Switch acceptance and persistence of adalimumab biosimilars in IBD patients: a prospective observational study.

IF 3.9 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Therapeutic Advances in Gastroenterology Pub Date : 2025-04-23 eCollection Date: 2025-01-01 DOI:10.1177/17562848251332025

Gabrielle D'Abbundo, Maria Nachury, Alice Wartski, Aurélie Blondeaux, Sofia Hambli, Romain Gérard, Pierre Desreumaux, Nicolas Duveau, Pauline Wils

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引用次数: 0

Abstract

Background: Prospective data about the acceptance and outcomes of switching from the adalimumab (ADA) reference product (RP) to multiple ADA biosimilars in inflammatory bowel disease (IBD) patients are lacking.

Objectives: To evaluate the acceptance rate of switching from the ADA RP to ADA biosimilars, identify factors associated with non-acceptance, assess persistence at 6 and 12 months, determine reasons for discontinuation, analyze changes in disease activity, and explore patient perceptions at 12 months.

Design: A prospective study was conducted at a French tertiary center between July 2020 and September 2021, including consecutive IBD outpatients treated with ADA RP for over 6 weeks.

Methods: Patients were offered a switch to five different ADA biosimilars, with the presence of a trained nurse. Data were collected on acceptance rates, persistence at 6 and 12 months, discontinuation reasons, disease activity, and patient perceptions using a 5-item questionnaire at 12 months.

Results: Of the 97 patients included, 91.8% accepted the switch. The only factor linked to non-acceptance was a poor opinion of generic drugs. Persistence with the initial ADA biosimilar was 68.6% at 6 months and 60.4% at 12 months. The overall survival rate without biosimilar discontinuation was 76.7% at 6 months and 71% at 12 months. Injection site pain (24.7%) was the leading cause of discontinuation, and 22 patients switched back to the ADA originator. Clinical remission was maintained in 90.4% of patients at 12 months. Among respondents, 65.8% reported a positive experience with the switch.

Conclusion: The study demonstrates high acceptance and favorable outcomes for switching to ADA biosimilars in IBD patients, including sustained efficacy and good treatment persistence. These findings suggest that switching to ADA biosimilars is a viable option for IBD patients, with positive results in terms of both clinical effectiveness and patient adherence.

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阿达木单抗生物类似药在IBD患者中的转换接受和持续性：一项前瞻性观察研究

背景：关于炎症性肠病（IBD）患者从阿达木单抗（ADA）参考产品（RP）转向多种ADA生物仿制药的接受度和结果的前瞻性数据缺乏。目的：评估从ADA RP切换到ADA生物仿制药的接受率，确定不接受的相关因素，评估6个月和12个月的持续性，确定停药的原因，分析疾病活动性的变化，并探讨患者在12个月时的感受。设计：一项前瞻性研究于2020年7月至2021年9月在法国三级中心进行，包括连续接受ADA RP治疗6周以上的IBD门诊患者。方法：在训练有素的护士在场的情况下，为患者提供五种不同的ADA生物仿制药的切换。在12个月时，使用5项问卷收集数据，包括接受率、6个月和12个月的持续时间、停药原因、疾病活动和患者感知。结果：纳入的97例患者中，91.8%接受了转换。不被接受的唯一因素是对仿制药的不良看法。最初的ADA生物仿制药在6个月和12个月的持久性分别为68.6%和60.4%。未停药的总生存率在6个月时为76.7%，在12个月时为71%。注射部位疼痛（24.7%）是停药的主要原因，22例患者转回ADA起始用药。90.4%的患者在12个月时保持临床缓解。在受访者中，65.8%的人表示对这一转变有积极的体验。结论：该研究表明，IBD患者改用ADA生物类似药的接受度高，结果良好，包括持续的疗效和良好的治疗持久性。这些发现表明，对于IBD患者来说，转向ADA生物类似药是一个可行的选择，在临床有效性和患者依从性方面都有积极的结果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Therapeutic Advances in Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

6.70

自引率

2.40%

发文量

103

审稿时长

15 weeks

期刊介绍： Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area. The editors welcome original research articles across all areas of gastroenterology and hepatology. The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.