title: Oral tacrolimus treatment of severe colitis in children.
abstract: OBJECTIVE
  To evaluate the efficacy of oral tacrolimus as an induction agent in steroid-refractory severe colitis.
  
  
  METHODS
  Open-label, multicenter trial of oral tacrolimus in patients with severe colitis. Patients not responding to conventional therapy received tacrolimus, 0.1 mg/kg/dose given twice a day, and the dosage was adjusted to achieve blood levels between 10 and 15 ng/mL. Response was defined as improvement in a number of clinical parameters (including abdominal pain, diarrhea, rectal bleeding, and cessation of transfusions). Patients who responded by 14 days continued to receive tacrolimus, and 6-mercaptopurine or azathioprine was added as a steroid-sparing agent 4 to 6 weeks after the tacrolimus was instituted.
  
  
  RESULTS
  Fourteen patients were enrolled in the study. One patient elected to withdraw after 48 hours. Of the 13 remaining, 9 (69%) responded and were discharged. Tacrolimus was continued for 2 to 3 months in the responders, except for 1 patient who was given tacrolimus for 11 months. After 1 year of follow-up, only 5 (38%) patients were receiving maintenance therapy; the other 4 responders had undergone colectomy.
  
  
  CONCLUSIONS
  Although tacrolimus is effective induction therapy for severe ulcerative or Crohn's colitis, fewer than 50% of patients treated will successfully achieve a long-term remission.
authors: Combined Program in Pediatric Gastroenterology and Nutrition, Boston Children's Hospital, Boston, Massachusetts 02115, USA.
authors: A
authors: A
authors: Bousvaros
authors: B S
authors: BS
authors: Kirschner
authors: S L
authors: SL
authors: Werlin
authors: L
authors: L
authors: Parker-Hartigan
authors: F
authors: F
authors: Daum
authors: K B
authors: KB
authors: Freeman
authors: J P
authors: JP
authors: Balint
authors: A S
authors: AS
authors: Day
authors: A M
authors: AM
authors: Griffiths
authors: D
authors: D
authors: Zurakowski
authors: G D
authors: GD
authors: Ferry
authors: A M
authors: AM
authors: Leichtner
mesh_terms: D000293:Adolescent; D000328:Adult; D001379:Azathioprine / Q000008:administration & dosage / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007223:Infant; D008297:Male; D015122:Mercaptopurine / Q000008:administration & dosage / Q000627:therapeutic use; D011446:Prospective Studies; D012074:Remission Induction; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D007166:Immunosuppressive Agents; D015122:Mercaptopurine; D001379:Azathioprine; D016559:Tacrolimus