Patients with Ankylosing Spondylitis Can Maintain Clinical and Functional Improvement after Switching from Infliximab Reference Product to Infliximab Biosimilar (REMSIMA): 12 Months Comparative Open-Label Study

Abstract

Objective: Efficacy, tolerance, and safety of infliximab biosimilar are the same as infliximab reference product (RP) in the management of ankylosing spondylitis (AS) patients previously were on infliximab RP. We aimed to evaluate the biosimilar CT-P13 (Remsima) in terms of efficacy, tolerance, and safety to its RP. Materials and methods: Seventy-eight consecutive randomly selected patients were recruited for the study. All patients were naïve to any other biologics before receiving infliximab RP, and all were in clinical remission. The sample of patients was divided into two subgroups: 40 patients were continued on infliximab RP and 38 patients were switched to infliximab biosimilar. All patients underwent clinical evaluation and investigation. Both groups followed up for further 12 months. The disease activity was calculated utilizing Ankylosing Spondylitis Disease Activity Score (ASDAS), using the C-reactive protein (CRP), and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Remission considered when BASDAI < 4 and ASDAS < 1.3. Functional scores for all patients were assessed using the Bath Ankylosing Spondylitis Functional Index (BASFI). Results: Sustained clinical remission was observed after 12 months of treatment in the infliximab RP continued and switched groups. At the end of the study, erythrocyte sedimentation rate (ESR), CRP, visual analog scale (VAS), ASDAS, BASDAI, and BASFI were 15.04 ± 2.37, 2.10 ± 0.88, 3.10 ± 0.78, 1.52 ± 0.40, 2.80 ± 0.37, and 3.05 ± 0.24 in the infliximab RP continued group, respectively, and were 15.15 ± 1.45, 2.29 ± 0.89, 3.21 ± 0.69, 1.59 ± 0.57, 2.76 ± 0.45, and 2.89 ± 0.92 for the switching group, respectively; the difference was statistically not significant ([Formula: see text] values > 0.05). No significant adverse events were noted in the switching group compared to the continuous group groups. Conclusion: We found infliximab biosimilar CT-P13 (Remsima) was not inferior to infliximab RP and can maintain patients with ankylosing spondylitis in clinical remission.