在一项随机 3 期临床试验中，维持 risankizumab 可维持克罗恩病患者的诱导缓解。
Maintenance Risankizumab Sustains Induction Response in Patients with Crohn's Disease in a Randomized Phase 3 Trial.
机构信息
Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
IBD Centre, Guy's and St Thomas' NHS Foundation Trust, London, UK.
出版信息
J Crohns Colitis. 2024 Mar 1;18(3):416-423. doi: 10.1093/ecco-jcc/jjad168.
BACKGROUND AND AIMS
Durable clinical remission, endoscopic healing, and biomarker normalization are key treatment goals for Crohn's disease. The selective anti-interleukin-23 p19 inhibitor risankizumab has demonstrated efficacy and safety in moderately to severely active Crohn's disease. This post-hoc analysis of data from the pivotal risankizumab maintenance study assessed whether risankizumab maintenance therapy sustained the clinical and endoscopic outcomes achieved with risankizumab induction therapy.
METHODS
We evaluated 462 patients who achieved a clinical response to risankizumab intravenous induction treatment and were re-randomized to receive subcutaneous risankizumab 360 mg, subcutaneous risankizumab 180 mg, or placebo [withdrawal] every 8 weeks for 52 weeks in the randomized, controlled FORTIFY maintenance study. Maintenance of clinical, endoscopic, and biomarker endpoints at week 52 among patients who achieved these endpoints after 12 weeks of induction treatment was evaluated.
RESULTS
A significantly higher proportion of patients receiving maintenance treatment with risankizumab 360 or 180 mg compared with placebo [withdrawal] maintained Crohn's Disease Activity Index remission [68.6%, 70.8%, vs 56.3%; p < 0.05], stool frequency/abdominal pain remission [69.2%, 64.1%, vs 50.5%; p < 0.01], endoscopic response [70.2%, 68.2%, vs 38.4%; p < 0.001], endoscopic remission [74.4%, 45.5%, vs 23.9%; p < 0.05], and Simple Endoscopic Score for Crohn's Disease of 0-2 [65.5%, 36.7%, vs 21.9%]. Most patients [56.8-83.3%] who achieved normalized faecal calprotectin or C-reactive protein during induction sustained them with maintenance risankizumab.
CONCLUSIONS
Subcutaneous risankizumab maintenance therapy results in durable improvement in clinical and endoscopic outcomes over 1 year in patients with moderately to severely active Crohn's disease.
CLINICAL TRIAL REGISTRATION NUMBER
NCT03105102.
背景与目的
缓解临床症状、内镜下愈合以及生物标志物正常化是克罗恩病的关键治疗目标。选择性抗白细胞介素-23 p19 抑制剂 risankizumab 已被证明在中重度活动期克罗恩病中具有疗效和安全性。这项关键性 risankizumab 维持研究的数据的事后分析评估了 risankizumab 维持治疗是否能维持 risankizumab 诱导治疗所取得的临床和内镜结局。
方法
我们评估了 462 名对 risankizumab 静脉诱导治疗有临床反应的患者，他们在随机对照的 FORTIFY 维持研究中被重新随机分配接受 risankizumab 皮下注射 360mg、risankizumab 皮下注射 180mg 或安慰剂（停药），每 8 周一次，持续 52 周。评估了在诱导治疗 12 周后达到这些终点的患者在第 52 周时维持临床、内镜和生物标志物终点的情况。
结果
与安慰剂（停药）相比，接受 risankizumab 360mg 或 180mg 维持治疗的患者中，有更高比例的患者维持了克罗恩病活动指数缓解[68.6%，70.8%，vs 56.3%；p<0.05]、粪便频率/腹痛缓解[69.2%，64.1%，vs 50.5%；p<0.01]、内镜反应[70.2%，68.2%，vs 38.4%；p<0.001]、内镜缓解[74.4%，45.5%，vs 23.9%；p<0.05]和简单克罗恩病内镜评分 0-2[65.5%，36.7%，vs 21.9%]。在诱导治疗期间达到粪便钙卫蛋白或 C 反应蛋白正常化的大多数患者[56.8-83.3%]在 risankizumab 维持治疗期间仍保持正常。
结论
在中重度活动期克罗恩病患者中，皮下 risankizumab 维持治疗可在 1 年内持续改善临床和内镜结局。
临床试验注册号
NCT03105102。
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