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P411 Four-year efficacy and safety of azathioprine treatment in the maintenance of steroid-free remission in inflammatory bowel disease patients

C. Cassieri*1, R. Pica1, E. v. V. Avallone1, G. Brandimarte2, M. Zippi1, P. Crispino1, G. Lecca2, C. Corrado1, P. Vernia1, P. Paoluzi1, E. v. S. Corazziari1

1 ‘Sapienza’ University, Internal Medicine and Medical Specialties, Rome, Italy, 2’Cristo Re’ Hospital, Internal Medicine, Rome, Italy

Background

Azathioprine (AZA) and thiopurine are widely used for induction and maintenance of remission in patients steroid-dependent with inflammatory bowel disease (IBD). The treatment must be withdrawn in 5%–30% of patients because of the occurrence of adverse events. The aim of this study has been to investigate its efficacy and safety in maintaining steroid-free remission in steroid-dependent IBD patients 4 year after the institution of treatment.

Methods

Data from consecutive IBD outpatients referred in our institution, between 1985 and 2013, 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 2 556 consecutive IBD outpatients visited in the index period, AZA was prescribed to 376 patients; 198 (52.7%) were affected by Crohn’s disease (CD), and 178 (47.3%) by ulcerative colitis (UC). Further, 104 patients with a follow-up < 48 months were excluded from the study. In addition, 272 patients were evaluated, 146 (53.7%) with CD and 126 (46.3%) with UC. Moreover, 149 (54.8%) were male, and 123 (45.2%) female (average age of 33.56 ± 14.34 SD years, range 14–74 yr). At year 4 after treatment, 149 (54.8%) patients remained in steroid-free remission (89 CD vs 60 UC, 61% and 47.6%, respectively, p = 0.0288), 71 (26.1%) had a relapse requiring retreatment with steroids (42 UC vs 29 CD, 33.4% and 19.8%, respectively, p = 0.0130), and 52 (19.1%) discontinued the treatment because of side effects (28 CD vs 24 UC, 19.2% and 19%, respectively). Loss of response from first to fourth year of follow-up was low, at about 15%.

Conclusion

Four years after the onset of treatment, 55% of patients did not require further steroid courses. After the first year, loss of response was low in the 3 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.