Comparative Effectiveness of Vedolizumab and Ustekinumab in Biologic-Experienced Ulcerative Colitis: A Real-World...

The study aimed to compare the effectiveness and safety of vedolizumab (VDZ) and ustekinumab (UST) in patients with ulcerative colitis (UC) previously exposed to biologic therapy and to determine whether prior biologic exposure affects treatment outcomes.

In this multicenter retrospective study, data from 420 patients treated at 14 centers with VDZ (n = 260) or UST (n = 160) between 2020 and 2024 were analyzed. Outcomes included steroid-free clinical remission (SFCR), clinical remission (CR), treatment persistence, and adverse events at weeks 14-16, 52, and 104. Inverse probability of treatment weighting was used to adjust for baseline differences between treatment groups.

In the weighted cohort, rates of SFCR and CR were comparable between treatments at weeks 14-16 and 52 (P > .05). At week 104, SFCR rates did not differ significantly between treatment groups, whereas VDZ was associated with higher CR rates (adjusted odds ratio [aOR] = 0.66; 95% CI = 0.45-0.91). In subgroup analyses, VDZ was associated with higher CR and SFCR rates among patients with 1 prior biologic exposure, whereas UST was associated with higher CR (aOR = 1.86; 95% CI = 1.10-3.16) and SFCR (aOR = 1.79; 95% CI = 1.05-3.09) rates at week 52 among patients with 2 or more prior biologic exposures. Treatment persistence was significantly higher with UST (aOR = 1.82; 95% CI = 1.36-2.44). Safety profiles were comparable between treatment groups.

VDZ and UST demonstrated broadly comparable effectiveness in biologic-experienced UC. The higher CR rate favoring VDZ at week 104 should be interpreted cautiously given the lack of a significant difference in SFCR rate and limitations of long-term followup assessment. Exploratory subgroup findings suggest that UST may have a potential role in patients who were heavily pretreated. These findings may inform hypotheses regarding individualized treatment sequencing.