Intest Res.  2019 Oct;17(4):476-485. 10.5217/ir.2019.00027.

Tacrolimus for ulcerative colitis in children: a multicenter survey in Japan

  • 1Department of Pediatrics and Child Health, Kurume University School of Medicine, Kurume, Japan.
  • 2Members of the Japanese Society for Pediatric Inflammatory Bowel Disease Working Group, Japan.
  • 3Clinical Research Support Office, Aso Iizuka Hospital, Iizuka, Japan.
  • 4PAL Children’s Clinic, Isesaki, Japan.
  • 5Department of Pediatrics, Osaka General Medical Center, Osaka, Japan.
  • 6Inflammatory Bowel Center, Yokohama City University Medical Center, Yokohama, Japan.
  • 7Department of Pediatrics, Gunma University Graduate School of Medicine, Maebashi, Japan.
  • 8Department of Pediatric Gastroenterology, Nutrition and Endocrinology, Osaka Women’s and Children’s Hospital, Osaka, Japan.
  • 9Division of Gastroenterology, National Center for Child Health and Development, Tokyo, Japan.
  • 10Department of Pediatrics, Osaka Medical College, Osaka, Japan.
  • 11Department of Pediatrics, Tokyo Women’s Medical University Hospital, Tokyo, Japan.
  • 12Department of Gastrointestinal and Pediatric Surgery, Mie University Graduate School of Medicine, Tsu, Japan.
  • 13Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.


Tacrolimus is effective for refractory ulcerative colitis in adults, while data for children is sparse. We aimed to evaluate the effectiveness and safety of tacrolimus for induction and maintenance therapy in Japanese children with ulcerative colitis.
We retrospectively reviewed the multicenter survey data of 67 patients with ulcerative colitis aged < 17 years treated with tacrolimus between 2000 and 2012. Patients' characteristics, disease activity, Pediatric Ulcerative Colitis Activity Index (PUCAI) score, initial oral tacrolimus dose, short-term (2-week) and long-term (1-year) outcomes, steroid-sparing effects, and adverse events were evaluated. Clinical remission was defined as a PUCAI score < 10; treatment response was defined as a PUCAI score reduction of ≥ 20 points compared with baseline.
Patients included 35 boys and 32 girls (median [interquartile range] at admission: 13 [11-15] years). Thirty-nine patients were steroid-dependent and 26 were steroidrefractory; 20 had severe colitis and 43 had moderate colitis. The initial tacrolimus dose was 0.09 mg/kg/day (range, 0.05-0.12 mg/kg/day). The short-term clinical remission rate was 47.8%, and the clinical response rate was 37.3%. The mean prednisolone dose was reduced from 19.2 mg/day at tacrolimus initiation to 5.7 mg/day at week 8 (P< 0.001). The adverse event rate was 53.7%; 6 patients required discontinuation of tacrolimus therapy.
Tacrolimus was a safe and effective second-line induction therapy for steroid-dependent and steroid-refractory ulcerative colitis in Japanese children.


Immunologic factors; Biological factors; Remission induction; Colectomy
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