# Comparative Effectiveness of Ustekinumab and Vedolizumab as Maintenance Therapy After Tacrolimus-Induced Improvement in Patients with Acute Severe Ulcerative Colitis: A Retrospective Cohort Study

## TL;DR

This study compares how well ustekinumab and vedolizumab work to maintain improvement in severe ulcerative colitis patients after initial tacrolimus treatment.

## Contribution

The study provides new evidence that ustekinumab is more effective than vedolizumab for long-term remission after tacrolimus induction in acute severe ulcerative colitis.

## Key findings

- Ustekinumab showed significantly higher clinical remission rates at week 8 and week 16 compared to vedolizumab.
- Ustekinumab had better biologic persistence and reduced the risk of relapse compared to vedolizumab.
- The results were consistent after adjusting for covariates using inverse probability of treatment weighting.

## Abstract

Background/Objectives: Acute severe ulcerative colitis (ASUC) is often managed by tacrolimus induction therapy followed by maintenance therapy. We compared the effectiveness of ustekinumab versus vedolizumab as maintenance therapies after tacrolimus induced improvement in patients with ASUC. Methods: This single-center retrospective cohort study included patients with ASUC who received tacrolimus induction therapy followed by ustekinumab or vedolizumab between January 2018 and November 2024. The primary outcome was clinical remission at week 16. Secondary and exploratory outcomes included clinical remission at week 8, biologic persistence, and relapse risk. An inverse probability of treatment weighting (IPTW) analysis was performed using the following covariates: male sex, prior biologics or JAK inhibitors, partial Mayo score, CRP, and albumin. Results: Among 235 tacrolimus-treated patients, 29 received ustekinumab and 22 received vedolizumab. After IPTW adjustment, the clinical remission rates were significantly higher in the ustekinumab group at both week 8 (82.1% vs. 51.8%, p = 0.02) and week 16 (85.4% vs. 36.8%, p = 0.02). Biologic persistence was significantly higher in the ustekinumab group (p = 0.004), and ustekinumab significantly reduced the hazard of relapse in multivariable analyses (HR 0.42 [95% CI: 0.20–0.88], p = 0.02). Conclusions: Ustekinumab showed greater effectiveness than vedolizumab in terms of achieving remission at 16 weeks after tacrolimus induction therapy in patients with ASUC.