Safety and efficacy of oral tacrolimus in the treatment of paediatric inflammatory bowel disease

Background: In certain clinical situations, such as acute and severe episodes of ulcerative colitis (UC) or Crohn's Disease (CD), that do not respond to conventional intravenous steroid treatment, we need potent, fast-acting drugs to induce clinical remission and avoid surgery. Objectives: To evaluate the efficacy and safety of oral tacrolimus treatment of acute and severe UC or CD to induce their remission, and also to assess its efficacy in delaying or avoiding surgery. Material and methods: We present a retrospective study that included all patients under 18 years of age with acute and severe bouts of CD (colonic or ileocolonic location) or UC who were treated with oral tacrolimus at our institution from January 1998 to December 2007. Results: We included a total of 8 patients (4 mates and 4 females), 6 presented with UC and 2 had CD. The mean age of our patients at the start of the treatment was 11.8 years (range 2.75-16.58 y) and the mean time from diagnosis to the start of tacrolimus therapy was 4 months (range 1-96 m). An initial response was obtained in 50% of patients. Plasma trough levels of tacrolimus remained between 5-11 ng/ml. Six of the eight patients (75%) required surgery. In one patient with UC and in another with CD, surgery was avoided. In 2 of the 6 patients with UC, surgery was postponed beyond 6 months. Conclusions: Tacrolimus is useful in inducing clinical remission in patients with acute and severe bouts of UC or CD, and so can avoid or delay the surgery; it may also be used as a bridging agent until the new maintenance therapy with other immunosuppressants is effective. (C) 2009 Asociacion Espanola de Pediatria. Published by Elsevier Espana, S.L. All rights reserved.