Efficacy and Safety of Ustekinumab in Asian Patients with Moderately to Severely Active Ulcerative Colitis: A Subpopulation Analysis of UNIFI Long-Term Extension through 4 Years.

ABSTRACT:

Introduction

This final long-term extension (LTE) analysis assessed long-term efficacy and safety of ustekinumab (UST) in the Asian patient subpopulation with ulcerative colitis (UC) in the UNIFI study.

Methods

Patients who completed 44 weeks of subcutaneous (SC) UST maintenance and agreed to enter the LTE continued maintenance therapy (UST 90 mg SC every 8 weeks [q8w] or 12 weeks [q12w] or placebo). The LTE lasted from week (WK) 44 through WK 220 (final safety visit), with the final efficacy visit at WK 200. At WK 56, randomized patients could receive a dose adjustment. Descriptive outcomes, such as symptomatic remission, full Mayo score outcomes, endoscopic improvement, and safety, were assessed.

Results

Forty-one randomized patients entered the LTE at WK 44 and con

SUBMITTER: Kim HJ 

PROVIDER: S-EPMC12826766 | biostudies-literature | 2026 Jan-Dec

REPOSITORIES: biostudies-literature