诱导后达到内镜缓解可减轻克罗恩病的住院负担:利桑珠单抗和乌帕他替尼III期试验的汇总后分析结果》(Pooled Post Hoc Analysis of Risankizumab and Upadacitinib Phase III Trials)。

Remo Panaccione, Christopher Ma, Vipul Jairath, Axel Dignass, Namita Joshi, Ryan Clark, Jenny Griffith, Kristina Kligys, Monika Semwal, Zachary Smith, Dominic Mitchell, Dominic Nunag, Marc Ferrante
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引用次数: 0

摘要

背景:内镜缓解已成为克罗恩病(CD)的一个重要治疗目标,并与长期预后的改善有关。我们对中度至重度活动性克罗恩病患者进行了为期 52 周的利桑珠单抗和乌达替尼维持治疗 III 期试验,研究了内镜缓解与住院治疗之间的关系:纳入的患者在使用利桑珠单抗或高达替尼进行为期 12 周的诱导治疗并获得临床应答后接受维持治疗。内镜下缓解的定义是:CD简单内镜评分不超过4分,与诱导基线相比至少降低2分,且没有子评分超过1分。在控制人口统计学、临床变量和治疗组的情况下,对暴露调整负二项回归模型进行了估计,以评估诱导后内镜缓解与长期住院之间的关系:结果:在诱导期结束时获得内镜缓解的患者诱导后住院率较低。在多变量模型中,诱导后内镜缓解与长期疾病相关住院和全因住院的IRR分别为0.45(95% CI [0.22-0.95],p=0.036)和0.71(95% CI [0.44-1.14],p=0.156):结论:第12周内镜治疗缓解与减少52周疾病相关住院率密切相关。结论:第12周内镜下缓解与减少52周疾病相关住院率密切相关。然而,在治疗12周内达到这一严格终点可能具有挑战性。内镜反应可能是诱导后更现实的早期内镜目标。还需要进行更多的研究来评估 CD 早期实现其他内镜终点的情况。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Achievement of Endoscopic Remission After Induction Reduces Hospitalization Burden in Crohn's Disease: Findings From a Pooled Post Hoc Analysis of Risankizumab and Upadacitinib Phase III Trials.

Background: Endoscopic remission has emerged as an important treatment target in Crohn's disease (CD) and has been associated with improvement in long-term outcomes. We examined the relationship between achievement of endoscopic remission and hospitalizations using pooled 52-week Phase III risankizumab and upadacitinib maintenance trials for patients with moderate-to-severely active CD.

Methods: Included patients received maintenance therapy after achieving a clinical response following a 12-week induction with risankizumab or upadacitinib. Endoscopic remission defined as a Simple Endoscopic Score for CD no greater than 4 with at least a 2-point reduction versus induction baseline and no subscore greater than 1. All subsequent hospitalization events were recorded until completion of the maintenance trial or discontinuation. Exposure-adjusted negative binomial regression models were estimated to assess the relationship between post-induction endoscopic remission and long-term hospitalization, controlling for demographics, clinical variables, and treatment arm.

Results: Post-induction hospitalization rates were lower in patients who achieved endoscopic remission at the end of the induction period. In multivariable models, post-induction endoscopic remission was independently associated with an IRR of 0.45 (95% CI [0.22-0.95], p=0.036) and 0.71 (95% CI [0.44-1.14], p=0.156) for long-term disease-related and all-cause hospitalizations, respectively.

Conclusions: Week 12 endoscopic remission is independently associated with reducing 52-week disease-related hospitalizations. However, achieving this stringent endpoint within 12 weeks of therapy may be challenging. Endoscopic response may be a more realistic early endoscopic target in the post-induction timeframe. Additional research is needed to evaluate early achievement of alternative endoscopic endpoints in CD.

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