在中重度活动型克罗恩病患者中，基于基线皮质类固醇使用情况和实现皮质类固醇免费的临床和内镜结局，评估 risankizumab 的疗效和安全性。

Efficacy and safety of risankizumab by baseline corticosteroid use and achievement of corticosteroid-free clinical and endoscopic outcomes in patients with moderately to severely active Crohn's disease.

机构信息

Department Internal Medicine I, University Hospital Schleswig-Holstein, Kiel University, Kiel, Germany.

Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.

出版信息

Aliment Pharmacol Ther. 2024 Oct;60(7):897-906. doi: 10.1111/apt.18184. Epub 2024 Jul 25.

DOI:10.1111/apt.18184

PMID:39054592

Abstract

BACKGROUND

Risankizumab is efficacious and well tolerated in adults with moderately to severely active Crohn's disease (CD).

AIM

To evaluate the corticosteroid-sparing effect of risankizumab in CD.

METHODS

During the 12-week induction period, patients maintained stable baseline corticosteroid doses, up to 20 mg/day prednisone or equivalent. At week 0 of maintenance, a mandatory corticosteroid taper was started. This post hoc analysis evaluated corticosteroid-free clinical and endoscopic outcomes at week 52 of maintenance; safety was also assessed.

RESULTS

Of 889 patients randomised to induction with risankizumab 600 mg or placebo, 285 (32.1%) were taking baseline concomitant corticosteroids. Week 12 clinical remission and endoscopic response rates were greater for risankizumab 600 mg versus placebo, regardless of concomitant corticosteroid use. At week 52, 66.7%, 50.0% and 41.2% of patients taking risankizumab 180 mg, risankizumab 360 mg and (withdrawal) placebo, respectively, discontinued corticosteroids. Week 52 corticosteroid-free clinical remission per stool frequency/abdominal pain score (risankizumab 180 mg [42.7%] or 360 mg [49.8%]; [withdrawal] placebo [39.0%]), corticosteroid-free clinical remission per Crohn's Disease Activity Index (risankizumab 180 mg [51.0%] or 360 mg [49.5%]; [withdrawal] placebo [40.2%]), and corticosteroid-free endoscopic response (risankizumab 180 mg [44.6%] or 360 mg [44.7%]; [withdrawal] placebo [20.7%]) rates were greater for risankizumab than placebo. Adverse event rates were generally similar, regardless of baseline corticosteroid use.

CONCLUSIONS

Efficacy of risankizumab 600 mg induction therapy was independent of concomitant corticosteroid use. Risankizumab 180 and 360 mg maintenance therapy yielded high rates of corticosteroid-free clinical and endoscopic outcomes at week 52.

摘要

背景

里扎鲁单抗在中重度活动期克罗恩病（CD）成人患者中的疗效和安全性均良好。

目的

评估里扎鲁单抗在 CD 中的皮质类固醇激素节省作用。

方法

在 12 周的诱导期内，患者维持稳定的基线皮质类固醇剂量，最大剂量为 20mg/天泼尼松或等效剂量。在维持治疗的第 0 周开始进行强制性皮质类固醇减量。本事后分析评估了维持治疗第 52 周时无皮质类固醇激素的临床和内镜结局；同时评估了安全性。

结果

在随机接受里扎鲁单抗 600mg 或安慰剂诱导治疗的 889 例患者中，285 例（32.1%）基线时同时使用皮质类固醇激素。无论是否同时使用皮质类固醇激素，与安慰剂相比，里扎鲁单抗 600mg 治疗第 12 周时的临床缓解率和内镜应答率均更高。第 52 周时，分别有 66.7%、50.0%和 41.2%接受里扎鲁单抗 180mg、里扎鲁单抗 360mg 和（停药）安慰剂治疗的患者停用了皮质类固醇激素。第 52 周时，根据粪便频率/腹痛评分评估的无皮质类固醇激素临床缓解率（里扎鲁单抗 180mg[42.7%]或 360mg[49.8%]；（停药）安慰剂[39.0%]）、根据克罗恩病活动指数评估的无皮质类固醇激素临床缓解率（里扎鲁单抗 180mg[51.0%]或 360mg[49.5%]；（停药）安慰剂[40.2%]）和无皮质类固醇激素内镜应答率（里扎鲁单抗 180mg[44.6%]或 360mg[44.7%]；（停药）安慰剂[20.7%]）在里扎鲁单抗组中均高于安慰剂组。无论基线时是否使用皮质类固醇激素，不良事件发生率总体相似。