Safety and Efficacy of Golimumab in Rheumatoid Arthritis: A Prospective, Multicenter, Real-World Study from India

Abstract

Abstract Background: Tumor necrosis factor (TNF) has been associated with inflammation and joint destruction in patients with rheumatoid arthritis (RA), and several anti-TNF agents, including golimumab, are currently in clinical use. This postmarketing surveillance (PMS) study was carried out at six rheumatology centers in India to assess the safety and efficacy of golimumab in patients with moderate-to-severe RA, in a real-world setting. Methods: This was a prospective, multicenter, open-label, single-arm, PMS study, where golimumab 50 mg subcutaneous was administered monthly as per locally approved prescribing regulations. The primary endpoint was to assess the safety of golimumab. Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), auto-injector satisfaction/user-friendliness, injection-site pain/reactions, and 28-joint Disease activity score (DAS-28) including erythrocyte sedimentation rate (ESR) (DAS-28-ESR) and C-reactive protein (CRP) (DAS-28 CRP), were evaluated as per investigator’s routine practice. Results: Over 6 months, 120 patients were enrolled and 109 completed the study. Sixty-two (51.7%) patients experienced ≥1 treatment-emergent adverse events (TEAEs). The majority of TEAEs reported in the study were mild to moderate in severity. No deaths were reported. The mean (standard deviation [SD]) change from baseline in HAQ-DI (−0.9 [0.65]) and FACIT-F (14.8 [10.20]) suggested improvement in physical function and fatigue, respectively. The majority of patients (n = 77 [64.2%]) were “very satisfied” on the satisfaction/user-friendliness parameters of auto-injector and majority (n = 99 [91.7%]) did not experience injection-site reactions. Mean (SD) change from baseline of DAS-28 scores (not assessed for all patients; DAS-28 ESR [n = 62]: −2.0 [1.25]) indicated an improvement in disease activity. Conclusions: Golimumab (50 mg) in combination with methotrexate was found to be safe and well-tolerated in Indian patients with moderate-to-severe RA. No new safety signals emerged.