Efficacy and safety of adalimumab in Japanese patients with moderately to severely active ulcerative colitis.

ABSTRACT:

Background

Adalimumab is a fully human, monoclonal antibody against tumor necrosis factor that is approved in Western countries for the treatment of moderately to severely active ulcerative colitis (UC).

Methods

This 52-week, phase 2/3, randomized, double-blind study evaluated adalimumab for induction and maintenance treatment in 273 anti-TNF-naive Japanese patients with UC who were refractory to corticosteroids, immunomodulators, or both. Patients received placebo, adalimumab 80/40 (80 mg at week 0, then 40 mg every other week), or adalimumab 160/80 (160/80 mg at weeks 0/2, then 40 mg every other week) in addition to background UC therapy.

Results

At week 8, remission rates were similar among treatment arms, but more patients treated with adalimumab 160/80 achieved r

SUBMITTER: Suzuki Y 

PROVIDER: S-EPMC3925299 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature