Objectives To investigate the efficacy and safety of switching from infliximab reference product (RP) to its biosimilar or maintaining biosimilar treatment in patients with ankylosing spondylitis (AS).
Methods This open-label extension study recruited patients with AS who completed a 54-week, randomised controlled study comparing CT-P13 with RP (PLANETAS). CT-P13 (5 mg/kg) was administered intravenously every 8 weeks from week 62 to week 102. Efficacy end points included the proportion of patients achieving Assessment of SpondyloArthritis international Society (ASAS)20. Antidrug antibodies (ADAs) were measured using an electrochemiluminescent method. Data were analysed for patients treated with CT-P13 in the main PLANETAS study and the extension (maintenance group) and those who were switched to CT-P13 during the extension study (switch group).
Results Overall, 174 (82.9%) of 210 patients who completed the first 54 weeks of PLANETAS and agreed to participate in the extension were enrolled. Among these, 88 were maintained on CT-P13 and 86 were switched to CT-P13 from RP. In these maintenance and switch groups, respectively, ASAS20 response rates at week 102 were 80.7% and 76.9%. ASAS40 and ASAS partial remission were also similar between groups. ADA positivity rates were comparable (week 102: 23.3% vs 27.4%). Adverse events led to treatment discontinuation during the extension study in 3 (3.3%) and 4 (4.8%) patients, respectively.
Conclusions This is the first study to show that switching from RP to its biosimilar CT-P13 is possible without negative effects on safety or efficacy in patients with AS. In the maintenance group, CT-P13 was effective and well tolerated over 2 years of treatment.
Trial registration number NCT01571206; Results.
- Ankylosing Spondylitis
- DMARDs (biologic)
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Handling editor Tore K Kvien
Contributors WP, DHY, JB, SJL, HUK, YJB and SYK were involved in the conception and design of the study, and/or 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. PM, MB, PW, SG-U, HM, Y-AL, SS, M-JL, VK and CA-M were involved in the acquisition of data, drafting of the manuscript and revising it critically for important intellectual content, and the final approval of the version to be published.
Funding This study was funded by CELLTRION Inc (Incheon, Republic of Korea).
Disclaimer 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. MB has received research grants from Celltrion, personal fees from lectures for Roche, Abbvie, MSD, Pfizer, Egis, UCB outside the submitted work; JB has received honoraria for talks, advisory boards, paid consultancies or grants for studies from Abbvie (Abbott), Amgen, Boehringer Ingelheim, Bristol-Myers-Squibb, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB. HUK, SJL, YJB and SYK are full-time employees of Celltrion. Otherwise, none declared.
Patient consent Obtained.
Ethics approval The protocol was reviewed and approved by each site's institutional review board or independent ethics committee.
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.
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