Scharl Michael, Christensen Britt, Bressler Brian, Brett Neil R, Gianchetti Lauren, Gisler Celine, Kamble Pravin, Adsul Shashi, Farhat Zeinab, Ferrante Marc
Department of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Department of Gastroenterology, The Royal Melbourne Hospital.
J Clin Gastroenterol. 2025 Jun 20. doi: 10.1097/MCG.0000000000002186.
This analysis compared the real-world effectiveness and safety of vedolizumab versus ustekinumab in biologic-naive patients by CD location.
Crohn's disease (CD) location may affect disease course and treatment decisions.
Medical charts of biologic-naive patients with CD aged 18 years or older initiating vedolizumab or ustekinumab were analyzed in the multicenter, observational, retrospective EVOLVE Expansion study. Outcomes with vedolizumab versus ustekinumab over 36 months were compared in patients with baseline isolated ileal, ileocolonic, and isolated colonic CD (Montreal classification).
This analysis included 293 patients with ileal (vedolizumab, n=158, ustekinumab, n=135), 185 with ileocolonic (vedolizumab, n=91, ustekinumab, n=94), and 121 with colonic (vedolizumab, n=84, ustekinumab, n=37) CD. Cumulative rates over 36 months were similar between vedolizumab and ustekinumab in ileal, ileocolonic, and colonic CD subgroups for clinical response, remission, mucosal healing, and treatment persistence. There were no differences in risks of serious adverse events, serious infections, CD exacerbations, and CD-related hospitalizations between cohorts across disease location; the risk of CD-related surgeries was similar in patients with ileocolonic and colonic CD, and higher with vedolizumab versus ustekinumab in patients with ileal CD. CD-related surgeries for ileal CD were reported in 12 of 158 (7.6%) vedolizumab-treated patients and 3 of 135 (2.2%) ustekinumab-treated patients.
Effectiveness, safety, and health care resource utilization outcomes over 36 months were similar between treatment cohorts regardless of baseline disease location. The number of patients requiring CD-related surgeries was low. Both vedolizumab and ustekinumab can be used as first-line biologics in patients with CD, regardless of disease location.
本分析按克罗恩病（CD）病变部位比较了维得利珠单抗与优特克单抗在初治患者中的真实疗效和安全性。
克罗恩病（CD）的病变部位可能影响疾病进程和治疗决策。
在多中心、观察性、回顾性EVOLVE扩展研究中，对18岁及以上初治的CD患者启动维得利珠单抗或优特克单抗治疗的病历进行了分析。在基线时有孤立性回肠、回结肠和孤立性结肠CD（蒙特利尔分类）的患者中，比较了维得利珠单抗与优特克单抗在36个月内的治疗结果。
本分析纳入了293例回肠CD患者（维得利珠单抗组158例，优特克单抗组135例）、185例回结肠CD患者（维得利珠单抗组91例，优特克单抗组94例）和121例结肠CD患者（维得利珠单抗组8例，优特克单抗组37例）。在回肠、回结肠和结肠CD亚组中，维得利珠单抗和优特克单抗在36个月内的临床缓解、黏膜愈合和治疗持续率累积相似。不同病变部位队列之间在严重不良事件、严重感染、CD病情加重和CD相关住院风险方面无差异；回结肠和结肠CD患者的CD相关手术风险相似，回肠CD患者中维得利珠单抗治疗者的CD相关手术风险高于优特克单抗治疗者。158例接受维得利珠单抗治疗的回肠CD患者中有12例（7.6%）进行了CD相关手术，135例接受优特克单抗治疗的患者中有3例（2.2%）进行了CD相关手术。
无论基线疾病部位如何，治疗队列在36个月内的疗效、安全性和医疗资源利用结果相似。需要进行CD相关手术的患者数量较少。维得利珠单抗和优特克单抗均可作为CD患者的一线生物制剂，无论疾病部位如何。
