Ustekinumab Persistence in Biologic-Experienced Crohn's Disease Patients: A Single-Center Retrospective Cohort Study.

Background and

Objectives

Ustekinumab has demonstrated high treatment persistence in Crohn's disease (CD), particularly in biologic-experienced populations. However, the impact of cumulative biologic exposure and disease severity on persistence remains insufficiently characterized in real-world settings.

Methods

This single-center retrospective cohort study included adult CD patients initiating ustekinumab between 2017 and 2026. All patients had prior biologic exposure. Treatment persistence was evaluated using Kaplan-Meier analysis, and subgroup comparisons were performed using log-rank tests.

Results

A total of 64 biologic-experienced patients were included (mean age 38.3 ± 13.2 years; 50% female). Treatment persistence was 89.7% at 12 months and 79.1% at 24 months, with a median follow-up of 25.5 months. A total of 13 discontinuation events occurred, most commonly due to lack of efficacy (10.9%), followed by extraintestinal manifestations (4.7%). Disease location and prior surgery were significantly associated with reduced persistence (log-rank p = 0.040 and p = 0.031, respectively). Log-rank analysis demonstrated significant differences in treatment persistence according to disease location (p = 0.040) and prior surgery (p = 0.031), while penetrating disease behavior showed a borderline association (p = 0.056).

Conclusions

Ustekinumab demonstrated high treatment persistence in this biologic-experienced Crohn's disease cohort. Lower treatment persistence appeared to be associated with ileocolonic disease location and prior surgery. Given the limited number of discontinuation events, these subgroup findings should be interpreted cautiously. Nevertheless, our findings support ustekinumab as a durable real-world treatment option for biologic-experienced Crohn's disease patients.