Safety of azathioprine and 6-mercaptopurine in pediatric patients with inflammatory bowel disease.
OBJECTIVE
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.
Kirschner
B S
BS
Section of Pediatric Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of Chicago Children's Hospital, Chicago, Illinois, USA.
D000293:Adolescent; D000328:Adult; D001379:Azathioprine / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D019992:Databases as Topic; D004342:Drug Hypersensitivity; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007239:Infections / Q000209:etiology; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D008499:Medical Records; D015122:Mercaptopurine / Q000009:adverse effects / Q000627:therapeutic use*; D011241:Prednisone / Q000008:administration & dosage / Q000627:therapeutic use
D007166:Immunosuppressive Agents; D015122:Mercaptopurine; D001379:Azathioprine; D011241:Prednisone