Vedolizumab (VDZ) and Ustekinumab (UST) are both effective treatments for Crohn's disease (CD). However, there are fewer comparative studies of these biologics in biologic-naïve patients with CD.

To compare the efficacy and safety of real-world UST and VDZ in biologic-naïve patients with moderately to severely active CD and to identify predictive factors associated with clinical efficacy.

Patients treated with VDZ or UST as the primary biologic agent for moderately to severely active CD were included from the First Affiliated Hospital of Zhejiang Chinese Medical University from January 2021 to January 2023. Clinical efficacy at Weeks 14 and 52, endoscopic efficacy, and treatment persistence at Week 52 were evaluated in a retrospective cohort. Factors influencing clinical remission at Week 52 were analyzed, and adverse drug reactions during treatment were documented.

A total of 72 patients with CD were included, with 27 receiving VDZ and 45 receiving UST. Of these, 67 completed 14 weeks of treatment (24 VDZ and 43 UST), and 57 completed 52 weeks of treatment (18 VDZ and 39 UST). There were no statistically significant differences in clinical response rates or clinical remission rates at 14 weeks between UST and VDZ (P>0.05). Similarly, at 52 weeks, no statistically significant differences were observed in clinical response rates or clinical remission rates between UST and VDZ (P>0.05). Endoscopic response rates and endoscopic remission rates at 52 weeks also showed no significant differences between the treatments (P>0.05). UST [86.7% (39/45) ] had a higher 52-week treatment persistence compared to VDZ [66.7% (18/27) ] (P=0.043). Multivariate Logistic regression analysis indicated that age (OR=0.965, 95%CI=0.938-0.993) and clinical response at Week 14 (OR=8.483, 95%CI=1.699-42.352) were significant factors for clinical remission at Week 52 in UST-treated patients. No multifactorial analysis was conducted for VDZ as no factors influencing clinical remission at Week 52 were identified in the univariate analysis. Adverse event rates were 7.4% (2/27) for VDZ and 4.4% (2/45) for UST, with no statistically significant difference between the groups (P>0.05) .

The clinical and endoscopic efficacy of UST in biologic-naïve patients with moderately to severely active CD is comparable to VDZ. However, the 52-week treatment persistence rate is higher for UST. Age and clinical response at Week 14 correlate with clinical remission at Week 52 in UST-treated CD patients. Safety profiles were similar between the two groups.

维得利珠单抗（VDZ）和乌司奴单抗（UST）均可有效治疗克罗恩病（CD）。然而，两者作为CD患者的初治生物制剂的比较研究较少。

比较真实世界中VDZ和UST在中重度活动期CD患者中作为初治生物制剂时的有效性和安全性，并探究与临床疗效相关的预测因素。

回顾性收集浙江中医药大学附属第一医院2021年1月—2023年1月使用VDZ或UST作为初治生物制剂治疗中重度CD患者资料。评估治疗14周和52周的临床疗效及治疗52周的内镜疗效和药物维持治疗率，分析治疗52周临床缓解的影响因素，并记录治疗期间药物不良反应发生情况。

共纳入72例CD患者，其中VDZ 27例，UST 45例；共67例完成14周治疗（VDZ 24例，UST 43例），57例完成52周治疗（VDZ 18例，UST 39例）。UST和VDZ治疗14周时的临床应答率和临床缓解率比较，差异均无统计学意义（P>0.05）。UST和VDZ治疗52周时的临床应答率和临床缓解率比较，差异均无统计学意义（P>0.05）。UST和VDZ治疗52周时的内镜应答率和内镜缓解率比较，差异均无统计学意义（P>0.05）。在52周药物维持治疗率方面，UST[86.7%（39/45）]高于VDZ[66.7%（18/27）]（P=0.043）。多因素Logistic回归分析结果显示，年龄（OR=0.965，95%CI=0.938~0.993）、治疗14周临床应答（OR=8.483，95%CI=1.699~42.352）是UST治疗52周临床缓解的影响因素（P<0.05）。因单因素分析中没有发现VDZ治疗52周临床缓解影响的因素，故未进行多因素分析。VDZ[7.4%（2/27）]和UST[4.4%（2/45）]治疗患者不良事件发生率比较，差异无统计学意义（P>0.05）。

UST作为初治生物制剂在中重度活动期CD患者中的临床和内镜疗效与VDZ相当，但UST治疗52周的药物维持治疗率高于VDZ。年龄和UST治疗14周临床应答与UST治疗第52周的临床缓解存在相关性。两者的不良反应发生率相近。