Efficacy and safety of opinercept tumor necrosis factor inhibitor therapy for drug-refractory rheumatoid arthritis: A randomized clinical trial
Journal
Archives of Rheumatology
Journal Volume
35
Journal Issue
2
Pages
170-179
Date Issued
2020
Author(s)
Abstract
Objectives: This study aims to evaluate the efficacy and safety profile of opinercept for rheumatoid arthritis (RA) patients undergoing disease-modifying anti-rheumatic drugs (DMARDs) therapy. Patients and methods: A total of 98 patients with active RA (17 males, 81 females; mean age 58.6±12.2 years; range, 24.3 to 85.3 years) were randomized into opinercept plus DMARDs (OD group) or placebo plus DMARDs (PD group), in a 24-week treatment period. Primary outcome was American College of Rheumatology score (ACR20) at week 24. Other exploratory endpoints included ACR50, ACR70 and disease activity score 28 (DAS28) at week 12 and 24, tender/swollen joint counts, pain, Health Assessment Questionnaire-Disability Index, erythrocyte sedimentation rate, and C-reactive protein level. Incidence of adverse events (AEs), vital signs and physical findings, and laboratory test results were also evaluated. Results: Patients in OD group showed significantly higher achievement percentage of ACR20 at week 24 than the PD group (76.6% vs. 30.3%, p<0.001). The evaluation of DAS28 was significantly improved in OD patients compared to PD patients at weeks 12 and 24. Most of the occurred AEs were mild or moderate and considered unrelated to study treatments. Conclusion: Opinercept concurrent with DMARDs was superior to DMARDs alone in slowing RA progression and ameliorating symptoms, with well-tolerated and acceptable safety profile. ? 2020 Turkish League Against Rheumatism. All rights reserved.
Subjects
Clinical trial; Disease-modifying anti-rheumatic drugs; Opinercept; Rheumatoid arthritis
SDGs
Other Subjects
azathioprine; C reactive protein; etanercept; hydroxychloroquine; leflunomide; methotrexate; prednisolone; salazosulfapyridine; adult; aged; antigen presenting cell; Article; controlled study; DAS28; disease activity; disease activity score; disease duration; disease severity; double blind procedure; drug efficacy; drug safety; erythrocyte sedimentation rate; female; follow up; Health Assessment Questionnaire; Health Assessment Questionnaire Disability Index; human; immunosuppressive treatment; lifestyle modification; lymphocyte count; major clinical study; male; Medical Dictionary for Regulatory Activities; outcome assessment; population growth; prevalence; prospective study; randomized controlled trial; rheumatoid arthritis; tuberculin test; urinalysis; very elderly; visual analog scale
Publisher
Turkish League Against Rheumatism (TLAR)
Type
journal article