Effectiveness of Tofacitinib for Hospitalized Patients with Acute Severe Ulcerative Colitis: Case Series

Dig Dis Sci. 2022 Nov;67(11):5213-5219. doi: 10.1007/s10620-022-07439-2. Epub 2022 Mar 4.

Abstract

Background: Treatment options for acute severe ulcerative colitis (ASUC) are limited. Tofacitinib, an approved treatment for moderate to severe ulcerative colitis, could be a potential rescue therapy for ASUC given its rapid onset of action.

Objective: To evaluate the effectiveness of tofacitinib in hospitalized patients with ASUC refractory to standard therapy in a real-world setting.

Methods: Retrospective observational study of hospitalized adult patients with ASUC treated with tofacitinib between January 2019 and September 2020 at five Canadian centers. We extracted patient demographics, clinical status, biomarkers (C-reactive protein and fecal calprotectin), endoscopic findings, and colectomy-free rate at admission, 30 days, 90 days, and 6 months after tofacitinib initiation.

Results: Eight patients with symptoms refractory to standard rescue therapy (corticosteroids ± infliximab if infliximab-naïve prior to admission) were treated with tofacitinib. During index hospitalization, clinical response was observed in 5/8 patients. The median time to discharge post-tofacitinib initiation was 5 days (IQR 5.0-6). At 30 and 90 days, all five responders were in clinical remission. At 6 months, only 3/5 responders remained in clinical remission. The colectomy-free rate was 37.5% during the follow-up period (two colectomies occurred within 30 days; one occurred within 90 days). No drug-related adverse reaction occurred.

Conclusion: In this small case-series, tofacitinib was an effective rescue therapy in patients with refractory ASUC. These findings need to be evaluated in a randomized controlled trial.

Keywords: Colectomy; Hospitalized; Severe ulcerative colitis; Tofacitinib.

Publication types

  • Observational Study

MeSH terms

  • Adrenal Cortex Hormones / therapeutic use
  • Adult
  • Biomarkers
  • C-Reactive Protein / metabolism
  • Canada
  • Colitis, Ulcerative* / diagnosis
  • Colitis, Ulcerative* / drug therapy
  • Humans
  • Infliximab / therapeutic use
  • Leukocyte L1 Antigen Complex

Substances

  • Infliximab
  • tofacitinib
  • C-Reactive Protein
  • Leukocyte L1 Antigen Complex
  • Adrenal Cortex Hormones
  • Biomarkers