欧洲炎症性肠病患者的 ABP 501 治疗持续性和转换模式。

IF 3.9 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Therapeutic Advances in Gastroenterology Pub Date : 2024-01-12 eCollection Date: 2024-01-01 DOI:10.1177/17562848231222332
Ran Jin, Silvia Kruppert, Florian Scholz, Isabelle Bardoulat, Khalil Karzazi, Greg Kricorian, James L O'Kelly, Walter Reinisch
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引用次数: 0

摘要

背景:阿达木单抗(ADA)生物类似药ABP 501用于炎症性肠病(IBD)适应症的批准是基于外推原则,没有特定适应症的临床试验数据:评估 ABP 501 在 IBD 患者中的实际治疗模式:设计:对德国和法国的药房理赔数据进行回顾性分析:纳入2018年10月至2020年3月期间开始使用ABP 501的连续投保成人IBD患者。对两个互斥组的治疗持续性、依从性和ABP 501后的转换模式进行了评估:结果:共纳入了 3362 名德国患者和 733 名法国患者,其中 54.4% 和 65.3% 的患者为 ADA 天真患者。在德国,ADA-naïve 患者 ABP 501 的中位持续时间(95% CI)为 10.9 个月(9.8-11.6),ADA-experienced 患者为 14.2 个月(12.7-15.2);在法国队列中,ADA-naïve 患者和ADA-experienced 患者的中位持续时间分别为 12.8 个月(10.2-14.7)和 11.5 个月(8.8-14.4)。在开始接受 ABP 501 治疗的前 12 个月中,53.7% 的德国患者和 51.0% 的法国患者坚持了治疗。在这两个国家中,约有 20% 的患者从 ABP 501 转用了另一种靶向疗法。在德国队列中,ADA无效的患者最常转用非肿瘤坏死因子抑制剂生物制剂,但ADA经验丰富的患者最常转用参比产品(RP);在法国队列中,无论之前是否接触过ADA产品,患者最常转用RP:结论:在两个欧洲大国,约50%的患者在开始治疗后的头12个月中坚持并依从ABP 501疗法。ABP 501 治疗后,不同国家的转换模式各不相同,这表明治疗方法多种多样,需要进一步研究转换原因和潜在的总体治疗效果。
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Treatment persistence and switching patterns of ABP 501 in European patients with inflammatory bowel disease.

Background: Approval of the adalimumab (ADA) biosimilar ABP 501 for inflammatory bowel disease (IBD) indications was based on the principle of extrapolation, without indication-specific clinical trial data.

Objectives: To evaluate the real-world treatment patterns of ABP 501 in patients with IBD.

Design: Retrospective analysis of pharmacy claims data from Germany and France.

Methods: Continuously insured adult IBD patients who initiated ABP 501 between October 2018 and March 2020 were included. Treatment persistence, adherence, and post-ABP 501 switching patterns were evaluated for two mutually exclusive groups: ADA-naïve patients (i.e. no baseline use of ADA products) and ADA-experienced patients (i.e. previously treated with ADA products).

Results: A total of 3362 German patients and 733 French patients were included, with 54.4% and 65.3% being ADA-naïve patients, respectively. Median persistence (95% CI) on ABP 501 was 10.9 months (9.8-11.6) in ADA-naïve patients and 14.2 months (12.7-15.2) in ADA-experienced patients in Germany; for the French cohort, ADA-naïve and -experienced patients had median persistence of 12.8 months (10.2-14.7) and 11.5 months (8.8-14.4), respectively. During the first 12 months of ABP 501 initiation, 53.7% of German patients and 51.0% of French patients were adherent to the therapy. About 20% of patients in both countries switched from ABP 501 to another targeted therapy. In the German cohort, ADA-naïve patients most frequently switched to non-tumor necrosis factor inhibitor biologics, but ADA-experienced patients most commonly switched to reference product (RP); in the French cohort, patients most often switched to RP regardless of prior exposure to ADA products.

Conclusion: About 50% of patients persisted on and were adherent to ABP 501 therapy during the first 12 months after treatment initiation in two large European countries. Post-ABP 501, switching patterns varied between countries, indicating diversified treatment practices warranting further research on reason(s) for switching and potential overall treatment outcomes.

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来源期刊
Therapeutic Advances in Gastroenterology
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.
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