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

Disclosures

Arthritis Res Ther. 2021;23(51) 

In This Article

Background

Biological disease-modifying antirheumatic drugs (bDMARDs), such as tumor necrosis factor (TNF) inhibitors, are recommended for the treatment of rheumatoid arthritis (RA) when disease activity remains moderate or high despite conventional synthetic DMARD (csDMARD) monotherapy.[1] Adalimumab is an anti-TNF monoclonal antibody that effectively treats RA.[2–5] Biosimilars are highly similar to their reference products in terms of quality characteristics, biological activity, safety, and efficacy.[6] Since 2016, several adalimumab biosimilars have been licensed by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).[7,8] European League Against Rheumatism (EULAR) recommendations for the treatment of RA position biosimilar DMARDs (bsDMARDs) equivalently to their reference products in treatment algorithms, and suggest that lower-priced biosimilars are preferred for their potential to reduce healthcare expenditures.[9]

CT-P17 is in development as a proposed adalimumab biosimilar.[10,11] CT-P17 is administered at 100 mg/ml, reflecting the high-concentration formulation of reference adalimumab,[12–14] and is also citrate-free, which could reduce discomfort during injection.[12,15] To date, CT-P17 has been evaluated in two randomized phase I studies evaluating the pharmacokinetics (PK) and safety of CT-P17 in healthy adults: a double-blind study comparing CT-P17 to European Union-approved adalimumab (EU-adalimumab) and US-licensed adalimumab (ClinicalTrials.gov NCT03970824)[11] and an open-label study comparing CT-P17 administration via autoinjector or prefilled syringe (ClinicalTrials.gov NCT04295356).[16]

This randomized, active-controlled, double-blind, multicenter, phase III study was designed to demonstrate that the efficacy of CT-P17 at week 24 is equivalent to that of EU-adalimumab. The study also evaluated PK, usability, and overall safety, including immunogenicity.

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