CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study.
David M Pariser, Mark G Lebwohl, Janusz Jaworski, Jakub Trefler, Stefan Daniluk, Anna Dudek, Wojciech Baran, Witold Owczarek, Pawel Brzewski, Mariusz Sikora, Marek Krogulec, SungHyun Kim, JeeHye Suh, EunJin Choi, JungBin Cha, HyunJin Lee, SungJeong Lee, John Y Koo
{"title":"CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study.","authors":"David M Pariser, Mark G Lebwohl, Janusz Jaworski, Jakub Trefler, Stefan Daniluk, Anna Dudek, Wojciech Baran, Witold Owczarek, Pawel Brzewski, Mariusz Sikora, Marek Krogulec, SungHyun Kim, JeeHye Suh, EunJin Choi, JungBin Cha, HyunJin Lee, SungJeong Lee, John Y Koo","doi":"10.1007/s13555-025-01383-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>A 27-week analysis of this phase 3 study demonstrated the interchangeability of the adalimumab biosimilar CT-P17 and reference adalimumab. The current 52-week analysis reports secondary data from the open-label extension period (OLE) of the study.</p><p><strong>Methods: </strong>In this randomized, double-blind, active-controlled phase 3 study, adults with moderate-to-severe chronic plaque psoriasis received (via prefilled syringe) 80 mg subcutaneous reference adalimumab on day 1, then 40 mg 1 week later, and every other week (EOW) until week 11. At week 13, patients were randomized (1:1) to continue reference adalimumab (\"continuous\" group) or undergo repeated switching between CT-P17 and reference adalimumab (\"switching\" group) until week 25. Thereafter, patients entered an OLE and received 40 mg CT-P17 EOW from week 27 to 49, with an end-of-study visit at week 52. Here we present findings from the OLE. Pharmacokinetics (PK), efficacy (including mean percent improvement from baseline in Psoriasis Area Severity Index [PASI] score), safety, and immunogenicity were evaluated. Post hoc subgroup analyses were also conducted.</p><p><strong>Results: </strong>Of 327 patients who initiated the OLE, 152 and 160 patients from the switching group and continuous group, respectively, completed the study. Mean serum concentrations were similar between groups throughout the OLE. Efficacy improvements observed up to week 27 were maintained during the OLE and were comparable between groups. At week 52, overall mean (standard deviation [SD]) improvement from baseline in PASI score was 90.34% (16.59). Safety profiles were similar between groups, and immunogenicity did not increase during the OLE. The mean (SD) percent improvement from baseline in PASI score was slightly lower in patients who were antidrug antibody (ADA)-positive versus those who were ADA-negative (89.57 [17.27] versus 97.29 [4.08]) at week 52.</p><p><strong>Conclusions: </strong>PK, efficacy, safety, and immunogenicity findings remained consistent throughout the OLE, regardless of prior treatment, and were generally comparable across timepoints.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT05495568.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5000,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13555-025-01383-5","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: A 27-week analysis of this phase 3 study demonstrated the interchangeability of the adalimumab biosimilar CT-P17 and reference adalimumab. The current 52-week analysis reports secondary data from the open-label extension period (OLE) of the study.
Methods: In this randomized, double-blind, active-controlled phase 3 study, adults with moderate-to-severe chronic plaque psoriasis received (via prefilled syringe) 80 mg subcutaneous reference adalimumab on day 1, then 40 mg 1 week later, and every other week (EOW) until week 11. At week 13, patients were randomized (1:1) to continue reference adalimumab ("continuous" group) or undergo repeated switching between CT-P17 and reference adalimumab ("switching" group) until week 25. Thereafter, patients entered an OLE and received 40 mg CT-P17 EOW from week 27 to 49, with an end-of-study visit at week 52. Here we present findings from the OLE. Pharmacokinetics (PK), efficacy (including mean percent improvement from baseline in Psoriasis Area Severity Index [PASI] score), safety, and immunogenicity were evaluated. Post hoc subgroup analyses were also conducted.
Results: Of 327 patients who initiated the OLE, 152 and 160 patients from the switching group and continuous group, respectively, completed the study. Mean serum concentrations were similar between groups throughout the OLE. Efficacy improvements observed up to week 27 were maintained during the OLE and were comparable between groups. At week 52, overall mean (standard deviation [SD]) improvement from baseline in PASI score was 90.34% (16.59). Safety profiles were similar between groups, and immunogenicity did not increase during the OLE. The mean (SD) percent improvement from baseline in PASI score was slightly lower in patients who were antidrug antibody (ADA)-positive versus those who were ADA-negative (89.57 [17.27] versus 97.29 [4.08]) at week 52.
Conclusions: PK, efficacy, safety, and immunogenicity findings remained consistent throughout the OLE, regardless of prior treatment, and were generally comparable across timepoints.
期刊介绍：
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and 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 quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
