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P577. Adverse effects of azathioprine in patients with inflammatory bowel disease (IBD)

P. Ramirez de la Piscina, S. Estrada, I. Duca, K. Spicakova, I. Ganchegui, M.d.R. Calderón, A. Campos, M. Salvador, E. Delgado, J.M. López Barbarin, F. Garcia Campos, HUA Txagorritxu, Digestive, Vitoria-Álava, Spain

Background

Maintenance treatment with azathioprine in patients with IBD is increasing its use in clinical practice. It has shown its efficacy in patients with ulcerative colitis (UC), both steroid-resistant and steroid-dependent, as well as Crohn's disease (CD). However, it is not side-effect free.

Our target is to analize the frequency and type of these side-effects; and how they modified our treatment attitude in a consecutive series of 198 patients diagnosed of IBD (UC and CD).

Methods

A total of 198 patients registered in our hospital data base have been included. 50.5% were women. 43.4% were UC (5.8% proctitis, 43% left-sided colitis and 51.2% pancolitis). 56.6% were CD (54% ileitis, 3% colonic presentation, 43% ileocolonic disease). 16.1% of the patients with CD presented concomitant perianal disease. In patients with UC, 81.4% received treatment with azathioprine for being steroid-dependent and 18.6% for being steroid-resistant. In CD, 49.1% of the patients presented an inflammatory pattern, 30.3% were stenotic and 20.6% had a fistulising pattern.

Results

A total of 42 side-effects were registered (21.2%), no more yhan one per patient was seen. In 54.7% of them, the drug needed to be stopped, with no evidence of fatal outcome in any of the cases.

Table 1.
Side effectsCrohn's diseaseUlcerative colitis% total side effectsTherapy attitude: stop/reduction
Dyspepsia153%83%/0
Cholestasis444%50%/25%
Hypertransaminasemia264%50%/12.5%
Acute pancreatitis232.5%100%/0
Myelotoxicity544.5%44.4%/33.3%
 mild23
 severe31
Infections31.5%0/0
Neoplasias 0/0
Others2 alopecia1 flushing1.5%66.6%/0

Conclusion

Azathioprine is a safe and effective drug for controlling IBD, although it has side-effects, which are generally minor and reversible after its suspension or dose-decreasing.

21.2% of our series had side-effects, a percentage slightly superior of that described in literature, probably because we included cases of dyspepsia and elevation of transaminases (without hepatitis) that conditioned the drug suspension in 21.4% of the patients.

The most frequent side-effects were myelotoxicity (4.5%), liver function test abnormalities (8%), dyspepsia (3%), acute pancreatitis (2.5%). Neither neoplasia nor fatal complications were reported.

Due to the heterogeneity of our sample, we are not able to find a common characteristic of the patients who developed side-effects.