effectiveness in each of the clinical domains” of psoriatic arthritis.

Results from both studies were presented at the virtual European League Against Rheumatism 2020 Congress.
 

SELECT-PsA 1

In SELECT-PsA 1, upadacitinib was compared with adalimumab and placebo in 1705 patients who previously had an inadequate response or intolerance to at least one nonbiologic DMARD. Participants were randomized to receive upadacitinib – 15 mg or 30 mg once daily – adalimumab 40 mg every other week, or placebo.

The primary endpoint was an improvement of at least 20% (ACR20) at week 12.

Secondary endpoints included change in Health Assessment Questionnaire Disability Index (HAQ-DI) score and change in patient assessment of pain on a numeric rating scale from baseline to week 12, achievement of ACR50 and ACR70 at week 12, and achievement of ACR20 at week 2.

Treatment-related adverse events were reported out to week 24 for patients who received at least one dose of upadacitinib.

Improvement in musculoskeletal symptoms, psoriasis, pain, physical function, and fatigue were seen by week 2 in both upadacitinib groups. At week 12, both doses of upadacitinib were noninferior to adalimumab for the achievement of ACR20 (P < .001), and the 30-mg dose was superior to adalimumab (P < .001).

More patients in the upadacitinib groups than in the placebo group met the stringent criteria for disease control, which included the achievement of minimal disease activity, ACR50, and ACR70.

The difference in effectiveness between the two doses of upadacitinib was small, but “there were relatively more adverse events,” such as infections, in the 30-mg group, Dr. Magrey reported, “so 15 mg seems like it will be the dose to go toward FDA approval.”
 

SELECT-PsA 2

SELECT-PsA 2 compared upadacitinib – 15 mg or 30 mg once daily – with placebo in 641 patients who previously had an inadequate response or intolerance to one or more biologic DMARDs.

The primary endpoint was the achievement of ACR20 at week 12.

Among the many secondary endpoints were a 75% improvement in Psoriasis Area and Severity Index score (PASI 75) at week 16, change in Self-Assessment of Psoriasis Symptoms (SAPS) score from baseline to week 16, the achievement of minimal disease activity at week 24, the achievement of ACR50 and ACR70 at week 12, and the achievement of ACR20 at week 2.

Adverse events were reported for patients who received at least one dose of upadacitinib.

At week 12, ACR20 was achieved by significantly more patients in the 15 mg and 30 mg upadacitinib groups than in the placebo group (56.9% vs. 63.8% vs. 24.1%; P < .0001), as was ACR50 (31.8% vs. 37.6% vs. 4.1%; P < .0001) and ACR70 (8.5% vs. 16.5% vs. 0.5%; P < .0001). In addition, all secondary endpoints were significantly better with upadacitinib than with placebo.

Rates of adverse events were similar in the 15 mg upadacitinib and placebo groups, but the rate was higher in the 30 mg upadacitinib group, including for herpes zoster.

“I was pleasantly surprised by the overall safety profile,” Dr. Mease said. “Yes, you need to pay attention to the potential for infection, but rates of serious infection were very low.”

“We didn’t see opportunistic infections occurring, and the overall adverse-events profile was one where we could be pretty reassuring with patients when introducing the medication and mechanism of action,” he added.

Upadacitinib appears to have significantly improved PASI scores in both trials, which is surprising, said Christopher Ritchlin, MD, from the University of Rochester Medical Center in New York.

“I think the data indicate that upadacitinib is a viable drug for treatment of psoriatic arthritis,” he told Medscape Medical News. “I don’t think it’s going to be tested in psoriasis, but for those with psoriatic arthritis and those whose burden of psoriasis is not particularly elevated, this drug looks like it might be very helpful to practicing physicians and their patients.”

Dr. Ritchlin added that he hopes future research will address whether upadacitinib is effective for axial disease in psoriatic arthritis, which wasn’t measured in these trials.

“I don’t see this as a weakness” of the current research, he said, but “having some spinal measures would be helpful. It’s something additional we’d like to know.”

Both trials were funded by AbbVie. Dr. Magrey reports financial relationships with Amgen, AbbVie, UCB Pharma, Novartis, Eli Lilly, Pfizer, and Janssen. Dr. Mease reports financial relationships with Abbott, Amgen, Biogen, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB, Genentech, and Janssen. Dr. Ritchlin has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.




 

Patients with rheumatoid arthritis remained on therapy longer with the relatively new JAK inhibitors than with TNF inhibitors, according to the large international JAK-pot study, offering encouraging signals about the efficacy and safety of JAK inhibitors in these patients.

“We saw that efficacy with JAK inhibitors was at least as good as other current drugs on the market,” said investigator Kim Lauper, MD, from the University of Geneva in Switzerland and the University of Manchester in the United Kingdom.

“We don’t have datasets on JAK inhibitors over a long period of time, but we do have a lot of registers,” Dr. Lauper told Medscape Medical News.

“In general, we were really happy to see no big difference in effectiveness” for these disease-modifying antirheumatic drugs (DMARDs) for patients with RA, she said.

In many countries, JAK inhibitors have only recently been approved as a treatment for RA, Lauper explained. In the past several years, baricitinib, tofacitinib, and upadacitinib have been approved by the U.S. Food and Drug Administration.

For their study, Dr. Lauper and her colleagues analyzed data from registers in 19 countries.

When JAK inhibitors became available in each country, the team assessed effectiveness by comparing how long patients remained on JAK inhibitors or on long-available biologics. Dr. Lauper presented the findings at the virtual European League Against Rheumatism (EULAR) 2020 Congress.

“In general, we know that drug retention is a measure of both effectiveness and safety,” she explained.

Of the 25,521 patients in the 19 registers, 6,063 started on a JAK inhibitor during the 3-year study period, 13,879 started on a TNF inhibitor, 2,348 started on abatacept, and 3,231 started on an interleukin-6 inhibitor.

Three-quarters of patients were women (average age, 55 years), and average time since the diagnosis of RA was 10 years.

At baseline, patients taking JAK inhibitors had higher levels of C-reactive protein and disease activity than patients taking a biologic. They had also been treated previously with more traditional and biologic DMARDs.

Ineffectiveness was the most common reason for discontinuing a drug, cited by 49% of patients, followed by adverse events, cited by 21%.

The rate of discontinuation was lower for JAK inhibitors than for TNF inhibitors, after adjustment. However, the discontinuation rate for JAK inhibitors, abatacept, and IL-6 inhibitors was comparable.

The observational nature of the study was a limitation, Dr. Lauper acknowledged, explaining that “we couldn’t adjust for confounding factors that were not measured.”

Notably, there were large variations in JAK inhibitor retention rates in the different countries, which surprised both Dr. Lauper and Loreto Carmona, MD, PhD, from the Musculoskeletal Health Institute in Madrid.

“It’s very interesting because there’s not much heterogeneity with abatacept and IL inhibitors,” said Dr. Carmona, who is chair of the EULAR abstract selection committee.

“It’s all over the spectrum with JAK inhibitors,” she told Medscape Medical News. But “what the research shows is that JAK inhibitors are maintained for longer, which means maybe the mix of efficacy, low toxicity, and adherence, on the whole, is better in JAK inhibitors.”

The study was funded by Pfizer. Dr. Lauper and Dr. Carmona have disclosed no relevant financial relationships.

This story first appeared on Medscape.com.




 

Patients with rheumatoid arthritis remained on therapy longer with the relatively new JAK inhibitors than with TNF inhibitors, according to the large international JAK-pot study, offering encouraging signals about the efficacy and safety of JAK inhibitors in these patients.

“We saw that efficacy with JAK inhibitors was at least as good as other current drugs on the market,” said investigator Kim Lauper, MD, from the University of Geneva in Switzerland and the University of Manchester in the United Kingdom.

“We don’t have datasets on JAK inhibitors over a long period of time, but we do have a lot of registers,” Dr. Lauper told Medscape Medical News.

“In general, we were really happy to see no big difference in effectiveness” for these disease-modifying antirheumatic drugs (DMARDs) for patients with RA, she said.

In many countries, JAK inhibitors have only recently been approved as a treatment for RA, Lauper explained. In the past several years, baricitinib, tofacitinib, and upadacitinib have been approved by the U.S. Food and Drug Administration.

For their study, Dr. Lauper and her colleagues analyzed data from registers in 19 countries.

When JAK inhibitors became available in each country, the team assessed effectiveness by comparing how long patients remained on JAK inhibitors or on long-available biologics. Dr. Lauper presented the findings at the virtual European League Against Rheumatism (EULAR) 2020 Congress.

“In general, we know that drug retention is a measure of both effectiveness and safety,” she explained.

Of the 25,521 patients in the 19 registers, 6,063 started on a JAK inhibitor during the 3-year study period, 13,879 started on a TNF inhibitor, 2,348 started on abatacept, and 3,231 started on an interleukin-6 inhibitor.

Three-quarters of patients were women (average age, 55 years), and average time since the diagnosis of RA was 10 years.

At baseline, patients taking JAK inhibitors had higher levels of C-reactive protein and disease activity than patients taking a biologic. They had also been treated previously with more traditional and biologic DMARDs.

Ineffectiveness was the most common reason for discontinuing a drug, cited by 49% of patients, followed by adverse events, cited by 21%.

The rate of discontinuation was lower for JAK inhibitors than for TNF inhibitors, after adjustment. However, the discontinuation rate for JAK inhibitors, abatacept, and IL-6 inhibitors was comparable.

The observational nature of the study was a limitation, Dr. Lauper acknowledged, explaining that “we couldn’t adjust for confounding factors that were not measured.”

Notably, there were large variations in JAK inhibitor retention rates in the different countries, which surprised both Dr. Lauper and Loreto Carmona, MD, PhD, from the Musculoskeletal Health Institute in Madrid.

“It’s very interesting because there’s not much heterogeneity with abatacept and IL inhibitors,” said Dr. Carmona, who is chair of the EULAR abstract selection committee.

“It’s all over the spectrum with JAK inhibitors,” she told Medscape Medical News. But “what the research shows is that JAK inhibitors are maintained for longer, which means maybe the mix of efficacy, low toxicity, and adherence, on the whole, is better in JAK inhibitors.”

The study was funded by Pfizer. Dr. Lauper and Dr. Carmona have disclosed no relevant financial relationships.

This story first appeared on Medscape.com.




 

Patients with rheumatoid arthritis remained on therapy longer with the relatively new JAK inhibitors than with TNF inhibitors, according to the large international JAK-pot study, offering encouraging signals about the efficacy and safety of JAK inhibitors in these patients.

“We saw that efficacy with JAK inhibitors was at least as good as other current drugs on the market,” said investigator Kim Lauper, MD, from the University of Geneva in Switzerland and the University of Manchester in the United Kingdom.

“We don’t have datasets on JAK inhibitors over a long period of time, but we do have a lot of registers,” Dr. Lauper told Medscape Medical News.

“In general, we were really happy to see no big difference in effectiveness” for these disease-modifying antirheumatic drugs (DMARDs) for patients with RA, she said.

In many countries, JAK inhibitors have only recently been approved as a treatment for RA, Lauper explained. In the past several years, baricitinib, tofacitinib, and upadacitinib have been approved by the U.S. Food and Drug Administration.

For their study, Dr. Lauper and her colleagues analyzed data from registers in 19 countries.

When JAK inhibitors became available in each country, the team assessed effectiveness by comparing how long patients remained on JAK inhibitors or on long-available biologics. Dr. Lauper presented the findings at the virtual European League Against Rheumatism (EULAR) 2020 Congress.

“In general, we know that drug retention is a measure of both effectiveness and safety,” she explained.

Of the 25,521 patients in the 19 registers, 6,063 started on a JAK inhibitor during the 3-year study period, 13,879 started on a TNF inhibitor, 2,348 started on abatacept, and 3,231 started on an interleukin-6 inhibitor.

Three-quarters of patients were women (average age, 55 years), and average time since the diagnosis of RA was 10 years.

At baseline, patients taking JAK inhibitors had higher levels of C-reactive protein and disease activity than patients taking a biologic. They had also been treated previously with more traditional and biologic DMARDs.

Ineffectiveness was the most common reason for discontinuing a drug, cited by 49% of patients, followed by adverse events, cited by 21%.

The rate of discontinuation was lower for JAK inhibitors than for TNF inhibitors, after adjustment. However, the discontinuation rate for JAK inhibitors, abatacept, and IL-6 inhibitors was comparable.

The observational nature of the study was a limitation, Dr. Lauper acknowledged, explaining that “we couldn’t adjust for confounding factors that were not measured.”

Notably, there were large variations in JAK inhibitor retention rates in the different countries, which surprised both Dr. Lauper and Loreto Carmona, MD, PhD, from the Musculoskeletal Health Institute in Madrid.

“It’s very interesting because there’s not much heterogeneity with abatacept and IL inhibitors,” said Dr. Carmona, who is chair of the EULAR abstract selection committee.

“It’s all over the spectrum with JAK inhibitors,” she told Medscape Medical News. But “what the research shows is that JAK inhibitors are maintained for longer, which means maybe the mix of efficacy, low toxicity, and adherence, on the whole, is better in JAK inhibitors.”

The study was funded by Pfizer. Dr. Lauper and Dr. Carmona have disclosed no relevant financial relationships.

This story first appeared on Medscape.com.




 

Opioid use does not decline after patients with inflammatory arthritis start TNF inhibitor therapy; in fact, average use appears to increase, results from a new study show.

“Starting a TNF inhibitor, you would think the pain would go down, and we were hoping the dose of opioids would go down with it,” said investigator Olafur Palsson, MD, from the University of Iceland in Reykjavik and Lund University in Sweden.

“But this research shows that the insertion of a TNF inhibitor has only a minor effect on that,” he told Medscape Medical News.

The findings are an “important reminder” to rheumatologists that they should broaden their consideration of other pain treatments and techniques for patients with inflammatory arthritis, Dr. Palsson said. “They should focus on trying other tactics to get patients’ pain and stiffness under control; there may be some underlying factors.”

The investigators compared opioid prescription rates in 940 patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and undifferentiated arthritis with a control group of 4,700 matched subjects. Dr. Palsson presented the findings at the virtual European League Against Rheumatism (EULAR) 2020 Congress.

The team assessed nationwide databases that capture all patients taking biologics for rheumatic diseases and more than 90% of all drug prescriptions. They found that patients with inflammatory arthritis in Iceland were more likely to have received at least one opioid prescription than control subjects (75% vs. 43%).

During the study period, average yearly opioid dose rose much more in the patient group than in the control group. And 2 years after the initiation of TNF inhibitors, the number of patients taking opioids was unchanged from baseline, at about 40%.

Overall, the patient group was prescribed nearly six times more opioids than the control group. The investigators used a bootstrapping analysis to obtain a reliable confidence interval.

“In a way, the data are extremely skewed,” Dr. Palsson explained. “Most patients were taking very low doses of opioids and a few were taking extremely high doses. It’s hard to do a statistical analysis.”

“With bootstrapping, you don’t detect small fluctuations in data,” he said, acknowledging this study limitation. Also, “prescription data don’t necessarily reflect consumption” of a drug. People prescribed high doses may not necessarily be consuming high doses.”

Additionally, the risk for addiction is low when opioids are used as intended, said John Isaacs, MBBS, PhD, from Newcastle University in Newcastle Upon Tyne, United Kingdom, who is chair of the EULAR scientific program committee.

To alleviate chronic pain, opioids “should, in any case, only be part of a comprehensive therapy program in which doctors, psychologists, and physiotherapists work together,” Dr. Isaacs said in a EULAR news release.

Dr. Palsson has disclosed no relevant financial relationships. Dr. Isaacs is a consultant or has received honoraria or grants from Pfizer, AbbVie, Amgen, Merck, Roche, and UCB.

This article first appeared on Medscape.com.



 

Opioid use does not decline after patients with inflammatory arthritis start TNF inhibitor therapy; in fact, average use appears to increase, results from a new study show.

“Starting a TNF inhibitor, you would think the pain would go down, and we were hoping the dose of opioids would go down with it,” said investigator Olafur Palsson, MD, from the University of Iceland in Reykjavik and Lund University in Sweden.

“But this research shows that the insertion of a TNF inhibitor has only a minor effect on that,” he told Medscape Medical News.

The findings are an “important reminder” to rheumatologists that they should broaden their consideration of other pain treatments and techniques for patients with inflammatory arthritis, Dr. Palsson said. “They should focus on trying other tactics to get patients’ pain and stiffness under control; there may be some underlying factors.”

The investigators compared opioid prescription rates in 940 patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and undifferentiated arthritis with a control group of 4,700 matched subjects. Dr. Palsson presented the findings at the virtual European League Against Rheumatism (EULAR) 2020 Congress.

The team assessed nationwide databases that capture all patients taking biologics for rheumatic diseases and more than 90% of all drug prescriptions. They found that patients with inflammatory arthritis in Iceland were more likely to have received at least one opioid prescription than control subjects (75% vs. 43%).

During the study period, average yearly opioid dose rose much more in the patient group than in the control group. And 2 years after the initiation of TNF inhibitors, the number of patients taking opioids was unchanged from baseline, at about 40%.

Overall, the patient group was prescribed nearly six times more opioids than the control group. The investigators used a bootstrapping analysis to obtain a reliable confidence interval.

“In a way, the data are extremely skewed,” Dr. Palsson explained. “Most patients were taking very low doses of opioids and a few were taking extremely high doses. It’s hard to do a statistical analysis.”

“With bootstrapping, you don’t detect small fluctuations in data,” he said, acknowledging this study limitation. Also, “prescription data don’t necessarily reflect consumption” of a drug. People prescribed high doses may not necessarily be consuming high doses.”

Additionally, the risk for addiction is low when opioids are used as intended, said John Isaacs, MBBS, PhD, from Newcastle University in Newcastle Upon Tyne, United Kingdom, who is chair of the EULAR scientific program committee.

To alleviate chronic pain, opioids “should, in any case, only be part of a comprehensive therapy program in which doctors, psychologists, and physiotherapists work together,” Dr. Isaacs said in a EULAR news release.

Dr. Palsson has disclosed no relevant financial relationships. Dr. Isaacs is a consultant or has received honoraria or grants from Pfizer, AbbVie, Amgen, Merck, Roche, and UCB.

This article first appeared on Medscape.com.



 

Opioid use does not decline after patients with inflammatory arthritis start TNF inhibitor therapy; in fact, average use appears to increase, results from a new study show.

“Starting a TNF inhibitor, you would think the pain would go down, and we were hoping the dose of opioids would go down with it,” said investigator Olafur Palsson, MD, from the University of Iceland in Reykjavik and Lund University in Sweden.

“But this research shows that the insertion of a TNF inhibitor has only a minor effect on that,” he told Medscape Medical News.

The findings are an “important reminder” to rheumatologists that they should broaden their consideration of other pain treatments and techniques for patients with inflammatory arthritis, Dr. Palsson said. “They should focus on trying other tactics to get patients’ pain and stiffness under control; there may be some underlying factors.”

The investigators compared opioid prescription rates in 940 patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and undifferentiated arthritis with a control group of 4,700 matched subjects. Dr. Palsson presented the findings at the virtual European League Against Rheumatism (EULAR) 2020 Congress.

The team assessed nationwide databases that capture all patients taking biologics for rheumatic diseases and more than 90% of all drug prescriptions. They found that patients with inflammatory arthritis in Iceland were more likely to have received at least one opioid prescription than control subjects (75% vs. 43%).

During the study period, average yearly opioid dose rose much more in the patient group than in the control group. And 2 years after the initiation of TNF inhibitors, the number of patients taking opioids was unchanged from baseline, at about 40%.

Overall, the patient group was prescribed nearly six times more opioids than the control group. The investigators used a bootstrapping analysis to obtain a reliable confidence interval.

“In a way, the data are extremely skewed,” Dr. Palsson explained. “Most patients were taking very low doses of opioids and a few were taking extremely high doses. It’s hard to do a statistical analysis.”

“With bootstrapping, you don’t detect small fluctuations in data,” he said, acknowledging this study limitation. Also, “prescription data don’t necessarily reflect consumption” of a drug. People prescribed high doses may not necessarily be consuming high doses.”

Additionally, the risk for addiction is low when opioids are used as intended, said John Isaacs, MBBS, PhD, from Newcastle University in Newcastle Upon Tyne, United Kingdom, who is chair of the EULAR scientific program committee.

To alleviate chronic pain, opioids “should, in any case, only be part of a comprehensive therapy program in which doctors, psychologists, and physiotherapists work together,” Dr. Isaacs said in a EULAR news release.

Dr. Palsson has disclosed no relevant financial relationships. Dr. Isaacs is a consultant or has received honoraria or grants from Pfizer, AbbVie, Amgen, Merck, Roche, and UCB.

This article first appeared on Medscape.com.



 

The risk for venous thromboembolism is almost 50% lower in patients with RA taking TNF inhibitors than in those taking conventional synthetic disease-modifying antirheumatic drugs (DMARDs), according to data from the German RABBIT registry.

“Some rheumatologists have thought TNF inhibitors could increase the risk for venous thromboembolism events, but we don’t think this is true, based on our findings,” said investigator Anja Strangfeld, MD, PhD, from the German Rheumatism Research Center in Berlin.

The risk is more than one-third lower in RA patients treated with other newer biologics, such as abatacept, rituximab, sarilumab, and tocilizumab.

However, risk for a serious venous thromboembolism is twice as high in patients with C-reactive protein (CRP) levels above 5 mg/L and is nearly three times as high in patients 65 years and older.

For the study, Dr. Strangfeld and her colleagues followed about 11,000 patients for more than 10 years. The findings were presented at the European League Against Rheumatism (EULAR) 2020 Congress.

“Patients with RA have a greater risk for venous thromboembolism compared with the general population, but we didn’t know the risk conveyed by different DMARD treatments,” Dr. Strangfeld told Medscape Medical News. “It is also evident that higher age and lower capacity for physical function increase the risk, which was not so surprising.”

Chronic inflammation in RA patients elevates the risk for deep vein and pulmonary thrombosis by two to three times, said John Isaacs, MBBS, PhD, from Newcastle University in Newcastle Upon Tyne, United Kingdom, who is chair of the EULAR scientific program committee.

Among the supporting studies Dr. Isaacs discussed during an online press conference was a Swedish trial of more than 46,000 RA patients, which had been presented earlier by Viktor Molander, a PhD candidate from the Karolinska Institute in Stockholm (abstract OP0034).

Mr. Molander’s team showed that one in 100 patients with high disease activity will develop venous thromboembolism within a year, which is twice the number of events seen among patients in remission.

Combined with the RABBIT data, both studies “show if you can control their disease in the right way, you’re not only helping rheumatoid arthritis patients feel better, but you could be prolonging their lives,” Dr. Isaacs said.

The prospective RABBIT study followed RA patients who began receiving a new DMARD after treatment failed with at least one conventional synthetic DMARD, such as methotrexate or leflunomide. At baseline, those taking TNF inhibitors or other biologics had higher CRP levels on average, as well as a higher rate of existing cardiovascular disease. They also received glucocorticoids, such as prednisone, more often.

The observational nature of the RABBIT study is a weakness, Dr. Strangfeld said, and it could not prove cause and effect. But the methodology had several strengths, including input on patient factors from participating rheumatologists at least every 6 months.

“We enrolled patients at the start of treatment and observed them, regardless of any treatment changes, for up to 10 years,” she added. “That’s a really long observation period.”

The RABBIT data can help shape treatment decisions, said Loreto Carmona, MD, PhD, from the Musculoskeletal Health Institute in Madrid, who is chair of the EULAR abstract selection committee.

For a woman with RA who smokes and takes oral contraceptives, for example, “if she has high levels of inflammation, I think it’s okay to use TNF inhibitors, where maybe in the past we wouldn’t have thought that,” she said.

“The TNF inhibitors are actually reducing the inflammation and, therefore, reducing the risk,” Dr. Carmona told Medscape Medical News. “It could be an effect of using the drugs on people with higher levels of inflammation. It’s an indirect protective effect.”

The study was funded by a joint unconditional grant from AbbVie, Amgen, BMS, Fresenius-Kabi, Hexal, Lilly, MSD, Mylan, Pfizer, Roche, Samsung Bioepis, Sanofi-Aventis, and UCB. Dr. Strangfeld is on the speakers bureau of AbbVie, BMS, Pfizer, Roche and Sanofi-Aventis. Dr. Isaacs is a consultant or has received honoraria or grants from Pfizer, AbbVie, Amgen, Merck, Roche, and UCB. Dr. Carmona has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.




 

The risk for venous thromboembolism is almost 50% lower in patients with RA taking TNF inhibitors than in those taking conventional synthetic disease-modifying antirheumatic drugs (DMARDs), according to data from the German RABBIT registry.

“Some rheumatologists have thought TNF inhibitors could increase the risk for venous thromboembolism events, but we don’t think this is true, based on our findings,” said investigator Anja Strangfeld, MD, PhD, from the German Rheumatism Research Center in Berlin.

The risk is more than one-third lower in RA patients treated with other newer biologics, such as abatacept, rituximab, sarilumab, and tocilizumab.

However, risk for a serious venous thromboembolism is twice as high in patients with C-reactive protein (CRP) levels above 5 mg/L and is nearly three times as high in patients 65 years and older.

For the study, Dr. Strangfeld and her colleagues followed about 11,000 patients for more than 10 years. The findings were presented at the European League Against Rheumatism (EULAR) 2020 Congress.

“Patients with RA have a greater risk for venous thromboembolism compared with the general population, but we didn’t know the risk conveyed by different DMARD treatments,” Dr. Strangfeld told Medscape Medical News. “It is also evident that higher age and lower capacity for physical function increase the risk, which was not so surprising.”

Chronic inflammation in RA patients elevates the risk for deep vein and pulmonary thrombosis by two to three times, said John Isaacs, MBBS, PhD, from Newcastle University in Newcastle Upon Tyne, United Kingdom, who is chair of the EULAR scientific program committee.

Among the supporting studies Dr. Isaacs discussed during an online press conference was a Swedish trial of more than 46,000 RA patients, which had been presented earlier by Viktor Molander, a PhD candidate from the Karolinska Institute in Stockholm (abstract OP0034).

Mr. Molander’s team showed that one in 100 patients with high disease activity will develop venous thromboembolism within a year, which is twice the number of events seen among patients in remission.

Combined with the RABBIT data, both studies “show if you can control their disease in the right way, you’re not only helping rheumatoid arthritis patients feel better, but you could be prolonging their lives,” Dr. Isaacs said.

The prospective RABBIT study followed RA patients who began receiving a new DMARD after treatment failed with at least one conventional synthetic DMARD, such as methotrexate or leflunomide. At baseline, those taking TNF inhibitors or other biologics had higher CRP levels on average, as well as a higher rate of existing cardiovascular disease. They also received glucocorticoids, such as prednisone, more often.

The observational nature of the RABBIT study is a weakness, Dr. Strangfeld said, and it could not prove cause and effect. But the methodology had several strengths, including input on patient factors from participating rheumatologists at least every 6 months.

“We enrolled patients at the start of treatment and observed them, regardless of any treatment changes, for up to 10 years,” she added. “That’s a really long observation period.”

The RABBIT data can help shape treatment decisions, said Loreto Carmona, MD, PhD, from the Musculoskeletal Health Institute in Madrid, who is chair of the EULAR abstract selection committee.

For a woman with RA who smokes and takes oral contraceptives, for example, “if she has high levels of inflammation, I think it’s okay to use TNF inhibitors, where maybe in the past we wouldn’t have thought that,” she said.

“The TNF inhibitors are actually reducing the inflammation and, therefore, reducing the risk,” Dr. Carmona told Medscape Medical News. “It could be an effect of using the drugs on people with higher levels of inflammation. It’s an indirect protective effect.”

The study was funded by a joint unconditional grant from AbbVie, Amgen, BMS, Fresenius-Kabi, Hexal, Lilly, MSD, Mylan, Pfizer, Roche, Samsung Bioepis, Sanofi-Aventis, and UCB. Dr. Strangfeld is on the speakers bureau of AbbVie, BMS, Pfizer, Roche and Sanofi-Aventis. Dr. Isaacs is a consultant or has received honoraria or grants from Pfizer, AbbVie, Amgen, Merck, Roche, and UCB. Dr. Carmona has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.




 

The risk for venous thromboembolism is almost 50% lower in patients with RA taking TNF inhibitors than in those taking conventional synthetic disease-modifying antirheumatic drugs (DMARDs), according to data from the German RABBIT registry.

“Some rheumatologists have thought TNF inhibitors could increase the risk for venous thromboembolism events, but we don’t think this is true, based on our findings,” said investigator Anja Strangfeld, MD, PhD, from the German Rheumatism Research Center in Berlin.

The risk is more than one-third lower in RA patients treated with other newer biologics, such as abatacept, rituximab, sarilumab, and tocilizumab.

However, risk for a serious venous thromboembolism is twice as high in patients with C-reactive protein (CRP) levels above 5 mg/L and is nearly three times as high in patients 65 years and older.

For the study, Dr. Strangfeld and her colleagues followed about 11,000 patients for more than 10 years. The findings were presented at the European League Against Rheumatism (EULAR) 2020 Congress.

“Patients with RA have a greater risk for venous thromboembolism compared with the general population, but we didn’t know the risk conveyed by different DMARD treatments,” Dr. Strangfeld told Medscape Medical News. “It is also evident that higher age and lower capacity for physical function increase the risk, which was not so surprising.”

Chronic inflammation in RA patients elevates the risk for deep vein and pulmonary thrombosis by two to three times, said John Isaacs, MBBS, PhD, from Newcastle University in Newcastle Upon Tyne, United Kingdom, who is chair of the EULAR scientific program committee.

Among the supporting studies Dr. Isaacs discussed during an online press conference was a Swedish trial of more than 46,000 RA patients, which had been presented earlier by Viktor Molander, a PhD candidate from the Karolinska Institute in Stockholm (abstract OP0034).

Mr. Molander’s team showed that one in 100 patients with high disease activity will develop venous thromboembolism within a year, which is twice the number of events seen among patients in remission.

Combined with the RABBIT data, both studies “show if you can control their disease in the right way, you’re not only helping rheumatoid arthritis patients feel better, but you could be prolonging their lives,” Dr. Isaacs said.

The prospective RABBIT study followed RA patients who began receiving a new DMARD after treatment failed with at least one conventional synthetic DMARD, such as methotrexate or leflunomide. At baseline, those taking TNF inhibitors or other biologics had higher CRP levels on average, as well as a higher rate of existing cardiovascular disease. They also received glucocorticoids, such as prednisone, more often.

The observational nature of the RABBIT study is a weakness, Dr. Strangfeld said, and it could not prove cause and effect. But the methodology had several strengths, including input on patient factors from participating rheumatologists at least every 6 months.

“We enrolled patients at the start of treatment and observed them, regardless of any treatment changes, for up to 10 years,” she added. “That’s a really long observation period.”

The RABBIT data can help shape treatment decisions, said Loreto Carmona, MD, PhD, from the Musculoskeletal Health Institute in Madrid, who is chair of the EULAR abstract selection committee.

For a woman with RA who smokes and takes oral contraceptives, for example, “if she has high levels of inflammation, I think it’s okay to use TNF inhibitors, where maybe in the past we wouldn’t have thought that,” she said.

“The TNF inhibitors are actually reducing the inflammation and, therefore, reducing the risk,” Dr. Carmona told Medscape Medical News. “It could be an effect of using the drugs on people with higher levels of inflammation. It’s an indirect protective effect.”

The study was funded by a joint unconditional grant from AbbVie, Amgen, BMS, Fresenius-Kabi, Hexal, Lilly, MSD, Mylan, Pfizer, Roche, Samsung Bioepis, Sanofi-Aventis, and UCB. Dr. Strangfeld is on the speakers bureau of AbbVie, BMS, Pfizer, Roche and Sanofi-Aventis. Dr. Isaacs is a consultant or has received honoraria or grants from Pfizer, AbbVie, Amgen, Merck, Roche, and UCB. Dr. Carmona has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.




 

The vast majority of patients with rheumatic and musculoskeletal diseases who contract COVID-19 recover from the virus, regardless of which medication they receive for their rheumatic condition, new international research suggests.

“These results provide, for the first time, information about the outcome of COVID-19 in patients with rheumatic and musculoskeletal diseases,” said study investigator Pedro Machado, MD, PhD, from University College London. “They should provide some reassurance to patients and healthcare providers.”

Machado and his colleagues looked at 600 COVID-19 patients from 40 countries, and found that those taking TNF inhibitors for their rheumatic disease were less likely to be hospitalized for COVID-19. However, treatment with more than 10 mg of prednisone daily — considered a moderate to high dose — was associated with a higher probability of hospitalization.

In addition, hospitalization was not associated with biologics; JAK inhibitors; conventional disease-modifying antirheumatic drugs (DMARDs), such as methotrexate; antimalarials, such as hydroxychloroquine; or nonsteroidal anti-inflammatory drugs (NSAIDs) — either alone or in combination with other biologics, such as TNF-alpha inhibitors.

The findings were presented at the virtual European League Against Rheumatism (EULAR) 2020 Congress and were published online in Annals of the Rheumatic Diseases.

“Initially, there was a huge concern that these drugs could affect the outcome of patients getting COVID-19, but what this is showing is that probably these drugs do not increase their risk of severe outcome,” Machado, who is chair of the EULAR standing committee on epidemiology and health services research, told Medscape Medical News.

As of June 1, 1061 patients from 28 participating countries had been entered into the EULAR COVID-19 database, which was launched as part of the international Global Rheumatology Alliance registry. Patient data are categorized by factors such as top rheumatology diagnosis, comorbidities, top-five COVID-19 symptoms, and DMARD therapy at the time of virus infection. Anonymized data will be shared with an international register based in the United States.

Machado’s team combined data from the EULAR and Global Rheumatology Alliance COVID-19 registries from March 24 to April 20. They looked at patient factors — such as age, sex, smoking status, rheumatic diagnosis, comorbidities, and rheumatic therapies — to examine the association of rheumatic therapies with hospitalization rates and COVID-19 disease course.

Of the 277 patients (46%) in the study cohort who required hospitalization, 55 (9%) died. But this finding shouldn’t be viewed as the true rate of hospitalization or death in patients with rheumatic disease and COVID-19, said Gerd Burmester, MD, from Charité–University Medicine Berlin.

“There’s tremendous bias in terms of more serious cases of COVID-19 being reported to the registries,” he explained, “because the mild cases won’t even show up at their rheumatologist’s office.”

“This can skew the idea that COVID-19 is much more dangerous to rheumatic patients than to the regular population,” Burmester told Medscape Medical News. “It scares the patients, obviously, but we believe this is not justified.”

It’s still unclear whether rituximab use raises the risk for severe COVID-19, he said. “It appears to be the only biologic for which the jury is still out,” he said.

“Anti-TNFs and anti-IL-6 drugs may even be beneficial, although we don’t have robust data,” he added.

The study can only highlight associations between rheumatic drugs and COVID-19 outcomes. “We cannot say there is a causal relationship between the findings,” Machado said.

Longer-term data, when available, should illuminate “more granular” aspects of COVID-19 outcomes in rheumatic patients, including their risks of requiring ventilation or developing a cytokine storm, he noted.

Burmester and Machado agree that research needs to continue as the pandemic rages on. But so far, “there are no data suggesting that, if you’re on a targeted, dedicated immunomodulator, your risk is higher to have a worse course of COVID-19 than the general population,” Burmester said.

“We simply didn’t know that when the pandemic started, and some patients even discontinued their drugs out of this fear,” he added. “It’s more reassuring than we originally thought.”

This article first appeared on Medscape.com.

The vast majority of patients with rheumatic and musculoskeletal diseases who contract COVID-19 recover from the virus, regardless of which medication they receive for their rheumatic condition, new international research suggests.

“These results provide, for the first time, information about the outcome of COVID-19 in patients with rheumatic and musculoskeletal diseases,” said study investigator Pedro Machado, MD, PhD, from University College London. “They should provide some reassurance to patients and healthcare providers.”

Machado and his colleagues looked at 600 COVID-19 patients from 40 countries, and found that those taking TNF inhibitors for their rheumatic disease were less likely to be hospitalized for COVID-19. However, treatment with more than 10 mg of prednisone daily — considered a moderate to high dose — was associated with a higher probability of hospitalization.

In addition, hospitalization was not associated with biologics; JAK inhibitors; conventional disease-modifying antirheumatic drugs (DMARDs), such as methotrexate; antimalarials, such as hydroxychloroquine; or nonsteroidal anti-inflammatory drugs (NSAIDs) — either alone or in combination with other biologics, such as TNF-alpha inhibitors.

The findings were presented at the virtual European League Against Rheumatism (EULAR) 2020 Congress and were published online in Annals of the Rheumatic Diseases.

“Initially, there was a huge concern that these drugs could affect the outcome of patients getting COVID-19, but what this is showing is that probably these drugs do not increase their risk of severe outcome,” Machado, who is chair of the EULAR standing committee on epidemiology and health services research, told Medscape Medical News.

As of June 1, 1061 patients from 28 participating countries had been entered into the EULAR COVID-19 database, which was launched as part of the international Global Rheumatology Alliance registry. Patient data are categorized by factors such as top rheumatology diagnosis, comorbidities, top-five COVID-19 symptoms, and DMARD therapy at the time of virus infection. Anonymized data will be shared with an international register based in the United States.

Machado’s team combined data from the EULAR and Global Rheumatology Alliance COVID-19 registries from March 24 to April 20. They looked at patient factors — such as age, sex, smoking status, rheumatic diagnosis, comorbidities, and rheumatic therapies — to examine the association of rheumatic therapies with hospitalization rates and COVID-19 disease course.

Of the 277 patients (46%) in the study cohort who required hospitalization, 55 (9%) died. But this finding shouldn’t be viewed as the true rate of hospitalization or death in patients with rheumatic disease and COVID-19, said Gerd Burmester, MD, from Charité–University Medicine Berlin.

“There’s tremendous bias in terms of more serious cases of COVID-19 being reported to the registries,” he explained, “because the mild cases won’t even show up at their rheumatologist’s office.”

“This can skew the idea that COVID-19 is much more dangerous to rheumatic patients than to the regular population,” Burmester told Medscape Medical News. “It scares the patients, obviously, but we believe this is not justified.”

It’s still unclear whether rituximab use raises the risk for severe COVID-19, he said. “It appears to be the only biologic for which the jury is still out,” he said.

“Anti-TNFs and anti-IL-6 drugs may even be beneficial, although we don’t have robust data,” he added.

The study can only highlight associations between rheumatic drugs and COVID-19 outcomes. “We cannot say there is a causal relationship between the findings,” Machado said.

Longer-term data, when available, should illuminate “more granular” aspects of COVID-19 outcomes in rheumatic patients, including their risks of requiring ventilation or developing a cytokine storm, he noted.

Burmester and Machado agree that research needs to continue as the pandemic rages on. But so far, “there are no data suggesting that, if you’re on a targeted, dedicated immunomodulator, your risk is higher to have a worse course of COVID-19 than the general population,” Burmester said.

“We simply didn’t know that when the pandemic started, and some patients even discontinued their drugs out of this fear,” he added. “It’s more reassuring than we originally thought.”

This article first appeared on Medscape.com.

The vast majority of patients with rheumatic and musculoskeletal diseases who contract COVID-19 recover from the virus, regardless of which medication they receive for their rheumatic condition, new international research suggests.

“These results provide, for the first time, information about the outcome of COVID-19 in patients with rheumatic and musculoskeletal diseases,” said study investigator Pedro Machado, MD, PhD, from University College London. “They should provide some reassurance to patients and healthcare providers.”

Machado and his colleagues looked at 600 COVID-19 patients from 40 countries, and found that those taking TNF inhibitors for their rheumatic disease were less likely to be hospitalized for COVID-19. However, treatment with more than 10 mg of prednisone daily — considered a moderate to high dose — was associated with a higher probability of hospitalization.

In addition, hospitalization was not associated with biologics; JAK inhibitors; conventional disease-modifying antirheumatic drugs (DMARDs), such as methotrexate; antimalarials, such as hydroxychloroquine; or nonsteroidal anti-inflammatory drugs (NSAIDs) — either alone or in combination with other biologics, such as TNF-alpha inhibitors.

The findings were presented at the virtual European League Against Rheumatism (EULAR) 2020 Congress and were published online in Annals of the Rheumatic Diseases.

“Initially, there was a huge concern that these drugs could affect the outcome of patients getting COVID-19, but what this is showing is that probably these drugs do not increase their risk of severe outcome,” Machado, who is chair of the EULAR standing committee on epidemiology and health services research, told Medscape Medical News.

As of June 1, 1061 patients from 28 participating countries had been entered into the EULAR COVID-19 database, which was launched as part of the international Global Rheumatology Alliance registry. Patient data are categorized by factors such as top rheumatology diagnosis, comorbidities, top-five COVID-19 symptoms, and DMARD therapy at the time of virus infection. Anonymized data will be shared with an international register based in the United States.

Machado’s team combined data from the EULAR and Global Rheumatology Alliance COVID-19 registries from March 24 to April 20. They looked at patient factors — such as age, sex, smoking status, rheumatic diagnosis, comorbidities, and rheumatic therapies — to examine the association of rheumatic therapies with hospitalization rates and COVID-19 disease course.

Of the 277 patients (46%) in the study cohort who required hospitalization, 55 (9%) died. But this finding shouldn’t be viewed as the true rate of hospitalization or death in patients with rheumatic disease and COVID-19, said Gerd Burmester, MD, from Charité–University Medicine Berlin.

“There’s tremendous bias in terms of more serious cases of COVID-19 being reported to the registries,” he explained, “because the mild cases won’t even show up at their rheumatologist’s office.”

“This can skew the idea that COVID-19 is much more dangerous to rheumatic patients than to the regular population,” Burmester told Medscape Medical News. “It scares the patients, obviously, but we believe this is not justified.”

It’s still unclear whether rituximab use raises the risk for severe COVID-19, he said. “It appears to be the only biologic for which the jury is still out,” he said.

“Anti-TNFs and anti-IL-6 drugs may even be beneficial, although we don’t have robust data,” he added.

The study can only highlight associations between rheumatic drugs and COVID-19 outcomes. “We cannot say there is a causal relationship between the findings,” Machado said.

Longer-term data, when available, should illuminate “more granular” aspects of COVID-19 outcomes in rheumatic patients, including their risks of requiring ventilation or developing a cytokine storm, he noted.

Burmester and Machado agree that research needs to continue as the pandemic rages on. But so far, “there are no data suggesting that, if you’re on a targeted, dedicated immunomodulator, your risk is higher to have a worse course of COVID-19 than the general population,” Burmester said.

“We simply didn’t know that when the pandemic started, and some patients even discontinued their drugs out of this fear,” he added. “It’s more reassuring than we originally thought.”

This article first appeared on Medscape.com.