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P543 Seven-year efficacy and safety of azathioprine treatment in the maintenance of steroid-free remission in inflammatory bowel disease patients

C. Cassieri*1, R. Pica2, E. V. Avallone1, G. Brandimarte3, M. Zippi2, P. Crispino1, D. De Nitto2, P. G. Lecca3, P. Vernia1, P. Paoluzi1, E. S. Corazziari1

1Sapienza University, Internal Medicine and Medical Specialties, Rome, Italy, 2Sandro Pertini Hospital, Unit of Gastroenterology and Digestive Endoscopy, Rome, Italy, 3’Cristo Re’ Hospital, Internal Medicine, Rome, Italy

Background

Azathioprine (AZA) and thiopurine are widely used for induction and maintenance of remission in dependent steroid patients 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 The treatment must be withdrawn in 5–30% of patients due to the occurrence of adverse events.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 seven year after the institution of treatment.

Methods

Data from consecutive IBD outpatients referred in our Institution, between 1985–2016, 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 2802 consecutive IBD outpatients visited in the index period, AZA was prescribed to 433 patients, 236 (54.5%) were affected by Crohn's disease (CD) and 197 (45.5%) by ulcerative colitis (UC). One hundred and seventy-nine patients with a follow-up < 84 months were excluded from the study. Two hundred and fifty-four patients were evaluated, 141 (55.5%) with CD and 113 (44.5%) with UC. One hundred and thirty-nine (54.7%) were male and 115 (45.3%) female (average age of 35.62 ± 14.20 SD years, range 14–74 y.). Seven year after the institution of treatment, 127 (50%) patients still were in steroid-free remission (83 CD vs. 44 UC, 58.8% and 38.9%, respectively, p = 0.0024), 71 (27.9%) had a relapse requiring retreatment with steroids (29 CD vs. 42 UC, 20.6% and 37.2%, respectively, p = 0.0047), 56 (22.1%) discontinued the treatment due to side effects (29 CD vs. 27 UC, 20.6% and 23.9%, respectively). Loss of response from first to seventh year of follow-up was low, about 20%.

Conclusion

Seven year after the onset of treatment 50% of patients did not require further steroid courses. After the first year loss of response was low in six 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.