☆ 4.7 Article

Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis

RHEUMATOLOGY (2022)

Journal

RHEUMATOLOGY

Volume 61, Issue 4, Pages 1385-1395

Publisher

OXFORD UNIV PRESS

DOI: 10.1093/rheumatology/keab460

Keywords

adalimumab; biosimilar; CT-P17; efficacy; immunogenicity; rheumatoid arthritis; safety; switching; tumour necrosis factor inhibitors

Funding

Celltrion, Inc. (Incheon, Republic of Korea)

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Abstract

The study found that the efficacy, pharmacokinetics, safety, and immunogenicity of CT-P17 and reference adalimumab were comparable after one year of treatment, including after switching from reference adalimumab to CT-P17.

Objective To compare the safety and efficacy of switching from reference adalimumab to adalimumab biosimilar CT-P17 with continuing reference adalimumab/CT-P17 in active RA. Methods This double-blind, phase III study randomized (1:1) subjects with active RA to receive 40 mg (100 mg/ml) CT-P17 or European Union-sourced reference adalimumab subcutaneously every 2 weeks (Q2W) until week (W) 24 [treatment period (TP) 1]. Thereafter, subjects receiving reference adalimumab were randomized (1:1) to continue reference adalimumab or switch to CT-P17 from W26 (both Q2W until W48; TP2). Subjects receiving CT-P17 in TP1 continued CT-P17. W0-W24 results were previously reported; we present W26-W52 findings. End points were efficacy (including joint damage progression), pharmacokinetics, safety and immunogenicity. Results Of 607 subjects who initiated TP2 treatment, 303 continued CT-P17, 153 continued reference adalimumab and 151 switched to CT-P17. Efficacy improvements up to W24 were maintained during TP2; efficacy was comparable among groups. At W52, 20% improvement in ACR response rates were 80.5% (continued CT-P17), 77.8% (continued reference adalimumab) and 82.2% (switched to CT-P17). Joint damage progression was minimal. Mean trough serum adalimumab concentrations were similar among groups. CT-P17 and reference adalimumab safety profiles were numerically similar and switching did not affect immunogenicity. At W52, 28.4% (continued CT-P17), 27.0% (continued reference adalimumab) and 28.3% (switched to CT-P17) of subjects were anti-drug antibody-positive. Conclusion Efficacy, pharmacokinetics, safety and immunogenicity of CT-P17 and reference adalimumab were comparable after 1 year of treatment, including after switching from reference adalimumab to CT-P17.

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Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study

Jonathan Kay, Janusz Jaworski, Rafal Wojciechowski, Piotr Wiland, Anna Dudek, Marek Krogulec, Slawomir Jeka, Agnieszka Zielinska, Jakub Trefler, Katarzyna Bartnicka-Maslowska, Magdalena Krajewska-Wlodarczyk, Piotr A. Klimiuk, Sang Joon Lee, Yun Ju Bae, Go Eun Yang, Jae Kyoung Yoo, Daniel E. Furst, Edward Keystone

Summary: This study demonstrates the equivalent efficacy of the proposed high-concentration, citrate-free adalimumab biosimilar CT-P17 to the European Union-approved adalimumab in treating subjects with active RA. The overall safety and immunogenicity of CT-P17 are comparable to EU-adalimumab.

ARTHRITIS RESEARCH & THERAPY (2021)