Effectiveness and Safety of Golimumab in the Treatment of Ulcerative Colitis: 52-Week Results from Post-Marketing Surveillance in Japan.

ABSTRACT:

Introduction

Real-world evidence for the effectiveness and safety of golimumab (GLM) in patients with ulcerative colitis (UC) is limited. The aim of this study was to investigate the 52-week effectiveness and safety of GLM treatment for UC.

Methods

This prospective, multicentre, post-marketing surveillance study is conducted in 393 patients with UC in Japan (UMIN000027542). Clinical remission (partial Mayo score ≤2), adverse drug reactions (ADRs) and their predictors, and treatment persistence were analysed.

Results

The safety analysis sets comprised 391 patients. Patients in clinical remission at baseline were excluded, and 336 were used for effectiveness analysis. Clinical remission was 47.9%, 48.5%, 44.6%, and 39.6% at weeks 6, 22, 36, and 52, respectively, in the

SUBMITTER: Nakamura S 

PROVIDER: S-EPMC10090977 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature