Panaccione Remo, Ma Christopher, Jairath Vipul, Dignass Axel, Joshi Namita, Clark Ryan, Griffith Jenny, Kligys Kristina, Semwal Monika, Smith Zachary, Mitchell Dominic, Nunag Dominic, Ferrante Marc
Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB, Canada.
Division of Epidemiology and Biostatistics, Western University, London, ON, Canada.
J Crohns Colitis. 2025 Feb 4;19(2). doi: 10.1093/ecco-jcc/jjae128.
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 data from 52-week Phase III maintenance trials of risankizumab and upadacitinib in patients with moderate-to-severe active CD.
Included patients received maintenance therapy after achieving a clinical response following a 12-week induction with risankizumab or upadacitinib. Endoscopic remission was defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) of no greater than 4, with at least a 2-point reduction vs 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.
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 incidence rate ratios of 0.45 (95% confidence interval [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.
Week 12 endoscopic remission is independently associated with a reduction in 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.
内镜缓解已成为克罗恩病（CD）的一个重要治疗目标，并且与长期预后的改善相关。我们使用来自risankizumab和upadacitinib治疗中度至重度活动性CD患者的52周III期维持试验的汇总数据，研究了内镜缓解的实现与住院治疗之间的关系。
纳入的患者在接受12周的risankizumab或upadacitinib诱导治疗获得临床缓解后接受维持治疗。内镜缓解定义为克罗恩病简单内镜评分（SES-CD）不大于4，相对于诱导基线至少降低2分且任何子评分不大于1。记录所有后续住院事件直至维持试验完成或停药。估计暴露调整后的负二项回归模型，以评估诱导后内镜缓解与长期住院之间的关系，同时控制人口统计学、临床变量和治疗组。
诱导期结束时实现内镜缓解的患者诱导后住院率较低。在多变量模型中，诱导后内镜缓解分别与长期疾病相关住院和全因住院的发病率比0.45（95%置信区间[CI]，0.22 - 0.95，p = 0.036）和0.71（95%CI，0.44 - 1.14，p = 0.156）独立相关。
第12周内镜缓解与52周疾病相关住院的减少独立相关。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时间段内更现实的早期内镜目标。需要进一步研究来评估CD中替代内镜终点的早期实现情况。
