Azathioprine in paediatric inflammatory bowel disease: an Italian multicentre survey.
OBJECTIVE
To assess the efficacy and safety of azathioprine in a paediatric population with inflammatory bowel disease.


METHODS
One hundred and twenty-three Italian children treated with azathioprine were studied retrospectively. The treatment duration and causes of its discontinuation, side-effects and variation in corticosteroid dose were assessed.


RESULTS
The mean age at inflammatory bowel disease diagnosis was 9.8 +/- 3.6 years, and at the start of azathioprine therapy 11.8 +/- 4.3 years. The mean duration of treatment was 19 +/- 16 months. Fifty patients (41%) stopped treatment due to surgery (12%), prolonged remission (11%), non-response (7%), severe side-effects (7%) and poor compliance (3%). Of the 73 patients (59%) remaining on azathioprine, 11 had never been treated with corticosteroids, 27 were able to stop them and 35 were still on a very low daily dose (91% < 0.3 mg/kg). The difference in the daily corticosteroid dose between the beginning of azathioprine treatment (1 +/- 0.6 mg/kg) and the conclusion of the study (0.18 +/- 0.16 mg/kg) was statistically significant. Side-effects were recorded in 48 of the 123 patients (39%), but only eight required discontinuation of azathioprine.


CONCLUSIONS
Azathioprine was efficacious in 70% of patients, but ineffective in 20% and induced severe toxicity in 7%. Corticosteroids were stopped or markedly reduced in 62% of patients, but they were never given in 9%.
Barabino
A
A
Paediatric Gastroenterology, IRCCS G. Gaslini, Largo G. Gaslini 5, 16148 Genoa, Italy. abarab@tin.it
Torrente
F
F
Ventura
A
A
Cucchiara
S
S
Castro
M
M
Barbera
C
C
D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D001379:Azathioprine / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006306:Health Surveys; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D007223:Infant; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy* / Q000473:pathology; D007558:Italy; D008297:Male; D010349:Patient Compliance; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D001379:Azathioprine