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.