Rheum Round-up: Different Effects of Rheumatic Diseases, Humira Biosimilar Approval, and more

Here are the top stories covered by DocWire News this week in the Rheumatology section. In this edition, read about how different rheumatic diseases affect patients in different domains including quality of life, psychological adjustment, and use of coping strategies; the recent approval of a Humira biosimilar; at-home activity among postoperative knee replacement patients; and five-year secukinumab outcomes.

A study compared how fibromyalgia, rheumatoid arthritis (RA), spondyloarthritis, and Sjögren’s syndrome affect patients in different domains including quality of life, psychological adjustment, and use of coping strategies. This multicenter study included 165 women with fibromyalgia (n = 48), RA (n = 47), spondyloarthritis (n = 47), and Sjögren’s syndrome (n = 23). All patients completed the General Health Questionnaire–28 (emotional distress), Fatigue Severity Scale (fatigue), Fibromyalgia Impact Questionnaire (impact of the disease), Coping Strategies Questionnaire (coping), and Mini International Neuropsychiatric Interview (comorbidity with DSM IV axis-I disorders). Patients with fibromyalgia, compared to the other rheumatic diseases, were more likely to have recurrent (past) major depressive episodes. Compared to patients with spondyloarthritis or Sjögren’s syndrome, fibromyalgia patients had higher rates of anxiety disorders (agoraphobia and generalized anxiety disorders), and fibromyalgia patients had a higher rate of post-traumatic stress disorder than RA patients. The authors concluded that fibromyalgia patients had higher levels of pain; greater incidence of anxiety, somatic symptoms, and depressive disorders; and poorer quality of life compared to patients with the rheumatic diseases studied in this trial. Fibromyalgia patients also had a harder time adjusting to the disease.

The Food and Drug Administration (FDA) granted approval to Pfizer’s Abrilada (adalimumab-afzb), a biosimilar to Humira (adalimumab). This is the FDA’s ninth approved biosimilar this year. The approval comes on the heels of 26-week results from a study comparing the two drugs in the treatment of biologic-naïve patients with active RA with persistent disease despite treatment with methotrexate. RA patients were randomized 1:1 to receive adalimumab-afzb or adalimumab in conjunction with methotrexate. The main outcome measure was 12-week American College of Rheumatology 20% improvement (ACR20). Secondary outcome measures included 26-week ACR20/50/70 change from baseline Disease Activity Score based on high-sensitivity C-reactive protein [DAS28–4(CRP)], European League Against Rheumatism (EULAR) response, DAS28–4(CRP) <2.6, and ACR/EULAR remission. In the study, adalimumab-afzb is referred to as PF-06410293, and adalimumab as adalimumab-EU. Mean baseline DAS28-4(CRP) values did not significantly differ between the groups (adalimumab-afzb, 5.9 vs. adalimumab, 6.1). At week 12, ACR20 was achieved by 68.7% of the adalimumab-afzb group and 72.7% of the adalimumab group in the intent-to-treat population. “With non-responder imputation, the treatment difference in week-12 ACR20 was −2.98% and corresponding CIs—95% CI (−10.38%, 4.44%) and 90% CI (−9.25%, 3.28%)—were entirely contained within the equivalence margins (symmetric and asymmetric, respectively),” wrote the study authors.

A study presented at the American College of Rheumatology/Association of Rheumatology Professionals Annual Meeting explored at-home exercise and physical activity among postoperative total knee replacement patients. The study included patients from several outpatient physical therapy sites spanning three states. Baseline data were self-reported and included patient demographics, health status, and joint-specific symptoms.  Patients used daily logs to track home exercises and physical activity, including the exercise name, repetitions, sets, resistance, perceived difficulty, and physical activity per day. Patients performed an average (SD) 45.4 (23.3) exercises per week and were more likely to perform strengthening (30.0 [18.8]) exercises than stretching (16.4 [9.2]). The average minutes of weekly physical activity was 264.0. While clinical attributes and types or quantity of exercise and physical activity were not largely correlated, the researchers observed trends toward an effect of sex, presence of low back pain, and preoperative function on home exercise engagement.

Patients with psoriatic arthritis (PsA) may observe improved long-term outcomes with secukinumab treatment. Inclusion criteria for FUTURE 1 included PsA patients with moderate to severe symptoms for at least six months, as well as at least three tender joints and three swollen joints at baseline. Anti-TNF inadequate responders (anti-TNF-IR) was defined as achieving no significant benefit from an anti-TNF therapy after three months or terminated treatment due to intolerability issues. Of 236 patients in the secukinumab 150-mg group, 193 (81.8%) finished five years of treatment; of those patients, 36.4% (n = 86/236) escalated from 150 mg to 300 mg. Secukinumab was associated with sustained improvements in all efficacy endpoints over five years; at five years, 71.0% of patients achieved ACR20 responses, 51.8% achieved ACR50 responses, and 36.3% achieved ACR70 responses. Patients who required dose escalation presented improved efficacy comparably with patients who did not require dose escalation. The authors reported the following exposure-adjusted incidence rates per 100-person years for any dose of secukinumab: serious infection, 1.8; Crohn’s disease, 0.2; Candida infection, 0.9; and major cardiac adverse events. 0.5. No new safety signals were reported.