Randomised controlled trial of azathioprine withdrawal in ulcerative colitis.

Abstract

Objective-To determine whether azathioprine can prevent relapse in ulcerative colitis.Design-One year placebo controlled double blind trial of withdrawal or continuation of azathioprine.Setting-Outpatient clinics of five hospitals. Subjects-79 patients with ulcerative colitis who had been taking azathioprine for six months or more. Patients in full remission for two months or more (67), and patients with chronic low grade or corticosteroid dependent disease (12) were randomised separately. 33 patients in remission received azathioprine and 34 placebo; five patients with chronic stable disease received azathioprine and seven placebo.Main outcome measure-Rate of relapse. Relapse was defined as worsening of symptoms or sigmoidoscopic appearance.Results-For the remission group the one year rate of relapse was 36% (12/33) for patients continuing azathioprine and 59% (20/34) for those taking placebo (hazard rate ratio 0-5, 95% confidence interval 0 25 to 1-0). For the subgroup of 54 patients in long term remission (greater than six months before entry to trial) benefit was still evident, with a 31% (8/26) rate of relapse with azathioprine and 61% (17/28) with placebo (p<001). For the small group of patients with chronic stable colitis (six were corticosteroid dependent and six had low grade symptoms) no benefit was found from continued azathioprine therapy. Adverse events were minimal.Conclusions-Azathioprine maintenance treatment in ulcerative colitis is beneficial for at least two years if patients have achieved remission while taking the drug. Demonstration of the relapse preventing properties of azathioprine has implications for a large number of patients with troublesome ulcerative colitis, who may benefit from treatment with azathioprine.

Ulcerative proctitis: an update on the pharmacotherapy and management

“…The 1-year relapse rates were significantly lower in patients taking AZA (36%) compared with placebo (59%, p = 0.04) [76]. In a recent randomized clinical trial, steroid-dependent UC patients treated with AZA (2 mg/kg/d) had a significantly higher rate of clinical and endoscopic remission, leading to steroids withdrawal in a greater percentage of cases compared with patients receiving only high-dose oral 5-ASA (53 vs 19%, p = 0.006) [77].…”

Thiopurine metabolite level and toxicity in Indians with inflammatory bowel disease

“…Erythrocyte thiopurine metabolite levels were determined by using acid hydrolysis 6. The RBC count in calibration standards, controls, and patients was normalized to 8 × 10 8 RBCs/250 μL.…”

“…The immunosuppressants, azathioprine (AZA) and 6‐mercaptopurine (6‐MP), are used as a second‐line therapy in almost 60% of patients with IBD to induce and maintain remission 1, 2, 3, 4, 5, 6. The recommended dose of AZA is up to 2.5 mg/kg and that of 6‐MP is 1–1.5 mg/kg/day.…”

Decision Tree Construction and Cost-Effectiveness Analysis of Treatment of Ulcerative Colitis With Pentasa®mesalazine 2 G Sachet

“…After reinduction, the maintenance of the patient is performed with azathioprine along with prednisone, the latter being removed gradually as recommended in the guideline. The risk of a new recurrence with maintenance treatment with azathioprine was 16% every three months (11,23) .…”