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P326 Three-year steroid free remission and safety of azathioprine treatment in inflammatory bowel disease patients.

C. Cassieri*, R. Pica, E.V. Avallone, C. Corrado, M. Zippi, P. Vernia, P. Paoluzi, E.S. Corazziari

"Sapienza" University, Internal Medicine and Medical Specialties, Rome, Italy


Purine analogue azathioprine (AZA) is widely used for induction and maintenance of remission in steroid dependent patients with inflammatory bowel disease (IBD). The treatment must be withdrawn in 5-30% of patients due to the occurrence of adverse events. We investigated its efficacy and safety in maintaining steroid-free remission in steroid dependent IBD patients three year after the institution of treatment.


Data from consecutive IBD outpatients referred in our Institution, between 1985-2012, 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.


Out of 2472 consecutive IBD outpatients visited in the index period, AZA was prescribed to 360 patients, 189 (52.5%) were affected by Crohn's disease (CD) and 171 (47.5%) by ulcerative colitis (UC). Seventy-eight patients with a follow-up <36 months were excluded from the study. Two hundred and eighty-two patients were evaluated, 152 (53.9%) with CD and 130 (46.1%) with UC. One hundred and fifty-four (54.6%) were male and 128 (45.4%) female (average age of 33.75 ± 13.82 SD years, range 14-76 y.). Three year after the institution of treatment, 170 (60.3%) patients still were in steroid-free remission (101 CD vs 69 UC, 66.4% and 53.1%, respectively, p=0.0279), 62 (22%) had a relapse requiring retreatment with steroids (38 UC vs 24 CD, 29.2% and 15.8%, respectively, p=0.0091), 50 (17.7%) discontinued the treatment due to side effects (27 CD vs 23 UC, 17.8% and 17.7%, respectively). Loss of response from 1st to 3rd year of follow-up was low, about 12%.


Three year after the onset of treatment 60% of patients did not require further steroid courses. After the first year loss of response was low in two subsequent years. In the present series the maintenance of steroid-free remission was significantly higher in CD than in UC patients. The occurrence of side effects leading to the withdrawal of AZA treatment has been low.