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

Overview

Journal Adv Ther

Date 2025 Feb 11

PMID 39932677

Authors

Mark G Lebwohl

John Y Koo

Janusz Jaworski

Jakub Trefler

Stefan Daniluk

Anna Dudek

Wojciech Baran

Witold Owczarek

Joanna Kolinek

Pawel Brzewski

Mariusz Sikora

Marek Krogulec

Sunghyun Kim

Yunju Bae

DaBee Jeon

EunJin Choi

JungBin Cha

Hyunjin Lee

Sujin Choi

David M Pariser

Affiliations

Soon will be listed here.

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 (AUC and C, 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 AUC and C 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.

Trial Registration: ClinicalTrials.gov, NCT05495568.

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