Repeated Switching Between CT-P17 and EU Reference Adalimumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Active-Controlled, Phase 3, Interchangeability Study.
Mark G Lebwohl, John Y Koo, Janusz Jaworski, Jakub Trefler, Stefan Daniluk, Anna Dudek, Wojciech Baran, Witold Owczarek, Joanna Kolinek, Paweł Brzewski, Mariusz Sikora, Marek Krogulec, SungHyun Kim, YunJu Bae, DaBee Jeon, EunJin Choi, JungBin Cha, HyunJin Lee, SuJin Choi, David M Pariser
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引用次数: 0
Abstract
Introduction: This study aimed to demonstrate the interchangeability of biosimilar CT-P17 and European Union reference adalimumab (EU-adalimumab) in a repeated-switch scenario.
Methods: In this ongoing, randomized, double-blind, active-controlled, phase 3 study, adults with moderate-to-severe plaque psoriasis received 80 mg EU-adalimumab on day 1, then 40 mg 1 week later and every other week until week 11. At week 13, patients were randomized (1:1, via an interactive web response system) to continue EU-adalimumab ("continuous" group) or undergo repeated switches between CT-P17 and EU-adalimumab ("switching" group). Dosing was via subcutaneous administration. The primary endpoints were area under the concentration-time curve and maximum serum concentration between weeks 25 and 27 (AUCtau,W25-27 and Cmax,W25-27, respectively). Secondary endpoints comprised additional pharmacokinetic (PK) parameters, efficacy, safety, and immunogenicity. Week 27 findings are presented.
Results: The first patient provided signed informed consent on November 7, 2022. Week 27 visits were completed by August 14, 2023. Of 367 patients enrolled, 346 were randomized (switching group, n = 172; continuous group, n = 174). The ratios of least squares means between groups and associated 90% confidence intervals (CIs) for AUCtau,W25-27 and Cmax,W25-27 were 99.45% (94.11-105.08%) and 100.45% (95.03-106.17%), respectively. For both endpoints, 90% CIs fell within the predefined equivalence margin of 80-125% and criteria were greater than calculated t values, satisfying bioequivalence. Additional PK endpoints and efficacy, safety, and immunogenicity findings were similar between groups. Safety profiles were in line with those previously reported.
Conclusions: Week 27 primary PK results demonstrated bioequivalence, and the overall study results supported the interchangeability of CT-P17 and EU-adalimumab.
期刊介绍：
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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