利桑单抗诱导和维持治疗对克罗恩病患者住院率的影响

Gastro hep advances Pub Date : 2025-01-01 DOI:10.1016/j.gastha.2024.100603

Brian G. Feagan , Remo Panaccione , Stefan Schreiber , Edward V. Loftus Jr. , Laurent Peyrin-Biroulet , Takehiro Arai , Wan-Ju Lee , Jenny Griffith , Jasmina Kalabic , Kristina Kligys , Si Xuan , Xiaomei Liao , Marc Ferrante

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引用次数: 0

摘要

在3期诱导（ADVANCE和MOTIVATE）和维持（FORTIFY）试验中，risankizumab显示有益于克罗恩病（CD）患者的症状和内镜定义的结局。在这些研究中，我们检查了利桑单抗对cd相关住院发生率的影响。在12周的诱导研究中，活动性CD患者在第0周、第4周和第8周随机接受静脉注射（IV）利桑单抗600或1200mg或安慰剂。临床应答者被重新随机分组，每8周使用皮下（SC）利桑单抗180或360 mg或安慰剂维持52周。比较两组间与cd相关的住院率，用诱导期事件和维持期事件/100人年（PYs）的比例表示。一项综合分析纳入了标签剂量诱导期和维持期cd相关住院的暴露时间和发生情况。结果与cd相关的住院发生率较低(3.2%或1.9% vs . 11.6%；P & lt;在诱导过程中，600 mg和1200 mg的risankizumab IV组与安慰剂IV组的差异为0.01)。在52周内，治疗组中每100个PYs的cd相关住院发生率相似，很少有事件报告（每组n = 5-9）。在综合分析中，risankizumab治疗组每100 PYs的cd相关住院发生率较低(600 mg IV/360 mg SC: 9.6；600 mg IV/180 mg SC: 7.9) vs安慰剂(40.0,P <；措施)。结论：利桑单抗治疗可降低cd相关住院率，且在随机化后12周内观察到治疗效果。

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Effect of Risankizumab Induction and Maintenance Therapy on the Rate of Hospitalization in Patients with Crohn’s Disease

Background and Aims

In phase 3 induction (ADVANCE and MOTIVATE) and maintenance (FORTIFY) trials, risankizumab was shown to benefit symptom and endoscopic defined outcomes in patients with Crohn’s disease (CD). We examined the effects of risankizumab on the incidence of CD-related hospitalizations in these studies.

Methods

Patients with active CD were randomized to intravenous (IV) risankizumab 600 or 1200 mg, or placebo at weeks 0, 4, and 8 in the 12-week induction studies. Clinical responders were rerandomized to maintenance with subcutaneous (SC) risankizumab 180 or 360 mg or placebo every 8 weeks for 52 weeks. Incidence of CD-related hospitalizations was compared between groups, expressed as proportions with an event during induction and event/100 person-years (PYs) during maintenance. An integrated analysis incorporated exposure time and occurrence of CD-related hospitalizations in induction and maintenance periods for labeled doses.

Results

The incidence of CD-related hospitalizations was lower (3.2% or 1.9% vs 11.6%; P < .01) in the risankizumab IV 600- and 1200-mg groups vs placebo IV during induction. Through 52 weeks, the incidence rate per 100 PYs of CD-related hospitalizations was similar among treatment groups, with few events reported (n = 5–9 per group). In the integrated analysis, a lower incidence rate per 100 PYs of CD-related hospitalizations was observed in the risankizumab-treated groups (600 mg IV/360 mg SC: 9.6; 600 mg IV/180 mg SC: 7.9) vs placebo (40.0, P < .001).