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.

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Tác giả: YunJu Bae, Wojciech Baran, Paweł Brzewski, JungBin Cha, EunJin Choi, SuJin Choi, Stefan Daniluk, Anna Dudek, Janusz Jaworski, DaBee Jeon, SungHyun Kim, Joanna Kolinek, John Y Koo, Marek Krogulec, Mark G Lebwohl, HyunJin Lee, Witold Owczarek, David M Pariser, Mariusz Sikora, Jakub Trefler

Ngôn ngữ: eng

Ký hiệu phân loại:

Thông tin xuất bản: United States : Advances in therapy , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 731757

 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 (AUC 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 AUC CONCLUSIONS: Week 27 primary PK results demonstrated bioequivalence, and the overall study results supported the interchangeability of CT-P17 and EU-adalimumab. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05495568.
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