Background: 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 CT-P13 (Remsima) efficacy and safety to its RP.
Methods: Seventy-eight consecutive randomly selected patients were recruited for the study. All were naïve to any other biologics, receiving infliximab RP, and all were in clinical remission. Patients were divided into two subgroups, 40 patients continued on infliximab RP, and 38 patients switched to infliximab biosimilar. Both groups followed up for further 12 months. The disease activity was measured utilizing the Ankylosing Spondylitis disease activity score (ASDAS), using the C-reactive protein, the 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: Both groups showed sustained clinical remission after 12 months of treatment. For the switching group, mean BASDAI, BASFI, and ASDAS were 1.2, 2.4, and 5.2, respectively. For the continuous group, mean BASDAI, BASFI, and ASDAS were 1.2, 2.2, and 5.1, respectively; the difference was statistically insignificant (p values>0.05). No significant adverse events were noted in the switching group compared to the continuous group.
Conclusion: Infliximab biosimilar CT-P13 (Remsima) was not inferior to infliximab RP and can maintain AS patients in clinical remission.