Christensen Britt, Scharl Michael, Bressler Brian, Khan Zaeem, Halchenko Yuliya, Gisler Celine, Kamble Pravin, Adsul Shashi, Farhat Zeinab, Ferrante Marc
Department of Gastroenterology, The Royal Melbourne Hospital, Melbourne, VIC, Australia.
Department of Medicine, The University of Melbourne, Melbourne, VIC, Australia.
Crohns Colitis 360. 2025 Jul 9;7(3):otaf031. doi: 10.1093/crocol/otaf031. eCollection 2025 Jul.
We evaluated the real-world effectiveness and safety of vedolizumab and ustekinumab as first-line biologics in patients with Crohn's disease (CD), by disease duration.
EVOLVE Expansion (ClinicalTrials.gov, NCT05056441) was a retrospective medical chart review study in Australia, Belgium, and Switzerland. Biologic-naïve patients with CD (≥18 years old) initiated first-line biologic treatment with vedolizumab or ustekinumab. Cumulative rates of clinical response, remission, mucosal healing, and treatment persistence were assessed over 36 months. Outcomes were compared between patients with early (≤2 years) and late (>2 years) disease at biologic initiation. Serious adverse events (SAEs), serious infections (SIs), and healthcare resource use (HCRU) were evaluated.
In early ( = 249) and late ( = 371) CD subgroups, there were no significant differences over 36 months between vedolizumab and ustekinumab in the cumulative rates of clinical response (early CD, 81.6% vs 80.7%; = .31; late CD, 83.7% vs 86.5%; = .31) or clinical remission (early CD, 87.9% vs 85.0%; = .74; late CD, 91.1% vs 90.6%; = .96). In patients with early CD, mucosal healing rates were significantly higher with vedolizumab than ustekinumab at both 24 ( = .02) and 36 months ( = .03). Treatment persistence was significantly higher with ustekinumab versus vedolizumab over 36 months in patients with late CD, but similar in patients with early CD. There were no significant differences in SAEs, SIs, or HCRU.
Both vedolizumab and ustekinumab are effective treatment options for early- and late-stage CD. Over 36 months, mucosal healing rates in patients with early CD were significantly higher with vedolizumab than with ustekinumab.
我们按病程评估了维多珠单抗和优特克单抗作为克罗恩病（CD）患者一线生物制剂的真实世界有效性和安全性。
EVOLVE扩展研究（ClinicalTrials.gov，NCT05056441）是一项在澳大利亚、比利时和瑞士开展的回顾性病历审查研究。初治生物制剂的CD患者（≥18岁）开始使用维多珠单抗或优特克单抗进行一线生物治疗。在36个月内评估临床缓解、黏膜愈合和治疗持续性的累积发生率。比较生物制剂起始治疗时疾病处于早期（≤2年）和晚期（>2年）的患者的结局。评估严重不良事件（SAE）、严重感染（SI）和医疗资源利用（HCRU）情况。
在早期（n = 249）和晚期（n = 371）CD亚组中，维多珠单抗和优特克单抗在36个月内的临床缓解累积发生率（早期CD，81.6%对80.7%；P = 0.31；晚期CD，83.7%对86.5%；P = 0.31）或临床缓解率（早期CD，87.9%对85.0%；P = 0.74；晚期CD，91.1%对90.6%；P = 0.96）方面无显著差异。在早期CD患者中，维多珠单抗在24个月（P = 0.02）和36个月（P = 0.03）时的黏膜愈合率均显著高于优特克单抗。在晚期CD患者中，优特克单抗在36个月内的治疗持续性显著高于维多珠单抗，但在早期CD患者中相似。SAE、SI或HCRU方面无显著差异。
维多珠单抗和优特克单抗都是早期和晚期CD的有效治疗选择。在36个月内，早期CD患者中维多珠单抗的黏膜愈合率显著高于优特克单抗。
