Oral tacrolimus for pediatric steroid-resistant ulcerative colitis

J Crohns Colitis. 2014 Jan;8(1):64-9. doi: 10.1016/j.crohns.2013.03.006. Epub 2013 Apr 9.

Abstract

Background: Ulcerative colitis (UC) occurring during childhood is generally extensive and is associated with severe flares that may require intravenous steroid treatment. In cases of corticosteroid resistance is necessary to introduce a second-line treatment to avoid or delay surgery.

Aims: To describe the efficacy and safety of oral tacrolimus for the treatment of severe steroid-resistant UC.

Methods: We performed a retrospective study that included all patients under age 18 suffering from severe steroid-resistant UC treated with oral tacrolimus during the period January 1998 to October 2012 and with a follow-up period after treatment of 24 months or more.

Results: A total of ten patients were included. The age at baseline was 9.4±4.9 years, and the time from diagnosis was 1.3 months (IQR, 1-5.7). Seven of the patients were in their first flare of disease. All of them received an oral dose of 0.12 mg/kg/day of tacrolimus divided in two doses. Trough plasma levels of tacrolimus were maintained between 4 and 13 ng/ml. Response was seen in 5/10 patients at 12 months, colectomy was eventually performed in 60% of patients during the follow-up period.

Conclusions: Tacrolimus is useful in inducing remission in patients with severe steroid-resistant UC, preventing or delaying colectomy, and allowing the patient and family to prepare for a probable surgery. Tacrolimus may also be used as a treatment bridge for corticosteroid-dependent patients until the new maintenance therapy takes effect.

Keywords: Children;; Paediatric; Steroids;; Surgery;; Tacrolimus;; Ulcerative colitis;.

MeSH terms

  • Administration, Oral
  • Adolescent
  • Child
  • Child, Preschool
  • Colectomy
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / surgery
  • Drug Resistance*
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / blood
  • Male
  • Remission Induction / methods
  • Retrospective Studies
  • Severity of Illness Index
  • Steroids / therapeutic use
  • Tacrolimus / administration & dosage*
  • Tacrolimus / adverse effects
  • Tacrolimus / blood

Substances

  • Immunosuppressive Agents
  • Steroids
  • Tacrolimus