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P241. Thiopurines in the treatment of inflammatory bowel diseases (IBD) – A single centre experience

F. Furfaro1, G. Costantino1, A. Alibrandi2, W. Fries1

1Department of Internal Medicine, University of Messina, Italy; 2Department of Economical, Financial, Social, Environmental, Statistical and Territorial Sciences, University of Messina, Italy

Thiopurines (THIO) represent the backbone of therapy in IBD. One of the unsolved questions is duration of therapy and the concern regarding adverse events (AE). AE in patients treated with THIO are reported to occur in 15–30%. The aim of our study was to investigate efficacy and safety of treatment with THIO in order to identify if prolonged treatment is associated with a major risk of AE.

Methods: We analyzed retrospectively the charts of 837 IBD patients followed in our clinic. Harvey-Bradshaw index (HBI) or partial Mayo score (pMS) before and after 6, 12, 24 and 36 months of treatment with THIO were registered. Indications for treatment, mean duration of treatment, and AE were recorded. AE were divided in early (within 4 wks of start), intermediate (from 2 to 6 months) and late (>6 months). Data are mean values ± SD. Comparison was performed with the Wilcoxon signed rank-test.

Results: We identified 266 patients (157 CD, 85 males, 109 UC, 56 males) treated with THIO. Indications for treatment were steroid dependency in 189 (71%), perianal fistulas in 12 (4.5%), post-surgery recurrence in 22 (8.3%), extensive disease in 36 (13.6%), other in 6 (2.3%). The mean duration of disease prior to IMM was 5.3 yrs ± 8.7; the mean duration of treatment was 2.8 yrs ±6.0 (range 0–240 months) In CD and in UC, the clinical activity indices (HBI, pMS) fell significantly compared to pretreatment values at 6 months up to 3 years (all p < 0.001 vs pre-treatment). For analysis of adverse events (AE) 733 patient years were available. Overall 115 AE were identified in 87 patients (32.7%), 14 (16.1%) resolved with dose reduction, 70 patients (80.5%) discontinued THIO because of AE.

We observed early AE in 41 patients (47.1%), the most frequent are represented by flu-like syndrome (21 AE; 13.5%), nausea, vomiting or abdominal pain (10 AE; 8.7%), pancreatic hyperenzymemia (9 AE; 7.8%); intermediate AE in 16 (18.4%), the most frequent is represented by hepatotoxicity (10 AE; 8.7%); late AE in 30 (34.5%), the most frequent are represented by leucopenia (11 AE; 9.6%), infections (9 AE; 7.8%), liver toxicity (6 AE; 5.2%). One probably therapy-related death occurred in UC 8 yrs after start of THIO. No neoplasia was observed.

Conclusions: THIO represent an valid treatment in IBD being equally effective in CD and UC, maintaining efficacy over time. AE did occur in 32.7% of patients leading to drug discontinuation in 26.3% of patients. Among late occurring AE, leucopenia, liver toxicity, and infections were the most frequent, emphasizing the need for continuous surveillance of patients.