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Combo of smoking while overweight boosts RA incidence
MADRID – Researchers have begun testing whether immunologic modification can forestall rheumatoid arthritis in people at high risk for the disease and also have identified smoking and overweight as two modifiable risk factors strongly linked to disease onset.
In a group of 55 people without rheumatoid arthritis (RA) who were enrolled because of a family history of RA or a positive RA blood marker, those with an elevated body mass index (BMI) who also smoked had a greater than seven-fold increased rate of incident RA, compared with lower-BMI people and nonsmokers, Dr. Danielle M. Gerlag said at the annual European Congress of Rheumatology.
The finding raises the possibility that weight loss and smoking cessation may be effective tools for preventing RA, said Dr. Gerlag, a rheumatologist at the Academic Medical Center in Amsterdam.
The finding came from 55 people she and her associates recruited because they were either first-degree relatives of RA patients or because they tested positive for either IgM anti-rheumatoid factor or anti-ctirullinated protein antibody or both. Their average age was about 45 years, and two-thirds were women. During a median follow-up of 27 months, 15 people (27%) developed RA. Two baseline characteristics stood out as strongly associated with RA incidence: history of smoking and a BMI of 25 kg/m2 or greater (Ann. Rheum. Dis. 2012;doi:10.1136/annrheumdis-2012-202254).
Patients who had both a history of smoking and an elevated BMI had a statistically significant, 7.5-fold increased rate of RA during follow-up, compared with all the others in the study group, including those who had smoked but were not overweight and those who were overweight but had never smoked.
Dr. Gerlag and her associates also have collected evidence for several specific changes in T and B cell profiles that link with subsequent development of early RA, which led to the hypothesis that a treatment aimed at dampening immune-cell activation might contain RA development. To explore this possibility, they have treated 75 people at high risk for developing RA with a single 1-g dose of rituximab (Rituxan). So far, during a median follow-up of 19 months, 16 patients (21%) have developed RA, she said.
Dr. Gerlag said that she had no disclosures.
On Twitter @mitchelzoler
MADRID – Researchers have begun testing whether immunologic modification can forestall rheumatoid arthritis in people at high risk for the disease and also have identified smoking and overweight as two modifiable risk factors strongly linked to disease onset.
In a group of 55 people without rheumatoid arthritis (RA) who were enrolled because of a family history of RA or a positive RA blood marker, those with an elevated body mass index (BMI) who also smoked had a greater than seven-fold increased rate of incident RA, compared with lower-BMI people and nonsmokers, Dr. Danielle M. Gerlag said at the annual European Congress of Rheumatology.
The finding raises the possibility that weight loss and smoking cessation may be effective tools for preventing RA, said Dr. Gerlag, a rheumatologist at the Academic Medical Center in Amsterdam.
The finding came from 55 people she and her associates recruited because they were either first-degree relatives of RA patients or because they tested positive for either IgM anti-rheumatoid factor or anti-ctirullinated protein antibody or both. Their average age was about 45 years, and two-thirds were women. During a median follow-up of 27 months, 15 people (27%) developed RA. Two baseline characteristics stood out as strongly associated with RA incidence: history of smoking and a BMI of 25 kg/m2 or greater (Ann. Rheum. Dis. 2012;doi:10.1136/annrheumdis-2012-202254).
Patients who had both a history of smoking and an elevated BMI had a statistically significant, 7.5-fold increased rate of RA during follow-up, compared with all the others in the study group, including those who had smoked but were not overweight and those who were overweight but had never smoked.
Dr. Gerlag and her associates also have collected evidence for several specific changes in T and B cell profiles that link with subsequent development of early RA, which led to the hypothesis that a treatment aimed at dampening immune-cell activation might contain RA development. To explore this possibility, they have treated 75 people at high risk for developing RA with a single 1-g dose of rituximab (Rituxan). So far, during a median follow-up of 19 months, 16 patients (21%) have developed RA, she said.
Dr. Gerlag said that she had no disclosures.
On Twitter @mitchelzoler
MADRID – Researchers have begun testing whether immunologic modification can forestall rheumatoid arthritis in people at high risk for the disease and also have identified smoking and overweight as two modifiable risk factors strongly linked to disease onset.
In a group of 55 people without rheumatoid arthritis (RA) who were enrolled because of a family history of RA or a positive RA blood marker, those with an elevated body mass index (BMI) who also smoked had a greater than seven-fold increased rate of incident RA, compared with lower-BMI people and nonsmokers, Dr. Danielle M. Gerlag said at the annual European Congress of Rheumatology.
The finding raises the possibility that weight loss and smoking cessation may be effective tools for preventing RA, said Dr. Gerlag, a rheumatologist at the Academic Medical Center in Amsterdam.
The finding came from 55 people she and her associates recruited because they were either first-degree relatives of RA patients or because they tested positive for either IgM anti-rheumatoid factor or anti-ctirullinated protein antibody or both. Their average age was about 45 years, and two-thirds were women. During a median follow-up of 27 months, 15 people (27%) developed RA. Two baseline characteristics stood out as strongly associated with RA incidence: history of smoking and a BMI of 25 kg/m2 or greater (Ann. Rheum. Dis. 2012;doi:10.1136/annrheumdis-2012-202254).
Patients who had both a history of smoking and an elevated BMI had a statistically significant, 7.5-fold increased rate of RA during follow-up, compared with all the others in the study group, including those who had smoked but were not overweight and those who were overweight but had never smoked.
Dr. Gerlag and her associates also have collected evidence for several specific changes in T and B cell profiles that link with subsequent development of early RA, which led to the hypothesis that a treatment aimed at dampening immune-cell activation might contain RA development. To explore this possibility, they have treated 75 people at high risk for developing RA with a single 1-g dose of rituximab (Rituxan). So far, during a median follow-up of 19 months, 16 patients (21%) have developed RA, she said.
Dr. Gerlag said that she had no disclosures.
On Twitter @mitchelzoler
AT THE EULAR CONGRESS 2013
Major finding: Patients who smoked and a BMI of at least 25 kg/m2 were 7.5-fold more likely to develop rheumatoid arthritis.
Data source: 27-month follow-up of 55 people selected for their high risk for developing rheumatoid arthritis.
Disclosures: Dr. Gerlag said that she had no disclosures.
Most American RA patients quit biologics after 2 years
MADRID – Half the patients who successfully start treatment on a biological drug for rheumatoid arthritis are off it within about 2 years, even when treatment was effective and tolerable for the first 6 months, according to U.S. registry data from more than 6,000 patients.
"These findings say to me that there is a fair amount of dissatisfaction even though we have all these treatments," Dr. Vibeke Strand said at the annual European Congress of Rheumatology. "When patients start a biologic treatment, they probably have fairly high expectations, and I might suppose that some of those expectations weren’t met," said Dr. Strand, a rheumatologist and drug consultant affiliated with Stanford (Calif.) University.
The most common reason patients dropped their biologic was lack of efficacy, cited in 36% of the discontinuations, followed by physician preference in 28%, safety in 20%, patient preference in 18%, and treatment access in 9%. (The total exceeds 100% because more than one reason could be cited.)
The strongest correlates of treatment discontinuation were higher disease activity; patient report of anxiety, depression, or both; and starting treatment during 2007-2010, compared with patients who started in 2002-2003.
The data that Dr. Strand and her associates analyzed came from a registry of U.S. rheumatoid arthritis patients kept by the CORRONA (Consortium of Rheumatology Researchers of North America) registry. During 2002-2011, 6,209 American adults with rheumatoid arthritis in the registry received at least 6 months of treatment with a tumor necrosis factor inhibitor (81% of these patients) or another biologic drug (the remaining 19%). The patients had a mean age of 58 years and had rheumatoid arthritis for a mean of 11 years. Many (43%) had not previously been treated with a biologic drug. Patients were followed in the registry for an average of about 3 years.
By 1 year after entry, a third of the patients were off the biologic drug they entered the registry on. Half were off their entry biologic after about 2 years, and during the average 3 years of follow-up 58% of the patients stopped their medication, Dr. Strand and her associates reported (Ann. Rheum. Dis. 2013;72:71). It took a median of 27 months for patients to drop a tumor necrosis factor inhibitor and a median of 21 months for them to come off another type of biologic.
Dr. Strand stressed that because patients had been receiving their biologic drug for at least 6 months to qualify for this analysis, the subsequent dropouts from treatment do not reflect an empiric search for a safe and tolerated agent.
"The guidelines call for figuring out [if a treatment works] in the first 3 months. By requiring patients to be on treatment for at least 6 months, we got away from empiric switching," Dr. Strand said in an interview. That suggests other factors make patients stop treatment. She said she plans to look for what they might be.
The CORRONA registry and related research projects are funded by a consortium of drug companies. Dr. Strand said that she is a consultant to CORRONA and a member of its advisory board.
On Twitter @mitchelzoler
MADRID – Half the patients who successfully start treatment on a biological drug for rheumatoid arthritis are off it within about 2 years, even when treatment was effective and tolerable for the first 6 months, according to U.S. registry data from more than 6,000 patients.
"These findings say to me that there is a fair amount of dissatisfaction even though we have all these treatments," Dr. Vibeke Strand said at the annual European Congress of Rheumatology. "When patients start a biologic treatment, they probably have fairly high expectations, and I might suppose that some of those expectations weren’t met," said Dr. Strand, a rheumatologist and drug consultant affiliated with Stanford (Calif.) University.
The most common reason patients dropped their biologic was lack of efficacy, cited in 36% of the discontinuations, followed by physician preference in 28%, safety in 20%, patient preference in 18%, and treatment access in 9%. (The total exceeds 100% because more than one reason could be cited.)
The strongest correlates of treatment discontinuation were higher disease activity; patient report of anxiety, depression, or both; and starting treatment during 2007-2010, compared with patients who started in 2002-2003.
The data that Dr. Strand and her associates analyzed came from a registry of U.S. rheumatoid arthritis patients kept by the CORRONA (Consortium of Rheumatology Researchers of North America) registry. During 2002-2011, 6,209 American adults with rheumatoid arthritis in the registry received at least 6 months of treatment with a tumor necrosis factor inhibitor (81% of these patients) or another biologic drug (the remaining 19%). The patients had a mean age of 58 years and had rheumatoid arthritis for a mean of 11 years. Many (43%) had not previously been treated with a biologic drug. Patients were followed in the registry for an average of about 3 years.
By 1 year after entry, a third of the patients were off the biologic drug they entered the registry on. Half were off their entry biologic after about 2 years, and during the average 3 years of follow-up 58% of the patients stopped their medication, Dr. Strand and her associates reported (Ann. Rheum. Dis. 2013;72:71). It took a median of 27 months for patients to drop a tumor necrosis factor inhibitor and a median of 21 months for them to come off another type of biologic.
Dr. Strand stressed that because patients had been receiving their biologic drug for at least 6 months to qualify for this analysis, the subsequent dropouts from treatment do not reflect an empiric search for a safe and tolerated agent.
"The guidelines call for figuring out [if a treatment works] in the first 3 months. By requiring patients to be on treatment for at least 6 months, we got away from empiric switching," Dr. Strand said in an interview. That suggests other factors make patients stop treatment. She said she plans to look for what they might be.
The CORRONA registry and related research projects are funded by a consortium of drug companies. Dr. Strand said that she is a consultant to CORRONA and a member of its advisory board.
On Twitter @mitchelzoler
MADRID – Half the patients who successfully start treatment on a biological drug for rheumatoid arthritis are off it within about 2 years, even when treatment was effective and tolerable for the first 6 months, according to U.S. registry data from more than 6,000 patients.
"These findings say to me that there is a fair amount of dissatisfaction even though we have all these treatments," Dr. Vibeke Strand said at the annual European Congress of Rheumatology. "When patients start a biologic treatment, they probably have fairly high expectations, and I might suppose that some of those expectations weren’t met," said Dr. Strand, a rheumatologist and drug consultant affiliated with Stanford (Calif.) University.
The most common reason patients dropped their biologic was lack of efficacy, cited in 36% of the discontinuations, followed by physician preference in 28%, safety in 20%, patient preference in 18%, and treatment access in 9%. (The total exceeds 100% because more than one reason could be cited.)
The strongest correlates of treatment discontinuation were higher disease activity; patient report of anxiety, depression, or both; and starting treatment during 2007-2010, compared with patients who started in 2002-2003.
The data that Dr. Strand and her associates analyzed came from a registry of U.S. rheumatoid arthritis patients kept by the CORRONA (Consortium of Rheumatology Researchers of North America) registry. During 2002-2011, 6,209 American adults with rheumatoid arthritis in the registry received at least 6 months of treatment with a tumor necrosis factor inhibitor (81% of these patients) or another biologic drug (the remaining 19%). The patients had a mean age of 58 years and had rheumatoid arthritis for a mean of 11 years. Many (43%) had not previously been treated with a biologic drug. Patients were followed in the registry for an average of about 3 years.
By 1 year after entry, a third of the patients were off the biologic drug they entered the registry on. Half were off their entry biologic after about 2 years, and during the average 3 years of follow-up 58% of the patients stopped their medication, Dr. Strand and her associates reported (Ann. Rheum. Dis. 2013;72:71). It took a median of 27 months for patients to drop a tumor necrosis factor inhibitor and a median of 21 months for them to come off another type of biologic.
Dr. Strand stressed that because patients had been receiving their biologic drug for at least 6 months to qualify for this analysis, the subsequent dropouts from treatment do not reflect an empiric search for a safe and tolerated agent.
"The guidelines call for figuring out [if a treatment works] in the first 3 months. By requiring patients to be on treatment for at least 6 months, we got away from empiric switching," Dr. Strand said in an interview. That suggests other factors make patients stop treatment. She said she plans to look for what they might be.
The CORRONA registry and related research projects are funded by a consortium of drug companies. Dr. Strand said that she is a consultant to CORRONA and a member of its advisory board.
On Twitter @mitchelzoler
AT THE EULAR CONGRESS 2013
Major finding: Half of U.S. rheumatoid arthritis patients on a biologic drug for at least 6 months stopped it after 2 years.
Data source: Data came from 6,209 U.S. rheumatoid arthritis patients in the CORRONA registry on a biologic drug for at least 6 months.
Disclosures: The CORRONA registry and related research projects are funded by a consortium of drug companies. Dr. Strand said that she is a consultant to CORRONA and a member of its advisory board.
Staying positive, healthy may keep long-term OA pain in CHECK
MADRID – Patients with knee osteoarthritis who "retreated" into a passive coping strategy and engaged in an unhealthy lifestyle were likely to develop more long-term pain than were patients who stayed physically healthy and emotionally strong, in a large Dutch cohort study.
"To diminish pain in patients with early symptomatic OA [osteoarthritis], attention should be given not only to pain complaints, but also to effective use of coping strategies and unhealthy lifestyle factors," said the lead author of the study, Janet Wesseling, Ph.D., of University Medical Center, Utrecht, the Netherlands. "This is a further argument to take coping and lifestyle factors into account in the management of early OA."
Her findings were extracted from data in the CHECK (Cohort Hip and Cohort Knee) study, a 10-year prospective cohort study with a mirror cohort in the United States. It’s following 1,002 patients with early OA-related complaints of hip and/or knee pain (Ann. Rheum. Dis 2013;72[Suppl. 3]:152)
The study’s pain trajectory subanalysis included 5-year data on 705 patients with symptomatic knee OA. Dr. Wesseling identified three trajectories in these patients: good, moderate, and poor pain outcomes.
Patients with a good outcome trajectory (n = 222) had over time a slight decrease in pain severity and ended up with a low pain severity. Those with a moderate outcome trajectory (n = 294) had a stable course of moderate pain over time. The poor outcome trajectory group (n = 189) had an increase in pain severity over time and ended up with severe pain.
Compared with the good-outcome group, participants in the other groups were significantly more likely to have a higher body mass index (odds ratio = 1.1). Patients in the moderate- and poor-outcome groups were significantly more likely to smoke than were those in the good-outcome group (moderate outcome, OR = 1.8; poor outcome, OR = 2.3), Dr. Wesseling reported at the annual European Congress of Rheumatology.
There were significant differences in coping strategies as well. The poorer-outcome groups were more likely to have a passive coping style. They were significantly more likely to worry about their condition than was the good-outcome group (moderate outcome, OR = 2.3; poor outcome, OR = 3.5), and more likely to rest often (moderate outcome, OR = 1.6; poor outcome, OR = 2.4).
Over the long run, there were also disease-related physical differences, Dr. Wesseling noted.
After 5 years, patients in the poor-outcome group experienced more joint destruction and changes in osteophyte size, she said. By that time, 13% of patients in the poor-outcome group had at least two grade changes on the Kellgren-Lawrence Grading Scale, indicating more joint space narrowing, osteophyte formation, sclerosis, and bony contour deformity.
Over time, these patients also experienced significantly more osteophyte enlargement than did patients in the moderate- and good-outcome groups, with a mean growth of 5.2 mm, compared with 3.4 mm and 2.9 mm, respectively.
Surgical outcomes were significantly different in the poor-outcome group, Dr. Wesseling said. There were 12 total knee replacements in the poor-outcome group, compared with 4 in the moderate-outcome group and just 1 in the good-outcome group.
Distinguishing different trajectories could have implications for treatment, Dr. Wesseling noted in an interview. Clinicians can suggest improvements in the way patients choose to deal with their condition – beginning with an up-front conversation.
"At the very least, the topic should be discussed during counseling on OA. Physicians should be alert to increasing stress levels in their patients. Sometimes, physicians can help counsel patients about managing stress, but a psychological consult might also be useful. And self-management programs can help patients manage and tolerate their pain."
The CHECK study is supported by the Dutch Arthritis Association. Dr. Wesseling and her colleagues had no disclosures to report.
MADRID – Patients with knee osteoarthritis who "retreated" into a passive coping strategy and engaged in an unhealthy lifestyle were likely to develop more long-term pain than were patients who stayed physically healthy and emotionally strong, in a large Dutch cohort study.
"To diminish pain in patients with early symptomatic OA [osteoarthritis], attention should be given not only to pain complaints, but also to effective use of coping strategies and unhealthy lifestyle factors," said the lead author of the study, Janet Wesseling, Ph.D., of University Medical Center, Utrecht, the Netherlands. "This is a further argument to take coping and lifestyle factors into account in the management of early OA."
Her findings were extracted from data in the CHECK (Cohort Hip and Cohort Knee) study, a 10-year prospective cohort study with a mirror cohort in the United States. It’s following 1,002 patients with early OA-related complaints of hip and/or knee pain (Ann. Rheum. Dis 2013;72[Suppl. 3]:152)
The study’s pain trajectory subanalysis included 5-year data on 705 patients with symptomatic knee OA. Dr. Wesseling identified three trajectories in these patients: good, moderate, and poor pain outcomes.
Patients with a good outcome trajectory (n = 222) had over time a slight decrease in pain severity and ended up with a low pain severity. Those with a moderate outcome trajectory (n = 294) had a stable course of moderate pain over time. The poor outcome trajectory group (n = 189) had an increase in pain severity over time and ended up with severe pain.
Compared with the good-outcome group, participants in the other groups were significantly more likely to have a higher body mass index (odds ratio = 1.1). Patients in the moderate- and poor-outcome groups were significantly more likely to smoke than were those in the good-outcome group (moderate outcome, OR = 1.8; poor outcome, OR = 2.3), Dr. Wesseling reported at the annual European Congress of Rheumatology.
There were significant differences in coping strategies as well. The poorer-outcome groups were more likely to have a passive coping style. They were significantly more likely to worry about their condition than was the good-outcome group (moderate outcome, OR = 2.3; poor outcome, OR = 3.5), and more likely to rest often (moderate outcome, OR = 1.6; poor outcome, OR = 2.4).
Over the long run, there were also disease-related physical differences, Dr. Wesseling noted.
After 5 years, patients in the poor-outcome group experienced more joint destruction and changes in osteophyte size, she said. By that time, 13% of patients in the poor-outcome group had at least two grade changes on the Kellgren-Lawrence Grading Scale, indicating more joint space narrowing, osteophyte formation, sclerosis, and bony contour deformity.
Over time, these patients also experienced significantly more osteophyte enlargement than did patients in the moderate- and good-outcome groups, with a mean growth of 5.2 mm, compared with 3.4 mm and 2.9 mm, respectively.
Surgical outcomes were significantly different in the poor-outcome group, Dr. Wesseling said. There were 12 total knee replacements in the poor-outcome group, compared with 4 in the moderate-outcome group and just 1 in the good-outcome group.
Distinguishing different trajectories could have implications for treatment, Dr. Wesseling noted in an interview. Clinicians can suggest improvements in the way patients choose to deal with their condition – beginning with an up-front conversation.
"At the very least, the topic should be discussed during counseling on OA. Physicians should be alert to increasing stress levels in their patients. Sometimes, physicians can help counsel patients about managing stress, but a psychological consult might also be useful. And self-management programs can help patients manage and tolerate their pain."
The CHECK study is supported by the Dutch Arthritis Association. Dr. Wesseling and her colleagues had no disclosures to report.
MADRID – Patients with knee osteoarthritis who "retreated" into a passive coping strategy and engaged in an unhealthy lifestyle were likely to develop more long-term pain than were patients who stayed physically healthy and emotionally strong, in a large Dutch cohort study.
"To diminish pain in patients with early symptomatic OA [osteoarthritis], attention should be given not only to pain complaints, but also to effective use of coping strategies and unhealthy lifestyle factors," said the lead author of the study, Janet Wesseling, Ph.D., of University Medical Center, Utrecht, the Netherlands. "This is a further argument to take coping and lifestyle factors into account in the management of early OA."
Her findings were extracted from data in the CHECK (Cohort Hip and Cohort Knee) study, a 10-year prospective cohort study with a mirror cohort in the United States. It’s following 1,002 patients with early OA-related complaints of hip and/or knee pain (Ann. Rheum. Dis 2013;72[Suppl. 3]:152)
The study’s pain trajectory subanalysis included 5-year data on 705 patients with symptomatic knee OA. Dr. Wesseling identified three trajectories in these patients: good, moderate, and poor pain outcomes.
Patients with a good outcome trajectory (n = 222) had over time a slight decrease in pain severity and ended up with a low pain severity. Those with a moderate outcome trajectory (n = 294) had a stable course of moderate pain over time. The poor outcome trajectory group (n = 189) had an increase in pain severity over time and ended up with severe pain.
Compared with the good-outcome group, participants in the other groups were significantly more likely to have a higher body mass index (odds ratio = 1.1). Patients in the moderate- and poor-outcome groups were significantly more likely to smoke than were those in the good-outcome group (moderate outcome, OR = 1.8; poor outcome, OR = 2.3), Dr. Wesseling reported at the annual European Congress of Rheumatology.
There were significant differences in coping strategies as well. The poorer-outcome groups were more likely to have a passive coping style. They were significantly more likely to worry about their condition than was the good-outcome group (moderate outcome, OR = 2.3; poor outcome, OR = 3.5), and more likely to rest often (moderate outcome, OR = 1.6; poor outcome, OR = 2.4).
Over the long run, there were also disease-related physical differences, Dr. Wesseling noted.
After 5 years, patients in the poor-outcome group experienced more joint destruction and changes in osteophyte size, she said. By that time, 13% of patients in the poor-outcome group had at least two grade changes on the Kellgren-Lawrence Grading Scale, indicating more joint space narrowing, osteophyte formation, sclerosis, and bony contour deformity.
Over time, these patients also experienced significantly more osteophyte enlargement than did patients in the moderate- and good-outcome groups, with a mean growth of 5.2 mm, compared with 3.4 mm and 2.9 mm, respectively.
Surgical outcomes were significantly different in the poor-outcome group, Dr. Wesseling said. There were 12 total knee replacements in the poor-outcome group, compared with 4 in the moderate-outcome group and just 1 in the good-outcome group.
Distinguishing different trajectories could have implications for treatment, Dr. Wesseling noted in an interview. Clinicians can suggest improvements in the way patients choose to deal with their condition – beginning with an up-front conversation.
"At the very least, the topic should be discussed during counseling on OA. Physicians should be alert to increasing stress levels in their patients. Sometimes, physicians can help counsel patients about managing stress, but a psychological consult might also be useful. And self-management programs can help patients manage and tolerate their pain."
The CHECK study is supported by the Dutch Arthritis Association. Dr. Wesseling and her colleagues had no disclosures to report.
AT THE EULAR CONGRESS 2013
Major finding: The poorer-outcome groups were significantly more likely to worry about their condition than was the good-outcome group (moderate outcome, OR = 2.3; poor outcome, OR = 3.5), and more likely to rest often (moderate outcome, OR = 1.6; poor outcome, OR = 2.4).
Data source: A subanalysis of 5-year data on 705 patients with symptomatic knee OA who are participating in the CHECK (Cohort Hip and Cohort Knee) study, a 10-year prospective cohort study of 1,002 patients with early OA-related complaints of hip and/or knee pain.
Disclosures: The CHECK study is supported by the Dutch Arthritis Association. Dr. Wesseling and her colleagues had no disclosures to report.
Earlier biologic use on the rise in juvenile arthritis
MADRID – Biologic agents are increasingly being used in the treatment of juvenile idiopathic arthritis, earlier in the course of the disease and in less severe cases, according to longitudinal data from the Dutch National Arthritis and Biologicals in Children Register.
Etanercept was the most commonly used biologic in nonsystemic cases of JIA, while anakinra was the most commonly prescribed biologic agent for systemic disease over a 12-year evaluation period.
"Treatment strategies in JIA have changed over the past decade, especially since the introduction of biologics," said Janneke Anink, a third-year postgraduate student at Erasmus MC-Sophia Children’s Hospital in Rotterdam, the Netherlands. This has been possible due to a better understanding of the immunologic and biologic mechanisms underlying the inflammatory joint disease.
Etanercept, which blocks tumor necrosis factor (TNF), was the first biologic agent to be registered in Holland in 1999, Ms. Anink noted. Additional anti-TNF therapies, such as infliximab and adalimumab, became available in 2007-2008, followed by the interleukin (IL-1) blockers canakinumab and anakinra in 2009-2010, and, more recently, the IL-6 blocker tocilizumab in 2011.
Alongside the availability of these novel drugs, treatment goals have changed, from the prevention of long-term joint damage and disability to achieving inactive disease through more aggressive and earlier therapy, Ms. Anink said at the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2013;72:154). It’s not known, however, whether the use of these drugs actually leads to better patient outcomes.
Ms. Anink and her associates therefore set out to determine how prescription trends had changed in Holland since biologic agents became available and how such trends might have influenced patient outcomes. The team used data from the Dutch National Arthritis and Biologicals in Children (ABC) Register, which is an ongoing, multicenter, prospective, observational initiative that began in 1999 with the aim of including all patients with JIA who are treated with a biologic agent for their condition.
Upon inclusion in the ABC Register, key patient characteristics are collected, including age, gender, JIA category, age at diagnosis, disease duration, and prior medication use. Patients are also assessed for current medication use, adverse events of treatment, and a host of laboratory and disease activity parameters, which are assessed again 3 and 6 months after inclusion, and then annually.
A total of 429 cases were included in the current analysis, of which 343 patients had nonsystemic and 86 had systemic disease. Patients had started treatment with at least one biologic agent between 1999 and 2010. There were 82 prescriptions for biologic agents in 2010 for both systemic and nonsystemic JIA, compared with only 12 during 1999-2000.
Biologic agents were prescribed after shorter disease durations in 2008-2010, compared with 1999-2001, dropping from 5.3 years to 3.0 years, respectively, in nonsystemic JIA and from 3.5 years to 0.4 years, respectively, for systemic disease, Ms. Anink reported.
Nonsystemic JIA patients with lower disease activity at baseline were also being treated with these drugs. Indeed, the median number of active joints at baseline fell from 18 before biologic therapy was given to 5. The median number of joints with limited motion decreased from 12 to 3, and Childhood Health Assessment Questionnaire (CHAQ) scores fell from 1.8 to 1.1 over the same time periods.
Importantly, the proportion of patients with inactive disease after 3 months of therapy increased dramatically, from 0% in 1999-2001 to 34% during 2008-2010 for nonsystemic disease and from 0% to 64% for systemic disease.
"We saw the threshold for prescription decreased, which was earlier in the disease course and in patients with lower disease activity," Ms. Anink summarized. "With these trends, we say the short-term treatment outcomes improved in all JIA categories."
Similar findings were presented separately at the meeting by a German team. Dr. Kirsten Minden of the German Rheumatism Research Centre, Berlin, and her associates reported that the use of traditional and biologic disease-modifying agents for the treatment of polyarticular JIA rose and occurred earlier over a 12-year period (Ann. Rheum. Dis. 2013;72:731). Improved patient health status, including functional capacity measured by the CHAQ score, disease activity measured by the 10-joint Juvenile Arthritis Disease Activity Score, and pain and overall well-being, coincided with treatment changes.
The ABC Register was financially supported by the Dutch Board of Health Insurances (from 2003 to 2006), Pfizer (formerly Wyeth International, since 2007), and Abbott (since 2010). Ms. Anink had no disclosures to report.
MADRID – Biologic agents are increasingly being used in the treatment of juvenile idiopathic arthritis, earlier in the course of the disease and in less severe cases, according to longitudinal data from the Dutch National Arthritis and Biologicals in Children Register.
Etanercept was the most commonly used biologic in nonsystemic cases of JIA, while anakinra was the most commonly prescribed biologic agent for systemic disease over a 12-year evaluation period.
"Treatment strategies in JIA have changed over the past decade, especially since the introduction of biologics," said Janneke Anink, a third-year postgraduate student at Erasmus MC-Sophia Children’s Hospital in Rotterdam, the Netherlands. This has been possible due to a better understanding of the immunologic and biologic mechanisms underlying the inflammatory joint disease.
Etanercept, which blocks tumor necrosis factor (TNF), was the first biologic agent to be registered in Holland in 1999, Ms. Anink noted. Additional anti-TNF therapies, such as infliximab and adalimumab, became available in 2007-2008, followed by the interleukin (IL-1) blockers canakinumab and anakinra in 2009-2010, and, more recently, the IL-6 blocker tocilizumab in 2011.
Alongside the availability of these novel drugs, treatment goals have changed, from the prevention of long-term joint damage and disability to achieving inactive disease through more aggressive and earlier therapy, Ms. Anink said at the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2013;72:154). It’s not known, however, whether the use of these drugs actually leads to better patient outcomes.
Ms. Anink and her associates therefore set out to determine how prescription trends had changed in Holland since biologic agents became available and how such trends might have influenced patient outcomes. The team used data from the Dutch National Arthritis and Biologicals in Children (ABC) Register, which is an ongoing, multicenter, prospective, observational initiative that began in 1999 with the aim of including all patients with JIA who are treated with a biologic agent for their condition.
Upon inclusion in the ABC Register, key patient characteristics are collected, including age, gender, JIA category, age at diagnosis, disease duration, and prior medication use. Patients are also assessed for current medication use, adverse events of treatment, and a host of laboratory and disease activity parameters, which are assessed again 3 and 6 months after inclusion, and then annually.
A total of 429 cases were included in the current analysis, of which 343 patients had nonsystemic and 86 had systemic disease. Patients had started treatment with at least one biologic agent between 1999 and 2010. There were 82 prescriptions for biologic agents in 2010 for both systemic and nonsystemic JIA, compared with only 12 during 1999-2000.
Biologic agents were prescribed after shorter disease durations in 2008-2010, compared with 1999-2001, dropping from 5.3 years to 3.0 years, respectively, in nonsystemic JIA and from 3.5 years to 0.4 years, respectively, for systemic disease, Ms. Anink reported.
Nonsystemic JIA patients with lower disease activity at baseline were also being treated with these drugs. Indeed, the median number of active joints at baseline fell from 18 before biologic therapy was given to 5. The median number of joints with limited motion decreased from 12 to 3, and Childhood Health Assessment Questionnaire (CHAQ) scores fell from 1.8 to 1.1 over the same time periods.
Importantly, the proportion of patients with inactive disease after 3 months of therapy increased dramatically, from 0% in 1999-2001 to 34% during 2008-2010 for nonsystemic disease and from 0% to 64% for systemic disease.
"We saw the threshold for prescription decreased, which was earlier in the disease course and in patients with lower disease activity," Ms. Anink summarized. "With these trends, we say the short-term treatment outcomes improved in all JIA categories."
Similar findings were presented separately at the meeting by a German team. Dr. Kirsten Minden of the German Rheumatism Research Centre, Berlin, and her associates reported that the use of traditional and biologic disease-modifying agents for the treatment of polyarticular JIA rose and occurred earlier over a 12-year period (Ann. Rheum. Dis. 2013;72:731). Improved patient health status, including functional capacity measured by the CHAQ score, disease activity measured by the 10-joint Juvenile Arthritis Disease Activity Score, and pain and overall well-being, coincided with treatment changes.
The ABC Register was financially supported by the Dutch Board of Health Insurances (from 2003 to 2006), Pfizer (formerly Wyeth International, since 2007), and Abbott (since 2010). Ms. Anink had no disclosures to report.
MADRID – Biologic agents are increasingly being used in the treatment of juvenile idiopathic arthritis, earlier in the course of the disease and in less severe cases, according to longitudinal data from the Dutch National Arthritis and Biologicals in Children Register.
Etanercept was the most commonly used biologic in nonsystemic cases of JIA, while anakinra was the most commonly prescribed biologic agent for systemic disease over a 12-year evaluation period.
"Treatment strategies in JIA have changed over the past decade, especially since the introduction of biologics," said Janneke Anink, a third-year postgraduate student at Erasmus MC-Sophia Children’s Hospital in Rotterdam, the Netherlands. This has been possible due to a better understanding of the immunologic and biologic mechanisms underlying the inflammatory joint disease.
Etanercept, which blocks tumor necrosis factor (TNF), was the first biologic agent to be registered in Holland in 1999, Ms. Anink noted. Additional anti-TNF therapies, such as infliximab and adalimumab, became available in 2007-2008, followed by the interleukin (IL-1) blockers canakinumab and anakinra in 2009-2010, and, more recently, the IL-6 blocker tocilizumab in 2011.
Alongside the availability of these novel drugs, treatment goals have changed, from the prevention of long-term joint damage and disability to achieving inactive disease through more aggressive and earlier therapy, Ms. Anink said at the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2013;72:154). It’s not known, however, whether the use of these drugs actually leads to better patient outcomes.
Ms. Anink and her associates therefore set out to determine how prescription trends had changed in Holland since biologic agents became available and how such trends might have influenced patient outcomes. The team used data from the Dutch National Arthritis and Biologicals in Children (ABC) Register, which is an ongoing, multicenter, prospective, observational initiative that began in 1999 with the aim of including all patients with JIA who are treated with a biologic agent for their condition.
Upon inclusion in the ABC Register, key patient characteristics are collected, including age, gender, JIA category, age at diagnosis, disease duration, and prior medication use. Patients are also assessed for current medication use, adverse events of treatment, and a host of laboratory and disease activity parameters, which are assessed again 3 and 6 months after inclusion, and then annually.
A total of 429 cases were included in the current analysis, of which 343 patients had nonsystemic and 86 had systemic disease. Patients had started treatment with at least one biologic agent between 1999 and 2010. There were 82 prescriptions for biologic agents in 2010 for both systemic and nonsystemic JIA, compared with only 12 during 1999-2000.
Biologic agents were prescribed after shorter disease durations in 2008-2010, compared with 1999-2001, dropping from 5.3 years to 3.0 years, respectively, in nonsystemic JIA and from 3.5 years to 0.4 years, respectively, for systemic disease, Ms. Anink reported.
Nonsystemic JIA patients with lower disease activity at baseline were also being treated with these drugs. Indeed, the median number of active joints at baseline fell from 18 before biologic therapy was given to 5. The median number of joints with limited motion decreased from 12 to 3, and Childhood Health Assessment Questionnaire (CHAQ) scores fell from 1.8 to 1.1 over the same time periods.
Importantly, the proportion of patients with inactive disease after 3 months of therapy increased dramatically, from 0% in 1999-2001 to 34% during 2008-2010 for nonsystemic disease and from 0% to 64% for systemic disease.
"We saw the threshold for prescription decreased, which was earlier in the disease course and in patients with lower disease activity," Ms. Anink summarized. "With these trends, we say the short-term treatment outcomes improved in all JIA categories."
Similar findings were presented separately at the meeting by a German team. Dr. Kirsten Minden of the German Rheumatism Research Centre, Berlin, and her associates reported that the use of traditional and biologic disease-modifying agents for the treatment of polyarticular JIA rose and occurred earlier over a 12-year period (Ann. Rheum. Dis. 2013;72:731). Improved patient health status, including functional capacity measured by the CHAQ score, disease activity measured by the 10-joint Juvenile Arthritis Disease Activity Score, and pain and overall well-being, coincided with treatment changes.
The ABC Register was financially supported by the Dutch Board of Health Insurances (from 2003 to 2006), Pfizer (formerly Wyeth International, since 2007), and Abbott (since 2010). Ms. Anink had no disclosures to report.
AT THE EULAR CONGRESS 2013
Major finding: The proportion of patients with inactive disease after 3 months of biologic therapy increased dramatically, from 0% in 1999-2001 to 34% in 2008-2010 for nonsystemic disease, and from 0% to 64% for systemic disease.
Data source: Data on 343 nonsystemic and 86 systemic juvenile idiopathic arthritis patients from the Dutch National Arthritis and Biologicals in Children (ABC) Register who were prescribed at least one biologic agent between 1999 and 2010
Disclosures: The ABC Register was financially supported by the Dutch Board of Health Insurances (from 2003 to 2006), Pfizer (formerly Wyeth International, since 2007), and Abbott (since 2010). Ms. Anink had no disclosures to report.
Arimoclomol eased inclusion body myositis in small trial
MADRID – Arimoclomol showed promise as a treatment for the most common type of inflammatory myopathy in adults over age 50 in a 1-year, phase IIa, "proof-of-concept" study.
Not only was the novel oral agent "well tolerated," which was the study’s main objective to assess, but it also showed early signs that it could be effective in the treatment of patients with sporadic inclusion body myositis (IBM). Indeed, there was a trend toward slower deterioration in physical function, muscle strength, and right-hand grip muscle strength for arimoclomol when compared against placebo at 8 months’ follow-up.
"IBM is an enigmatic disease," study investigator Dr. Pedro Machado said at the recent annual European Congress of Rheumatology. "IBM muscle tissue displays [both] inflammatory and degenerative features."
Dr. Machado, a senior clinical research associate at the MRC Centre for Neuromuscular Diseases at University College London (UCL), explained that arimoclomol targets the heat shock response, amplifying the expression of heat shock protein. As such, it potentially targets both the degenerative and inflammatory components of the disease. "Previous studies have only involved agents directly purely at the inflammatory component of IBM pathology, and all were ineffective," the researcher observed.
For the double-blind study, teams based at UCL and the University of Kansas, Kansas City, collaborated to recruit 17 men and 7 women (mean age, 67 years) who had had IBM for an average of about 8 years. These patients were randomized in a 2:1 ratio to receive active therapy with arimoclomol 100 mg three times daily or matching placebo for 4 months, with follow-up lasting for 12 months (Ann. Rheum. Dis. 2013;72:164).
The investigators assessed patients for the development of adverse events, physical function using the IBM functional rating scale (IBMFRS), and muscle strength via manual muscle testing and maximum voluntary isometric contraction testing (MVICT) at 4, 8, and 12 months. They also measured the patients’ fat-free mass percentage with dual-energy x-ray absorptiometry at 4 and 12 months, and took muscle biopsies to assess the levels of heat shock protein 70 in muscle tissue before and after 4 months of treatment.
Fourteen of the 16 patients randomized to arimoclomol completed 4 months of treatment; 1 patient returned for final assessment at 12 months’ follow-up. All eight placebo patients completed 12 months of follow-up.
"The drug was very safe and well tolerated. Compliance was, on average, 99%, and we also performed ophthalmological assessment, and there were no ophthalmological problems," Dr. Machado said.
The most common adverse events were gastrointestinal problems, infections, and falls, although there was no difference between the arimoclomol and placebo groups in terms of the frequency, type, or severity of these or other adverse events. "We have to remind ourselves that this is an elderly population," Dr. Machado said, noting that the infections seen all responded to standard antibiotic therapy.
"There was one serious adverse event," he conceded. This was a case of hypertension requiring prolonged hospitalization in a patient given arimoclomol. "There were also two cases of hyponatremia in the arimoclomol group, but this was mild, transient, and asymptomatic, and it resolved without treatment."
At 4, 8, and 12 months after baseline, scores on the IBMFRS in the arimoclomol versus the placebo arm changed by a respective –0.34 vs. –0.88 (P = .239), –0.68 vs. –2.50 (P = .055), and –2.03 vs. –3.50 (P = .538). These data suggest that less deterioration in physical function occurred with arimoclomol than with placebo, Dr. Machado said.
Muscle strength appeared to improve with active treatment, as did right-hand grip strength based on MVICT results at 8 months that approached significance (1.26 vs. –0.54; P = .064).
"A trend towards a slower deterioration was observed in the arimoclomol group for the IBMFRS, for the [muscle] strength score, and for the quantitative muscle assessment only for the right-hand grip assessment at 8 months," Dr. Machado said.
He concluded: "This shows a preliminary signal for potential therapeutic benefit in patients with IBM, and therefore we believe that these data support further research of arimoclomol in inclusion body myositis."
The study was funded by Arthritis Research UK, a University of Kansas Neurology Ziegler Grant, and a University of Kansas General Clinical Research Center CReFF Grant. Dr. Machado had no disclosures.
MADRID – Arimoclomol showed promise as a treatment for the most common type of inflammatory myopathy in adults over age 50 in a 1-year, phase IIa, "proof-of-concept" study.
Not only was the novel oral agent "well tolerated," which was the study’s main objective to assess, but it also showed early signs that it could be effective in the treatment of patients with sporadic inclusion body myositis (IBM). Indeed, there was a trend toward slower deterioration in physical function, muscle strength, and right-hand grip muscle strength for arimoclomol when compared against placebo at 8 months’ follow-up.
"IBM is an enigmatic disease," study investigator Dr. Pedro Machado said at the recent annual European Congress of Rheumatology. "IBM muscle tissue displays [both] inflammatory and degenerative features."
Dr. Machado, a senior clinical research associate at the MRC Centre for Neuromuscular Diseases at University College London (UCL), explained that arimoclomol targets the heat shock response, amplifying the expression of heat shock protein. As such, it potentially targets both the degenerative and inflammatory components of the disease. "Previous studies have only involved agents directly purely at the inflammatory component of IBM pathology, and all were ineffective," the researcher observed.
For the double-blind study, teams based at UCL and the University of Kansas, Kansas City, collaborated to recruit 17 men and 7 women (mean age, 67 years) who had had IBM for an average of about 8 years. These patients were randomized in a 2:1 ratio to receive active therapy with arimoclomol 100 mg three times daily or matching placebo for 4 months, with follow-up lasting for 12 months (Ann. Rheum. Dis. 2013;72:164).
The investigators assessed patients for the development of adverse events, physical function using the IBM functional rating scale (IBMFRS), and muscle strength via manual muscle testing and maximum voluntary isometric contraction testing (MVICT) at 4, 8, and 12 months. They also measured the patients’ fat-free mass percentage with dual-energy x-ray absorptiometry at 4 and 12 months, and took muscle biopsies to assess the levels of heat shock protein 70 in muscle tissue before and after 4 months of treatment.
Fourteen of the 16 patients randomized to arimoclomol completed 4 months of treatment; 1 patient returned for final assessment at 12 months’ follow-up. All eight placebo patients completed 12 months of follow-up.
"The drug was very safe and well tolerated. Compliance was, on average, 99%, and we also performed ophthalmological assessment, and there were no ophthalmological problems," Dr. Machado said.
The most common adverse events were gastrointestinal problems, infections, and falls, although there was no difference between the arimoclomol and placebo groups in terms of the frequency, type, or severity of these or other adverse events. "We have to remind ourselves that this is an elderly population," Dr. Machado said, noting that the infections seen all responded to standard antibiotic therapy.
"There was one serious adverse event," he conceded. This was a case of hypertension requiring prolonged hospitalization in a patient given arimoclomol. "There were also two cases of hyponatremia in the arimoclomol group, but this was mild, transient, and asymptomatic, and it resolved without treatment."
At 4, 8, and 12 months after baseline, scores on the IBMFRS in the arimoclomol versus the placebo arm changed by a respective –0.34 vs. –0.88 (P = .239), –0.68 vs. –2.50 (P = .055), and –2.03 vs. –3.50 (P = .538). These data suggest that less deterioration in physical function occurred with arimoclomol than with placebo, Dr. Machado said.
Muscle strength appeared to improve with active treatment, as did right-hand grip strength based on MVICT results at 8 months that approached significance (1.26 vs. –0.54; P = .064).
"A trend towards a slower deterioration was observed in the arimoclomol group for the IBMFRS, for the [muscle] strength score, and for the quantitative muscle assessment only for the right-hand grip assessment at 8 months," Dr. Machado said.
He concluded: "This shows a preliminary signal for potential therapeutic benefit in patients with IBM, and therefore we believe that these data support further research of arimoclomol in inclusion body myositis."
The study was funded by Arthritis Research UK, a University of Kansas Neurology Ziegler Grant, and a University of Kansas General Clinical Research Center CReFF Grant. Dr. Machado had no disclosures.
MADRID – Arimoclomol showed promise as a treatment for the most common type of inflammatory myopathy in adults over age 50 in a 1-year, phase IIa, "proof-of-concept" study.
Not only was the novel oral agent "well tolerated," which was the study’s main objective to assess, but it also showed early signs that it could be effective in the treatment of patients with sporadic inclusion body myositis (IBM). Indeed, there was a trend toward slower deterioration in physical function, muscle strength, and right-hand grip muscle strength for arimoclomol when compared against placebo at 8 months’ follow-up.
"IBM is an enigmatic disease," study investigator Dr. Pedro Machado said at the recent annual European Congress of Rheumatology. "IBM muscle tissue displays [both] inflammatory and degenerative features."
Dr. Machado, a senior clinical research associate at the MRC Centre for Neuromuscular Diseases at University College London (UCL), explained that arimoclomol targets the heat shock response, amplifying the expression of heat shock protein. As such, it potentially targets both the degenerative and inflammatory components of the disease. "Previous studies have only involved agents directly purely at the inflammatory component of IBM pathology, and all were ineffective," the researcher observed.
For the double-blind study, teams based at UCL and the University of Kansas, Kansas City, collaborated to recruit 17 men and 7 women (mean age, 67 years) who had had IBM for an average of about 8 years. These patients were randomized in a 2:1 ratio to receive active therapy with arimoclomol 100 mg three times daily or matching placebo for 4 months, with follow-up lasting for 12 months (Ann. Rheum. Dis. 2013;72:164).
The investigators assessed patients for the development of adverse events, physical function using the IBM functional rating scale (IBMFRS), and muscle strength via manual muscle testing and maximum voluntary isometric contraction testing (MVICT) at 4, 8, and 12 months. They also measured the patients’ fat-free mass percentage with dual-energy x-ray absorptiometry at 4 and 12 months, and took muscle biopsies to assess the levels of heat shock protein 70 in muscle tissue before and after 4 months of treatment.
Fourteen of the 16 patients randomized to arimoclomol completed 4 months of treatment; 1 patient returned for final assessment at 12 months’ follow-up. All eight placebo patients completed 12 months of follow-up.
"The drug was very safe and well tolerated. Compliance was, on average, 99%, and we also performed ophthalmological assessment, and there were no ophthalmological problems," Dr. Machado said.
The most common adverse events were gastrointestinal problems, infections, and falls, although there was no difference between the arimoclomol and placebo groups in terms of the frequency, type, or severity of these or other adverse events. "We have to remind ourselves that this is an elderly population," Dr. Machado said, noting that the infections seen all responded to standard antibiotic therapy.
"There was one serious adverse event," he conceded. This was a case of hypertension requiring prolonged hospitalization in a patient given arimoclomol. "There were also two cases of hyponatremia in the arimoclomol group, but this was mild, transient, and asymptomatic, and it resolved without treatment."
At 4, 8, and 12 months after baseline, scores on the IBMFRS in the arimoclomol versus the placebo arm changed by a respective –0.34 vs. –0.88 (P = .239), –0.68 vs. –2.50 (P = .055), and –2.03 vs. –3.50 (P = .538). These data suggest that less deterioration in physical function occurred with arimoclomol than with placebo, Dr. Machado said.
Muscle strength appeared to improve with active treatment, as did right-hand grip strength based on MVICT results at 8 months that approached significance (1.26 vs. –0.54; P = .064).
"A trend towards a slower deterioration was observed in the arimoclomol group for the IBMFRS, for the [muscle] strength score, and for the quantitative muscle assessment only for the right-hand grip assessment at 8 months," Dr. Machado said.
He concluded: "This shows a preliminary signal for potential therapeutic benefit in patients with IBM, and therefore we believe that these data support further research of arimoclomol in inclusion body myositis."
The study was funded by Arthritis Research UK, a University of Kansas Neurology Ziegler Grant, and a University of Kansas General Clinical Research Center CReFF Grant. Dr. Machado had no disclosures.
AT THE EULAR CONGRESS 2013
Major finding: Arimoclomol resulted in less physical function deterioration at 8 months than placebo (IBM functional rating scale, 0.68 vs. –2.50; P = .055).
Data source: Randomized, two-center, double-blind, placebo-controlled phase IIa study of arimoclomol in the treatment of 24 adults with sporadic inclusion body myositis.
Disclosures: The study was funded by Arthritis Research UK, a University of Kansas Neurology Ziegler Grant, and a University of Kansas General Clinical Research Center CReFF Grant. Dr. Machado had no disclosures.
Ultrasound speeds new RA diagnoses
MADRID – Routine joint scans by ultrasound in patients with suspected rheumatoid arthritis led to faster diagnoses and quicker initiation of disease-modifying treatment in a multicenter-study of more than 250 patients.
But the results did not address whether this earlier diagnosis and treatment produced better outcomes. "While earlier diagnosis and treatment is known to lead to better outcomes, a large, prospective study is required to explore the long-term clinical impact and cost effectiveness of wider routine use of ultrasound by rheumatologists," Dr. Stephen Kelly said at the annual European Congress of Rheumatology.
Despite this current limitation of the available evidence, Dr. Kelly is convinced of the value of routine ultrasound examinations for joint assessment in patients with possible rheumatoid arthritis (RA). "You can see raging inflammation in joints that are not swollen or tender," he said in an interview. The discrepancy between clinical symptoms and the ultrasound appearance can be "surprising," said Dr. Kelly, a rheumatologist at Mile End Hospital in Barts Health NHS Trust in London.
The current study involved observation of patients referred by primary-care physicians to rheumatologists at four U.K. hospitals. Each of the four sites selected included some rheumatologists who routinely used ultrasound and others who did not. By the end of the study, 134 patients had been assessed with ultrasound joint examinations and 124 had been assessed without ultrasound. All patients were initially seen in the referral rheumatology clinics an average of 5 months after symptom onset. They had a mean age of about 53 years, and about 70% were women.
Among the 134 patients assessed initially with ultrasound, the average time to a formal RA diagnosis was 2.24 months, and the median time was 0.89 months. Among the patients not examined with ultrasound, a formal RA diagnosis was made at a mean of 2.76 months and a median of 2 months. These differences were statistically significant.
The investigators eventually diagnosed RA in 54 of the patients assessed with ultrasound and in 58 patients assessed without ultrasound. The median time to the start of treatment with a disease-modifying antirheumatic drug (DMARD) was 0.62 months among patients routinely examined with ultrasound and 1.41 months among those examined without ultrasound.
Put another way, among the patients eventually diagnosed with RA, 67% were diagnosed within a month of initial referral when their rheumatologists routinely used ultrasound, compared with 37% of the RA patients diagnosed within the first month when ultrasound wasn’t used. Initiation of DMARD treatment for the subgroup eventually diagnosed with RA happened in the first month for 63% of the patients routinely assessed by ultrasound, and in 32% of those worked-up without ultrasound.
In a further analysis, the rheumatologists who assessed 134 patients with ultrasound were asked whether their use of ultrasound made a difference. Fifty-three percent said that the first scan they obtained was instrumental in making their diagnosis, and 39% said that a subsequent ultrasound exam was critical in their diagnostic process.
The researchers also asked the rheumatologists who used ultrasound whether the ultrasound results played an important role in management decisions. Thirty-eight percent of the rheumatologists said that the first ultrasound scan they obtained played an important role in their management decisions, and 57% said that a subsequent ultrasound scan affected management.
The study was sponsored by AbbVie. Dr. Kelly said that he had no personal disclosures.
On Twitter @mitchelzoler
The main issue when imaging joints in patients with suspected rheumatoid arthritis (RA) or early disease is: What does imaging add to a standard clinical examination? Standard x-rays do not show many erosions in patients with early disease; ultrasound, as well as MRI, are much more sensitive. Both ultrasound and MRI can be very helpful for difficult-to-diagnose cases. In my experience, about 5%-10% of early-diagnosis cases benefit from using ultrasound or MRI imaging of joints.
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Ultrasound is more widely used than MRI is and also costs less. You can examine multiple joints with ultrasound, you don’t need to inject contrast, and you can also use the ultrasound to guide injections. For all these reasons, ultrasound has rapidly become widely used to aid early diagnoses. But not every clinician has the expertise to perform ultrasound examinations, and it has not yet been definitively proven that using ultrasound routinely for diagnostically challenging cases is cost effective. I suspect it is cost effective to perform ultrasound examinations fairly broadly on patients suspected of having RA, compared with the financial and social costs of delayed RA diagnosis in which the patient goes untreated for an added period of time, but study results are still needed to prove this.
In June, I chaired a task force that issued the European League Against Rheumatism’s first recommendations on using joint imaging in the management of RA (Ann. Rheum. Dis. 2013;72:804-14). The 10 recommendations made by the task force include several that support and encourage the use of ultrasound or MRI for both the initial diagnosis of RA as well as subsequent management. However, because evidence is currently lacking to fully document the feasibility, cost, and training required to use methods like ultrasound in routine practice, our recommendations could not be unqualified. For example, our first recommendation says, "When there is diagnostic doubt, conventional radiography, ultrasound, or MRI can be used to improve the certainty of a diagnosis of RA above clinical criteria alone." The level of evidence for this recommendation is level III, which is not the highest level. In addition, note that the recommendation says "can be used" rather than mandating the use of ultrasound or another imaging method. In the same way, our third recommendation says, "Ultrasound and MRI are superior to clinical examination in the detection of joint inflammation; these techniques should be considered for more accurate assessment of inflammation." Again, the level of evidence, III, precluded us from saying anything more definitive than "should be considered."
The main issue when imaging joints in patients with suspected rheumatoid arthritis (RA) or early disease is: What does imaging add to a standard clinical examination? Standard x-rays do not show many erosions in patients with early disease; ultrasound, as well as MRI, are much more sensitive. Both ultrasound and MRI can be very helpful for difficult-to-diagnose cases. In my experience, about 5%-10% of early-diagnosis cases benefit from using ultrasound or MRI imaging of joints.
|
|
Ultrasound is more widely used than MRI is and also costs less. You can examine multiple joints with ultrasound, you don’t need to inject contrast, and you can also use the ultrasound to guide injections. For all these reasons, ultrasound has rapidly become widely used to aid early diagnoses. But not every clinician has the expertise to perform ultrasound examinations, and it has not yet been definitively proven that using ultrasound routinely for diagnostically challenging cases is cost effective. I suspect it is cost effective to perform ultrasound examinations fairly broadly on patients suspected of having RA, compared with the financial and social costs of delayed RA diagnosis in which the patient goes untreated for an added period of time, but study results are still needed to prove this.
In June, I chaired a task force that issued the European League Against Rheumatism’s first recommendations on using joint imaging in the management of RA (Ann. Rheum. Dis. 2013;72:804-14). The 10 recommendations made by the task force include several that support and encourage the use of ultrasound or MRI for both the initial diagnosis of RA as well as subsequent management. However, because evidence is currently lacking to fully document the feasibility, cost, and training required to use methods like ultrasound in routine practice, our recommendations could not be unqualified. For example, our first recommendation says, "When there is diagnostic doubt, conventional radiography, ultrasound, or MRI can be used to improve the certainty of a diagnosis of RA above clinical criteria alone." The level of evidence for this recommendation is level III, which is not the highest level. In addition, note that the recommendation says "can be used" rather than mandating the use of ultrasound or another imaging method. In the same way, our third recommendation says, "Ultrasound and MRI are superior to clinical examination in the detection of joint inflammation; these techniques should be considered for more accurate assessment of inflammation." Again, the level of evidence, III, precluded us from saying anything more definitive than "should be considered."
The main issue when imaging joints in patients with suspected rheumatoid arthritis (RA) or early disease is: What does imaging add to a standard clinical examination? Standard x-rays do not show many erosions in patients with early disease; ultrasound, as well as MRI, are much more sensitive. Both ultrasound and MRI can be very helpful for difficult-to-diagnose cases. In my experience, about 5%-10% of early-diagnosis cases benefit from using ultrasound or MRI imaging of joints.
|
|
Ultrasound is more widely used than MRI is and also costs less. You can examine multiple joints with ultrasound, you don’t need to inject contrast, and you can also use the ultrasound to guide injections. For all these reasons, ultrasound has rapidly become widely used to aid early diagnoses. But not every clinician has the expertise to perform ultrasound examinations, and it has not yet been definitively proven that using ultrasound routinely for diagnostically challenging cases is cost effective. I suspect it is cost effective to perform ultrasound examinations fairly broadly on patients suspected of having RA, compared with the financial and social costs of delayed RA diagnosis in which the patient goes untreated for an added period of time, but study results are still needed to prove this.
In June, I chaired a task force that issued the European League Against Rheumatism’s first recommendations on using joint imaging in the management of RA (Ann. Rheum. Dis. 2013;72:804-14). The 10 recommendations made by the task force include several that support and encourage the use of ultrasound or MRI for both the initial diagnosis of RA as well as subsequent management. However, because evidence is currently lacking to fully document the feasibility, cost, and training required to use methods like ultrasound in routine practice, our recommendations could not be unqualified. For example, our first recommendation says, "When there is diagnostic doubt, conventional radiography, ultrasound, or MRI can be used to improve the certainty of a diagnosis of RA above clinical criteria alone." The level of evidence for this recommendation is level III, which is not the highest level. In addition, note that the recommendation says "can be used" rather than mandating the use of ultrasound or another imaging method. In the same way, our third recommendation says, "Ultrasound and MRI are superior to clinical examination in the detection of joint inflammation; these techniques should be considered for more accurate assessment of inflammation." Again, the level of evidence, III, precluded us from saying anything more definitive than "should be considered."
MADRID – Routine joint scans by ultrasound in patients with suspected rheumatoid arthritis led to faster diagnoses and quicker initiation of disease-modifying treatment in a multicenter-study of more than 250 patients.
But the results did not address whether this earlier diagnosis and treatment produced better outcomes. "While earlier diagnosis and treatment is known to lead to better outcomes, a large, prospective study is required to explore the long-term clinical impact and cost effectiveness of wider routine use of ultrasound by rheumatologists," Dr. Stephen Kelly said at the annual European Congress of Rheumatology.
Despite this current limitation of the available evidence, Dr. Kelly is convinced of the value of routine ultrasound examinations for joint assessment in patients with possible rheumatoid arthritis (RA). "You can see raging inflammation in joints that are not swollen or tender," he said in an interview. The discrepancy between clinical symptoms and the ultrasound appearance can be "surprising," said Dr. Kelly, a rheumatologist at Mile End Hospital in Barts Health NHS Trust in London.
The current study involved observation of patients referred by primary-care physicians to rheumatologists at four U.K. hospitals. Each of the four sites selected included some rheumatologists who routinely used ultrasound and others who did not. By the end of the study, 134 patients had been assessed with ultrasound joint examinations and 124 had been assessed without ultrasound. All patients were initially seen in the referral rheumatology clinics an average of 5 months after symptom onset. They had a mean age of about 53 years, and about 70% were women.
Among the 134 patients assessed initially with ultrasound, the average time to a formal RA diagnosis was 2.24 months, and the median time was 0.89 months. Among the patients not examined with ultrasound, a formal RA diagnosis was made at a mean of 2.76 months and a median of 2 months. These differences were statistically significant.
The investigators eventually diagnosed RA in 54 of the patients assessed with ultrasound and in 58 patients assessed without ultrasound. The median time to the start of treatment with a disease-modifying antirheumatic drug (DMARD) was 0.62 months among patients routinely examined with ultrasound and 1.41 months among those examined without ultrasound.
Put another way, among the patients eventually diagnosed with RA, 67% were diagnosed within a month of initial referral when their rheumatologists routinely used ultrasound, compared with 37% of the RA patients diagnosed within the first month when ultrasound wasn’t used. Initiation of DMARD treatment for the subgroup eventually diagnosed with RA happened in the first month for 63% of the patients routinely assessed by ultrasound, and in 32% of those worked-up without ultrasound.
In a further analysis, the rheumatologists who assessed 134 patients with ultrasound were asked whether their use of ultrasound made a difference. Fifty-three percent said that the first scan they obtained was instrumental in making their diagnosis, and 39% said that a subsequent ultrasound exam was critical in their diagnostic process.
The researchers also asked the rheumatologists who used ultrasound whether the ultrasound results played an important role in management decisions. Thirty-eight percent of the rheumatologists said that the first ultrasound scan they obtained played an important role in their management decisions, and 57% said that a subsequent ultrasound scan affected management.
The study was sponsored by AbbVie. Dr. Kelly said that he had no personal disclosures.
On Twitter @mitchelzoler
MADRID – Routine joint scans by ultrasound in patients with suspected rheumatoid arthritis led to faster diagnoses and quicker initiation of disease-modifying treatment in a multicenter-study of more than 250 patients.
But the results did not address whether this earlier diagnosis and treatment produced better outcomes. "While earlier diagnosis and treatment is known to lead to better outcomes, a large, prospective study is required to explore the long-term clinical impact and cost effectiveness of wider routine use of ultrasound by rheumatologists," Dr. Stephen Kelly said at the annual European Congress of Rheumatology.
Despite this current limitation of the available evidence, Dr. Kelly is convinced of the value of routine ultrasound examinations for joint assessment in patients with possible rheumatoid arthritis (RA). "You can see raging inflammation in joints that are not swollen or tender," he said in an interview. The discrepancy between clinical symptoms and the ultrasound appearance can be "surprising," said Dr. Kelly, a rheumatologist at Mile End Hospital in Barts Health NHS Trust in London.
The current study involved observation of patients referred by primary-care physicians to rheumatologists at four U.K. hospitals. Each of the four sites selected included some rheumatologists who routinely used ultrasound and others who did not. By the end of the study, 134 patients had been assessed with ultrasound joint examinations and 124 had been assessed without ultrasound. All patients were initially seen in the referral rheumatology clinics an average of 5 months after symptom onset. They had a mean age of about 53 years, and about 70% were women.
Among the 134 patients assessed initially with ultrasound, the average time to a formal RA diagnosis was 2.24 months, and the median time was 0.89 months. Among the patients not examined with ultrasound, a formal RA diagnosis was made at a mean of 2.76 months and a median of 2 months. These differences were statistically significant.
The investigators eventually diagnosed RA in 54 of the patients assessed with ultrasound and in 58 patients assessed without ultrasound. The median time to the start of treatment with a disease-modifying antirheumatic drug (DMARD) was 0.62 months among patients routinely examined with ultrasound and 1.41 months among those examined without ultrasound.
Put another way, among the patients eventually diagnosed with RA, 67% were diagnosed within a month of initial referral when their rheumatologists routinely used ultrasound, compared with 37% of the RA patients diagnosed within the first month when ultrasound wasn’t used. Initiation of DMARD treatment for the subgroup eventually diagnosed with RA happened in the first month for 63% of the patients routinely assessed by ultrasound, and in 32% of those worked-up without ultrasound.
In a further analysis, the rheumatologists who assessed 134 patients with ultrasound were asked whether their use of ultrasound made a difference. Fifty-three percent said that the first scan they obtained was instrumental in making their diagnosis, and 39% said that a subsequent ultrasound exam was critical in their diagnostic process.
The researchers also asked the rheumatologists who used ultrasound whether the ultrasound results played an important role in management decisions. Thirty-eight percent of the rheumatologists said that the first ultrasound scan they obtained played an important role in their management decisions, and 57% said that a subsequent ultrasound scan affected management.
The study was sponsored by AbbVie. Dr. Kelly said that he had no personal disclosures.
On Twitter @mitchelzoler
AT THE EULAR CONGRESS 2013
Major finding: Rheumatoid arthritis diagnosis using ultrasound took a median of 0.89 months, compared with 2.00 months when ultrasound wasn’t used.
Data source: A prospective study of 258 patients with suspected rheumatoid arthritis who were examined at four U.K. centers.
Disclosures: The study was sponsored by AbbVie. Dr. Kelly said that he had no personal disclosures.
Serum biomarker predicts radiographic progression in spondyloarthritis
MADRID – Elevated serum levels of vascular endothelial growth factor may be predictive of radiographic progression in the spine, according to data from a German study of patients with spondyloarthritis.
The cutoff point appears to be at 600 pg/mL, with the effects particularly strong in patients who also develop syndesmophytes, which are bony growths that develop within ligaments.
"In patients with syndesmophytes, VEGF [vascular endothelial growth factor], as a predictor of radiographic progression, performed better than CRP [C-reactive protein]," reported Dr. Denis Poddubnyy at the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2013;72:125).
"We all know that radiographic progression varies substantially among patients with spondyloarthritis," Dr. Poddubnyy observed. "Until recently there was only one strong predictor of radiographic progression: the presence of syndesmophytes at baseline," he added.
Last year, however, Dr. Poddubnyy of Charité Universitätsmedizin Berlin, Germany, and his associates published the findings of a study involving 210 patients with early axial spondyloarthritis (axSpA) who were recruited from the German Spondyloarthritis Inception Cohort (GESPIC). This study looked at baseline predictors of spinal radiographic progression over 2 years and found that in addition to radiographic damage, elevated CRP levels and cigarette smoking were independently predictive (Arthritis Rheum. 2012;64:1388-98).
The team’s research also suggested that there could be a few serum biomarkers, including VEGF, that could be predictive, so the investigators conducted a larger study in 172 patients with definite (n = 95) or nonradiographic (n = 77) axSpA to look specifically at the possible association.
Radiographs of the spine taken at baseline and at 2 years’ follow-up were reviewed independently by two readers, who used the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) to record the extent of radiographic progression. If there was a worsening of 2 units or more in mSASSS and the formation of new or increased growth of syndesmophytes, radiographic progression had occurred.
In total, 22 patients had radiographic progression, including 18 with new formation or growth of syndesmophytes.
Baseline VEGF was measured in the serum at baseline and was significantly higher in patients who developed radiographic progression at 2 years than in those who did not (562 plus or minus 357 pg/mL vs. 402 plus or minus 309 pg/mL; P = .027).
Serum VEGF levels were also significantly higher in the patients who had developed new syndesmophytes at 2 years when compared with those who had not (579 plus or minus 386 pg/mL vs. 404 plus or minus 307 pg/mL; P = .041).
"Patients with elevated VEGF had an odds ratio of 2.9 for [radiographic] progression and 3.1 for syndesmophyte formation," Dr. Poddubnyy reported. This was a little disappointing, he noted, as CRP and the erythrocyte sedimentation rate had similar predictive power.
However, in patients at high risk of progression, namely those with syndesmophytes already present at baseline, VEGF was significantly better than CRP at predicting both radiographic progression and new syndesmophyte formation or growth.
Patients with elevated VEGF at baseline were 36.6 times more likely to have radiographic progression and 13.6 times more likely to have new syndesmophyte formation or growth at 2 years than were those with levels below 600 pg/mL. In comparison, elevated CRP levels increased the risks by only 2.4 and 2.5 times, respectively.
VEGF is an essential mediator of angiogenesis and endochondral ossification, Dr. Poddubnyy observed. It’s been shown to have "a chemoattractive effect on osteoblasts and mesenchymal progenitor cells," he added, and also stimulate osteoblast differentiation and bone turnover.
While the results are very promising, further research is of course required. The possible predictive value of VEGF in relation to spinal radiographic progression in patients treated with tumor necrosis factor–alpha inhibitors remains to be seen, for example, and future studies should perhaps look at this question.
"With VEGF we are probably able to improve our prediction of spinal progression in patients with axSpA," Dr. Poddubnyy said in an interview. This is addition to assessing "classical factors," such as syndesmophytes, CRP, and smoking status.
Dr. Poddubnyy had no disclosures.
MADRID – Elevated serum levels of vascular endothelial growth factor may be predictive of radiographic progression in the spine, according to data from a German study of patients with spondyloarthritis.
The cutoff point appears to be at 600 pg/mL, with the effects particularly strong in patients who also develop syndesmophytes, which are bony growths that develop within ligaments.
"In patients with syndesmophytes, VEGF [vascular endothelial growth factor], as a predictor of radiographic progression, performed better than CRP [C-reactive protein]," reported Dr. Denis Poddubnyy at the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2013;72:125).
"We all know that radiographic progression varies substantially among patients with spondyloarthritis," Dr. Poddubnyy observed. "Until recently there was only one strong predictor of radiographic progression: the presence of syndesmophytes at baseline," he added.
Last year, however, Dr. Poddubnyy of Charité Universitätsmedizin Berlin, Germany, and his associates published the findings of a study involving 210 patients with early axial spondyloarthritis (axSpA) who were recruited from the German Spondyloarthritis Inception Cohort (GESPIC). This study looked at baseline predictors of spinal radiographic progression over 2 years and found that in addition to radiographic damage, elevated CRP levels and cigarette smoking were independently predictive (Arthritis Rheum. 2012;64:1388-98).
The team’s research also suggested that there could be a few serum biomarkers, including VEGF, that could be predictive, so the investigators conducted a larger study in 172 patients with definite (n = 95) or nonradiographic (n = 77) axSpA to look specifically at the possible association.
Radiographs of the spine taken at baseline and at 2 years’ follow-up were reviewed independently by two readers, who used the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) to record the extent of radiographic progression. If there was a worsening of 2 units or more in mSASSS and the formation of new or increased growth of syndesmophytes, radiographic progression had occurred.
In total, 22 patients had radiographic progression, including 18 with new formation or growth of syndesmophytes.
Baseline VEGF was measured in the serum at baseline and was significantly higher in patients who developed radiographic progression at 2 years than in those who did not (562 plus or minus 357 pg/mL vs. 402 plus or minus 309 pg/mL; P = .027).
Serum VEGF levels were also significantly higher in the patients who had developed new syndesmophytes at 2 years when compared with those who had not (579 plus or minus 386 pg/mL vs. 404 plus or minus 307 pg/mL; P = .041).
"Patients with elevated VEGF had an odds ratio of 2.9 for [radiographic] progression and 3.1 for syndesmophyte formation," Dr. Poddubnyy reported. This was a little disappointing, he noted, as CRP and the erythrocyte sedimentation rate had similar predictive power.
However, in patients at high risk of progression, namely those with syndesmophytes already present at baseline, VEGF was significantly better than CRP at predicting both radiographic progression and new syndesmophyte formation or growth.
Patients with elevated VEGF at baseline were 36.6 times more likely to have radiographic progression and 13.6 times more likely to have new syndesmophyte formation or growth at 2 years than were those with levels below 600 pg/mL. In comparison, elevated CRP levels increased the risks by only 2.4 and 2.5 times, respectively.
VEGF is an essential mediator of angiogenesis and endochondral ossification, Dr. Poddubnyy observed. It’s been shown to have "a chemoattractive effect on osteoblasts and mesenchymal progenitor cells," he added, and also stimulate osteoblast differentiation and bone turnover.
While the results are very promising, further research is of course required. The possible predictive value of VEGF in relation to spinal radiographic progression in patients treated with tumor necrosis factor–alpha inhibitors remains to be seen, for example, and future studies should perhaps look at this question.
"With VEGF we are probably able to improve our prediction of spinal progression in patients with axSpA," Dr. Poddubnyy said in an interview. This is addition to assessing "classical factors," such as syndesmophytes, CRP, and smoking status.
Dr. Poddubnyy had no disclosures.
MADRID – Elevated serum levels of vascular endothelial growth factor may be predictive of radiographic progression in the spine, according to data from a German study of patients with spondyloarthritis.
The cutoff point appears to be at 600 pg/mL, with the effects particularly strong in patients who also develop syndesmophytes, which are bony growths that develop within ligaments.
"In patients with syndesmophytes, VEGF [vascular endothelial growth factor], as a predictor of radiographic progression, performed better than CRP [C-reactive protein]," reported Dr. Denis Poddubnyy at the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2013;72:125).
"We all know that radiographic progression varies substantially among patients with spondyloarthritis," Dr. Poddubnyy observed. "Until recently there was only one strong predictor of radiographic progression: the presence of syndesmophytes at baseline," he added.
Last year, however, Dr. Poddubnyy of Charité Universitätsmedizin Berlin, Germany, and his associates published the findings of a study involving 210 patients with early axial spondyloarthritis (axSpA) who were recruited from the German Spondyloarthritis Inception Cohort (GESPIC). This study looked at baseline predictors of spinal radiographic progression over 2 years and found that in addition to radiographic damage, elevated CRP levels and cigarette smoking were independently predictive (Arthritis Rheum. 2012;64:1388-98).
The team’s research also suggested that there could be a few serum biomarkers, including VEGF, that could be predictive, so the investigators conducted a larger study in 172 patients with definite (n = 95) or nonradiographic (n = 77) axSpA to look specifically at the possible association.
Radiographs of the spine taken at baseline and at 2 years’ follow-up were reviewed independently by two readers, who used the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) to record the extent of radiographic progression. If there was a worsening of 2 units or more in mSASSS and the formation of new or increased growth of syndesmophytes, radiographic progression had occurred.
In total, 22 patients had radiographic progression, including 18 with new formation or growth of syndesmophytes.
Baseline VEGF was measured in the serum at baseline and was significantly higher in patients who developed radiographic progression at 2 years than in those who did not (562 plus or minus 357 pg/mL vs. 402 plus or minus 309 pg/mL; P = .027).
Serum VEGF levels were also significantly higher in the patients who had developed new syndesmophytes at 2 years when compared with those who had not (579 plus or minus 386 pg/mL vs. 404 plus or minus 307 pg/mL; P = .041).
"Patients with elevated VEGF had an odds ratio of 2.9 for [radiographic] progression and 3.1 for syndesmophyte formation," Dr. Poddubnyy reported. This was a little disappointing, he noted, as CRP and the erythrocyte sedimentation rate had similar predictive power.
However, in patients at high risk of progression, namely those with syndesmophytes already present at baseline, VEGF was significantly better than CRP at predicting both radiographic progression and new syndesmophyte formation or growth.
Patients with elevated VEGF at baseline were 36.6 times more likely to have radiographic progression and 13.6 times more likely to have new syndesmophyte formation or growth at 2 years than were those with levels below 600 pg/mL. In comparison, elevated CRP levels increased the risks by only 2.4 and 2.5 times, respectively.
VEGF is an essential mediator of angiogenesis and endochondral ossification, Dr. Poddubnyy observed. It’s been shown to have "a chemoattractive effect on osteoblasts and mesenchymal progenitor cells," he added, and also stimulate osteoblast differentiation and bone turnover.
While the results are very promising, further research is of course required. The possible predictive value of VEGF in relation to spinal radiographic progression in patients treated with tumor necrosis factor–alpha inhibitors remains to be seen, for example, and future studies should perhaps look at this question.
"With VEGF we are probably able to improve our prediction of spinal progression in patients with axSpA," Dr. Poddubnyy said in an interview. This is addition to assessing "classical factors," such as syndesmophytes, CRP, and smoking status.
Dr. Poddubnyy had no disclosures.
AT THE EULAR CONGRESS 2013
Major finding: Baseline serum VEGF levels were 562 plus or minus 357 pg/mL vs. 402 plus or minus 309 pg/mL in patients with and without radiographic progression, respectively, at 2 years (P = .027).
Data source: Study of 95 patients with definite axial spondyloarthritis (axSpA) and 77 with nonradiographic axSpA recruited from the German Spondyloarthritis Inception Cohort (GESPIC).
Disclosures: Dr. Poddubnyy had no disclosures.
Expert panel sets broad SpA treat-to-target goals
MADRID – A panel of clinicians with expertise in the management of patients with spondyloarthritis took another step toward better defining this disease category and the goals of its treatment by producing the first "treat-to-target" recommendations for spondyloarthritis.
The new recommendations will "guide physicians, patients, and other stakeholders on how to optimize reduction of signs and symptoms and, ideally, outcomes, and will drive" the current research agenda, Dr. Josef S. Smolen said while presenting the panel’s recommendations at the annual European Congress of Rheumatology.
"Treat to target proposes a stepwise approach to achieving optimal outcomes based on available evidence and expert opinion. Treat to target has been successfully applied to management of diabetes, hypertension, hyperlipidemia, and rheumatoid arthritis," and the new task force set out to address whether it could be used when treating patients with spondyloarthritis (SpA), a question that required the expert task force to review the evidence for setting specific treatment goals for patients with SpA, said Dr. Smolen, professor of medicine at the Medical University of Vienna.
The task force eventually decided that the treat-to-target concept was applicable to SpA, but that the data available so far prevented the task force from setting specific treatment goals. While the recommendations underscore the importance of treating SpA patients with a goal of remission or inactive disease, and failing that, at least low disease activity, they fall short of giving clinicians guidance on how to best measure and define remission or low disease activity or how to achieve these goals.
For example, for axial SpA – the subtype that received the most specific recommendations – the panel advised clinicians to guide treatment decisions by using a "validated composite measure of disease activity" such as the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) plus acute phase reactants, or the Ankylosing Spondylitis Disease Activity Score (ASDAS) with or without functional measures such as the Bath Ankylosing Spondylitis Functional Index (BASFI). But the recommendations say nothing about what scores by these measures would define remission or low disease activity. The recommendations also talk about using other factors to further gauge axial SpA disease activity such as MRI analysis of inflammation and radiographic progression, but again Dr. Smolen provided no specific targets when using these measures.
For other, less well studied types of SpA, the new recommendations were even more nebulous. For psoriatic arthritis, the panel indicated that "validated measures of musculoskeletal disease activity" should be "performed and documented regularly" as should other factors such as spinal and extraarticular manifestations, imaging findings, and comorbidities, but the recommendations gave no specifics on what any of these measures might be or what level might equal remission or low disease. The same held true for peripheral SpA.
Other factors touched on by the new recommendations include the need for individualized and shared decision making between physicians and patients, the need for coordination of care among rheumatologists and other medical specialists who treat SpA patients (dermatologists, gastroenterologists, and ophthalmologists), and the need to take into account extraarticular manifestations of SpA diseases, comorbidities, and treatment risks along with the goal of low disease activity.
"I think it was important to document that there is a paucity of trials that have looked at strategies to treat" SpA. "For rheumatoid arthritis we have strategies, but not in spondyloarthritis, and I think it is important to say that," said Dr. Jürgen Braun, medical director of Rheumazentrum Ruhrgebiet in Herne, Germany.
SpA also lags behind rheumatoid arthritis by not having any treatments proven to slow radiographic progression. "Although we say that it is presumably important to treat inflammation [in patients with SpA], we are not sure," said Dr. Braun, who served as a member of the treat-to-target task force.
Even though the task force’s report highlights the absence of evidence for most facets of SpA management, "in the absence of evidence you need eminence, and that’s what was produced." Dr. Braun predicted that rheumatologists and other clinicians who care for patients with SpA would welcome these new recommendations despite their shortcomings. "What we say is what clinicians feel: If a patient’s CRP is elevated we must do something about it, but the evidence supporting this is limited. Presumably, it is important to treat inflammation, but we are not yet sure," he said in an interview.
"We don’t have trial results yet where you set up a quantifiable endpoint as your target, but that is coming," said Dr. Philip J. Mease, director of the rheumatology clinical research division at Swedish Medical Center in Seattle and a member of the task force. For example, the results from the Tight Control of Psoriatic Arthritis (TICOPA) trial "will tell us whether more aggressive treatment to a quantifiable target is appropriate and makes a difference. We anticipate that it will, but evidence is currently lacking." The primary endpoint of the TICOPA trial is change in the ACR20 response, but the trial includes several other clinical measures as secondary endpoints, including the Assessment in Ankylosing Spondylitis (ASAS), the BASDAI, and the psoriasis area severity index (PASI).
"The rheumatoid model is prompting us to develop quantifiable measures like the ASDAS and the new Psoriatic Arthritis Disease Activity Score (PASDAS) that we’ll start to see used. I just spoke with a colleague about the need to also develop a similar measure for peripheral SpA," Dr. Mease said in an interview.
The task force that developed the treat-to-target recommendations included 16 physicians and patients on its steering committee and 16 on an advisory committee. The majority came from various European locations, but about a quarter of the task force members were from the United States. To arrive at its recommendations, the task force used a comprehensive literature review that identified 22 published reports that addressed treatment targets for SpA (Ann. Rheum. Dis. 2013 June 10 [doi:10.1136/annrheumdis-2013-203860]). The treat-to-target recommendations were published online a few days before Dr. Smolen’s presentation at the meeting (Ann. Rheum. Dis. 2013 June 8 [doi:10.1136/annrheumdis-2013-203419]).
Dr. Smolen, Dr. Braun, and Dr. Mease said that they had no disclosures relevant to the topic.
On Twitter @mitchelzoler
MADRID – A panel of clinicians with expertise in the management of patients with spondyloarthritis took another step toward better defining this disease category and the goals of its treatment by producing the first "treat-to-target" recommendations for spondyloarthritis.
The new recommendations will "guide physicians, patients, and other stakeholders on how to optimize reduction of signs and symptoms and, ideally, outcomes, and will drive" the current research agenda, Dr. Josef S. Smolen said while presenting the panel’s recommendations at the annual European Congress of Rheumatology.
"Treat to target proposes a stepwise approach to achieving optimal outcomes based on available evidence and expert opinion. Treat to target has been successfully applied to management of diabetes, hypertension, hyperlipidemia, and rheumatoid arthritis," and the new task force set out to address whether it could be used when treating patients with spondyloarthritis (SpA), a question that required the expert task force to review the evidence for setting specific treatment goals for patients with SpA, said Dr. Smolen, professor of medicine at the Medical University of Vienna.
The task force eventually decided that the treat-to-target concept was applicable to SpA, but that the data available so far prevented the task force from setting specific treatment goals. While the recommendations underscore the importance of treating SpA patients with a goal of remission or inactive disease, and failing that, at least low disease activity, they fall short of giving clinicians guidance on how to best measure and define remission or low disease activity or how to achieve these goals.
For example, for axial SpA – the subtype that received the most specific recommendations – the panel advised clinicians to guide treatment decisions by using a "validated composite measure of disease activity" such as the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) plus acute phase reactants, or the Ankylosing Spondylitis Disease Activity Score (ASDAS) with or without functional measures such as the Bath Ankylosing Spondylitis Functional Index (BASFI). But the recommendations say nothing about what scores by these measures would define remission or low disease activity. The recommendations also talk about using other factors to further gauge axial SpA disease activity such as MRI analysis of inflammation and radiographic progression, but again Dr. Smolen provided no specific targets when using these measures.
For other, less well studied types of SpA, the new recommendations were even more nebulous. For psoriatic arthritis, the panel indicated that "validated measures of musculoskeletal disease activity" should be "performed and documented regularly" as should other factors such as spinal and extraarticular manifestations, imaging findings, and comorbidities, but the recommendations gave no specifics on what any of these measures might be or what level might equal remission or low disease. The same held true for peripheral SpA.
Other factors touched on by the new recommendations include the need for individualized and shared decision making between physicians and patients, the need for coordination of care among rheumatologists and other medical specialists who treat SpA patients (dermatologists, gastroenterologists, and ophthalmologists), and the need to take into account extraarticular manifestations of SpA diseases, comorbidities, and treatment risks along with the goal of low disease activity.
"I think it was important to document that there is a paucity of trials that have looked at strategies to treat" SpA. "For rheumatoid arthritis we have strategies, but not in spondyloarthritis, and I think it is important to say that," said Dr. Jürgen Braun, medical director of Rheumazentrum Ruhrgebiet in Herne, Germany.
SpA also lags behind rheumatoid arthritis by not having any treatments proven to slow radiographic progression. "Although we say that it is presumably important to treat inflammation [in patients with SpA], we are not sure," said Dr. Braun, who served as a member of the treat-to-target task force.
Even though the task force’s report highlights the absence of evidence for most facets of SpA management, "in the absence of evidence you need eminence, and that’s what was produced." Dr. Braun predicted that rheumatologists and other clinicians who care for patients with SpA would welcome these new recommendations despite their shortcomings. "What we say is what clinicians feel: If a patient’s CRP is elevated we must do something about it, but the evidence supporting this is limited. Presumably, it is important to treat inflammation, but we are not yet sure," he said in an interview.
"We don’t have trial results yet where you set up a quantifiable endpoint as your target, but that is coming," said Dr. Philip J. Mease, director of the rheumatology clinical research division at Swedish Medical Center in Seattle and a member of the task force. For example, the results from the Tight Control of Psoriatic Arthritis (TICOPA) trial "will tell us whether more aggressive treatment to a quantifiable target is appropriate and makes a difference. We anticipate that it will, but evidence is currently lacking." The primary endpoint of the TICOPA trial is change in the ACR20 response, but the trial includes several other clinical measures as secondary endpoints, including the Assessment in Ankylosing Spondylitis (ASAS), the BASDAI, and the psoriasis area severity index (PASI).
"The rheumatoid model is prompting us to develop quantifiable measures like the ASDAS and the new Psoriatic Arthritis Disease Activity Score (PASDAS) that we’ll start to see used. I just spoke with a colleague about the need to also develop a similar measure for peripheral SpA," Dr. Mease said in an interview.
The task force that developed the treat-to-target recommendations included 16 physicians and patients on its steering committee and 16 on an advisory committee. The majority came from various European locations, but about a quarter of the task force members were from the United States. To arrive at its recommendations, the task force used a comprehensive literature review that identified 22 published reports that addressed treatment targets for SpA (Ann. Rheum. Dis. 2013 June 10 [doi:10.1136/annrheumdis-2013-203860]). The treat-to-target recommendations were published online a few days before Dr. Smolen’s presentation at the meeting (Ann. Rheum. Dis. 2013 June 8 [doi:10.1136/annrheumdis-2013-203419]).
Dr. Smolen, Dr. Braun, and Dr. Mease said that they had no disclosures relevant to the topic.
On Twitter @mitchelzoler
MADRID – A panel of clinicians with expertise in the management of patients with spondyloarthritis took another step toward better defining this disease category and the goals of its treatment by producing the first "treat-to-target" recommendations for spondyloarthritis.
The new recommendations will "guide physicians, patients, and other stakeholders on how to optimize reduction of signs and symptoms and, ideally, outcomes, and will drive" the current research agenda, Dr. Josef S. Smolen said while presenting the panel’s recommendations at the annual European Congress of Rheumatology.
"Treat to target proposes a stepwise approach to achieving optimal outcomes based on available evidence and expert opinion. Treat to target has been successfully applied to management of diabetes, hypertension, hyperlipidemia, and rheumatoid arthritis," and the new task force set out to address whether it could be used when treating patients with spondyloarthritis (SpA), a question that required the expert task force to review the evidence for setting specific treatment goals for patients with SpA, said Dr. Smolen, professor of medicine at the Medical University of Vienna.
The task force eventually decided that the treat-to-target concept was applicable to SpA, but that the data available so far prevented the task force from setting specific treatment goals. While the recommendations underscore the importance of treating SpA patients with a goal of remission or inactive disease, and failing that, at least low disease activity, they fall short of giving clinicians guidance on how to best measure and define remission or low disease activity or how to achieve these goals.
For example, for axial SpA – the subtype that received the most specific recommendations – the panel advised clinicians to guide treatment decisions by using a "validated composite measure of disease activity" such as the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) plus acute phase reactants, or the Ankylosing Spondylitis Disease Activity Score (ASDAS) with or without functional measures such as the Bath Ankylosing Spondylitis Functional Index (BASFI). But the recommendations say nothing about what scores by these measures would define remission or low disease activity. The recommendations also talk about using other factors to further gauge axial SpA disease activity such as MRI analysis of inflammation and radiographic progression, but again Dr. Smolen provided no specific targets when using these measures.
For other, less well studied types of SpA, the new recommendations were even more nebulous. For psoriatic arthritis, the panel indicated that "validated measures of musculoskeletal disease activity" should be "performed and documented regularly" as should other factors such as spinal and extraarticular manifestations, imaging findings, and comorbidities, but the recommendations gave no specifics on what any of these measures might be or what level might equal remission or low disease. The same held true for peripheral SpA.
Other factors touched on by the new recommendations include the need for individualized and shared decision making between physicians and patients, the need for coordination of care among rheumatologists and other medical specialists who treat SpA patients (dermatologists, gastroenterologists, and ophthalmologists), and the need to take into account extraarticular manifestations of SpA diseases, comorbidities, and treatment risks along with the goal of low disease activity.
"I think it was important to document that there is a paucity of trials that have looked at strategies to treat" SpA. "For rheumatoid arthritis we have strategies, but not in spondyloarthritis, and I think it is important to say that," said Dr. Jürgen Braun, medical director of Rheumazentrum Ruhrgebiet in Herne, Germany.
SpA also lags behind rheumatoid arthritis by not having any treatments proven to slow radiographic progression. "Although we say that it is presumably important to treat inflammation [in patients with SpA], we are not sure," said Dr. Braun, who served as a member of the treat-to-target task force.
Even though the task force’s report highlights the absence of evidence for most facets of SpA management, "in the absence of evidence you need eminence, and that’s what was produced." Dr. Braun predicted that rheumatologists and other clinicians who care for patients with SpA would welcome these new recommendations despite their shortcomings. "What we say is what clinicians feel: If a patient’s CRP is elevated we must do something about it, but the evidence supporting this is limited. Presumably, it is important to treat inflammation, but we are not yet sure," he said in an interview.
"We don’t have trial results yet where you set up a quantifiable endpoint as your target, but that is coming," said Dr. Philip J. Mease, director of the rheumatology clinical research division at Swedish Medical Center in Seattle and a member of the task force. For example, the results from the Tight Control of Psoriatic Arthritis (TICOPA) trial "will tell us whether more aggressive treatment to a quantifiable target is appropriate and makes a difference. We anticipate that it will, but evidence is currently lacking." The primary endpoint of the TICOPA trial is change in the ACR20 response, but the trial includes several other clinical measures as secondary endpoints, including the Assessment in Ankylosing Spondylitis (ASAS), the BASDAI, and the psoriasis area severity index (PASI).
"The rheumatoid model is prompting us to develop quantifiable measures like the ASDAS and the new Psoriatic Arthritis Disease Activity Score (PASDAS) that we’ll start to see used. I just spoke with a colleague about the need to also develop a similar measure for peripheral SpA," Dr. Mease said in an interview.
The task force that developed the treat-to-target recommendations included 16 physicians and patients on its steering committee and 16 on an advisory committee. The majority came from various European locations, but about a quarter of the task force members were from the United States. To arrive at its recommendations, the task force used a comprehensive literature review that identified 22 published reports that addressed treatment targets for SpA (Ann. Rheum. Dis. 2013 June 10 [doi:10.1136/annrheumdis-2013-203860]). The treat-to-target recommendations were published online a few days before Dr. Smolen’s presentation at the meeting (Ann. Rheum. Dis. 2013 June 8 [doi:10.1136/annrheumdis-2013-203419]).
Dr. Smolen, Dr. Braun, and Dr. Mease said that they had no disclosures relevant to the topic.
On Twitter @mitchelzoler
AT THE EULAR CONGRESS 2013
Spinal MRI does not enhance spondyloarthropathy diagnosis
MADRID – There is no added benefit of performing spinal MRI in the diagnosis of spondyloarthritis, the results of an international, multicenter study suggest.
Around one-quarter of patients with nonradiographic axial spondyloarthritis (nr-axSpA) who had a negative MRI scan of the sacroiliac joints (SIJs) were reclassified as being positive for SpA by a combined evaluation of SIJ MRI and spinal MRI scans.
However, 17.5% of healthy volunteers and up to 26.8% of patients with mechanical back pain who had a negative SIJ MRI were also reclassified as having SpA. This false-positive result balances out the value of combined spinal and SIJ MRI.
"Combined MRI added little incremental value compared to SIJ MRI alone for diagnosis of nr-axSpA," said Dr. Ulrich Weber, who presented the findings at the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2013;72:145).
"Although you get about 20% more patients – which is the good news – we found about the same magnitude of false-positive controls," he said in an interview. He added that he "was very disappointed with this result, and these data need confirming." Dr. Weber collected data for the study while at the Balgrist University Clinic in Zurich, and also as a visiting professor in the rheumatology department at the University of Alberta, Edmonton.
SIJ MRI is a major criterion of the Assessment of SpondyloArthritis classification criteria for ankylosing spondylitis (AS). If a patient is strongly suspected of having early SpA, but this is not yet visible on radiographs, then an SIJ MRI is often the next step. If this is negative, however, it may be unclear what to do next.
"Our question was, ‘Would it help to order an additional spinal MRI in this situation?’ " Dr. Weber explained. These data suggest that it is not.
The collaborative study included 130 individuals with newly diagnosed back pain and aged 50 years or younger who were recruited from clinics based in Canada, China, Denmark, and Switzerland, as well as 20 healthy control individuals in whom MRI scans of the SIJ and spine were available.
The investigators used a clinical examination and pelvic radiography to stratify patients into groups, with 50 found to have nr-axSpA, 33 with AS, and 47 with mechanical back pain.
Three separate researchers blinded to the initial stratification read the MRI of the SIJ. An MRI of the spine was then performed 6 months later, with a combined SIJ/spinal scan done 1-12 months later. The presence or absence of SpA was determined in these scans, and comparisons were made between the results for MRI of the SIJ alone versus spinal MRI alone, as well as for the SIJ alone versus a combined read of both the spinal and SIJ MRI scans.
Dr. Weber noted that he would not recommend changing current practice as a result of this study. Further data are eagerly awaited from an ongoing Danish initiative that hopes to scan and assess around 2,000 whole-body MRIs in patients with suspected spondyloarthropathy by the end of the year. "This study will be very informative and very important for us because this is a large sample size. Preliminary data on about 1,000 MRIs point in the same direction," he observed.
Other data from the study, which Dr. Weber presented separately at the meeting, looked at the frequency and possible reasons for false-positive results with spinal MRI in the control groups (Ann. Rheum. Dis. 2013;72:125).
"Patients with mechanical back pain and healthy volunteers may show spinal MRI lesions suggestive of spondyloarthritis, such as corner inflammatory lesions or corner fat lesions," he explained. "We found that about 30% of those controls were misclassified as having spondyloarthritis by evaluation of the spinal MRI alone, so without SIJ MRI," said Dr. Weber. Bone marrow edema and fat infiltration were the MRI lesions largely responsible for this misclassification.
Dr. Weber said that, at least in Switzerland, general practitioners were more likely to order a spinal MRI than an SIJ MRI to assess a young patient with nonspecific back pain. "We think that caution is needed if a classification of SpA is based on MRI of the spine alone," he concluded.
Dr. Weber had no disclosures.
MADRID – There is no added benefit of performing spinal MRI in the diagnosis of spondyloarthritis, the results of an international, multicenter study suggest.
Around one-quarter of patients with nonradiographic axial spondyloarthritis (nr-axSpA) who had a negative MRI scan of the sacroiliac joints (SIJs) were reclassified as being positive for SpA by a combined evaluation of SIJ MRI and spinal MRI scans.
However, 17.5% of healthy volunteers and up to 26.8% of patients with mechanical back pain who had a negative SIJ MRI were also reclassified as having SpA. This false-positive result balances out the value of combined spinal and SIJ MRI.
"Combined MRI added little incremental value compared to SIJ MRI alone for diagnosis of nr-axSpA," said Dr. Ulrich Weber, who presented the findings at the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2013;72:145).
"Although you get about 20% more patients – which is the good news – we found about the same magnitude of false-positive controls," he said in an interview. He added that he "was very disappointed with this result, and these data need confirming." Dr. Weber collected data for the study while at the Balgrist University Clinic in Zurich, and also as a visiting professor in the rheumatology department at the University of Alberta, Edmonton.
SIJ MRI is a major criterion of the Assessment of SpondyloArthritis classification criteria for ankylosing spondylitis (AS). If a patient is strongly suspected of having early SpA, but this is not yet visible on radiographs, then an SIJ MRI is often the next step. If this is negative, however, it may be unclear what to do next.
"Our question was, ‘Would it help to order an additional spinal MRI in this situation?’ " Dr. Weber explained. These data suggest that it is not.
The collaborative study included 130 individuals with newly diagnosed back pain and aged 50 years or younger who were recruited from clinics based in Canada, China, Denmark, and Switzerland, as well as 20 healthy control individuals in whom MRI scans of the SIJ and spine were available.
The investigators used a clinical examination and pelvic radiography to stratify patients into groups, with 50 found to have nr-axSpA, 33 with AS, and 47 with mechanical back pain.
Three separate researchers blinded to the initial stratification read the MRI of the SIJ. An MRI of the spine was then performed 6 months later, with a combined SIJ/spinal scan done 1-12 months later. The presence or absence of SpA was determined in these scans, and comparisons were made between the results for MRI of the SIJ alone versus spinal MRI alone, as well as for the SIJ alone versus a combined read of both the spinal and SIJ MRI scans.
Dr. Weber noted that he would not recommend changing current practice as a result of this study. Further data are eagerly awaited from an ongoing Danish initiative that hopes to scan and assess around 2,000 whole-body MRIs in patients with suspected spondyloarthropathy by the end of the year. "This study will be very informative and very important for us because this is a large sample size. Preliminary data on about 1,000 MRIs point in the same direction," he observed.
Other data from the study, which Dr. Weber presented separately at the meeting, looked at the frequency and possible reasons for false-positive results with spinal MRI in the control groups (Ann. Rheum. Dis. 2013;72:125).
"Patients with mechanical back pain and healthy volunteers may show spinal MRI lesions suggestive of spondyloarthritis, such as corner inflammatory lesions or corner fat lesions," he explained. "We found that about 30% of those controls were misclassified as having spondyloarthritis by evaluation of the spinal MRI alone, so without SIJ MRI," said Dr. Weber. Bone marrow edema and fat infiltration were the MRI lesions largely responsible for this misclassification.
Dr. Weber said that, at least in Switzerland, general practitioners were more likely to order a spinal MRI than an SIJ MRI to assess a young patient with nonspecific back pain. "We think that caution is needed if a classification of SpA is based on MRI of the spine alone," he concluded.
Dr. Weber had no disclosures.
MADRID – There is no added benefit of performing spinal MRI in the diagnosis of spondyloarthritis, the results of an international, multicenter study suggest.
Around one-quarter of patients with nonradiographic axial spondyloarthritis (nr-axSpA) who had a negative MRI scan of the sacroiliac joints (SIJs) were reclassified as being positive for SpA by a combined evaluation of SIJ MRI and spinal MRI scans.
However, 17.5% of healthy volunteers and up to 26.8% of patients with mechanical back pain who had a negative SIJ MRI were also reclassified as having SpA. This false-positive result balances out the value of combined spinal and SIJ MRI.
"Combined MRI added little incremental value compared to SIJ MRI alone for diagnosis of nr-axSpA," said Dr. Ulrich Weber, who presented the findings at the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2013;72:145).
"Although you get about 20% more patients – which is the good news – we found about the same magnitude of false-positive controls," he said in an interview. He added that he "was very disappointed with this result, and these data need confirming." Dr. Weber collected data for the study while at the Balgrist University Clinic in Zurich, and also as a visiting professor in the rheumatology department at the University of Alberta, Edmonton.
SIJ MRI is a major criterion of the Assessment of SpondyloArthritis classification criteria for ankylosing spondylitis (AS). If a patient is strongly suspected of having early SpA, but this is not yet visible on radiographs, then an SIJ MRI is often the next step. If this is negative, however, it may be unclear what to do next.
"Our question was, ‘Would it help to order an additional spinal MRI in this situation?’ " Dr. Weber explained. These data suggest that it is not.
The collaborative study included 130 individuals with newly diagnosed back pain and aged 50 years or younger who were recruited from clinics based in Canada, China, Denmark, and Switzerland, as well as 20 healthy control individuals in whom MRI scans of the SIJ and spine were available.
The investigators used a clinical examination and pelvic radiography to stratify patients into groups, with 50 found to have nr-axSpA, 33 with AS, and 47 with mechanical back pain.
Three separate researchers blinded to the initial stratification read the MRI of the SIJ. An MRI of the spine was then performed 6 months later, with a combined SIJ/spinal scan done 1-12 months later. The presence or absence of SpA was determined in these scans, and comparisons were made between the results for MRI of the SIJ alone versus spinal MRI alone, as well as for the SIJ alone versus a combined read of both the spinal and SIJ MRI scans.
Dr. Weber noted that he would not recommend changing current practice as a result of this study. Further data are eagerly awaited from an ongoing Danish initiative that hopes to scan and assess around 2,000 whole-body MRIs in patients with suspected spondyloarthropathy by the end of the year. "This study will be very informative and very important for us because this is a large sample size. Preliminary data on about 1,000 MRIs point in the same direction," he observed.
Other data from the study, which Dr. Weber presented separately at the meeting, looked at the frequency and possible reasons for false-positive results with spinal MRI in the control groups (Ann. Rheum. Dis. 2013;72:125).
"Patients with mechanical back pain and healthy volunteers may show spinal MRI lesions suggestive of spondyloarthritis, such as corner inflammatory lesions or corner fat lesions," he explained. "We found that about 30% of those controls were misclassified as having spondyloarthritis by evaluation of the spinal MRI alone, so without SIJ MRI," said Dr. Weber. Bone marrow edema and fat infiltration were the MRI lesions largely responsible for this misclassification.
Dr. Weber said that, at least in Switzerland, general practitioners were more likely to order a spinal MRI than an SIJ MRI to assess a young patient with nonspecific back pain. "We think that caution is needed if a classification of SpA is based on MRI of the spine alone," he concluded.
Dr. Weber had no disclosures.
AT THE EULAR CONGRESS 2013
Major finding: More than 25% of patients with nonradiographic axial spondyloarthritis who had a negative MRI scan of the sacroiliac joints (SIJs) were reclassified as being positive for spondyloarthritis by a combined evaluation of SIJ MRI and spinal MRI scans, but this was balanced by a similarly high rate of false-positive results.
Data source: An international, multicenter study of combined SIJ and spinal MRI in 130 patients with newly diagnosed back pain and 20 healthy controls.
Disclosures: Dr. Weber had no disclosures.
New spondyloarthropathy index measures patient-relevant outcomes
MADRID – An international team has developed a new composite health index specifically for use in patients with ankylosing spondylitis.
The Assessment of SpondyloArthritis International Society Health Index (ASAS HI) is based on the ICF (International Classification of Functioning, Disability and Health) and includes 17 dichotomous items that ask about patients’ levels of pain, emotional functioning, sleep habits, sexual function, mobility, self-care, life in the community, and employment. The ICF is a comprehensive and already well-recognized and validated means of classifying and describing functioning, disability, and health in a systematic way,
The tool has yet to be "field tested" to see if it can measure changes in health status in response to treatment, Dr. Uta Kiltz said at the annual European Congress of Rheumatology.
Dr. Kiltz, of Rheumazentrum Ruhrgebiet, Herne, Germany, noted that the development of the tool involved five key stages. These have been outlined previously (Rheumatology 2011;50:894-8) and included a preparatory stage in which potential items for inclusion were identified. Dr. Kiltz and her colleagues considered a total of 251 items obtained from more than 60 existing questionnaires, such as the BASFI (Bath Ankylosing Spondylitis Functional Index), the Dougados Functional Index, and the AS Quality of Life Questionnaire.
The investigators then conducted an international, cross-sectional study involving 1,915 patients with AS (mean age, 51 years). In this second phase, they sent a postal survey to patients to ask about various parameters. An expert committee then assessed the results in the third phase and selected 50 items for possible inclusion in the final model. The penultimate stage in the development process involved sending a second postal survey to 628 patients with AS (mean age, 48.5 years).
In the final stage, an expert consensus meeting was held in which the final 17-item tool was agreed upon (Ann. Rheum. Dis. 2013;72:124).
"ASAS HI is a new composite index that captures relevant information on the health status of patients with AS," Dr. Kiltz said. "It is the first disease-specific index which is based on the ICF, and the items represent a whole range of abilities as defined by the ICF."
ASAS HI could eventually be used in clinical trials and clinical practice as a new composite index that captures relevant information on the health status of patients, Dr. Kiltz suggested.
"We are now doing a field test to test the 17 items in a wider range of patients," she said. After this is completed, the specifics of the tool will be published.
Dr. Kiltz had no conflicts of interest.
MADRID – An international team has developed a new composite health index specifically for use in patients with ankylosing spondylitis.
The Assessment of SpondyloArthritis International Society Health Index (ASAS HI) is based on the ICF (International Classification of Functioning, Disability and Health) and includes 17 dichotomous items that ask about patients’ levels of pain, emotional functioning, sleep habits, sexual function, mobility, self-care, life in the community, and employment. The ICF is a comprehensive and already well-recognized and validated means of classifying and describing functioning, disability, and health in a systematic way,
The tool has yet to be "field tested" to see if it can measure changes in health status in response to treatment, Dr. Uta Kiltz said at the annual European Congress of Rheumatology.
Dr. Kiltz, of Rheumazentrum Ruhrgebiet, Herne, Germany, noted that the development of the tool involved five key stages. These have been outlined previously (Rheumatology 2011;50:894-8) and included a preparatory stage in which potential items for inclusion were identified. Dr. Kiltz and her colleagues considered a total of 251 items obtained from more than 60 existing questionnaires, such as the BASFI (Bath Ankylosing Spondylitis Functional Index), the Dougados Functional Index, and the AS Quality of Life Questionnaire.
The investigators then conducted an international, cross-sectional study involving 1,915 patients with AS (mean age, 51 years). In this second phase, they sent a postal survey to patients to ask about various parameters. An expert committee then assessed the results in the third phase and selected 50 items for possible inclusion in the final model. The penultimate stage in the development process involved sending a second postal survey to 628 patients with AS (mean age, 48.5 years).
In the final stage, an expert consensus meeting was held in which the final 17-item tool was agreed upon (Ann. Rheum. Dis. 2013;72:124).
"ASAS HI is a new composite index that captures relevant information on the health status of patients with AS," Dr. Kiltz said. "It is the first disease-specific index which is based on the ICF, and the items represent a whole range of abilities as defined by the ICF."
ASAS HI could eventually be used in clinical trials and clinical practice as a new composite index that captures relevant information on the health status of patients, Dr. Kiltz suggested.
"We are now doing a field test to test the 17 items in a wider range of patients," she said. After this is completed, the specifics of the tool will be published.
Dr. Kiltz had no conflicts of interest.
MADRID – An international team has developed a new composite health index specifically for use in patients with ankylosing spondylitis.
The Assessment of SpondyloArthritis International Society Health Index (ASAS HI) is based on the ICF (International Classification of Functioning, Disability and Health) and includes 17 dichotomous items that ask about patients’ levels of pain, emotional functioning, sleep habits, sexual function, mobility, self-care, life in the community, and employment. The ICF is a comprehensive and already well-recognized and validated means of classifying and describing functioning, disability, and health in a systematic way,
The tool has yet to be "field tested" to see if it can measure changes in health status in response to treatment, Dr. Uta Kiltz said at the annual European Congress of Rheumatology.
Dr. Kiltz, of Rheumazentrum Ruhrgebiet, Herne, Germany, noted that the development of the tool involved five key stages. These have been outlined previously (Rheumatology 2011;50:894-8) and included a preparatory stage in which potential items for inclusion were identified. Dr. Kiltz and her colleagues considered a total of 251 items obtained from more than 60 existing questionnaires, such as the BASFI (Bath Ankylosing Spondylitis Functional Index), the Dougados Functional Index, and the AS Quality of Life Questionnaire.
The investigators then conducted an international, cross-sectional study involving 1,915 patients with AS (mean age, 51 years). In this second phase, they sent a postal survey to patients to ask about various parameters. An expert committee then assessed the results in the third phase and selected 50 items for possible inclusion in the final model. The penultimate stage in the development process involved sending a second postal survey to 628 patients with AS (mean age, 48.5 years).
In the final stage, an expert consensus meeting was held in which the final 17-item tool was agreed upon (Ann. Rheum. Dis. 2013;72:124).
"ASAS HI is a new composite index that captures relevant information on the health status of patients with AS," Dr. Kiltz said. "It is the first disease-specific index which is based on the ICF, and the items represent a whole range of abilities as defined by the ICF."
ASAS HI could eventually be used in clinical trials and clinical practice as a new composite index that captures relevant information on the health status of patients, Dr. Kiltz suggested.
"We are now doing a field test to test the 17 items in a wider range of patients," she said. After this is completed, the specifics of the tool will be published.
Dr. Kiltz had no conflicts of interest.
AT THE EULAR CONGRESS 2013
