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A 5-year Retrospective Analysis of Drug Survival, Safety, and Effectiveness of the Infliximab Biosimilar CT-P13 in Patients with Rheumatoid Arthritis and Ankylosing Spondylitis

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Abstract

Background

The infliximab biosimilar CT-P13 has widely received regulatory approval in all indications of reference infliximab, including rheumatoid arthritis (RA) and ankylosing spondylitis (AS).

Objective

This retrospective analysis investigated drug survival and long-term safety and effectiveness of CT-P13 in patients with RA or AS in the Republic of Korea.

Methods

This non-interventional, retrospective, multicenter analysis collected medical record data for adult patients with RA or AS who received CT-P13 treatment at five Korean referral hospitals (2012–2017). Drug survival and long-term safety were primary outcomes. The secondary outcome was long-term effectiveness, assessed by disease activity measures.

Results

Overall, 491 patients were treated with CT-P13 (154 patients with RA [135 infliximab-naïve; 19 switched from reference infliximab]; 337 patients with AS [219 infliximab-naïve; 118 switched from reference infliximab]). Drug survival was similar in naïve and switched patients. Treatment-emergent adverse events (TEAEs) occurred in 31.8% and 29.4% of patients with RA and AS, respectively; incidence was similar in naïve and switched groups. Upper respiratory tract infection, influenza-like illness, and urticaria were the most common TEAEs. Overall, nine (1.8%) patients experienced serious adverse events (SAEs) deemed potentially drug-related; SAEs led to permanent CT-P13 discontinuation in five (1.0%) patients, including three with tuberculosis. Disease activity decreased over time.

Conclusion

Up to 5 years of CT-P13 treatment was safe and effective in patients with RA and AS, based on drug survival, incidence of TEAEs, and disease activity. Drug survival and safety were similar in naïve patients and switched groups, supporting switching from reference infliximab to CT-P13.

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Data Availability Statement

All data generated during the current analysis are included in this published article and its supplementary information file.

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Acknowledgements

Medical writing support (including development of a draft outline and subsequent drafts in consultation with the authors, assembling tables and figures, collating author comments, copyediting, fact checking and referencing) was provided by Beatrice Tyrrell, DPhil at Aspire Scientific (Bollington, UK) and was funded by Celltrion Healthcare Co., Ltd. (Incheon, Republic of Korea). The results included in this article were presented in part as a poster at the European League Against Rheumatism (EULAR) European Congress of Rheumatology 2019, held in Madrid, Spain on 12–15 June 2019.

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Author notes

  1. Tae-Hwan Kim and Shin-Seok Lee contributed equally to this paper as first authors.

Authors and Affiliations

  1. Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea

    Tae-Hwan Kim & Dae Hyun Yoo

  2. Rheumatology, Chonnam National University Medical School and Hospital, Gwangju, Republic of Korea

    Shin-Seok Lee

  3. School of Medicine, Inha University, Incheon, Republic of Korea

    Won Park

  4. Rheumatology, Seoul National University Hospital, Seoul National University, Seoul, Republic of Korea

    Yeong Wook Song

  5. Rheumatology, Ajou University School of Medicine, Suwon, Republic of Korea

    Chang-Hee Suh

  6. Celltrion Healthcare Co. Ltd., Incheon, Republic of Korea

    SooKyoung Kim & Young Nam Lee

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Contributions

T-HK made a substantial contribution to the acquisition of data. S-SL, WP, YWS, SKK, YNL and DHY made a substantial contribution to the conception or design of the study and the acquisition/interpretation of data. CHS made a substantial contribution to the conception or design of the study. All authors made a substantial contribution to manuscript development, gave final approval of the manuscript for submission and agree to be accountable for all aspects of the work. DHY is the guarantor for the overall content of the manuscript.

Corresponding author

Correspondence to Dae Hyun Yoo.

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Funding

This study was supported by Celltrion Healthcare Co., Ltd. (Incheon, Republic of Korea).

Research Involving Human Participants

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (Ajou University Hospital Institutional Review Board, AJIRB-MED-MDB-17-449; Chonnam National University Hospital Institutional Review Board, CNUH-2018-030; Hanyang University Hospital Institutional Review Board, HYU 2017-12-037; Inha University Hospital Institutional Review Board, INHAUH201712010; Seoul National University College of Medicine/Seoul National University Hospital Institutional Review Board, H-1801-047-914) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

For this type of retrospective analysis, formal informed consent was not required, in accordance with Article 16 of the Bioethics and Safety Act of the Republic of Korea.

Conflict of interest

T-HK, S-SL and YWS report no conflicts of interest. WP received consulting fees from Celltrion Healthcare. C-HS received consulting fees (< $10,000) from CELLTRION. SKK and YNL are employees of Celltrion Healthcare and own stock/stock options for Celltrion Healthcare. DHY received fees from Celltrion for grants, consulting, advisory board meetings, speakers’ bureau and lectures.

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Kim, TH., Lee, SS., Park, W. et al. A 5-year Retrospective Analysis of Drug Survival, Safety, and Effectiveness of the Infliximab Biosimilar CT-P13 in Patients with Rheumatoid Arthritis and Ankylosing Spondylitis. Clin Drug Investig 40, 541–553 (2020). https://doi.org/10.1007/s40261-020-00907-5

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