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

Author:

Pandey Bimlesh Dhar1,Krishnamurthy Venkataraman2,Kumar Uma3,Upadhyaya Sundeep Kumar4,Jain Neeraj5,Dugar Manish6,Panchal Sagar7,Shah Nishita7,Korde Tanuja8,Dixit Jitendra7

Affiliation:

1. Department of Rheumatology, Fortis Hospital, Noida, Uttar Pradesh, India

2. Department of Rheumatology, Chennai Meenakshi Multispecialty Hospital, Chennai, Tamil Nadu, India

3. Department of Rheumatology, All India Institute of Medical Sciences, New Delhi, India

4. Department of Rheumatology, Apollo Indraprastha, New Delhi, India

5. Department of Rheumatology, Sir Ganga Ram Hospital, New Delhi, India

6. Department of Rheumatology, Apollo Hospitals, Hyderabad, Telangana, India

7. Medical Affairs, Johnson and Johnson Private Limited, Mumbai, Maharashtra, India

8. GD-MAO Asia Pacific, Johnson and Johnson Private Limited, Mumbai, Maharashtra, 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.

Publisher

Medknow

Subject

Rheumatology

Reference21 articles.

1. Literature review of rheumatoid arthritis in India;Handa;Int J Rheum Dis,2016

2. Epidemiology of eight common rheumatic diseases in China:A large-scale cross-sectional survey in Beijing;Li;Rheumatology (Oxford),2012

3. Efficacy and safety results from a Phase 3, randomized, placebo-controlled trial of subcutaneous golimumab in Chinese patients with active rheumatoid arthritis despite methotrexate therapy;Li;Int J Rheum Dis,2016

4. WHO-ILAR COPCORD Study WHO International League of Associations from Rheumatology Community Oriented Program from Control of Rheumatic Diseases. Prevalence of rheumatic diseases in a rural population in western India: A WHO-ILAR COPCORD Study;Chopra;J Assoc Physicians India,2001

5. Is there an urban-rural divide?Population surveys of rheumatic musculoskeletal disorders in the Pune region of India using the COPCORD Bhigwan model;Joshi;J Rheumatol,2009

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