Article Text
Abstract
Objectives To assess the efficacy and safety of switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing CT-P13 in patients with rheumatoid arthritis (RA) for an additional six infusions.
Methods This open-label extension study recruited patients with RA who had completed the 54-week, randomised, parallel-group study comparing CT-P13 with RP (PLANETRA; NCT01217086). CT-P13 (3 mg/kg) was administered intravenously every 8 weeks from weeks 62 to 102. All patients received concomitant methotrexate. Endpoints included American College of Rheumatology 20% (ACR20) response, ACR50, ACR70, immunogenicity and safety. Data were analysed for patients who received CT-P13 for 102 weeks (maintenance group) and for those who received RP for 54 weeks and then switched to CT-P13 (switch group).
Results Overall, 302 of 455 patients who completed the PLANETRA study enrolled into the extension. Of these, 158 had received CT-P13 (maintenance group) and 144 RP (switch group). Response rates at week 102 for maintenance versus switch groups, respectively, were 71.7% vs 71.8% for ACR20, 48.0% vs 51.4% for ACR50 and 24.3% vs 26.1% for ACR70. The proportion of patients with antidrug antibodies was comparable between groups (week 102: 40.3% vs 44.8%, respectively). Treatment-emergent adverse events occurred in similar proportions of patients in the two groups during the extension study (53.5% and 53.8%, respectively).
Conclusions Comparable efficacy and tolerability were observed in patients who switched from RP to its biosimilar CT-P13 for an additional year and in those who had long-term CT-P13 treatment for 2 years.
Trial registration number NCT01571219; Results.
- Treatment
- DMARDs (biologic)
- Rheumatoid Arthritis
- Anti-TNF
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Footnotes
Handling editor Tore K Kvien
Contributors DHY, WP, HUK, SJL and SYK were involved in the conception and design of the study and/or the analysis and interpretation of data, drafting of the manuscript and revising it critically for important intellectual content and final approval of the version to be published. NP, JJ, PM, ER, AL, AB, PW, CA-B, BO and SS were involved in the acquisition of data, drafting of the manuscript and revising it critically for important intellectual content and final approval of the version to be published.
Funding This study was funded by CELLTRION Inc. The sponsor participated in study design, in the collection, analysis and interpretation of study data and in reviewing drafts of the manuscript. The final decision to submit the manuscript was made by the authors.
Competing interests DHY and WP: consultation for CELLTRION. AB reports personal fees from Abbvie and grants from Samsung Bioepis and Abbvie, outside the submitted work; HUK, SJL and SYK are full-time employees of CELLTRION.
Patient consent Obtained.
Ethics approval Study protocols, consent forms and other written information were approved by the relevant MoH, each site's institutional review board and independent EC for each study centre.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All data available for this paper are included in the manuscript and online supplementary appendices.