Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): An interventional, multicenter, open-label, single-arm clinical trial with clinical, ultrasound and biomarker assessments

抄録

Rheumatoid arthritis (RA) is a systemic inflammatory disease characterized by the presence of autoantibodies, with infliximab (IFX), the first biological disease-modifying anti-rheumatic drug (DMARD) targeting tumor necrosis factor α, significantly improving treatment but prompting the development of cost-effective biosimilar DMARDs due to its high cost. This study aimed to investigate the efficacy and safety of switching from originator to biosimilar IFX, CT-P13, in patients with RA using musculoskeletal ultrasound (MSUS) and clinical disease activity indices. This prospective, open-label, interventional, single-arm clinical trial involved a 24-week follow-up, enrolling patients with RA who had achieved clinical remission during treatment with originator IFX. CT-P13 was switched from the originator IFX with an unchanged dosing regimen for 24 weeks. The study utilized not only clinical disease activity indices but also MSUS and serum cytokines/chemokines. Eighteen patients were evaluated during the study period. From baseline to week 24, two of the 18 patients experienced clinical relapse (11.1% [95% CI: 3.1–32.8]). No changes were observed in the MSUS score, including total grayscale and power Doppler scores, Disease Activity Score 28 (DAS28)-erythrocyte sedimentation rate, DAS28-C-reactive protein, Health Assessment Questionnaire-Disability Index, and van der Heijde-modified total Sharp score from baseline to week 24. Serum levels of multiple cytokines/chemokines showed no apparent changes. Three non-serious adverse events occurred, with no study discontinuations due to adverse events. In conclusion, most RA patients undergoing treatment with originator IFX in clinical remission could safely switch to CT-P13 without an increased risk of relapse, as evidenced by MSUS, clinical indices, and biomarker levels.