Real-World Comparative Effectiveness and Safety of Filgotinib and Upadacitinib for Ulcerative Colitis: A Multicentre Cohort Study.

IF 5.8 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

United European Gastroenterology Journal Pub Date : 2024-11-13 DOI:10.1002/ueg2.12704

Akira Nogami, Kunio Asonuma, Shinji Okabayashi, Maiko Ikenouchi, Takahisa Matsuda, Shinichiro Shinzaki, Masayuki Fukata, Taku Kobayashi

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引用次数: 0

Abstract

Background: Janus kinase (JAK) inhibitors, filgotinib (FIL) and upadacitinib (UPA) have emerged as promising treatments for ulcerative colitis (UC). However, a comparative analysis of these JAK inhibitors, particularly in patients previously treated with tofacitinib (TOF), has not been performed.

Aims: To compare the efficacy and safety of FIL and UPA in patients with UC, including those previously exposed to TOF.

Methods: A multicentre retrospective cohort study was conducted to compare the effectiveness and safety of FIL and UPA in patients with UC whose treatment was initiated between March 2022 and December 2023. The co-primary outcomes were clinical response and remission at week 8. The secondary outcomes included treatment persistence and adverse events (AEs). Modified Poisson and Cox regression models with multivariable analysis to adjust for confounders and propensity score matching were conducted. Subgroup analyses stratified by previous exposure to TOF and biologics were also conducted.

Results: In total, 168 patients (98 treated with FIL and 70 treated with UPA) were enrolled in this study, with a median follow-up period of 181 days. The clinical response/remission rates at week 8 were 55.1/46.9% for FIL and 71.4/65.7% for UPA, respectively. UPA was associated with significantly higher rates of clinical response (adjusted risk ratio [RR] 1.40 [95% confidence interval [CI], 1.09 to 1.80]) and clinical remission (adjusted RR 1.54 [95% CI, 1.16 to 2.05]) compared with FIL. This result was consistent across subgroup analyses based on previous exposure to TOF or biologics, except for bio-naive patients. There was no significant difference in the treatment persistence. AEs were more frequent with UPA (45.7%) than with FIL (24.5%) (p = 0.0049). Propensity score matching confirmed the superior overall effectiveness of UPA.

Conclusions: UPA demonstrated better short-term effectiveness than FIL, with a higher incidence of AEs.

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Filgotinib 和 Upadacitinib 治疗溃疡性结肠炎的实际效果和安全性比较：多中心队列研究》。

背景：Janus激酶（JAK）抑制剂、非格替尼（FIL）和乌达替尼（UPA）已成为治疗溃疡性结肠炎（UC）的有前途的药物。目的：比较FIL和UPA对UC患者（包括曾接受过TOF治疗的患者）的疗效和安全性：方法：开展一项多中心回顾性队列研究，比较FIL和UPA在2022年3月至2023年12月期间开始治疗的UC患者中的有效性和安全性。共同主要结果是第8周时的临床反应和缓解。次要结果包括治疗持续性和不良事件（AEs）。研究采用了修正的泊松和考克斯回归模型，并进行了多变量分析以调整混杂因素和倾向评分匹配。此外，还根据既往TOF和生物制剂暴露情况进行了分组分析：本研究共纳入168名患者（98名接受FIL治疗，70名接受UPA治疗），中位随访时间为181天。第8周时，FIL和UPA的临床应答/缓解率分别为55.1%/46.9%和71.4%/65.7%。与 FIL 相比，UPA 的临床应答率（调整后风险比 [RR] 1.40 [95% 置信区间 [CI]，1.09 至 1.80]）和临床缓解率（调整后 RR 1.54 [95% CI，1.16 至 2.05]）明显更高。除生物免疫患者外，这一结果在基于既往接触过TOF或生物制剂的亚组分析中是一致的。在治疗持续性方面没有明显差异。UPA的AEs发生率（45.7%）高于FIL（24.5%）（p = 0.0049）。倾向评分匹配证实了UPA的总体疗效更优：结论：UPA的短期疗效优于FIL，但AEs发生率更高。

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

United European Gastroenterology Journal GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

10.50

自引率

13.30%

发文量

147

期刊介绍： United European Gastroenterology Journal (UEG Journal) is the official Journal of the United European Gastroenterology (UEG), a professional non-profit organisation combining all the leading European societies concerned with digestive disease. UEG’s member societies represent over 22,000 specialists working across medicine, surgery, paediatrics, GI oncology and endoscopy, which makes UEG a unique platform for collaboration and the exchange of knowledge.