Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies

Author:

Takeuchi Tsutomu,Nishikawa KiyohiroORCID,Yamada Fumika,Morita Akimichi,Ohtsuki Mamitaro,Suzuki Yasuo,Watanabe Mamoru,Yamanaka Hisashi,Hibi Toshifumi

Funder

Nippon Kayaku

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Reference34 articles.

1. Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72(10):1605–12. https://doi.org/10.1136/annrheumdis-2012-203091.

2. Takeuchi T, Yamanaka H, Tanaka Y, Sakurai T, Saito K, Ohtsubo H, et al. Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis. Mod Rheumatol. 2015;25(6):817–24. https://doi.org/10.3109/14397595.2015.1022297.

3. Westhovens R, Wiland P, Zawadzki M, Ivanova D, Kasay AB, El-Khouri EC, et al. Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial. Rheumatology (Oxford). 2021;60(5):2277–87. https://doi.org/10.1093/rheumatology/keaa580.

4. Alten R, An Y, Kim DH, Yoon S, Peyrin-Biroulet L. Re-routing infliximab therapy: subcutaneous infliximab opens a path towards greater convenience and clinical benefit. Clin Drug Investig. 2022;42(6):477–89. https://doi.org/10.1007/s40261-022-01162-6. 

5. Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72(10):1613–20. https://doi.org/10.1136/annrheumdis-2012-203090.

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