{"title":"Real-World Effectiveness and Safety of Infliximab Biosimilar CT-P13 for Rheumatic Diseases: A National Observational Cohort Study (ReFLECT).","authors":"Hubert Marotte, Alain Cantagrel, Fabienne Coury, Thierry Schaeverbeke, Maryse Assing, Meriem Kessouri, Yves Brault, Bruno Fautrel","doi":"10.1007/s12325-025-03304-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>ReFLECT was a French multicenter, observational cohort study evaluating the effectiveness and safety of CT-P13, an infliximab (IFX) biosimilar, in a real-world setting. Here, we describe the results for patients with rheumatic disease.</p><p><strong>Methods: </strong>Eligible patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA) were recruited and received intravenous CT-P13 induction and/or maintenance therapy. Patients were either naive to IFX (IFX-naive) or had been previously treated with IFX originator or another IFX biosimilar (IFX-switched). CT-P13 persistence (primary objective) was measured as a time-dependent variable during a 2-year follow-up period. Safety was also assessed.</p><p><strong>Results: </strong>The patient population comprised 142 patients with RA (IFX-naive: n = 70; IFX-switched: n = 69; other [i.e., previously received IFX, but received another treatment before switching to CT-P13]: n = 3); 411 patients with AS (IFX-naive: n = 189; IFX-switched; n = 201; other: n = 21); and 96 patients with PsA (IFX-naive: n = 44; IFX-switched: n = 47; other: n = 5). After 2 years of follow-up, CT-P13 persistence rates were 49.6% (95% confidence interval [CI] 40.4-60.8%), 62.7% (95% CI 56.6-69.5%), and 73.0% (95% CI 62.7-85.1%) in patients with RA, AS, and PsA, respectively. CT-P13 persistence was greater for IFX-switched than IFX-naive groups in patients with RA (65.4% [95% CI 52.8-81.0%] vs. 33.3% [22.7-49.1%]) and AS (66.5% [95% CI 58.3-76.0%] vs. 56.6% [47.6-67.4%]) and was similar between IFX-switched and IFX-naive groups in patients with PsA (75.9% [95% CI 62.2-92.8%] vs. 72.0% [57.5-90.1%]). The main reason for CT-P13 discontinuation was loss of response (RA/AS/PsA) in both IFX-naive (38.6%/23.3%/22.7%) and IFX-switched 18.8%/18.4%/12.8%) groups. Among patients (RA, AS, and PsA), 52.1%, 57.9%, and 56.3%, respectively, reported ≥ 1 adverse event (AE), and 14.1%, 11.4%, and 10.4%, respectively, reported serious AEs.</p><p><strong>Conclusion: </strong>After 2 years of follow-up, the effectiveness of intravenous CT-P13 was maintained in > 65% of IFX-switched patients and CT-P13 induced effective therapeutic maintenance in IFX-naive patients. CT-P13 had an acceptable safety profile.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT02925338.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0000,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s12325-025-03304-6","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: ReFLECT was a French multicenter, observational cohort study evaluating the effectiveness and safety of CT-P13, an infliximab (IFX) biosimilar, in a real-world setting. Here, we describe the results for patients with rheumatic disease.
Methods: Eligible patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA) were recruited and received intravenous CT-P13 induction and/or maintenance therapy. Patients were either naive to IFX (IFX-naive) or had been previously treated with IFX originator or another IFX biosimilar (IFX-switched). CT-P13 persistence (primary objective) was measured as a time-dependent variable during a 2-year follow-up period. Safety was also assessed.
Results: The patient population comprised 142 patients with RA (IFX-naive: n = 70; IFX-switched: n = 69; other [i.e., previously received IFX, but received another treatment before switching to CT-P13]: n = 3); 411 patients with AS (IFX-naive: n = 189; IFX-switched; n = 201; other: n = 21); and 96 patients with PsA (IFX-naive: n = 44; IFX-switched: n = 47; other: n = 5). After 2 years of follow-up, CT-P13 persistence rates were 49.6% (95% confidence interval [CI] 40.4-60.8%), 62.7% (95% CI 56.6-69.5%), and 73.0% (95% CI 62.7-85.1%) in patients with RA, AS, and PsA, respectively. CT-P13 persistence was greater for IFX-switched than IFX-naive groups in patients with RA (65.4% [95% CI 52.8-81.0%] vs. 33.3% [22.7-49.1%]) and AS (66.5% [95% CI 58.3-76.0%] vs. 56.6% [47.6-67.4%]) and was similar between IFX-switched and IFX-naive groups in patients with PsA (75.9% [95% CI 62.2-92.8%] vs. 72.0% [57.5-90.1%]). The main reason for CT-P13 discontinuation was loss of response (RA/AS/PsA) in both IFX-naive (38.6%/23.3%/22.7%) and IFX-switched 18.8%/18.4%/12.8%) groups. Among patients (RA, AS, and PsA), 52.1%, 57.9%, and 56.3%, respectively, reported ≥ 1 adverse event (AE), and 14.1%, 11.4%, and 10.4%, respectively, reported serious AEs.
Conclusion: After 2 years of follow-up, the effectiveness of intravenous CT-P13 was maintained in > 65% of IFX-switched patients and CT-P13 induced effective therapeutic maintenance in IFX-naive patients. CT-P13 had an acceptable safety profile.
ReFLECT是法国一项多中心、观察性队列研究，在现实环境中评估英夫利昔单抗（IFX）生物类似药CT-P13的有效性和安全性。在这里，我们描述了风湿性疾病患者的结果。方法：招募符合条件的类风湿性关节炎（RA）、强直性脊柱炎（AS）或银屑病关节炎（PsA）患者，并接受静脉注射CT-P13诱导和/或维持治疗。患者要么是首次使用IFX (IFX-naive)，要么之前曾接受过IFX原药或另一种IFX生物类似药（IFX-switched）治疗。CT-P13持续性（主要目标）在2年随访期间作为时间相关变量进行测量。安全性也进行了评估。结果：患者群体包括142例RA患者(IFX-naive: n = 70；ifx开关：n = 69；other[即先前接受过IFX，但在转为CT-P13之前接受过另一种治疗]:n = 3)；411例AS (IFX-naive: n = 189；IFX-switched;n = 201；其他：n = 21)；96例PsA患者(IFX-naive: n = 44；ifx切换：n = 47；其他：n = 5)。随访2年后，RA、AS和PsA患者的CT-P13持续率分别为49.6%（95%可信区间[CI] 40.4-60.8%）、62.7% （95% CI 56.6-69.5%）和73.0% （95% CI 62.7-85.1%）。在RA患者中，ifx切换组的CT-P13持久性高于ifx初始组（65.4% [95% CI 52.8-81.0%] vs. 33.3%[22.7-49.1%]）和AS (66.5% [95% CI 58.3-76.0%] vs. 56.6%[47.6-67.4%])，在PsA患者中，ifx切换组和ifx初始组的CT-P13持久性相似（75.9% [95% CI 62.2-92.8%] vs. 72.0%[57.5-90.1%]）。CT-P13停药的主要原因是ifx初始组（38.6%/23.3%/22.7%）和ifx切换组（18.8%/18.4%/12.8%）的反应丧失（RA/AS/PsA）。在RA、AS和PsA患者中，分别有52.1%、57.9%和56.3%的患者报告≥1次不良事件（AE）， 14.1%、11.4%和10.4%的患者报告严重AE。结论：经过2年的随访，静脉注射CT-P13在65%的ifx转换患者中保持了有效性，CT-P13在未接受ifx治疗的患者中诱导了有效的治疗维持。CT-P13具有可接受的安全性。试验注册：ClinicalTrials.gov标识符：NCT02925338。
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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