4 years ago

Subjective Complaints as Main Reason for Biosimilar Discontinuation after Open Label Transitioning from Originator to Biosimilar Infliximab

Alfons A den Broeder, Frank H J den Hoogen, Willemijn H der Laan, Iris L Ingen, Alphons J L Jong, Lieke Tweehuysen, Bart J F den Bemt
Objective To evaluate drug survival, effectiveness, pharmacokinetics, immunogenicity and safety after transitioning treatment from originator infliximab (Remicade®, REM) to biosimilar infliximab (CT-P13) in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis in daily practice. Methods 192 of 222 REM-treated patients agreed to transition to CT-P13 and were included in this multicenter prospective cohort study. Change in DAS28-CRP, BASDAI, CRP and (anti-) infliximab levels were assessed after six months and adverse events (AEs) were documented. Drug survival and prognostic factors were analyzed using Kaplan–Meier and Cox regression analyses. Results 24% of patients discontinued CT-P13 during six months follow-up. 37 patients restarted REM, 7 patients switched to another biologic and 3 patients maintained biologic-free. DAS28-CRP remained stable from baseline to month 6: 2.2 (SD 0.9) to 2.2 (SD 0.8) (difference 0.0, 95%CI -0.1 to 0.2). BASDAI increased from 3.8 (SD 2.0) to 4.3 (SD 2.1) (difference +0.5, 95%CI 0.1 to 0.9). CRP and (anti-) infliximab levels did not change. Just prior to CT-P13 discontinuation, DAS28-CRP components tender joint count and patients’ global disease activity, and BASDAI were increased compared to baseline. Most frequently reported AEs were arthralgia, fatigue, pruritus and myalgia. Shorter REM infusion interval (hazard rate:  0.77, 95%CI 0.62 to 0.95) at baseline was predictive for CT-P13 discontinuation. Conclusion In our cohort, a quarter of patients discontinued CT-P13 during six months follow-up, mainly due to an increase in subjective tender joint count and patients’ global disease activity and/or subjective AEs, possibly explained by nocebo and/or incorrect causal attribution effects. This article is protected by copyright. All rights reserved.

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1002/art.40324

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