In the randomized, double-blind, placebo-controlled CHARM trial, adalimumab was more effective than placebo in maintaining clinical remission for patients with moderate-to-severe Crohn's disease through 56 weeks.
Dr Panaccione and colleagues from Canada substantiated the long-term safety and clinical benefits of adalimumab through 2 years of therapy in CHARM and its open-label extension.
Patients entering ADHERE on blinded therapy received adalimumab 40 mg every other week.
Patients who had already moved to open-label adalimumab every other week or weekly in CHARM continued their regimens.
The research team analyzed data by originally randomized treatment group at CHARM baseline, regardless of whether patients entered ADHERE or received open-label adalimumab.
|50% randomized to adalimumab weekly were in clinical remission|
|Alimentary Pharmacology & Therapeutics|
After up to 2 years of therapy, 38%, 42% and 50% of patients originally randomized to placebo, adalimumab every other week and adalimumab weekly, respectively, were in clinical remission.
The research team found that all groups experienced sustained improvements on the Inflammatory Bowel Disease questionnaire.
The researchers observed decreasing hazard rates over time for both all-cause and Crohn's disease-related hospitalizations.
Over a 2-year period, the rates of serious adverse events and malignancies were similar to those observed during the overall adalimumab Crohn's disease clinical development program.
Dr Panaccione's team concluded, "Adalimumab demonstrated sustained maintenance of clinical remission, improvements in quality of life and reductions in hospitalization during long-term treatment for Crohn's disease, with no new safety concerns identified."