Abatacept for Crohns Disease and Ulcerative Colitis
Sandborn WJ et al. – The studies showed that abatacept is not efficacious for the treatment of moderate–to–severe Crohn's disease (CD) or ulcerative colitis (UC).Methods
- Four placebo–controlled trials evaluated the efficacy and safety of abatacept as induction (IP) and maintenance (MP) therapy in adults with active, moderate–to–severe CD (CD–IP; CD–MP) and UC (UC–IP1; UC–MP).
- In CD–IP and UC–IP1, 451 patients with CD and 490 patients with UC were randomized to abatacept 30, 10, or 3 mg/kg (according to body weight) or placebo, and dosed at weeks 0, 2, 4, and 8.
- In MP, 90 patients with CD and 131 patients with UC who responded to abatacept at week 12 in the induction trials were randomized to abatacept 10 mg/kg or placebo every 4 weeks through week 52.
- In CD–IP, 17.2%, 10.2%, and 15.5% of patients receiving abatacept 30, 10, and 3 mg/kg achieved a clinical response at weeks 8 and 12, vs 14.4% receiving placebo (P=.611, P=.311, and P=.812, respectively).
- In UC–IP1, 21.4%, 19.0%, and 20.3% of patients receiving abatacept 30, 10, and 3 mg/kg achieved a clinical response at week 12, vs 29.5% receiving placebo (P=.124, P=.043, and P=.158, respectively).
- In CD–MP, 23.8% vs 11.1% of abatacept vs placebo patients were in remission at week 52.
- In UC–MP, 12.5% vs 14.1% of patients receiving abatacept vs placebo were in remission at week 52. Safety generally was comparable between groups.