Gastroenterology

Gastroenterology

Volume 115, Issue 4, October 1998, Pages 813-821
Gastroenterology

Alimentary Tract
Safety of azathioprine and 6-mercaptopurine in pediatric patients with inflammatory bowel disease,☆☆

https://doi.org/10.1016/S0016-5085(98)70251-3Get rights and content

Abstract

Background & Aims: Azathioprine (AZA) and 6-mercaptopurine (6-MP) are used in pediatric patients with ulcerative colitis and Crohn's disease to reduce disease activity, maintain remission, prevent relapse, and lower corticosteroid dosage, but their long-term side effects remain to be studied. The aim of this study was to analyze the safety of AZA and 6-MP and steroid reduction in this age group. Methods: The investigators' database identified 118 patients who received either drug; 23 were excluded (single visit, noncompliance, or therapy < 1 week), leaving 95 patients, with a mean (±SD) age of 14.2 ± 4.4 years. Medical files were reviewed for adverse side effects: fever, pancreatitis, infections, gastrointestinal intolerance, aminotransferase level increase, leukopenia, and thrombocytopenia. Prednisone doses before and after immunomodulatory therapy were compared. Results: AZA or 6-MP was tolerated in 51 of 95 patients (54%) without adverse reaction; 27 of 95 (28%) experienced side effects that responded to dose reduction (23 patients) or spontaneously (4 patients), most commonly increased aminotransferase level (13.7%). Cessation of therapy was needed in 17 of 95 patients (18%), including recurrent fever (4), pancreatitis (4), gastrointestinal intolerance (4), and recurrent infections (3). Mean prednisone dose decreased from 24.3 to 8.6 mg/day. Conclusions: AZA and 6-MP were well tolerated in 82% of patients; of these, prednisone reduction occurred in 87%. However, 18% required discontinuation because of hypersensitivity or infectious side effects.

GASTROENTEROLOGY 1998;115:813-821

Section snippets

Materials and methods

A computerized database listing patients with UC and CD evaluated by the author in the Pediatric Gastroenterology Clinic of the University of Chicago Children's Hospital was used to identify patients who had received either AZA or 6-MP. One hundred eighteen patients were identified as having been treated with either of the two preparations. Twenty-three patients were excluded from further analysis for the following reasons: single consultation (n = 11), infrequent visits due to noncompliance (n

Results

Fifty-one of 95 of pediatric patients (54%) tolerated AZA or 6-MP without any adverse reaction. An additional 27 of 95 (28%) experienced an adverse reaction that responded to reduction in medication dose (21 of 27) or improved spontaneously without dose reduction (4 of 27) or after surgery (2 of 27; Table 4).

. Results: Adverse reactions with outcomes observed in 95 pediatric and adolescent patients with IBD after treatment with 6-MP or AZA

Specific adverse reactionn%Effect of adverse reaction on

Discussion

The results of this analysis show that AZA and 6-MP are well tolerated in most pediatric and adolescent patients with chronic IBD. Eighty-two percent of patients who were started on these medications were able to remain on therapy. Acute toxicity, characterized by fever or pancreatitis, which required discontinuation of these drugs, occurred in 8% of patients. Because the symptoms of pancreatitis included severe pain necessitating hospitalization in 2 of 4 affected patients, only 2 patients

Acknowledgements

The author thanks Marco Guandalini for technical assistance.

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  • Cited by (0)

    Address requests fo reprints to: Barbara S. Kirschner, M.D., Section of Pediatric Gastroenterology, Hepatology, and Nutrition, University of Chicago Children's Hospital, 5825 South Maryland Avenue, MC-4065, Chicago, Illinois 60637.

    ☆☆

    Supported by Glaxo-Wellcome Inc. and the Martin and Mary Boyer Pediatric Inflammatory Bowel Disease Activities Program, University of Chicago.

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