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P602. Azathioprine in the maintainance of steroid-free remission in inflammatory bowel disease patients: one-year efficacy and safety

C. Cassieri1, R. Pica1, E.V. Avallone1, M. Zippi1, C. Corrado1, P. Vernia1, P. Paoluzi1, E.S. Corazziari1, 1Sapienza University, Internal Medicine and Medical Specialties, “Gastroenterology Unit”, Rome, Italy


Purine analogue azathioprine (AZA) is the most frequently used immunosuppressant for inducing and maintaining remission in inflammatory bowel disease (IBD). The occurrence of adverse effects is the major drawback in the use of these drugs, leading to withdrawal of treatment in 5–30% of patients. Aim of this study has been to investigate its efficacy in maintaining steroid-free remission and its safety in steroid dependent/resistent IBD patients one year after the institution of treatment.


Data from consecutive IBD patients referred in our Institution, between 1985–2010, were reviewed and all patients treated with AZA were included in this retrospective study. AZA was administered at the recommended dose of 2–2.5 mg/kg. Blood chemistry was analysed before administration of the drug, every 10–15 days for the first 3 months and then every 1–2 months following the institution of treatment.


Out of 2330 consecutive IBD outpatients visited in the index period, AZA was prescribed to 337 patients, 159 (47.2%) were affected by ulcerative colitis (UC) and 178 (52.8%) by Crohn's disease (CD). Of this 35 patients with a follow-up <12 months were excluded from the study. Three hundred and two patients were evaluated, 138 (45.7%) with UC and 164 (54.3%) with CD. One hundred and sixty-eight (55.6%) were male and 134 (44.4%) female (average age of 32.38±13.33 SD years, range 10–75 y.). One year after the institution of treatment, 217 (71.9%) patients still were in steroid-free remission (94 UC vs 123 CD, 68.1% and 75%, respectively), 46 (15.2%) had a relapse requiring retreatment with steroids (25 UC vs 21 CD, 18.1% and 12.8%, respectively), 39 (12.9%) discontinued the treatment due to side effects (19 UC vs 20 CD, 13.8% and 12.2%, respectively).


The study confirms previous data indicating that AZA is an effective therapeutic tool for maintaining steroid-free remission in IBD patients, one year after the onset of treatment. In our series over two/thirds of patients did not require further steroid courses in the twelve months of follow-up. The occurrence of major side effects has been low, and less than 8% of patients had required a reduction of the initial AZA dose.