E093 Real-life switching from infliximab innovator (Remicade) to biosimilar (Inflectra) in patients with various rheumatic diseases: a 6-month single-centre prospective observational study

Abstract

Background: Inflectra, a biosimilar infliximab has been approved by the European Medicine Agency since September 2013 for all licensed indications of Remicade (innovator infliximab) claiming its pharmacokinetics, safety, and efficacy was comparable to those of innovator INX. Although biosimilars can offer significant cost savings, there is a paucity of real-world data and guidelines about switching from innovator Remicade to Inflectra. The aim of our study was to explore efficacy, safety, acceptance and retention rate of biosimilar CT-P13 after switching from Remicade, originator infliximab in patients with various rheumatic diseases. Method(s): Switching was proposed to all patients attending our rheumatology infusion unit. Baseline demographics and clinical characteristics were obtained before switching to Inflectra (biosimilar). Disease activity and safety assessment were done before and then every 12 weeks after switching. The retention rate of Inflectra switch patients was compared with cohorts of Inflectra naive (11 patients) and historic Remicade (31 patients) groups. Result(s): 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 and 1 with JIA, graves ophthalmopathy, juvenile dermatomyositis and undifferentiated inflammatory arthritis each) agreed for switching. After 6 months of Inflectra, we could not found any statistical difference in term of mean values of PGA {33 (26.3) vs 35.3 (24) p=0.37}, BASDAI (3.12 (1.2) vs 2.98 (1.5) p=0.60}, ASDASCRP{ 1.7 (0.57) vs 1.7 (0.57) p=0.90} , SDAI {14.6 (16.5) vs 13.1 (10.4) p=0.65}, DAS28CRP {3.9 (1.6) vs 3.28 (1.0) p=0.85}, DAS28ESR {3.97 (2.04) vs 3.49 (1.20) p=0.45}, CRP {3.13 (4.2) vs 3.48 (4.8) p=0.09}, Behcet's disease score {1.17 (1.3) vs 1.33 (2.16) p=0.77} and HAQ-DI {0.42 (0.45) vs 0.45 (0.47) p=0.18}. The retention rate on Inflectra switch was 86.7% as compared to 90.9% on Inflectra naive cohort and 100% for historic Remicade cohort. Conclusion(s): We are reassured after these results that Inflectra is comparable to Remicade in efficacy and there is no new safety signal. Subjective reasons were an important cause of slightly lower retention rate in the switch group. (Table Presented) .