Efficacy and safety of adalimumab in Chinese patients with moderately to severely active Crohn's disease: results from a randomized trial.

ABSTRACT: Background and Aims:Efficacy of adalimumab in Crohn's disease (CD) has not been shown in China. The aim of this study was to evaluate the efficacy and safety of adalimumab in Chinese patients with CD. Methods:This 26-week, multicenter, phase?III study evaluated patients with moderately to severely active CD and elevated high-sensitivity C-reactive protein (?3?mg/l) who were naïve to anti-tumor necrosis factor therapy. Patients were randomized to double-blind adalimumab 160/80?mg at weeks 0/2 and 40?mg at weeks 4/6 or placebo at weeks 0/2 followed by blinded adalimumab 160/80?mg at weeks 4/6. At week 8, all patients received open-label 40?mg adalimumab every other week through week 26. The primary endpoint was clinical remission [CD activity index (CDAI) <150] at week 4. Clinical remission at week 26 was assessed in week-8 responders (decrease in CDAI ?70 points at week 8 from baseline) and compared with a clinically meaningful threshold of 30%. Adverse events (AEs) were recorded throughout the study. Results:At baseline, 205 patients were enrolled, with mean [standard deviation (SD)] age of 32.9 (9.9) years and CD duration of 2.7 (3.0) years. At week 4, 38/102 patients (37%) receiving adalimumab and 7/103 (7%) receiving placebo (p?

SUBMITTER: Chen B 

PROVIDER: S-EPMC7370564 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature