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

• Published in: Journal of Crohn's and colitis Vol. 7; no. 3; pp. 213 - 221
• Main Authors: Schreiber, S, Reinisch, W, Colombel, J F, Sandborn, W J, Hommes, D W, Robinson, A M, Huang, B, Lomax, K G, Pollack, P F
• Format: Journal Article
• Language: English
• Published: England 01.04.2013
• Subjects: Adalimumab; Adolescent; Adult; Aged; Anti-Inflammatory Agents - therapeutic use; Antibodies, Monoclonal, Humanized - therapeutic use; Crohn Disease - drug therapy; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Induction Chemotherapy; Kaplan-Meier Estimate; Logistic Models; Maintenance Chemotherapy; Male; Middle Aged; Severity of Illness Index; Time Factors; Treatment Outcome; Young Adult
• ISSN: 1876-4479
• DOI: 10.1016/j.crohns.2012.05.015

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. 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. 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. 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.