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P335. Two-year efficacy and safety of azathioprine treatment in the maintenance of steroid-free remission in inflammatory bowel disease patients

C. Cassieri, R. Pica, E.V. Avallone, M. Zippi, C. Corrado, P. Vernia, P. Paoluzi, E.S. Corazziari, “Sapienza”, Department of Internal Medicine and Medical Specialties, Rome, Italy

Background

Azathioprine (AZA) and thiopurine are widely used for induction and maintenance of remission in patients steroid-resistant or dependent with inflammatory bowel disease (IBD). The treatment must be withdrawn in 5–30% of patients due to the occurrence of adverse events. Aim of this study has been to investigate its efficacy and safety in maintaining steroid-free remission in steroid dependent IBD patients two year after the institution of treatment.

Methods

Data from consecutive IBD outpatients referred in our Institution, between 1985–2011, 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.

Results

Out of 2396 consecutive IBD outpatients visited in the index period, AZA was prescribed to 347 patients, 182 (52.4%) were affected by Crohn's disease (CD) and 165 (47.6%) by ulcerative colitis (UC). Fifty-five patients with a follow-up <24 months were excluded from the study. Two hundred and ninety-two patients were evaluated, 158 (54.1%) with CD and 134 (45.9%) with UC. One hundred and sixty-one (55.1%) were male and 131 (44.9%) female (average age of 34.15±14.34 SD years, range 12–76 y.). Two year after the institution of treatment, 188 (64.4%) patients still were in steroid-free remission (110 CD vs 78 UC, 69.6% and 58.2%, respectively, p = 0.0499), 57 (19.5%) had a relapse requiring retreatment with steroids (35 UC vs 22 CD, 26.1% and 13.9%, respectively, p = 0.0115), 47 (16.1%) discontinued the treatment due to side effects (26 CD vs 21 UC, 16.5% and 15.7%, respectively).

Conclusion

The study confirms that AZA is an effective therapeutic tool for maintaining steroid-free remission in IBD patients. Two year after the onset of treatment about two/thirds of patients did not required further steroid courses. 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.