Oral tacrolimus treatment of severe colitis in children. J Pediatr 2000 Dec;137(6):794-9
Date
12/13/2000Pubmed ID
11113835DOI
10.1067/mpd.2000.109193Scopus ID
2-s2.0-0033635087 (requires institutional sign-in at Scopus site) 128 CitationsAbstract
OBJECTIVE: To evaluate the efficacy of oral tacrolimus as an induction agent in steroid-refractory severe colitis.
STUDY DESIGN: 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.
CONCLUSION: 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.
Author List
Bousvaros A, Kirschner BS, Werlin SL, Parker-Hartigan L, Daum F, Freeman KB, Balint JP, Day AS, Griffiths AM, Zurakowski D, Ferry GD, Leichtner AMAuthor
Steven L. Werlin MD Emeritus Professor in the Pediatrics department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Azathioprine
Child
Child, Preschool
Colitis, Ulcerative
Crohn Disease
Drug Therapy, Combination
Female
Humans
Immunosuppressive Agents
Infant
Male
Mercaptopurine
Prospective Studies
Remission Induction
Severity of Illness Index
Tacrolimus
