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  • Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study

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Clinical and epidemiological research
Extended report
Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study
  1. Won Park1,
  2. Dae Hyun Yoo2,
  3. Pedro Miranda3,
  4. Marek Brzosko4,
  5. Piotr Wiland5,
  6. Sergio Gutierrez-Ureña6,
  7. Helena Mikazane7,
  8. Yeon-Ah Lee8,
  9. Svitlana Smiyan9,
  10. Mie-Jin Lim1,
  11. Vladimir Kadinov10,
  12. Carlos Abud-Mendoza11,
  13. HoUng Kim12,
  14. Sang Joon Lee12,
  15. YunJu Bae12,
  16. SuYeon Kim12,
  17. Jürgen Braun13
  1. 1IN-HA University, School of Medicine, Medicine/Rheumatology, Incheon, Republic of Korea
  2. 2Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea
  3. 3Universidad de Chile and Centro de Estudios Reumatologicos, Santiago de Chile, Chile
  4. 4Department of Rheumatology and Internal Diseases, Pomeranian Medical University in Szczecin, Szczecin, Poland
  5. 5Medical University of Wroclaw, Wroclaw, Poland
  6. 6Department of Rheumatology, Hospital Civil de Guadalajara “Fray Antonio Alcalde” CUCS, Universidad de Guadalajara, Guadalajara Jalisco, Mexico
  7. 7Outpatient Clinic ‘ORTO’, Riga, Latvia
  8. 8Division of Rheumatology, Department of Internal Medicine, School of Medicine, Kyung Hee University, Seoul, Republic of Korea
  9. 9I.Ya. Horbachevsky Ternopil State Medical University, Municipal Institution of Ternopil Regional Council “Ternopil University Hospital”, Ternopil, Ukraine
  10. 10Multiprofile Hospital for Active Treatment ‘Sv. Marina’, Varna, Bulgaria
  11. 11Hospital Central and Faculty of Medicine, Universidad Autónoma de San Luis Potosi, San Luis Potosi, Mexico
  12. 12CELLTRION, Incheon, Republic of Korea
  13. 13Rheumazentrum Ruhrgebiet, Herne, Germany
  1. Correspondence to Professor Jürgen Braun, Rheumazentrum Ruhrgebiet, Claudiusstr. 45, Herne 44649, Germany; j.braun{at}rheumazentrumruhrgebiet.de and Professor Dae Hyun Yoo, Division of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 222-1 Wangsimni-Ro, Seongdong-Gu, Seoul 04763, Republic of Korea; dhyoo{at}hanyang.ac.kr

Abstract

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
  • Treatment
  • Anti-TNF
  • DMARDs (biologic)

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/annrheumdis-2015-208783

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    Footnotes

    • 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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