Jeff Evans

Patients with systemic lupus erythematosus (SLE) who received transcutaneous auricular vagus nerve stimulation (taVNS) had a clinically significant reduction in musculoskeletal pain when compared with those who received sham stimulation during a brief pilot trial.

“Our study population included individuals with significant pain and exemplifies the unmet need for adequate control of pain and fatigue in SLE. Importantly, this was a double-blind, sham-controlled study and neither the subject nor assessor was aware of a subject’s intervention. Objective outcomes, that is, tender and swollen joint counts, were also significantly reduced in subjects receiving taVNS, compared with those receiving [sham stimulation]. The stimulation was well tolerated with no adverse events attributed to the intervention, and, clinical benefits continued after taVNS was stopped,” first author Cynthia Aranow, MD, and her colleagues at the Feinstein Institutes for Medical Research in Manhasset, N.Y., wrote in Annals of the Rheumatic Diseases.

Stimulation of the vagus nerve can be achieved through the ear via its auricular branch, which innervates the cymba concha in the outer ear. Past pilot studies of implanted VNS devices lasting 6 weeks to 6 months in patients with Crohn’s disease or rheumatoid arthritis have shown improvements in measures of disease activity as well as objective markers of inflammation, and a more recent trial testing a transcutaneous devices’s effect in patients with Sjögren’s syndrome found significant reductions in fatigue over a 26-day period, the investigators noted.

In the taVNS device study, the researchers recruited 18 patients with SLE who had musculoskeletal pain rated as 4 or higher on a 10-cm visual analog scale and randomized them in a 2:1 ratio to receive taVNS once per day for 5 minutes for 4 consecutive days versus sham stimulation. Patients were allowed to be on stable doses of disease-modifying antirheumatic drugs, biologics, and/or prednisone ≤ 10 mg/day, with no change of dose within 28 days prior to baseline. The study excluded patients who used tobacco or an anticholinergic medication and those with a diagnosis of fibromyalgia.

The 12 patients who received actual taVNS had a significantly greater reduction in their pain, compared with 6 sham-treated patients (–5.00 vs. 0.10; P = .049), with 10 of 12 and 1 of 6 having a clinical response (a reduction of at least 1.58 on a 10-cm visual analog scale from baseline to day 5). Stimulation-treated patients also reported significantly greater reductions in fatigue, with 10 of 12 achieving a meaningful reduction, defined as a 4-point improvement on the Functional Assessment of Chronic Illness Therapy Fatigue Subscale; none of the sham-treated patients experienced meaningful improvement of fatigue. The patients who received taVNS had resolution of all swollen and tender joints, compared with 5.3% of tender and 9.1% of swollen joints in sham-treated patients. Ex vivo lipopolysaccharide stimulation of whole-blood samples from taVNS-treated patients, however, showed no reductions of inflammatory mediators or chemokines in tests on day 5 and day 12.

The investigators reported that there were no adverse events attributed to taVNS, including no reports of headache, lightheadedness, tinnitus, ear irritation, or changes to the external skin of the outer ear.

The study was supported by a grant from the John and Marcia Goldman Foundation. One author reported a financial relationship with Set Point Medical and My String, and three authors reported having a provisional patent application titled “Auricular stimulation device, system and methods of use.”

jevans@mdedge.com

SOURCE: Aranow C et al. Ann Rheum Dis. 2020 Nov 3. doi: 10.1136/annrheumdis-2020-217872.

Patients with systemic lupus erythematosus (SLE) who received transcutaneous auricular vagus nerve stimulation (taVNS) had a clinically significant reduction in musculoskeletal pain when compared with those who received sham stimulation during a brief pilot trial.

“Our study population included individuals with significant pain and exemplifies the unmet need for adequate control of pain and fatigue in SLE. Importantly, this was a double-blind, sham-controlled study and neither the subject nor assessor was aware of a subject’s intervention. Objective outcomes, that is, tender and swollen joint counts, were also significantly reduced in subjects receiving taVNS, compared with those receiving [sham stimulation]. The stimulation was well tolerated with no adverse events attributed to the intervention, and, clinical benefits continued after taVNS was stopped,” first author Cynthia Aranow, MD, and her colleagues at the Feinstein Institutes for Medical Research in Manhasset, N.Y., wrote in Annals of the Rheumatic Diseases.

Stimulation of the vagus nerve can be achieved through the ear via its auricular branch, which innervates the cymba concha in the outer ear. Past pilot studies of implanted VNS devices lasting 6 weeks to 6 months in patients with Crohn’s disease or rheumatoid arthritis have shown improvements in measures of disease activity as well as objective markers of inflammation, and a more recent trial testing a transcutaneous devices’s effect in patients with Sjögren’s syndrome found significant reductions in fatigue over a 26-day period, the investigators noted.

In the taVNS device study, the researchers recruited 18 patients with SLE who had musculoskeletal pain rated as 4 or higher on a 10-cm visual analog scale and randomized them in a 2:1 ratio to receive taVNS once per day for 5 minutes for 4 consecutive days versus sham stimulation. Patients were allowed to be on stable doses of disease-modifying antirheumatic drugs, biologics, and/or prednisone ≤ 10 mg/day, with no change of dose within 28 days prior to baseline. The study excluded patients who used tobacco or an anticholinergic medication and those with a diagnosis of fibromyalgia.

The 12 patients who received actual taVNS had a significantly greater reduction in their pain, compared with 6 sham-treated patients (–5.00 vs. 0.10; P = .049), with 10 of 12 and 1 of 6 having a clinical response (a reduction of at least 1.58 on a 10-cm visual analog scale from baseline to day 5). Stimulation-treated patients also reported significantly greater reductions in fatigue, with 10 of 12 achieving a meaningful reduction, defined as a 4-point improvement on the Functional Assessment of Chronic Illness Therapy Fatigue Subscale; none of the sham-treated patients experienced meaningful improvement of fatigue. The patients who received taVNS had resolution of all swollen and tender joints, compared with 5.3% of tender and 9.1% of swollen joints in sham-treated patients. Ex vivo lipopolysaccharide stimulation of whole-blood samples from taVNS-treated patients, however, showed no reductions of inflammatory mediators or chemokines in tests on day 5 and day 12.

The investigators reported that there were no adverse events attributed to taVNS, including no reports of headache, lightheadedness, tinnitus, ear irritation, or changes to the external skin of the outer ear.

The study was supported by a grant from the John and Marcia Goldman Foundation. One author reported a financial relationship with Set Point Medical and My String, and three authors reported having a provisional patent application titled “Auricular stimulation device, system and methods of use.”

jevans@mdedge.com

SOURCE: Aranow C et al. Ann Rheum Dis. 2020 Nov 3. doi: 10.1136/annrheumdis-2020-217872.

Patients with systemic lupus erythematosus (SLE) who received transcutaneous auricular vagus nerve stimulation (taVNS) had a clinically significant reduction in musculoskeletal pain when compared with those who received sham stimulation during a brief pilot trial.

“Our study population included individuals with significant pain and exemplifies the unmet need for adequate control of pain and fatigue in SLE. Importantly, this was a double-blind, sham-controlled study and neither the subject nor assessor was aware of a subject’s intervention. Objective outcomes, that is, tender and swollen joint counts, were also significantly reduced in subjects receiving taVNS, compared with those receiving [sham stimulation]. The stimulation was well tolerated with no adverse events attributed to the intervention, and, clinical benefits continued after taVNS was stopped,” first author Cynthia Aranow, MD, and her colleagues at the Feinstein Institutes for Medical Research in Manhasset, N.Y., wrote in Annals of the Rheumatic Diseases.

Stimulation of the vagus nerve can be achieved through the ear via its auricular branch, which innervates the cymba concha in the outer ear. Past pilot studies of implanted VNS devices lasting 6 weeks to 6 months in patients with Crohn’s disease or rheumatoid arthritis have shown improvements in measures of disease activity as well as objective markers of inflammation, and a more recent trial testing a transcutaneous devices’s effect in patients with Sjögren’s syndrome found significant reductions in fatigue over a 26-day period, the investigators noted.

In the taVNS device study, the researchers recruited 18 patients with SLE who had musculoskeletal pain rated as 4 or higher on a 10-cm visual analog scale and randomized them in a 2:1 ratio to receive taVNS once per day for 5 minutes for 4 consecutive days versus sham stimulation. Patients were allowed to be on stable doses of disease-modifying antirheumatic drugs, biologics, and/or prednisone ≤ 10 mg/day, with no change of dose within 28 days prior to baseline. The study excluded patients who used tobacco or an anticholinergic medication and those with a diagnosis of fibromyalgia.

The 12 patients who received actual taVNS had a significantly greater reduction in their pain, compared with 6 sham-treated patients (–5.00 vs. 0.10; P = .049), with 10 of 12 and 1 of 6 having a clinical response (a reduction of at least 1.58 on a 10-cm visual analog scale from baseline to day 5). Stimulation-treated patients also reported significantly greater reductions in fatigue, with 10 of 12 achieving a meaningful reduction, defined as a 4-point improvement on the Functional Assessment of Chronic Illness Therapy Fatigue Subscale; none of the sham-treated patients experienced meaningful improvement of fatigue. The patients who received taVNS had resolution of all swollen and tender joints, compared with 5.3% of tender and 9.1% of swollen joints in sham-treated patients. Ex vivo lipopolysaccharide stimulation of whole-blood samples from taVNS-treated patients, however, showed no reductions of inflammatory mediators or chemokines in tests on day 5 and day 12.

The investigators reported that there were no adverse events attributed to taVNS, including no reports of headache, lightheadedness, tinnitus, ear irritation, or changes to the external skin of the outer ear.

The study was supported by a grant from the John and Marcia Goldman Foundation. One author reported a financial relationship with Set Point Medical and My String, and three authors reported having a provisional patent application titled “Auricular stimulation device, system and methods of use.”

jevans@mdedge.com

SOURCE: Aranow C et al. Ann Rheum Dis. 2020 Nov 3. doi: 10.1136/annrheumdis-2020-217872.

Few patient characteristics of men and women with nonradiographic axial spondyloarthritis (nr-axSpA) appear to differ, yet women with the condition have a significantly lower response rate to treatment with tumor necrosis factor (TNF) inhibitors, according to results from a prospective cohort study.

Despite these similarities between the sexes, first author Regula Neuenschwander of the department of rheumatology at Zurich University Hospital and colleagues reported in Arthritis Research & Therapy that women treated with a TNF inhibitor were 81% less likely than men to have a 40% or greater improvement on Assessment of Spondyloarthritis International Society (ASAS) response criteria by 1 year. Statistically significant differences at baseline included women’s longer time to nr-axSpA diagnosis, slightly lower HLA-B27 positivity rate, higher mean baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score, higher rate of current enthesitis, and lower mean body mass index (BMI).

With radiographic disease, women have been reported to more often “present with higher self-reported disease activity and functional impairment, a lower quality of life, less severe spinal radiographic changes, and more peripheral disease (arthritis and enthesitis),” whereas men more often have “objective markers of inflammation, such as elevated C-reactive protein (CRP) levels and magnetic resonance imaging (MRI) inflammation of the axial skeleton,” the researchers wrote. Radiographic disease also tends to occur more often in men, and some studies have reported men to have a greater response to TNF inhibitors. However, the current study sought to understand whether these differences between sexes exist in patients with nonradiographic disease.

The researchers included 495 patients (231 men and 264 women) with a clinical diagnosis of nr-axSpA in the Swiss Clinical Quality Management cohort during 2005-2018 who fulfilled ASAS classification criteria for axSpA and lacked definite radiographic sacroiliac joint changes according to the modified New York criteria. The radiographs were centrally digitized and independently scored in a blinded manner by a rotating group of two readers (out of six total).

Both women and men had a mean age of around 28 years at symptom onset, but women had a significantly longer diagnostic delay of 6.0 years vs. 4.7 years. Also, women were significantly less likely to be HLA-B27 positive (67.0% vs. 76.5%) and had a significantly higher mean BASDAI score at baseline (5.3 vs. 4.6). More women than men also showed signs of current enthesitis (79.6% vs. 64.0%), and women had a lower mean BMI (24.3 vs. 25.7 kg/m²). Concomitant clinically diagnosed fibromyalgia was higher in women than in men (13.1% vs. 2.7%), and when patients with fibromylagia (n = 25) were excluded the remaining differences in BASDAI were mainly because of fatigue and enthesitis, both of which occurred more often in women than in men.

A total of 163 patients without fibromyalgia started a first TNF inhibitor, and 120 had a follow-up visit at 1 year. An ASAS40 response is defined as 40% improvement in at least three of four domains on the ASAS response criteria: patient global assessment of disease activity for the past week, patient assessment of back pain over the past week, function (as assessed on the Bath Ankylosing Spondylitis Functional Index [BASFI]), and inflammation (mean of BASDAI questions 5 and 6). An ASAS40 response was achieved by 17% of women and 38% of men (odds ratio, 0.34; 95% confidence interval, 0.12-0.93), and this difference became more pronounced after adjustment for baseline differences in BASDAI, Maastricht Ankylosing Spondylitis Enthesitis Score, BMI, and diagnostic delay (OR, 0.19; 95% CI, 0.05-0.61). ASAS40 response rates were lower for patients with higher BMI but better for those with higher BASDAI levels. The researchers found comparable results when they excluded patients who stopped a TNF inhibitor because of other reasons for discontinuation and also when they counted patients who discontinued the TNF inhibitor because of remission as responders.

The sex difference in nr-axSpA patients’ treatment response to TNF inhibitors was even larger than the 56% lower odds the same group of researchers reported finding between women and men with radiographic disease in an earlier report, according to the new paper.

Given that this study and others in nr-axSpA patients have found higher remission rates to TNF inhibitor therapy in men versus women, the “current study therefore adds to available data to support the claim for future randomized controlled trials in axSpA to be sufficiently powered to detect potential sex differences,” the researchers said.

The authors acknowledged that a lack of MRI scans available for central scoring made it impossible to evaluate potential imaging misinterpretation, such as possible abnormalities mimicking mild sacroiliitis that have been reported to be more prevalent in women. It is also possible that some patients with fibromyalgia were missed because of screening for the condition by expert opinion of the treating rheumatologist “on a comorbidity questionnaire and not through fulfillment of classification criteria for fibromyalgia or via the use of a standardized fibromyalgia questionnaire,” they said.

The study was funded by the Stiftung für Rheumaforschung in Zurich. The Swiss Clinical Quality Management Foundation is supported by the Swiss Society of Rheumatology and by 11 pharmaceutical companies. Two study authors reported receiving consulting and/or speaking fees from some of those same companies.

jevans@mdedge.com

SOURCE: Neuenschwander R et al. Arthritis Res Ther. 2020;22(1):233.

Few patient characteristics of men and women with nonradiographic axial spondyloarthritis (nr-axSpA) appear to differ, yet women with the condition have a significantly lower response rate to treatment with tumor necrosis factor (TNF) inhibitors, according to results from a prospective cohort study.

Despite these similarities between the sexes, first author Regula Neuenschwander of the department of rheumatology at Zurich University Hospital and colleagues reported in Arthritis Research & Therapy that women treated with a TNF inhibitor were 81% less likely than men to have a 40% or greater improvement on Assessment of Spondyloarthritis International Society (ASAS) response criteria by 1 year. Statistically significant differences at baseline included women’s longer time to nr-axSpA diagnosis, slightly lower HLA-B27 positivity rate, higher mean baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score, higher rate of current enthesitis, and lower mean body mass index (BMI).

With radiographic disease, women have been reported to more often “present with higher self-reported disease activity and functional impairment, a lower quality of life, less severe spinal radiographic changes, and more peripheral disease (arthritis and enthesitis),” whereas men more often have “objective markers of inflammation, such as elevated C-reactive protein (CRP) levels and magnetic resonance imaging (MRI) inflammation of the axial skeleton,” the researchers wrote. Radiographic disease also tends to occur more often in men, and some studies have reported men to have a greater response to TNF inhibitors. However, the current study sought to understand whether these differences between sexes exist in patients with nonradiographic disease.

The researchers included 495 patients (231 men and 264 women) with a clinical diagnosis of nr-axSpA in the Swiss Clinical Quality Management cohort during 2005-2018 who fulfilled ASAS classification criteria for axSpA and lacked definite radiographic sacroiliac joint changes according to the modified New York criteria. The radiographs were centrally digitized and independently scored in a blinded manner by a rotating group of two readers (out of six total).

Both women and men had a mean age of around 28 years at symptom onset, but women had a significantly longer diagnostic delay of 6.0 years vs. 4.7 years. Also, women were significantly less likely to be HLA-B27 positive (67.0% vs. 76.5%) and had a significantly higher mean BASDAI score at baseline (5.3 vs. 4.6). More women than men also showed signs of current enthesitis (79.6% vs. 64.0%), and women had a lower mean BMI (24.3 vs. 25.7 kg/m²). Concomitant clinically diagnosed fibromyalgia was higher in women than in men (13.1% vs. 2.7%), and when patients with fibromylagia (n = 25) were excluded the remaining differences in BASDAI were mainly because of fatigue and enthesitis, both of which occurred more often in women than in men.

A total of 163 patients without fibromyalgia started a first TNF inhibitor, and 120 had a follow-up visit at 1 year. An ASAS40 response is defined as 40% improvement in at least three of four domains on the ASAS response criteria: patient global assessment of disease activity for the past week, patient assessment of back pain over the past week, function (as assessed on the Bath Ankylosing Spondylitis Functional Index [BASFI]), and inflammation (mean of BASDAI questions 5 and 6). An ASAS40 response was achieved by 17% of women and 38% of men (odds ratio, 0.34; 95% confidence interval, 0.12-0.93), and this difference became more pronounced after adjustment for baseline differences in BASDAI, Maastricht Ankylosing Spondylitis Enthesitis Score, BMI, and diagnostic delay (OR, 0.19; 95% CI, 0.05-0.61). ASAS40 response rates were lower for patients with higher BMI but better for those with higher BASDAI levels. The researchers found comparable results when they excluded patients who stopped a TNF inhibitor because of other reasons for discontinuation and also when they counted patients who discontinued the TNF inhibitor because of remission as responders.

The sex difference in nr-axSpA patients’ treatment response to TNF inhibitors was even larger than the 56% lower odds the same group of researchers reported finding between women and men with radiographic disease in an earlier report, according to the new paper.

Given that this study and others in nr-axSpA patients have found higher remission rates to TNF inhibitor therapy in men versus women, the “current study therefore adds to available data to support the claim for future randomized controlled trials in axSpA to be sufficiently powered to detect potential sex differences,” the researchers said.

The authors acknowledged that a lack of MRI scans available for central scoring made it impossible to evaluate potential imaging misinterpretation, such as possible abnormalities mimicking mild sacroiliitis that have been reported to be more prevalent in women. It is also possible that some patients with fibromyalgia were missed because of screening for the condition by expert opinion of the treating rheumatologist “on a comorbidity questionnaire and not through fulfillment of classification criteria for fibromyalgia or via the use of a standardized fibromyalgia questionnaire,” they said.

The study was funded by the Stiftung für Rheumaforschung in Zurich. The Swiss Clinical Quality Management Foundation is supported by the Swiss Society of Rheumatology and by 11 pharmaceutical companies. Two study authors reported receiving consulting and/or speaking fees from some of those same companies.

jevans@mdedge.com

SOURCE: Neuenschwander R et al. Arthritis Res Ther. 2020;22(1):233.

Few patient characteristics of men and women with nonradiographic axial spondyloarthritis (nr-axSpA) appear to differ, yet women with the condition have a significantly lower response rate to treatment with tumor necrosis factor (TNF) inhibitors, according to results from a prospective cohort study.

Despite these similarities between the sexes, first author Regula Neuenschwander of the department of rheumatology at Zurich University Hospital and colleagues reported in Arthritis Research & Therapy that women treated with a TNF inhibitor were 81% less likely than men to have a 40% or greater improvement on Assessment of Spondyloarthritis International Society (ASAS) response criteria by 1 year. Statistically significant differences at baseline included women’s longer time to nr-axSpA diagnosis, slightly lower HLA-B27 positivity rate, higher mean baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score, higher rate of current enthesitis, and lower mean body mass index (BMI).

With radiographic disease, women have been reported to more often “present with higher self-reported disease activity and functional impairment, a lower quality of life, less severe spinal radiographic changes, and more peripheral disease (arthritis and enthesitis),” whereas men more often have “objective markers of inflammation, such as elevated C-reactive protein (CRP) levels and magnetic resonance imaging (MRI) inflammation of the axial skeleton,” the researchers wrote. Radiographic disease also tends to occur more often in men, and some studies have reported men to have a greater response to TNF inhibitors. However, the current study sought to understand whether these differences between sexes exist in patients with nonradiographic disease.

The researchers included 495 patients (231 men and 264 women) with a clinical diagnosis of nr-axSpA in the Swiss Clinical Quality Management cohort during 2005-2018 who fulfilled ASAS classification criteria for axSpA and lacked definite radiographic sacroiliac joint changes according to the modified New York criteria. The radiographs were centrally digitized and independently scored in a blinded manner by a rotating group of two readers (out of six total).

Both women and men had a mean age of around 28 years at symptom onset, but women had a significantly longer diagnostic delay of 6.0 years vs. 4.7 years. Also, women were significantly less likely to be HLA-B27 positive (67.0% vs. 76.5%) and had a significantly higher mean BASDAI score at baseline (5.3 vs. 4.6). More women than men also showed signs of current enthesitis (79.6% vs. 64.0%), and women had a lower mean BMI (24.3 vs. 25.7 kg/m²). Concomitant clinically diagnosed fibromyalgia was higher in women than in men (13.1% vs. 2.7%), and when patients with fibromylagia (n = 25) were excluded the remaining differences in BASDAI were mainly because of fatigue and enthesitis, both of which occurred more often in women than in men.

A total of 163 patients without fibromyalgia started a first TNF inhibitor, and 120 had a follow-up visit at 1 year. An ASAS40 response is defined as 40% improvement in at least three of four domains on the ASAS response criteria: patient global assessment of disease activity for the past week, patient assessment of back pain over the past week, function (as assessed on the Bath Ankylosing Spondylitis Functional Index [BASFI]), and inflammation (mean of BASDAI questions 5 and 6). An ASAS40 response was achieved by 17% of women and 38% of men (odds ratio, 0.34; 95% confidence interval, 0.12-0.93), and this difference became more pronounced after adjustment for baseline differences in BASDAI, Maastricht Ankylosing Spondylitis Enthesitis Score, BMI, and diagnostic delay (OR, 0.19; 95% CI, 0.05-0.61). ASAS40 response rates were lower for patients with higher BMI but better for those with higher BASDAI levels. The researchers found comparable results when they excluded patients who stopped a TNF inhibitor because of other reasons for discontinuation and also when they counted patients who discontinued the TNF inhibitor because of remission as responders.

The sex difference in nr-axSpA patients’ treatment response to TNF inhibitors was even larger than the 56% lower odds the same group of researchers reported finding between women and men with radiographic disease in an earlier report, according to the new paper.

Given that this study and others in nr-axSpA patients have found higher remission rates to TNF inhibitor therapy in men versus women, the “current study therefore adds to available data to support the claim for future randomized controlled trials in axSpA to be sufficiently powered to detect potential sex differences,” the researchers said.

The authors acknowledged that a lack of MRI scans available for central scoring made it impossible to evaluate potential imaging misinterpretation, such as possible abnormalities mimicking mild sacroiliitis that have been reported to be more prevalent in women. It is also possible that some patients with fibromyalgia were missed because of screening for the condition by expert opinion of the treating rheumatologist “on a comorbidity questionnaire and not through fulfillment of classification criteria for fibromyalgia or via the use of a standardized fibromyalgia questionnaire,” they said.

The study was funded by the Stiftung für Rheumaforschung in Zurich. The Swiss Clinical Quality Management Foundation is supported by the Swiss Society of Rheumatology and by 11 pharmaceutical companies. Two study authors reported receiving consulting and/or speaking fees from some of those same companies.

jevans@mdedge.com

SOURCE: Neuenschwander R et al. Arthritis Res Ther. 2020;22(1):233.

The 2019 systemic lupus erythematosus (SLE) classification criteria jointly developed by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) proved significantly better at detecting true positive cases of the disease in children and young adults than did the 1997 ACR criteria, according to results from a single-center, retrospective study.

However, the 2019 criteria, which were developed using cohorts of adult patients with SLE, were statistically no better than the 1997 ACR criteria at identifying those without the disease, first author Najla Aljaberi, MBBS, of the Cincinnati Children’s Hospital Medical Center, and colleagues reported in Arthritis Care & Research.

The 2019 criteria were especially good at correctly classifying SLE in non-White youths, but the two sets of criteria performed equally well among male and female youths with SLE and across age groups.

“Our study confirms superior sensitivity of the new criteria over the 1997-ACR criteria in youths with SLE. The difference in sensitivity estimates between the two criteria sets (2019-EULAR/ACR vs. 1997-ACR) may be explained by a higher weight being assigned to immunologic criteria, less strict hematologic criteria (not requiring >2 occurrences), and the inclusion of subjective features of arthritis. Notably, our estimates of the sensitivity of the 2019-EULAR/ACR criteria were similar to those reported from a Brazilian pediatric study by Fonseca et al. (87.7%) that also used physician diagnosis as reference standard,” the researchers wrote.

Dr. Aljaberi and colleagues reviewed electronic medical records of 112 patients with SLE aged 2-21 years and 105 controls aged 1-19 years at Cincinnati Children’s Hospital Medical Center during 2008-2019. Patients identified in the records at the center were considered to have SLE based on ICD-10 codes assigned by experienced pediatric rheumatologists. The control patients included 69 (66%) with juvenile dermatomyositis and 36 with juvenile scleroderma/systemic sclerosis, based on corresponding ICD-10 codes.

Among the SLE cases, 57% were White and 81% were female, while Whites represented 83% and females 71% of control patients. Young adults aged 18-21 years represented a minority of SLE cases (18%) and controls (7%).

The 2019 criteria had significantly higher sensitivity than did the 1997 criteria (85% vs. 72%, respectively; P = .023) but similar specificity (83% vs. 87%; P = .456). A total of 17 out of the 112 SLE cases failed to meet the 2019 criteria, 13 (76%) of whom were White. Overall, 31 SLE cases did not meet the 1997 criteria, but 15 of those fulfilled the 2019 criteria. While there was no statistically significant difference in the sensitivity of the 2019 criteria between non-White and White cases (92% vs. 80%, respectively; P = .08), the difference in sensitivity was significant with the 1997 criteria (83% vs. 64%; P < .02).

The 2019 criteria had similar sensitivity in males and females (86% vs. 81%, respectively), as well as specificity (81% vs. 87%). The 1997 criteria also provided similar sensitivity between males and females (71% vs. 76%) as well as specificity (85% vs. 90%).

In only four instances did SLE cases meet 2019 criteria before ICD-10 diagnosis of SLE, whereas in the other 108 cases the ICD-10 diagnosis coincided with reaching the threshold for meeting 2019 criteria.

There was no funding secured for the study, and the authors had no conflicts of interest to disclose.

jevans@mdedge.com

SOURCE: Aljaberi N et al. Arthritis Care Res. 2020 Aug 25. doi: 10.1002/acr.24430.

The 2019 systemic lupus erythematosus (SLE) classification criteria jointly developed by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) proved significantly better at detecting true positive cases of the disease in children and young adults than did the 1997 ACR criteria, according to results from a single-center, retrospective study.

However, the 2019 criteria, which were developed using cohorts of adult patients with SLE, were statistically no better than the 1997 ACR criteria at identifying those without the disease, first author Najla Aljaberi, MBBS, of the Cincinnati Children’s Hospital Medical Center, and colleagues reported in Arthritis Care & Research.

The 2019 criteria were especially good at correctly classifying SLE in non-White youths, but the two sets of criteria performed equally well among male and female youths with SLE and across age groups.

“Our study confirms superior sensitivity of the new criteria over the 1997-ACR criteria in youths with SLE. The difference in sensitivity estimates between the two criteria sets (2019-EULAR/ACR vs. 1997-ACR) may be explained by a higher weight being assigned to immunologic criteria, less strict hematologic criteria (not requiring >2 occurrences), and the inclusion of subjective features of arthritis. Notably, our estimates of the sensitivity of the 2019-EULAR/ACR criteria were similar to those reported from a Brazilian pediatric study by Fonseca et al. (87.7%) that also used physician diagnosis as reference standard,” the researchers wrote.

Dr. Aljaberi and colleagues reviewed electronic medical records of 112 patients with SLE aged 2-21 years and 105 controls aged 1-19 years at Cincinnati Children’s Hospital Medical Center during 2008-2019. Patients identified in the records at the center were considered to have SLE based on ICD-10 codes assigned by experienced pediatric rheumatologists. The control patients included 69 (66%) with juvenile dermatomyositis and 36 with juvenile scleroderma/systemic sclerosis, based on corresponding ICD-10 codes.

Among the SLE cases, 57% were White and 81% were female, while Whites represented 83% and females 71% of control patients. Young adults aged 18-21 years represented a minority of SLE cases (18%) and controls (7%).

The 2019 criteria had significantly higher sensitivity than did the 1997 criteria (85% vs. 72%, respectively; P = .023) but similar specificity (83% vs. 87%; P = .456). A total of 17 out of the 112 SLE cases failed to meet the 2019 criteria, 13 (76%) of whom were White. Overall, 31 SLE cases did not meet the 1997 criteria, but 15 of those fulfilled the 2019 criteria. While there was no statistically significant difference in the sensitivity of the 2019 criteria between non-White and White cases (92% vs. 80%, respectively; P = .08), the difference in sensitivity was significant with the 1997 criteria (83% vs. 64%; P < .02).

The 2019 criteria had similar sensitivity in males and females (86% vs. 81%, respectively), as well as specificity (81% vs. 87%). The 1997 criteria also provided similar sensitivity between males and females (71% vs. 76%) as well as specificity (85% vs. 90%).

In only four instances did SLE cases meet 2019 criteria before ICD-10 diagnosis of SLE, whereas in the other 108 cases the ICD-10 diagnosis coincided with reaching the threshold for meeting 2019 criteria.

There was no funding secured for the study, and the authors had no conflicts of interest to disclose.

jevans@mdedge.com

SOURCE: Aljaberi N et al. Arthritis Care Res. 2020 Aug 25. doi: 10.1002/acr.24430.

The 2019 systemic lupus erythematosus (SLE) classification criteria jointly developed by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) proved significantly better at detecting true positive cases of the disease in children and young adults than did the 1997 ACR criteria, according to results from a single-center, retrospective study.

However, the 2019 criteria, which were developed using cohorts of adult patients with SLE, were statistically no better than the 1997 ACR criteria at identifying those without the disease, first author Najla Aljaberi, MBBS, of the Cincinnati Children’s Hospital Medical Center, and colleagues reported in Arthritis Care & Research.

The 2019 criteria were especially good at correctly classifying SLE in non-White youths, but the two sets of criteria performed equally well among male and female youths with SLE and across age groups.

“Our study confirms superior sensitivity of the new criteria over the 1997-ACR criteria in youths with SLE. The difference in sensitivity estimates between the two criteria sets (2019-EULAR/ACR vs. 1997-ACR) may be explained by a higher weight being assigned to immunologic criteria, less strict hematologic criteria (not requiring >2 occurrences), and the inclusion of subjective features of arthritis. Notably, our estimates of the sensitivity of the 2019-EULAR/ACR criteria were similar to those reported from a Brazilian pediatric study by Fonseca et al. (87.7%) that also used physician diagnosis as reference standard,” the researchers wrote.

Dr. Aljaberi and colleagues reviewed electronic medical records of 112 patients with SLE aged 2-21 years and 105 controls aged 1-19 years at Cincinnati Children’s Hospital Medical Center during 2008-2019. Patients identified in the records at the center were considered to have SLE based on ICD-10 codes assigned by experienced pediatric rheumatologists. The control patients included 69 (66%) with juvenile dermatomyositis and 36 with juvenile scleroderma/systemic sclerosis, based on corresponding ICD-10 codes.

Among the SLE cases, 57% were White and 81% were female, while Whites represented 83% and females 71% of control patients. Young adults aged 18-21 years represented a minority of SLE cases (18%) and controls (7%).

The 2019 criteria had significantly higher sensitivity than did the 1997 criteria (85% vs. 72%, respectively; P = .023) but similar specificity (83% vs. 87%; P = .456). A total of 17 out of the 112 SLE cases failed to meet the 2019 criteria, 13 (76%) of whom were White. Overall, 31 SLE cases did not meet the 1997 criteria, but 15 of those fulfilled the 2019 criteria. While there was no statistically significant difference in the sensitivity of the 2019 criteria between non-White and White cases (92% vs. 80%, respectively; P = .08), the difference in sensitivity was significant with the 1997 criteria (83% vs. 64%; P < .02).

The 2019 criteria had similar sensitivity in males and females (86% vs. 81%, respectively), as well as specificity (81% vs. 87%). The 1997 criteria also provided similar sensitivity between males and females (71% vs. 76%) as well as specificity (85% vs. 90%).

In only four instances did SLE cases meet 2019 criteria before ICD-10 diagnosis of SLE, whereas in the other 108 cases the ICD-10 diagnosis coincided with reaching the threshold for meeting 2019 criteria.

There was no funding secured for the study, and the authors had no conflicts of interest to disclose.

jevans@mdedge.com

SOURCE: Aljaberi N et al. Arthritis Care Res. 2020 Aug 25. doi: 10.1002/acr.24430.

Patients aged 2 years and older now have intravenous golimumab (Simponi Aria) as an option to treat active polyarticular-course juvenile idiopathic arthritis (pJIA) or psoriatic arthritis (PsA) after the Food and Drug Administration approved the tumor necrosis factor inhibitor for these indications on Sept. 30, according to an announcement from its manufacturer, Janssen.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Results from the open-label, single-arm, multicenter, phase 3, GO-VIVA clinical trial formed the basis for the agency’s approval of IV golimumab. GO-VIVA was conducted in 127 patients aged 2-17 years with JIA with arthritis in five or more joints (despite receiving treatment with methotrexate for at least 2 months) as part of a postmarketing requirement under the Pediatric Research Equity Act after the intravenous formulation of the biologic was approved for adults with rheumatoid arthritis in 2013. It demonstrated that pediatric patients had a level of pharmacokinetic exposure to golimumab that was similar to what was observed in two pivotal phase 3 trials in adults with moderately to severely active RA and active PsA, as well as efficacy that was generally consistent with responses seen in adult patients with RA, the manufacturer said.

Besides RA, intravenous golimumab was previously approved for adults with PsA and ankylosing spondylitis. As opposed to the IV dosing for adults with RA, PsA, and ankylosing spondylitis at 2 mg/kg infused over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter, dosing for pediatric patients with pJIA and PsA is based on body surface area at 80 mg/m², also given as an IV infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter.

The adverse reactions observed in GO-VIVA were consistent with the established safety profile of intravenous golimumab in adult patients with RA and PsA, according to Janssen.

The full prescribing information for intravenous golimumab can be found on the FDA website.

jevans@mdedge.com

Patients aged 2 years and older now have intravenous golimumab (Simponi Aria) as an option to treat active polyarticular-course juvenile idiopathic arthritis (pJIA) or psoriatic arthritis (PsA) after the Food and Drug Administration approved the tumor necrosis factor inhibitor for these indications on Sept. 30, according to an announcement from its manufacturer, Janssen.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Results from the open-label, single-arm, multicenter, phase 3, GO-VIVA clinical trial formed the basis for the agency’s approval of IV golimumab. GO-VIVA was conducted in 127 patients aged 2-17 years with JIA with arthritis in five or more joints (despite receiving treatment with methotrexate for at least 2 months) as part of a postmarketing requirement under the Pediatric Research Equity Act after the intravenous formulation of the biologic was approved for adults with rheumatoid arthritis in 2013. It demonstrated that pediatric patients had a level of pharmacokinetic exposure to golimumab that was similar to what was observed in two pivotal phase 3 trials in adults with moderately to severely active RA and active PsA, as well as efficacy that was generally consistent with responses seen in adult patients with RA, the manufacturer said.

Besides RA, intravenous golimumab was previously approved for adults with PsA and ankylosing spondylitis. As opposed to the IV dosing for adults with RA, PsA, and ankylosing spondylitis at 2 mg/kg infused over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter, dosing for pediatric patients with pJIA and PsA is based on body surface area at 80 mg/m², also given as an IV infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter.

The adverse reactions observed in GO-VIVA were consistent with the established safety profile of intravenous golimumab in adult patients with RA and PsA, according to Janssen.

The full prescribing information for intravenous golimumab can be found on the FDA website.

jevans@mdedge.com

Patients aged 2 years and older now have intravenous golimumab (Simponi Aria) as an option to treat active polyarticular-course juvenile idiopathic arthritis (pJIA) or psoriatic arthritis (PsA) after the Food and Drug Administration approved the tumor necrosis factor inhibitor for these indications on Sept. 30, according to an announcement from its manufacturer, Janssen.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Results from the open-label, single-arm, multicenter, phase 3, GO-VIVA clinical trial formed the basis for the agency’s approval of IV golimumab. GO-VIVA was conducted in 127 patients aged 2-17 years with JIA with arthritis in five or more joints (despite receiving treatment with methotrexate for at least 2 months) as part of a postmarketing requirement under the Pediatric Research Equity Act after the intravenous formulation of the biologic was approved for adults with rheumatoid arthritis in 2013. It demonstrated that pediatric patients had a level of pharmacokinetic exposure to golimumab that was similar to what was observed in two pivotal phase 3 trials in adults with moderately to severely active RA and active PsA, as well as efficacy that was generally consistent with responses seen in adult patients with RA, the manufacturer said.

Besides RA, intravenous golimumab was previously approved for adults with PsA and ankylosing spondylitis. As opposed to the IV dosing for adults with RA, PsA, and ankylosing spondylitis at 2 mg/kg infused over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter, dosing for pediatric patients with pJIA and PsA is based on body surface area at 80 mg/m², also given as an IV infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter.

The adverse reactions observed in GO-VIVA were consistent with the established safety profile of intravenous golimumab in adult patients with RA and PsA, according to Janssen.

The full prescribing information for intravenous golimumab can be found on the FDA website.

jevans@mdedge.com

The Food and Drug Administration has approved tablet and oral solution formulations of the Janus kinase (JAK) inhibitor tofactinib (Xeljanz) for the treatment of children and adolescents 2 years and older with active polyarticular-course juvenile idiopathic arthritis (pJIA).

The approval, announced Sept. 28 by tofacitinib’s manufacturer, Pfizer, marks the first JAK inhibitor to be approved for the condition in the United States and is the fourth indication to be approved for the drug after approvals in adult patients with moderate to severe rheumatoid arthritis following methotrexate failure, active psoriatic arthritis after disease-modifying antirheumatic drug failure, and moderate to severe ulcerative colitis after failure on a tumor necrosis factor inhibitor.

The agency based its approval on a phase 3, multinational, randomized, double-blind, controlled withdrawal study that had an 18-week, open-label, run-in phase involving 225 patients who twice daily took either a 5-mg tablet or, in patients under 40 kg, a weight-based lower dose in the form of a 1 mg/mL oral solution, according to the company press release. A total of 173 patients from this phase met JIA American College of Rheumatology 30 response criteria, defined as 30% or greater improvement in three of six JIA core set variables and worsening in no more than one of the core set variables; they were then randomized in part 2 of the study to continue the same dose of tofacitinib or receive placebo until 44 weeks. By the end of this period, 31% who received tofacitinib had a disease flare, compared with 55% on placebo (P = .0007). Disease flare was defined as a 30% or greater worsening in at least three of the six variables of the JIA core set, with no more than one of the remaining JIA core response variables improving by 30% or more after randomization.

The types of adverse drug reactions in patients with pJIA were consistent with those seen in adult rheumatoid arthritis patients, according to Pfizer. Serious adverse drug reactions have most commonly been serious infections that may lead to hospitalization or death, and most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. Common adverse drug reactions reported in 2% or more of patients during the first 3 months in controlled clinical trials in patients with rheumatoid arthritis taking tofacitinib at 5 mg twice daily were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension.

While the 5-mg tablet formulation is already available, Pfizer said it expects the oral solution to be available by the end of the first quarter in 2021.

Prescribing information can be found on the FDA website.

jevans@mdedge.com

The Food and Drug Administration has approved tablet and oral solution formulations of the Janus kinase (JAK) inhibitor tofactinib (Xeljanz) for the treatment of children and adolescents 2 years and older with active polyarticular-course juvenile idiopathic arthritis (pJIA).

The approval, announced Sept. 28 by tofacitinib’s manufacturer, Pfizer, marks the first JAK inhibitor to be approved for the condition in the United States and is the fourth indication to be approved for the drug after approvals in adult patients with moderate to severe rheumatoid arthritis following methotrexate failure, active psoriatic arthritis after disease-modifying antirheumatic drug failure, and moderate to severe ulcerative colitis after failure on a tumor necrosis factor inhibitor.

The agency based its approval on a phase 3, multinational, randomized, double-blind, controlled withdrawal study that had an 18-week, open-label, run-in phase involving 225 patients who twice daily took either a 5-mg tablet or, in patients under 40 kg, a weight-based lower dose in the form of a 1 mg/mL oral solution, according to the company press release. A total of 173 patients from this phase met JIA American College of Rheumatology 30 response criteria, defined as 30% or greater improvement in three of six JIA core set variables and worsening in no more than one of the core set variables; they were then randomized in part 2 of the study to continue the same dose of tofacitinib or receive placebo until 44 weeks. By the end of this period, 31% who received tofacitinib had a disease flare, compared with 55% on placebo (P = .0007). Disease flare was defined as a 30% or greater worsening in at least three of the six variables of the JIA core set, with no more than one of the remaining JIA core response variables improving by 30% or more after randomization.

The types of adverse drug reactions in patients with pJIA were consistent with those seen in adult rheumatoid arthritis patients, according to Pfizer. Serious adverse drug reactions have most commonly been serious infections that may lead to hospitalization or death, and most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. Common adverse drug reactions reported in 2% or more of patients during the first 3 months in controlled clinical trials in patients with rheumatoid arthritis taking tofacitinib at 5 mg twice daily were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension.

While the 5-mg tablet formulation is already available, Pfizer said it expects the oral solution to be available by the end of the first quarter in 2021.

Prescribing information can be found on the FDA website.

jevans@mdedge.com

The Food and Drug Administration has approved tablet and oral solution formulations of the Janus kinase (JAK) inhibitor tofactinib (Xeljanz) for the treatment of children and adolescents 2 years and older with active polyarticular-course juvenile idiopathic arthritis (pJIA).

The approval, announced Sept. 28 by tofacitinib’s manufacturer, Pfizer, marks the first JAK inhibitor to be approved for the condition in the United States and is the fourth indication to be approved for the drug after approvals in adult patients with moderate to severe rheumatoid arthritis following methotrexate failure, active psoriatic arthritis after disease-modifying antirheumatic drug failure, and moderate to severe ulcerative colitis after failure on a tumor necrosis factor inhibitor.

The agency based its approval on a phase 3, multinational, randomized, double-blind, controlled withdrawal study that had an 18-week, open-label, run-in phase involving 225 patients who twice daily took either a 5-mg tablet or, in patients under 40 kg, a weight-based lower dose in the form of a 1 mg/mL oral solution, according to the company press release. A total of 173 patients from this phase met JIA American College of Rheumatology 30 response criteria, defined as 30% or greater improvement in three of six JIA core set variables and worsening in no more than one of the core set variables; they were then randomized in part 2 of the study to continue the same dose of tofacitinib or receive placebo until 44 weeks. By the end of this period, 31% who received tofacitinib had a disease flare, compared with 55% on placebo (P = .0007). Disease flare was defined as a 30% or greater worsening in at least three of the six variables of the JIA core set, with no more than one of the remaining JIA core response variables improving by 30% or more after randomization.

The types of adverse drug reactions in patients with pJIA were consistent with those seen in adult rheumatoid arthritis patients, according to Pfizer. Serious adverse drug reactions have most commonly been serious infections that may lead to hospitalization or death, and most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. Common adverse drug reactions reported in 2% or more of patients during the first 3 months in controlled clinical trials in patients with rheumatoid arthritis taking tofacitinib at 5 mg twice daily were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension.

While the 5-mg tablet formulation is already available, Pfizer said it expects the oral solution to be available by the end of the first quarter in 2021.

Prescribing information can be found on the FDA website.

jevans@mdedge.com

An elevated Health Assessment Questionnaire Disability Index (HAQ) score at 1 year significantly increased all-cause mortality in patients with early RA over the course of up to 10 years of follow-up, according to an analysis of patients enrolled in the Canadian Early Arthritis Cohort (CATCH).

Higher Disease Activity Score in 28 joints (DAS28) at follow-up was also associated with higher all-cause mortality among the patients, who all took at least one conventional synthetic or biologic disease-modifying antirheumatic drug during the first year. Higher DAS28 scores in previous studies has been associated with increased disability as measured by the HAQ, Safoora Fatima, MD, of the University of Western Ontario, London, and colleagues wrote in Arthritis & Rheumatology.

“Combining our study findings with this association suggests that poorer disease control (high DAS28) within the first treatment year for RA may lead to increased disability (high HAQ scores) which in turn may contribute to higher mortality. This may indicate that RA patients who do not have a deep response in the first year to treatment have higher subsequent mortality,” the researchers wrote.

In addition to higher HAQ scores, all-cause mortality was independently associated with age, male sex, lower education, smoking, more comorbidities, higher baseline disease activity, and glucocorticoid use. “This is helpful in a clinical setting as it can guide physician-patient discussions in terms of risk factors associated with prognosis, prescribing glucocorticoids, counseling on smoking cessation, monitoring treatment responses, and focusing on patient education,” the authors wrote.

While the impact of increased disease activity and damage likely plays a role in the association between high HAQ score and increased mortality, the authors noted that “comorbidities could be causing deaths and those with comorbidities in [early RA] have less chance of remission and more functional impairment at 1 year versus those without any comorbidities, as has been shown [before] in the CATCH [early RA] cohort.”

Dr. Fatima and associates studied 1,724 patients with RA who had a symptom duration of less than 1 year at the time of enrollment in CATCH during 2007-2017. These patients had a mean age of 55 years, and 72% were women. Over the 10-year follow up period, 62 patients (2.4%) died. HAQ scores proved to be significantly higher at both baseline and 1 year for those who died, going from 1.2 to 0.9, compared with scores moving from 1.0 to 0.5 among patients who did not die. (The HAQ has eight categories that are each scored 0-3, with 0 meaning no self-reported functional impairment and 3 meaning severe functional impairment.) Similarly, DAS28 scores were significantly higher at both time points for patients who died versus those who lived, declining from 5.4 to 3.6 for deceased and from 4.9 to 2.8 for nondeceased patients in a year.

Whereas HAQ at baseline was not significantly associated with all-cause mortality in a multivariate, discrete-time survival model that adjusted for age, gender, comorbidities, disease activity, smoking, education, seropositivity, symptom duration, and glucocorticoid use, the association between HAQ at 1 year and death remained statistically significant with a hazard ratio of 1.87.

The authors noted that potential confounders may not have been adjusted for in the comparisons, such as “variable access to advanced therapies, other comorbidities not in the standardized comorbidity questionnaire, [and] severity of comorbidities.”

CATCH has been funded over many years by multiple companies including Amgen and Pfizer Canada, AbbVie, Medexus, Eli Lilly Canada, Merck Canada, Sandoz, Hoffman–La Roche, Janssen, UCB Canada, Bristol-Myers Squibb Canada, and Sanofi Genzyme. The authors had no disclosures.

SOURCE: Fatima S et al. Arthritis Rheumatol. 2020 Sep 6. doi: 10.1002/art.41513.

An elevated Health Assessment Questionnaire Disability Index (HAQ) score at 1 year significantly increased all-cause mortality in patients with early RA over the course of up to 10 years of follow-up, according to an analysis of patients enrolled in the Canadian Early Arthritis Cohort (CATCH).

Higher Disease Activity Score in 28 joints (DAS28) at follow-up was also associated with higher all-cause mortality among the patients, who all took at least one conventional synthetic or biologic disease-modifying antirheumatic drug during the first year. Higher DAS28 scores in previous studies has been associated with increased disability as measured by the HAQ, Safoora Fatima, MD, of the University of Western Ontario, London, and colleagues wrote in Arthritis & Rheumatology.

“Combining our study findings with this association suggests that poorer disease control (high DAS28) within the first treatment year for RA may lead to increased disability (high HAQ scores) which in turn may contribute to higher mortality. This may indicate that RA patients who do not have a deep response in the first year to treatment have higher subsequent mortality,” the researchers wrote.

In addition to higher HAQ scores, all-cause mortality was independently associated with age, male sex, lower education, smoking, more comorbidities, higher baseline disease activity, and glucocorticoid use. “This is helpful in a clinical setting as it can guide physician-patient discussions in terms of risk factors associated with prognosis, prescribing glucocorticoids, counseling on smoking cessation, monitoring treatment responses, and focusing on patient education,” the authors wrote.

While the impact of increased disease activity and damage likely plays a role in the association between high HAQ score and increased mortality, the authors noted that “comorbidities could be causing deaths and those with comorbidities in [early RA] have less chance of remission and more functional impairment at 1 year versus those without any comorbidities, as has been shown [before] in the CATCH [early RA] cohort.”

Dr. Fatima and associates studied 1,724 patients with RA who had a symptom duration of less than 1 year at the time of enrollment in CATCH during 2007-2017. These patients had a mean age of 55 years, and 72% were women. Over the 10-year follow up period, 62 patients (2.4%) died. HAQ scores proved to be significantly higher at both baseline and 1 year for those who died, going from 1.2 to 0.9, compared with scores moving from 1.0 to 0.5 among patients who did not die. (The HAQ has eight categories that are each scored 0-3, with 0 meaning no self-reported functional impairment and 3 meaning severe functional impairment.) Similarly, DAS28 scores were significantly higher at both time points for patients who died versus those who lived, declining from 5.4 to 3.6 for deceased and from 4.9 to 2.8 for nondeceased patients in a year.

Whereas HAQ at baseline was not significantly associated with all-cause mortality in a multivariate, discrete-time survival model that adjusted for age, gender, comorbidities, disease activity, smoking, education, seropositivity, symptom duration, and glucocorticoid use, the association between HAQ at 1 year and death remained statistically significant with a hazard ratio of 1.87.

The authors noted that potential confounders may not have been adjusted for in the comparisons, such as “variable access to advanced therapies, other comorbidities not in the standardized comorbidity questionnaire, [and] severity of comorbidities.”

CATCH has been funded over many years by multiple companies including Amgen and Pfizer Canada, AbbVie, Medexus, Eli Lilly Canada, Merck Canada, Sandoz, Hoffman–La Roche, Janssen, UCB Canada, Bristol-Myers Squibb Canada, and Sanofi Genzyme. The authors had no disclosures.

SOURCE: Fatima S et al. Arthritis Rheumatol. 2020 Sep 6. doi: 10.1002/art.41513.

An elevated Health Assessment Questionnaire Disability Index (HAQ) score at 1 year significantly increased all-cause mortality in patients with early RA over the course of up to 10 years of follow-up, according to an analysis of patients enrolled in the Canadian Early Arthritis Cohort (CATCH).

Higher Disease Activity Score in 28 joints (DAS28) at follow-up was also associated with higher all-cause mortality among the patients, who all took at least one conventional synthetic or biologic disease-modifying antirheumatic drug during the first year. Higher DAS28 scores in previous studies has been associated with increased disability as measured by the HAQ, Safoora Fatima, MD, of the University of Western Ontario, London, and colleagues wrote in Arthritis & Rheumatology.

“Combining our study findings with this association suggests that poorer disease control (high DAS28) within the first treatment year for RA may lead to increased disability (high HAQ scores) which in turn may contribute to higher mortality. This may indicate that RA patients who do not have a deep response in the first year to treatment have higher subsequent mortality,” the researchers wrote.

In addition to higher HAQ scores, all-cause mortality was independently associated with age, male sex, lower education, smoking, more comorbidities, higher baseline disease activity, and glucocorticoid use. “This is helpful in a clinical setting as it can guide physician-patient discussions in terms of risk factors associated with prognosis, prescribing glucocorticoids, counseling on smoking cessation, monitoring treatment responses, and focusing on patient education,” the authors wrote.

While the impact of increased disease activity and damage likely plays a role in the association between high HAQ score and increased mortality, the authors noted that “comorbidities could be causing deaths and those with comorbidities in [early RA] have less chance of remission and more functional impairment at 1 year versus those without any comorbidities, as has been shown [before] in the CATCH [early RA] cohort.”

Dr. Fatima and associates studied 1,724 patients with RA who had a symptom duration of less than 1 year at the time of enrollment in CATCH during 2007-2017. These patients had a mean age of 55 years, and 72% were women. Over the 10-year follow up period, 62 patients (2.4%) died. HAQ scores proved to be significantly higher at both baseline and 1 year for those who died, going from 1.2 to 0.9, compared with scores moving from 1.0 to 0.5 among patients who did not die. (The HAQ has eight categories that are each scored 0-3, with 0 meaning no self-reported functional impairment and 3 meaning severe functional impairment.) Similarly, DAS28 scores were significantly higher at both time points for patients who died versus those who lived, declining from 5.4 to 3.6 for deceased and from 4.9 to 2.8 for nondeceased patients in a year.

Whereas HAQ at baseline was not significantly associated with all-cause mortality in a multivariate, discrete-time survival model that adjusted for age, gender, comorbidities, disease activity, smoking, education, seropositivity, symptom duration, and glucocorticoid use, the association between HAQ at 1 year and death remained statistically significant with a hazard ratio of 1.87.

The authors noted that potential confounders may not have been adjusted for in the comparisons, such as “variable access to advanced therapies, other comorbidities not in the standardized comorbidity questionnaire, [and] severity of comorbidities.”

CATCH has been funded over many years by multiple companies including Amgen and Pfizer Canada, AbbVie, Medexus, Eli Lilly Canada, Merck Canada, Sandoz, Hoffman–La Roche, Janssen, UCB Canada, Bristol-Myers Squibb Canada, and Sanofi Genzyme. The authors had no disclosures.

SOURCE: Fatima S et al. Arthritis Rheumatol. 2020 Sep 6. doi: 10.1002/art.41513.

Patients with RA were at lower risk for developing incident type 2 diabetes mellitus (T2DM) in comparison with patients with hypertension, psoriatic arthritis (PsA), or osteoarthritis, as well as the general population without RA in a retrospective cohort study of a large, nationwide, commercial health insurance claims database.

This result goes against what the study researchers from the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, initially hypothesized: The “risk of incident T2DM in RA patients would be similar to or less than PsA and [hypertension] patients, but higher, compared to general non-RA and OA patients.”

Prior epidemiologic studies of the relationship between RA and incident diabetes have yielded inconclusive results suggesting a small increase or no increase in risk of T2DM in patients with RA, possibly because of differences in the risk of T2DM in comparison groups used by previous studies to calculate relative risk, first author Yinzhu Jin and colleagues noted in their report published in Arthritis Care & Research.

After mining a nationwide U.S. commercial health insurance claims database, the Optum Clinformatics Data Mart, for claims data from Jan. 1, 2005, to Dec. 31, 2017, the researchers matched a total of 108,568 patients in RA, general population non-RA, hypertension, and OA cohorts based on age, sex, and index date (the date of disease-specific medication dispensing). Overall, 77% of those patients were female and had a mean age of nearly 56 years, whereas 48% of patients with PsA were female and their mean age was nearly 49 years. (PsA patients were not matched because of smaller numbers.)

During a median follow-up period of 1.4-1.8 years across the comparison groups, the crude incidence rate for diabetes per 1,000 person-years in the cohorts was 7.0 for RA, 7.4 for general non-RA, 12.3 for hypertension, 7.8 for OA, and 9.9 for PsA. The hazard ratios and 95% confidence interval for risk of diabetes in patients with RA – after adjustment for more than 40 baseline covariates that included demographics, comorbidities, medication use, and health care utilization – was 0.72 (0.66-0.78) in comparison withh the general non-RA cohort, 0.65 (0.60-0.71) in comparison with the hypertension cohort, 0.75 (0.69-0.81) in comparison with the OA cohort, and 0.76 (0.67-0.86) in comparison with the PsA cohort. These values correspond to RA patients having a 24%-35% lower risk of incident diabetes versus the comparison groups, the researchers noted. They observed results consistent to these when they conducted a sensitivity analysis using a 1-year lag time from the index date before starting follow-up.

The lower risk of T2DM in patients with RA in comparison with patients in the non-RA cohort “may be, in part, due to the effect of biologic DMARD [disease-modifying antirheumatic drug] treatment in RA which likely modifies the risk of DM,” the researchers wrote. “Both the increasing use of biologic DMARDs for RA in the U.S. over the last decade and our cohort entry criteria for the RA cohort (i.e., at least one dispensing of a DMARD) may explain the finding of the lower risk of DM in RA.”

The results found with the other three cohorts did not surprise the researchers. The reduced risk of diabetes among RA patients versus those with OA jibes with “higher rates of obesity and other comorbidities in patients with OA” as well as findings from a recent study that found a higher incidence rate of diabetes in OA, compared with RA. Ms. Jin and colleagues also acknowledged it is well known that “hypertension and PsA are associated with metabolic dysregulation and increase the risk of diabetes.”

The researchers defined patients with RA as having at least twoinpatient or outpatient ICD-9 or ICD-10 diagnosis codes of RA, separated by 7-365 days and having at least one dispensing for DMARDs within 1 year from the first RA diagnosis date, and defined the primary outcome of incident T2DM as at least one inpatient or outpatient diagnosis of T2DM plus at least one dispensing of an antidiabetic drug. They set the general non-RA cohort by selecting patients with any inpatient or outpatient diagnosis codes and a dispensing of any medications, and the hypertension, PsA, and OA comparator groups as having at least two inpatient or outpatient disease-specific ICD-9/ICD-10 codes separated by 7-365 days and at least one dispensing of disease-specific medication within 1 year from the first diagnosis date. They excluded patients with RA, PsA, or psoriasis diagnosis or disease-specific medication dispensing any time prior to or on the index date (the date of disease-specific medication dispensing).

The researchers recognized that the conclusions that can be drawn from the study are limited by the “potential misclassification of cohorts and covariates” because they “mainly used diagnosis codes and pharmacy dispensing records in claims data,” and some “important covariates such as baseline obesity are likely underreported and not adequately captured in claims data.” The level of covariate misclassification also may have been different across the study cohorts on “unmeasured covariates such as body mass index, diet, and physical activity, as well as disease specific measures,” thus introducing residual confounding. They also could not “examine potential difference in the risk of T2DM in untreated or undertreated RA patients” because “RA and all the non-RA comparator cohorts were required to use a disease-specific drug,” they wrote.

“While systemic inflammation in RA is thought to increase the risk of [cardiovascular disease] and cardiovascular risk factors such as DM, our findings suggest having RA itself does not confer an increased risk of DM. Future study should determine whether untreated RA or undertreated RA is associated with a greater risk of developing DM,” the researchers concluded.

The study was supported by a research grant from Bristol-Myers Squibb, which “played no role in the study design, data analysis or interpretation of data or presentation of results,” the researchers said. The company was “given the opportunity to make nonbinding comments on a draft of the manuscript, but the authors retained the right of publication and to determine the final wording.” One author reported receiving research grants from Brigham and Women’s Hospital from Pfizer, AbbVie, Bristol-Myers Squibb, and Roche for unrelated topics.

jevans@mdedge.com

SOURCE: Jin Y et al. Arthritis Care Res. 2020 Aug 4. doi: 10.1002/acr.24343.

Patients with RA were at lower risk for developing incident type 2 diabetes mellitus (T2DM) in comparison with patients with hypertension, psoriatic arthritis (PsA), or osteoarthritis, as well as the general population without RA in a retrospective cohort study of a large, nationwide, commercial health insurance claims database.

This result goes against what the study researchers from the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, initially hypothesized: The “risk of incident T2DM in RA patients would be similar to or less than PsA and [hypertension] patients, but higher, compared to general non-RA and OA patients.”

Prior epidemiologic studies of the relationship between RA and incident diabetes have yielded inconclusive results suggesting a small increase or no increase in risk of T2DM in patients with RA, possibly because of differences in the risk of T2DM in comparison groups used by previous studies to calculate relative risk, first author Yinzhu Jin and colleagues noted in their report published in Arthritis Care & Research.

After mining a nationwide U.S. commercial health insurance claims database, the Optum Clinformatics Data Mart, for claims data from Jan. 1, 2005, to Dec. 31, 2017, the researchers matched a total of 108,568 patients in RA, general population non-RA, hypertension, and OA cohorts based on age, sex, and index date (the date of disease-specific medication dispensing). Overall, 77% of those patients were female and had a mean age of nearly 56 years, whereas 48% of patients with PsA were female and their mean age was nearly 49 years. (PsA patients were not matched because of smaller numbers.)

During a median follow-up period of 1.4-1.8 years across the comparison groups, the crude incidence rate for diabetes per 1,000 person-years in the cohorts was 7.0 for RA, 7.4 for general non-RA, 12.3 for hypertension, 7.8 for OA, and 9.9 for PsA. The hazard ratios and 95% confidence interval for risk of diabetes in patients with RA – after adjustment for more than 40 baseline covariates that included demographics, comorbidities, medication use, and health care utilization – was 0.72 (0.66-0.78) in comparison withh the general non-RA cohort, 0.65 (0.60-0.71) in comparison with the hypertension cohort, 0.75 (0.69-0.81) in comparison with the OA cohort, and 0.76 (0.67-0.86) in comparison with the PsA cohort. These values correspond to RA patients having a 24%-35% lower risk of incident diabetes versus the comparison groups, the researchers noted. They observed results consistent to these when they conducted a sensitivity analysis using a 1-year lag time from the index date before starting follow-up.

The lower risk of T2DM in patients with RA in comparison with patients in the non-RA cohort “may be, in part, due to the effect of biologic DMARD [disease-modifying antirheumatic drug] treatment in RA which likely modifies the risk of DM,” the researchers wrote. “Both the increasing use of biologic DMARDs for RA in the U.S. over the last decade and our cohort entry criteria for the RA cohort (i.e., at least one dispensing of a DMARD) may explain the finding of the lower risk of DM in RA.”

The results found with the other three cohorts did not surprise the researchers. The reduced risk of diabetes among RA patients versus those with OA jibes with “higher rates of obesity and other comorbidities in patients with OA” as well as findings from a recent study that found a higher incidence rate of diabetes in OA, compared with RA. Ms. Jin and colleagues also acknowledged it is well known that “hypertension and PsA are associated with metabolic dysregulation and increase the risk of diabetes.”

The researchers defined patients with RA as having at least twoinpatient or outpatient ICD-9 or ICD-10 diagnosis codes of RA, separated by 7-365 days and having at least one dispensing for DMARDs within 1 year from the first RA diagnosis date, and defined the primary outcome of incident T2DM as at least one inpatient or outpatient diagnosis of T2DM plus at least one dispensing of an antidiabetic drug. They set the general non-RA cohort by selecting patients with any inpatient or outpatient diagnosis codes and a dispensing of any medications, and the hypertension, PsA, and OA comparator groups as having at least two inpatient or outpatient disease-specific ICD-9/ICD-10 codes separated by 7-365 days and at least one dispensing of disease-specific medication within 1 year from the first diagnosis date. They excluded patients with RA, PsA, or psoriasis diagnosis or disease-specific medication dispensing any time prior to or on the index date (the date of disease-specific medication dispensing).

The researchers recognized that the conclusions that can be drawn from the study are limited by the “potential misclassification of cohorts and covariates” because they “mainly used diagnosis codes and pharmacy dispensing records in claims data,” and some “important covariates such as baseline obesity are likely underreported and not adequately captured in claims data.” The level of covariate misclassification also may have been different across the study cohorts on “unmeasured covariates such as body mass index, diet, and physical activity, as well as disease specific measures,” thus introducing residual confounding. They also could not “examine potential difference in the risk of T2DM in untreated or undertreated RA patients” because “RA and all the non-RA comparator cohorts were required to use a disease-specific drug,” they wrote.

“While systemic inflammation in RA is thought to increase the risk of [cardiovascular disease] and cardiovascular risk factors such as DM, our findings suggest having RA itself does not confer an increased risk of DM. Future study should determine whether untreated RA or undertreated RA is associated with a greater risk of developing DM,” the researchers concluded.

The study was supported by a research grant from Bristol-Myers Squibb, which “played no role in the study design, data analysis or interpretation of data or presentation of results,” the researchers said. The company was “given the opportunity to make nonbinding comments on a draft of the manuscript, but the authors retained the right of publication and to determine the final wording.” One author reported receiving research grants from Brigham and Women’s Hospital from Pfizer, AbbVie, Bristol-Myers Squibb, and Roche for unrelated topics.

jevans@mdedge.com

SOURCE: Jin Y et al. Arthritis Care Res. 2020 Aug 4. doi: 10.1002/acr.24343.

Patients with RA were at lower risk for developing incident type 2 diabetes mellitus (T2DM) in comparison with patients with hypertension, psoriatic arthritis (PsA), or osteoarthritis, as well as the general population without RA in a retrospective cohort study of a large, nationwide, commercial health insurance claims database.

This result goes against what the study researchers from the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, initially hypothesized: The “risk of incident T2DM in RA patients would be similar to or less than PsA and [hypertension] patients, but higher, compared to general non-RA and OA patients.”

Prior epidemiologic studies of the relationship between RA and incident diabetes have yielded inconclusive results suggesting a small increase or no increase in risk of T2DM in patients with RA, possibly because of differences in the risk of T2DM in comparison groups used by previous studies to calculate relative risk, first author Yinzhu Jin and colleagues noted in their report published in Arthritis Care & Research.

After mining a nationwide U.S. commercial health insurance claims database, the Optum Clinformatics Data Mart, for claims data from Jan. 1, 2005, to Dec. 31, 2017, the researchers matched a total of 108,568 patients in RA, general population non-RA, hypertension, and OA cohorts based on age, sex, and index date (the date of disease-specific medication dispensing). Overall, 77% of those patients were female and had a mean age of nearly 56 years, whereas 48% of patients with PsA were female and their mean age was nearly 49 years. (PsA patients were not matched because of smaller numbers.)

During a median follow-up period of 1.4-1.8 years across the comparison groups, the crude incidence rate for diabetes per 1,000 person-years in the cohorts was 7.0 for RA, 7.4 for general non-RA, 12.3 for hypertension, 7.8 for OA, and 9.9 for PsA. The hazard ratios and 95% confidence interval for risk of diabetes in patients with RA – after adjustment for more than 40 baseline covariates that included demographics, comorbidities, medication use, and health care utilization – was 0.72 (0.66-0.78) in comparison withh the general non-RA cohort, 0.65 (0.60-0.71) in comparison with the hypertension cohort, 0.75 (0.69-0.81) in comparison with the OA cohort, and 0.76 (0.67-0.86) in comparison with the PsA cohort. These values correspond to RA patients having a 24%-35% lower risk of incident diabetes versus the comparison groups, the researchers noted. They observed results consistent to these when they conducted a sensitivity analysis using a 1-year lag time from the index date before starting follow-up.

The lower risk of T2DM in patients with RA in comparison with patients in the non-RA cohort “may be, in part, due to the effect of biologic DMARD [disease-modifying antirheumatic drug] treatment in RA which likely modifies the risk of DM,” the researchers wrote. “Both the increasing use of biologic DMARDs for RA in the U.S. over the last decade and our cohort entry criteria for the RA cohort (i.e., at least one dispensing of a DMARD) may explain the finding of the lower risk of DM in RA.”

The results found with the other three cohorts did not surprise the researchers. The reduced risk of diabetes among RA patients versus those with OA jibes with “higher rates of obesity and other comorbidities in patients with OA” as well as findings from a recent study that found a higher incidence rate of diabetes in OA, compared with RA. Ms. Jin and colleagues also acknowledged it is well known that “hypertension and PsA are associated with metabolic dysregulation and increase the risk of diabetes.”

The researchers defined patients with RA as having at least twoinpatient or outpatient ICD-9 or ICD-10 diagnosis codes of RA, separated by 7-365 days and having at least one dispensing for DMARDs within 1 year from the first RA diagnosis date, and defined the primary outcome of incident T2DM as at least one inpatient or outpatient diagnosis of T2DM plus at least one dispensing of an antidiabetic drug. They set the general non-RA cohort by selecting patients with any inpatient or outpatient diagnosis codes and a dispensing of any medications, and the hypertension, PsA, and OA comparator groups as having at least two inpatient or outpatient disease-specific ICD-9/ICD-10 codes separated by 7-365 days and at least one dispensing of disease-specific medication within 1 year from the first diagnosis date. They excluded patients with RA, PsA, or psoriasis diagnosis or disease-specific medication dispensing any time prior to or on the index date (the date of disease-specific medication dispensing).

The researchers recognized that the conclusions that can be drawn from the study are limited by the “potential misclassification of cohorts and covariates” because they “mainly used diagnosis codes and pharmacy dispensing records in claims data,” and some “important covariates such as baseline obesity are likely underreported and not adequately captured in claims data.” The level of covariate misclassification also may have been different across the study cohorts on “unmeasured covariates such as body mass index, diet, and physical activity, as well as disease specific measures,” thus introducing residual confounding. They also could not “examine potential difference in the risk of T2DM in untreated or undertreated RA patients” because “RA and all the non-RA comparator cohorts were required to use a disease-specific drug,” they wrote.

“While systemic inflammation in RA is thought to increase the risk of [cardiovascular disease] and cardiovascular risk factors such as DM, our findings suggest having RA itself does not confer an increased risk of DM. Future study should determine whether untreated RA or undertreated RA is associated with a greater risk of developing DM,” the researchers concluded.

The study was supported by a research grant from Bristol-Myers Squibb, which “played no role in the study design, data analysis or interpretation of data or presentation of results,” the researchers said. The company was “given the opportunity to make nonbinding comments on a draft of the manuscript, but the authors retained the right of publication and to determine the final wording.” One author reported receiving research grants from Brigham and Women’s Hospital from Pfizer, AbbVie, Bristol-Myers Squibb, and Roche for unrelated topics.

jevans@mdedge.com

SOURCE: Jin Y et al. Arthritis Care Res. 2020 Aug 4. doi: 10.1002/acr.24343.

Lindsey Criswell, MD, MPH, DSc, has been selected as the next director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Dr. Criswell, vice chancellor of research at the University of California, San Francisco, will replace acting director Robert H. Carter, MD, who has overseen NIAMS since December 2018, following the unexpected death of longtime director Stephen I. Katz, MD, PhD, who had directed the institute since 1995. She will start her new role in early 2021, according to the NIH.

“Dr. Criswell has rich experience as a clinician, researcher, and administrator. Her ability to oversee the research program of one of the country’s top research-intensive medical schools, and her expertise in autoimmune diseases, including rheumatoid arthritis and lupus, make her well-positioned to direct NIAMS,” said NIH director Francis S. Collins, MD, PhD, said in an announcement.

Dr. Criswell, who holds the Kenneth H. Fye, M.D., endowed chair in rheumatology and the Jean S. Engleman Distinguished Professorship in Rheumatology at UCSF, spent most of her career at the university, focusing her research on the genetics and epidemiology of human autoimmune disease, particularly rheumatoid arthritis and systemic lupus erythematosus. Using genome-wide association and other genetic studies, her research team contributed to the identification of more than 30 genes linked to these disorders, according to the NIH.

NIAMS has a budget of nearly $625 million and its extramural research program supports scientific studies and research training and career development throughout the country through grants and contracts to research organizations in fields that include rheumatology, muscle biology, orthopedics, bone and mineral metabolism, and dermatology.

jevans@mdedge.com

Lindsey Criswell, MD, MPH, DSc, has been selected as the next director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Dr. Criswell, vice chancellor of research at the University of California, San Francisco, will replace acting director Robert H. Carter, MD, who has overseen NIAMS since December 2018, following the unexpected death of longtime director Stephen I. Katz, MD, PhD, who had directed the institute since 1995. She will start her new role in early 2021, according to the NIH.

“Dr. Criswell has rich experience as a clinician, researcher, and administrator. Her ability to oversee the research program of one of the country’s top research-intensive medical schools, and her expertise in autoimmune diseases, including rheumatoid arthritis and lupus, make her well-positioned to direct NIAMS,” said NIH director Francis S. Collins, MD, PhD, said in an announcement.

Dr. Criswell, who holds the Kenneth H. Fye, M.D., endowed chair in rheumatology and the Jean S. Engleman Distinguished Professorship in Rheumatology at UCSF, spent most of her career at the university, focusing her research on the genetics and epidemiology of human autoimmune disease, particularly rheumatoid arthritis and systemic lupus erythematosus. Using genome-wide association and other genetic studies, her research team contributed to the identification of more than 30 genes linked to these disorders, according to the NIH.

NIAMS has a budget of nearly $625 million and its extramural research program supports scientific studies and research training and career development throughout the country through grants and contracts to research organizations in fields that include rheumatology, muscle biology, orthopedics, bone and mineral metabolism, and dermatology.

jevans@mdedge.com

Lindsey Criswell, MD, MPH, DSc, has been selected as the next director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Dr. Criswell, vice chancellor of research at the University of California, San Francisco, will replace acting director Robert H. Carter, MD, who has overseen NIAMS since December 2018, following the unexpected death of longtime director Stephen I. Katz, MD, PhD, who had directed the institute since 1995. She will start her new role in early 2021, according to the NIH.

“Dr. Criswell has rich experience as a clinician, researcher, and administrator. Her ability to oversee the research program of one of the country’s top research-intensive medical schools, and her expertise in autoimmune diseases, including rheumatoid arthritis and lupus, make her well-positioned to direct NIAMS,” said NIH director Francis S. Collins, MD, PhD, said in an announcement.

Dr. Criswell, who holds the Kenneth H. Fye, M.D., endowed chair in rheumatology and the Jean S. Engleman Distinguished Professorship in Rheumatology at UCSF, spent most of her career at the university, focusing her research on the genetics and epidemiology of human autoimmune disease, particularly rheumatoid arthritis and systemic lupus erythematosus. Using genome-wide association and other genetic studies, her research team contributed to the identification of more than 30 genes linked to these disorders, according to the NIH.

NIAMS has a budget of nearly $625 million and its extramural research program supports scientific studies and research training and career development throughout the country through grants and contracts to research organizations in fields that include rheumatology, muscle biology, orthopedics, bone and mineral metabolism, and dermatology.

jevans@mdedge.com

Guselkumab is now the second interleukin (IL)–23 inhibitor to be approved by the Food and Drug Administration for the treatment of adults with active psoriatic arthritis (PsA), according to a July 14 announcement from its manufacturer, Janssen.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The FDA’s approval marks the second indication for guselkumab, which was first approved for adults with plaque psoriasis in 2017.

The agency based its approval on two pivotal phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which tested the biologic in 1,120 adults with active PsA who were naive to biologics (both trials) or had an inadequate response or intolerance to one or two tumor necrosis factor inhibitors (in about 30% of patients in DISCOVER-1). Part of this pretrial standard treatment could include at least 4 months of Otezla (apremilast), at least 3 months of nonbiologic disease-modifying antirheumatic drugs (DMARDs), or at least 4 weeks of NSAIDs. In both trials, about 58% of patients took methotrexate.

Participants who took guselkumab achieved 20% improvement in American College of Rheumatology response criteria at week 24 at rates of 52% in DISCOVER-1 and 64% in DISCOVER-2, whereas placebo-treated patients had rates of 22% and 33%, respectively.

Guselkumab improved patients’ other symptoms, including skin manifestations of psoriasis, physical functioning, enthesitis, dactylitis, and fatigue, according to the Janssen release.

Guselkumab, a fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23, is administered as a 100-mg subcutaneous injection every 8 weeks, following two starter doses at weeks 0 and 4, and can be used alone or in combination with a conventional DMARD.

In guselkumab clinical trials of patients with PsA, a minority had bronchitis or a decreased neutrophil count, but the safety profile was otherwise generally consistent with what has been seen in patients with plaque psoriasis, according to the company release. Other common side effects described in 1% or more of patients have included upper respiratory infections, headache, injection-site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

jevans@mdedge.com

Guselkumab is now the second interleukin (IL)–23 inhibitor to be approved by the Food and Drug Administration for the treatment of adults with active psoriatic arthritis (PsA), according to a July 14 announcement from its manufacturer, Janssen.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The FDA’s approval marks the second indication for guselkumab, which was first approved for adults with plaque psoriasis in 2017.

The agency based its approval on two pivotal phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which tested the biologic in 1,120 adults with active PsA who were naive to biologics (both trials) or had an inadequate response or intolerance to one or two tumor necrosis factor inhibitors (in about 30% of patients in DISCOVER-1). Part of this pretrial standard treatment could include at least 4 months of Otezla (apremilast), at least 3 months of nonbiologic disease-modifying antirheumatic drugs (DMARDs), or at least 4 weeks of NSAIDs. In both trials, about 58% of patients took methotrexate.

Participants who took guselkumab achieved 20% improvement in American College of Rheumatology response criteria at week 24 at rates of 52% in DISCOVER-1 and 64% in DISCOVER-2, whereas placebo-treated patients had rates of 22% and 33%, respectively.

Guselkumab improved patients’ other symptoms, including skin manifestations of psoriasis, physical functioning, enthesitis, dactylitis, and fatigue, according to the Janssen release.

Guselkumab, a fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23, is administered as a 100-mg subcutaneous injection every 8 weeks, following two starter doses at weeks 0 and 4, and can be used alone or in combination with a conventional DMARD.

In guselkumab clinical trials of patients with PsA, a minority had bronchitis or a decreased neutrophil count, but the safety profile was otherwise generally consistent with what has been seen in patients with plaque psoriasis, according to the company release. Other common side effects described in 1% or more of patients have included upper respiratory infections, headache, injection-site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

jevans@mdedge.com

Guselkumab is now the second interleukin (IL)–23 inhibitor to be approved by the Food and Drug Administration for the treatment of adults with active psoriatic arthritis (PsA), according to a July 14 announcement from its manufacturer, Janssen.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The FDA’s approval marks the second indication for guselkumab, which was first approved for adults with plaque psoriasis in 2017.

The agency based its approval on two pivotal phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which tested the biologic in 1,120 adults with active PsA who were naive to biologics (both trials) or had an inadequate response or intolerance to one or two tumor necrosis factor inhibitors (in about 30% of patients in DISCOVER-1). Part of this pretrial standard treatment could include at least 4 months of Otezla (apremilast), at least 3 months of nonbiologic disease-modifying antirheumatic drugs (DMARDs), or at least 4 weeks of NSAIDs. In both trials, about 58% of patients took methotrexate.

Participants who took guselkumab achieved 20% improvement in American College of Rheumatology response criteria at week 24 at rates of 52% in DISCOVER-1 and 64% in DISCOVER-2, whereas placebo-treated patients had rates of 22% and 33%, respectively.

Guselkumab improved patients’ other symptoms, including skin manifestations of psoriasis, physical functioning, enthesitis, dactylitis, and fatigue, according to the Janssen release.

Guselkumab, a fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23, is administered as a 100-mg subcutaneous injection every 8 weeks, following two starter doses at weeks 0 and 4, and can be used alone or in combination with a conventional DMARD.

In guselkumab clinical trials of patients with PsA, a minority had bronchitis or a decreased neutrophil count, but the safety profile was otherwise generally consistent with what has been seen in patients with plaque psoriasis, according to the company release. Other common side effects described in 1% or more of patients have included upper respiratory infections, headache, injection-site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

jevans@mdedge.com

The American College of Rheumatology will hold its annual meeting as a completely online event during Nov. 5-9, 2020, rather than in Washington, Nov. 6-11, as originally planned “due to public health/safety concerns related to the COVID-19 pandemic,” according to an announcement from the organization.

“We’ve given our annual meeting a new name, ACR Convergence 2020, and a fresh look, and we have reimagined #ACR20 without losing the elements you care about most: stellar rheumatology education, cutting-edge advances in science, and outstanding networking opportunities,” according to the announcement.

A frequently asked questions page for the meeting says that “ACR Convergence will include oral and poster discussion presentations, track-based clinical and basic science symposia, opportunities to engage with speakers and participants, as well as an exhibition and several special events.”

The ACR said that the meeting will be held on a new online platform, with more details to come in August, when registration will open. The final program for the virtual meeting will be available on the ACR website in July.

jevans@mdedge.com

The American College of Rheumatology will hold its annual meeting as a completely online event during Nov. 5-9, 2020, rather than in Washington, Nov. 6-11, as originally planned “due to public health/safety concerns related to the COVID-19 pandemic,” according to an announcement from the organization.

“We’ve given our annual meeting a new name, ACR Convergence 2020, and a fresh look, and we have reimagined #ACR20 without losing the elements you care about most: stellar rheumatology education, cutting-edge advances in science, and outstanding networking opportunities,” according to the announcement.

A frequently asked questions page for the meeting says that “ACR Convergence will include oral and poster discussion presentations, track-based clinical and basic science symposia, opportunities to engage with speakers and participants, as well as an exhibition and several special events.”

The ACR said that the meeting will be held on a new online platform, with more details to come in August, when registration will open. The final program for the virtual meeting will be available on the ACR website in July.

jevans@mdedge.com

The American College of Rheumatology will hold its annual meeting as a completely online event during Nov. 5-9, 2020, rather than in Washington, Nov. 6-11, as originally planned “due to public health/safety concerns related to the COVID-19 pandemic,” according to an announcement from the organization.

“We’ve given our annual meeting a new name, ACR Convergence 2020, and a fresh look, and we have reimagined #ACR20 without losing the elements you care about most: stellar rheumatology education, cutting-edge advances in science, and outstanding networking opportunities,” according to the announcement.

A frequently asked questions page for the meeting says that “ACR Convergence will include oral and poster discussion presentations, track-based clinical and basic science symposia, opportunities to engage with speakers and participants, as well as an exhibition and several special events.”

The ACR said that the meeting will be held on a new online platform, with more details to come in August, when registration will open. The final program for the virtual meeting will be available on the ACR website in July.

jevans@mdedge.com