Intravenous tacrolimus is a superior induction therapy for acute severe ulcerative colitis compared to oral tacrolimus

BMC Gastroenterol. 2021 Dec 23;21(1):494. doi: 10.1186/s12876-021-02043-6.

Abstract

Background: Intravenous corticosteroid is the mainstay for managing acute severe ulcerative colitis, but one-third of patients do not respond to intravenous corticosteroid. Tacrolimus, a salvage therapy before colectomy, is usually orally administered, though its bioavailability is low compared intravenous administration. The efficacy of intravenous tacrolimus has not been widely studied.

Aim: To determine the efficacy and safety of intravenous tacrolimus for the treatment of acute severe ulcerative colitis.

Methods: Eighty-seven hospitalized acute severe ulcerative colitis patients were enrolled for a prospective cohort study between 2009 and 2017. Sixty-five patients received intravenous tacrolimus and 22 received oral tacrolimus. The primary outcome was the achievement of clinical remission within 2 weeks. Relapse and colectomy incidence and adverse events were assessed at 24 weeks.

Results: Response rates of both treatments exceeded 50% but were not significantly different. The remission rate was higher in intravenous tacrolimus compared with oral tacrolimus. At 24 weeks, oral and intravenous tacrolimus showed similar relapse-free survival rates; however, colectomy-free survival rates were higher in intravenous tacrolimus compared with oral tacrolimus.

Conclusions: Patients receiving intravenous tacrolimus achieved superior remission and colectomy-free survival rates compared with patients receiving oral tacrolimus. Safety was similar between the two treatments.

Keywords: Acute severe ulcerative colitis; Intravenous tacrolimus; Ulcerative colitis.

MeSH terms

  • Administration, Intravenous*
  • Colitis, Ulcerative* / drug therapy
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Induction Chemotherapy
  • Prospective Studies
  • Remission Induction
  • Severity of Illness Index
  • Tacrolimus / administration & dosage*
  • Treatment Outcome

Substances

  • Immunosuppressive Agents
  • Tacrolimus