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Clinical Trial
. 2025 Mar;42(3):1582-1599.
doi: 10.1007/s12325-024-03100-8. Epub 2025 Feb 11.

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  1 , John Y Koo  2 , Janusz Jaworski  3 , Jakub Trefler  4 , Stefan Daniluk  5 , Anna Dudek  6 , Wojciech Baran  7 , Witold Owczarek  8 , Joanna Kolinek  9 , Paweł Brzewski  10 , Mariusz Sikora  11 , Marek Krogulec  12 , SungHyun Kim  13 , YunJu Bae  13 , DaBee Jeon  13 , EunJin Choi  13 , JungBin Cha  13 , HyunJin Lee  13 , SuJin Choi  13 , David M Pariser  14
Affiliations
Clinical Trial

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 et al. Adv Ther. 2025 Mar.

Erratum in

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.

Trial registration: ClinicalTrials.gov, NCT05495568.

Keywords: Adalimumab; Biosimilar; CT-P17; Efficacy; Interchangeability; Pharmacokinetics.

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Conflict of interest statement

Declarations. Conflict of Interest: Mark G. Lebwohl is an employee of Mount Sinai and receives research funds from AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant Sciences, Eli Lilly, Incyte, Inozyme, Janssen Research & Development, LLC, Ortho Dermatologics, Pfizer, Sanofi-Regeneron, and UCB; and is a consultant for Almirall, AltruBio Inc., AnaptysBio, Apogee, Arcutis Inc., AstraZeneca, Atomwise, Avotres Therapeutics, Brickell Biotech, Boehringer Ingelheim, Bristol Myers Squibb, Castle Biosciences, Celltrion, Corevitas, Dermavant Sciences, Dermsquared, EPI, Evommune Inc., Facilitation of International Dermatology Education, Forte Biosciences, Galderma, Genentech, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera, Pfizer, Sanofi-Regeneron, Seanergy, Strata, Takeda, Trevi, and Verrica. John Y. Koo is a consultant for Arcutis and Castle Pharmaceutical Corporation and is a speaker for AbbVie, Amgen, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Leo, Ortho-Dermatologic, Pfizer, Sanofi-Regeneron, and UCB. Paweł Brzewski has received consulting fees from AbbVie, Aristo, Eli Lilly, and Leo; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, and/or educational events from Eli Lilly, Leo, and Pfizer; payment for expert testimony from Avene, Cutis Lab, and La Roche Posay; support for attending meetings and/or travel from AbbVie, Leo, and UCB; has patents planned, issued, or pending from Leo; and is a member of EADV and a secretary for PDV Krakow. Marek Krogulec has received support for attending meetings and/or travel from Accord, Adamed, Belin-Chemie, Egis, Medac, and Sandoz. SungHyun Kim is an employee of Celltrion. YunJu Bae, DaBee Jeon, EunJin Choi, JungBin Cha, HyunJin Lee, and SuJin Choi are employees and stockholders of Celltrion, Inc. David M. Pariser has received consulting fees from Celltrion and has participated on a Data Safety Monitoring Board and/or Advisory Board for Celltrion. Janusz Jaworski, Jakub Trefler, Stefan Daniluk, Anna Dudek, Wojciech Baran, Witold Owczarek, Joanna Kolinek, and Mariusz Sikora have nothing to declare. Ethical Approval: All patients provided written, informed consent. The study was conducted in line with the principles of the Declaration of Helsinki 1964 (and its later amendments) and of Good Clinical Practice. Study protocols and documentation were approved by local independent ethics committees or institutional review boards at each study center (Table S1).

Figures

Fig. 1
Fig. 1
Study design. aOnly study center visits presented. bPharmacokinetic sampling: W11–13 (predose/24/72/120/168/240/336 h after W11 study drug); W25–27 (predose/24/72/120/168/240/336 h after W25 study drug). cSafety assessment: W0/7/13/17/21/27/35/43; electrocardiography: W13/52; tuberculosis screening throughout. EU-adalimumab European Union reference adalimumab, SC subcutaneously, W week(s)
Fig. 2
Fig. 2
Patient disposition (intent-to-treat population). aOne patient erroneously received CT-P17 at week 23 and thus was included in the switching group for the safety analysis. EU-adalimumab European Union reference adalimumab
Fig. 3
Fig. 3
a Trough and b mean (SD) serum adalimumab concentrations (pharmacokinetic population). Ctrough trough serum concentration, EU-adalimumab European Union reference adalimumab, SD standard deviation, W week
See this image and copyright information in PMC

References

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