-
Views
-
Cite
Cite
Philip M. Ginsburg, Themistocles Dassopoulos, Steroid dependent ulcerative colitis: Azathioprine use is finally “evidence-based”, Inflammatory Bowel Diseases, Volume 12, Issue 9, 1 September 2006, Pages 921–922, https://doi.org/10.1097/01.mib.0000242277.10770.b9
Close - Share Icon Share
Extract
Randomized controlled trial of azathioprine and 5-aminosalicylic acid for treatment of steroid dependent ulcerative colitis. Ardizzone S, Maconi G, Russo A, et al. Gut. 2006; 55:47–53.
There are few data on the efficacy of azathioprine (AZA) for the treatment of steroid-dependent ulcerative colitis (UC). Ardizzone et al performed a randomized, investigator-blind trial comparing AZA and mesalamine at a single center in Italy. Eligible patients had to have clinically and endoscopically active disease (Powell-Tuck index ≥ 8 and Baron index ≥ 2 respectively) despite taking at least 10 mg of prednisolone daily. Patients had failed at least 2 steroid tapers within the preceding 6 months. Previous responders to aminosalicylates (5-ASA) were allowed with a 6 month washout.
Treatment consisted of AZA (Wellcome Foundation, Italy) 2 mg/kg/day or mesalamine (Asacol®; Bracco SpA, Milan, Italy) 3.2 grams daily for 6 months. To control for steroid use and evaluate for steroid sparing, all patients were given 40mg prednisolone at study entry and were subsequently tapered according to a standardized protocol. The primary outcome was treatment success, defined as induction of clinical and endoscopic remission (Powell-Tuck index of 0 and Baron index of 0 or 1, respectively) and steroid discontinuation at 6 months. The sample size was calculated based on predicted rates of treatment success of 70% and 35%in the AZA and mesalamine arms respectively.
