Azathioprine maintains long‐term steroid‐free remission through 3 years in patients with steroid‐dependent ulcerative colitis

Background: Studies assessing the efficacy of azathioprine (AZA) in steroid‐dependent ulcerative colitis (SD‐UC) are scarce. The purpose of this trial was to explore the efficacy of AZA in maintaining steroid‐free remission in SD‐UC patients and the factors associated with sustained response. Methods: In this observational cohort study, 42 subjects with SD‐UC were recruited for AZA therapy during a 3‐year period. AZA was adjusted for a target dose of 2–3 mg/kg/day. Steroid therapy was tapered off following a standardized regimen. The primary endpoint was the annual rate of steroid‐free response to AZA. Secondary endpoints included clinical recurrence, yearly steroid dose, and safety of treatment. Results: On an intention‐to‐treat basis, the proportion of patients remaining in steroid‐free remission at 12, 24, and 36 months was 0.55, 0.52, and 0.45, respectively. A significant decrease in the flare‐ups rate and in requirement for steroids were observed during 3 years on AZA compared with the previous year (P = 0.000 for both). Patients with and without sustained response were comparable according to demographics, extent of disease, dose of AZA, steroids, and 5‐aminosalicylate (5‐ASA) use. Only disease duration