Efficacy and safety of azathioprine and 6-mercaptopurine in Japanese pediatric patients with ulcerative colitis: a survey of the Japanese Society for Pediatric Inflammatory Bowel Disease.
OBJECTIVE
Azathioprine (AZA) and 6-mercaptopurine (6-MP) have recently been used in Japanese pediatric patients with ulcerative colitis. The aims of this study were to evaluate both the therapeutic efficacy and safety of AZA/6-MP in this group of patients.


METHODS
Fourteen members of the Japanese Society for Pediatric Inflammatory Bowel Disease reported 35 retrospective cases that received AZA/6-MP and were evaluated for adverse drug effects. In those who tolerated AZA/6-MP, disease activity and corticosteroid doses before and during the first 6 months of therapy were assessed.


RESULTS
AZA or 6-MP was safely used in 21 of 35 patients (60%) without adverse drug effects. The disease activity began to decrease from the first month of therapy and the maximum effect was achieved after 3 months. The mean daily prednisolone dose was decreased from 26.9 to 11.6 mg and dose reduction was achieved in 58% of patients after 6 months of therapy. Fourteen of the 35 patients (40%) experienced adverse drug effects, including leukopenia (n = 11), aplastic anemia (n = 1), pancreatitis (n = 1) and liver dysfunction (n = 1).


CONCLUSIONS
The majority of Japanese children with ulcerative colitis tolerated AZA/6-MP and experienced favorable effects. However, 40% experienced adverse drug effects, mainly myelosuppression.
Tajiri
Hitoshi
H
Department of Pediatrics, Osaka General Medical Center, Osaka, Japan. tajiriji@gh.pref.osaka.jp
Tomomasa
Tsuyoshi
T
Yoden
Atsushi
A
Konno
Mutsuko
M
Sasaki
Mika
M
Maisawa
Shuniti
S
Sumazaki
Ryo
R
Shimizu
Toshikazu
T
Toyoda
Shigeru
S
Etani
Yuri
Y
Nakacho
Mariko
M
Ushijima
Kosuke
K
Kobayashi
Akio
A
D000293:Adolescent; D000465:Algorithms; D001379:Azathioprine / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D015122:Mercaptopurine / Q000009:adverse effects / Q000627:therapeutic use*; D011239:Prednisolone / Q000008:administration & dosage; D012189:Retrospective Studies
D007166:Immunosuppressive Agents; D011239:Prednisolone; D015122:Mercaptopurine; D001379:Azathioprine