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P530 Azathioprine in the maintenance of steroid-free remission in inflammatory bowel disease patients: efficacy and safety in five years of follow-up

Cassieri C.*1, Pica R.1, Avallone E.V.1, Brandimarte G.2, Zippi M.1, Crispino P.1, De Nitto D.1, Lecca G.2, Corrado C.1, Vernia P.1, Paoluzi P.1, Corazziari E.S.1

1“Sapienza” University, Department of Internal Medicine and Medical Specialties, Rome, Italy 2“Cristo Re” Hospital, Department of Internal Medicine, Rome, Italy

Background

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 The treatment must be withdrawn in 5–30% of patients due to the occurrence of adverse events.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 five year after the institution of treatment.

Methods

Data from consecutive IBD outpatients referred in our Institution, between 1985–2014, 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.

Results

Out of 2684 consecutive IBD outpatients visited in the index period, AZA was prescribed to 398 patients, 216 (54.3%) were affected by Crohn's disease (CD) and 182 (45.7%) by ulcerative colitis (UC). One hundred and thirty-eight patients with a follow-up <60 months were excluded from the study. Two hundred and sixty patients were evaluated, 145 (55.8%) with CD and 115 (44.2%) with UC. One hundred and forty-six (56.2%) were male and 114 (43.8%) female (average age of 34.85±14.92 SD years, range 14–74 years). Five year after the institution of treatment, 135 (51.9%) patients still were in steroid-free remission (86 CD vs 49 UC, 59.3% and 42.6%, respectively, p=0.0087), 71 (27.3%) had a relapse requiring retreatment with steroids (29 CD vs 42 UC, 20% and 36.5%, respectively, p=0.0033), 54 (20.8%) discontinued the treatment due to side effects (30 CD vs 24 UC, 20.7% and 20.9%, respectively). Loss of response from 1st to 5rd year of follow-up was low, about 18%.

Conclusion

Five year after the onset of treatment 52% of patients did not require further steroid courses. After the first year loss of response was low in four 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.