Abstract
Ustekinumab (UST) has been proved to be effective in the treatment of Crohn's disease (CD). However, data on the efficacy of UST in treating CD patients with penetrating complications are limited. The objective of this study was to evaluate the efficacy and safety of UST in the treatment of penetrating CD.
In this single-center, prospective, observational real-world study, we enrolled patients with penetrating CD who were undergoing UST treatment. The primary endpoint was the rate of transmural healing at week 26 and 52 evaluated by computerized tomography enterography or magnetic resonance enterography. Secondary endpoints included radiologic response rates and surgery-free survival rates at week 26 and 52, as well as surgery-free survival duration and safety. Statistical analysis was conducted using the Kaplan-Meier method.
The study included 134 patients, among whom 26.8% had complex intestinal fistula. Transmural healing rates at week 26 and 52 were 11.9% and 17.8%, respectively. Radiologic response rates were 60% and 50.6% at week 26 and 52. Surgery-free survival rates were 90.5% and 87.1% at week 26 and 52, respectively. After a median follow-up period of 55.57 weeks, 17 patients required abdominal surgery. The median surgery-free survival duration was 164.5 weeks (95% CI 145.6-183.5 weeks). During the follow-up period, only one patient developed erythema, with no serious adverse events reported.
UST demonstrates promising efficacy and safety profiles for treating penetrating CD.
