欧洲炎症性肠病患者的 ABP 501 治疗持续性和转换模式。

IF 4.3 3区 材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC
ACS Applied Electronic Materials 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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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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CiteScore
7.20
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