A real life experience with novel biosimilar InfimabTM in biologic naive patients with active rheumatoid arthritis

Abstract

Objective: To determine the efficacy and safety of novel infliximab biosimilar, Infimab TM (IFB) in rheumatoid arthritis (RA) patients. Materials and Methods: Eight patients with active RA who failed to demonstrate clinical improvement with methotrexate were enrolled. Post consent, patients were administered infliximab biosimilar 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks on demand. Patients were assessed for Health assessment questionnaire (HAQ, India Score), disease activity score 28 (DAS 28), Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC), erythrocyte sedimentation rate (ESR) and Visual Analogue Scale (VAS) score at baseline and at each visit. They were also observed for any adverse effects or tuberculosis infection. Wilcoxon sign rank test was used to assess the change between baseline to each follow-up visit. Results: On any average 3 infusions were administered to patients. At visit 3 there was significant improvement in HAQ score (p=0.046), WOMAC score (p=0.018), Tender joints count (p=0.027), swollen joints count (p=0.027) and also in general health (p=0.043). Though the VAS scores and ESR values decreased at visit 3, they were not significant. At the end of visit 5, there was considerable decrease in the tested parameters, except in tender joint count. None of the patients reported any adverse effects, indicating that infliximab biosimilar was well-tolerated in tested patients. Conclusion: In this preliminary trial conducted in eight RA patients, treatment with IFB improved clinical outcomes and was well-tolerated in RA patients who failed initial treatment with methotrexate