Subgroup analysis of the placebo-controlled CHARM trial: Increased remission rates through 3years for adalimumab-treated patients with early Crohn's disease

摘要

Background and aims: We examined the impact of disease duration on clinical outcomes and safety in a post hoc analysis of a remission maintenance trial with adalimumab in patients with moderate to severe CD. Methods: Patients in the CHARM trial were divided into 3 disease duration categories: <. 2 (. n=. 93), 2 to <. 5 (. n=. 148), and ??. 5. years (. n=. 536). Clinical remission and response rates at weeks 26 and 56 were compared between adalimumab and placebo subgroups, and assessed through 3. years of adalimumab treatment in the ADHERE follow-on trial. Logistic regression assessed the effect of disease duration and other factors on remission and safety. Results: At week 56, clinical remission rates were significantly greater for adalimumab-treated versus placebo-treated patients in all 3 duration subgroups (19% versus 43% for <. 2. years; P=. 0.024; 13% versus 30% for 2 to <. 5. years; P=. 0.028; 8% versus 28% for ??. 5. years, P<. 0.001). Logistic regression identified shorter duration as a significant predictor for higher remission rate in adalimumab-treated patients. Patients with disease duration <. 2. years maintained higher remission rates than patients with longer disease duration through 3. years of treatment. The incidence of serious adverse events in adalimumab-treated patients was lowest with disease duration <. 2. years. Conclusions: Adalimumab was superior to placebo for maintaining clinical remission in patients with moderately to severely active CD after 1. year of treatment regardless of disease duration. Clinical remission rates through 3. years of treatment were highest in the shortest disease duration subgroup in adalimumab-treated patients, with a trend to fewer side effects. ? 2012 European Crohn's and Colitis Organisation.