Real Life Switching from Infliximab Innovator to Biosimilar in Rheumatic Diseases: A 6-Month Single-Centre Prospective Observational Study

Abstract

Background: Although Inflectra, biosimilar infliximab, has been approved by the EMA since September 2013 for all licensed indications of Remicade (innovator infliximab) but there is a paucity of real-world data and guidelines regarding switching from innovator Remicade to Inflectra. Objectives: To explore efficacy, safety, and retention rate of biosimilar Inflectra when switching from Remicade, in patients with rheumatic diseases. Methods: Informed consent was sought from all patients attending our rheumatology unit to undertake a switching programme. Baseline demographics and clinical characteristics were obtained before switching to Inflectra. Disease activity and safety assessment were undertaken before and then every 12 weeks after switching. The retention rate of Inflectra switch patients was compared with a cohort of non-switch Inflectra naive (11 patients) and historic Remicade (31 patients) patients. Results: Thirty out of thirty-one patients {median (IQR) age 50 (18), 20F} with various rheumatic diseases (9 with diagnosis of AS, 6 with RA, 6 with Behcet’s disease, 3 with Enteropathic arthritis, 2 with psoriatic arthritis) agreed to the switch. There was no statistical difference noted between pre-switch and 6 months post-switch mean values of PGA (p=0.37), BASDAI (p=0.60), ASDAS-CRP (p=0.90), DAS28CRP (p=0.85), DAS28ESR (p=0.45), CRP (p=0.09), Behcet’s disease activity score (p=0.77) and HAQ-DI (p=0.18). The retention rate on Inflectra switch was 86.7% as compared to 90.9% in the Inflectra naive cohort and 100% for historic Remicade cohort. Conclusion: These results demonstrate that in this cohort at 6 months Inflectra is comparable to Remicade in efficacy and there are no new safety signals.