Jin Ran, Kruppert Silvia, Scholz Florian, Bardoulat Isabelle, Karzazi Khalil, Kricorian Greg, O'Kelly James L, Reinisch Walter
Amgen Inc., 1 Amgen Center Dr, Thousand Oaks, CA 91320, USA.
IQVIA Real World Solutions, Frankfurt, Germany.
Therap Adv Gastroenterol. 2024 Jan 12;17:17562848231222332. doi: 10.1177/17562848231222332. eCollection 2024.
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.
To evaluate the real-world treatment patterns of ABP 501 in patients with IBD.
Retrospective analysis of pharmacy claims data from Germany and France.
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).
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.
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.
阿达木单抗（ADA）生物类似药ABP 501获批用于炎症性肠病（IBD）适应症是基于外推原则，没有特定适应症的临床试验数据。
评估ABP 501在IBD患者中的真实世界治疗模式。
对来自德国和法国的药房报销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的持续参保成年IBD患者。对两个相互排斥的组评估治疗持续性、依从性和ABP 501治疗后的换药模式：未使用过ADA的患者（即基线未使用过ADA产品）和使用过ADA的患者（即先前接受过ADA产品治疗）。
共纳入3362例德国患者和733例法国患者，分别有54.4%和65.3%为未使用过ADA的患者。在德国，未使用过ADA的患者中ABP 501的中位持续时间（95%CI）为10.9个月（9.8 - 11.6），使用过ADA的患者为14.2个月（12.7 - 15.2）；对于法国队列，未使用过ADA和使用过ADA的患者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）。在开始使用ABP 501的前12个月内，53.7%的德国患者和51.0%的法国患者坚持治疗。两国约20%的患者从ABP 501换用了另一种靶向治疗药物。在德国队列中，未使用过ADA的患者最常换用非肿瘤坏死因子抑制剂生物制剂，但使用过ADA的患者最常换用参照产品（RP）；在法国队列中，无论先前是否接触过ADA产品，患者最常换用RP。
在两个欧洲大国，约50%的患者在开始治疗后的前12个月坚持使用ABP 501治疗且依从性良好。ABP 501治疗后，换药模式因国家而异，表明治疗方式多样，需要进一步研究换药原因和潜在的总体治疗结果。
