A Randomized, Double-Blind, Controlled Withdrawal Trial in Crohn’s Disease Patients in Long-term Remission on Azathioprine

摘要: Background & Aims: An open study reported that patients with Crohn's disease in remission who have taken azathioprine for longer than 3.5 years are at low risk of relapse when is discontinued. To confirm this observation, we performed a multicenter, double-blind, noninferiority withdrawal study. Methods: Patients were clinical on ≥42 months randomized to continue or receive an equivalent placebo 18 months. The primary end point was Results: Forty randomly assigned and 43 placebo. Characteristics entry similar the 2 groups. At months, 3 had group, 9 group. Kaplan-Meier estimates rate 8% ± 4% 21% 6%, respectively. hypothesis inferior not rejected ( P = .195). Among baseline variables, C-reactive protein level >20 mg/L, time without steroids Conclusions: This shows continued therapy maintenance been ≥3.5 years. Thus, should be beyond