Predictive Factors for Efficacy of Oral Tacrolimus Induction Therapy in Moderate to Severe Ulcerative Colitis Patients: Large Multicenter Retrospective Cohort Study

Inflamm Bowel Dis. 2024 Jul 3;30(7):1087-1093. doi: 10.1093/ibd/izad150.

Abstract

Background: Tacrolimus (TAC), a calcineurin inhibitor, is used for remission induction therapy in patients with moderate to severe ulcerative colitis (UC), with short-term efficacy and related predictive factors shown in previous cohort studies. However, most studies reported data for only a limited number of patients enrolled from a single center. We performed a large multicenter retrospective cohort study to identify factors related to prediction of clinical remission in UC patients treated with oral TAC.

Methods: The medical records of patients with moderate to severe UC treated with oral TAC as induction therapy at 7 institutions between April 2009 and March 2017 were retrospectively reviewed.

Results: A total of 216 patients who received TAC for induction were analyzed, of whom 123 (56.9%) showed clinical remission at week 12. Logistic regression analysis indicated that previous or current use of antitumor necrosis factor (TNF)-α antibodies (odds ratio [OR], 0.259; P = .006), and concomitant treatment with 5-aminosalicylate (5-ASA) at the baseline (OR, 0.268; P = .005) were independent predictive factors correlated with failure of clinical remission, whereas higher levels of C-reactive protein (OR, 1.124; P = .014) predicted achievement of clinical remission.

Conclusions: Results of this multicenter study clearly indicate the efficacy of TAC induction therapy for patients with moderate to severe UC. Notably, previous or current use of anti-TNF-α antibodies was associated with poor achievement of clinical remission by week 12.

Keywords: induction therapy; predictive factors; tacrolimus; ulcerative colitis.

Publication types

  • Multicenter Study

MeSH terms

  • Administration, Oral
  • Adult
  • Colitis, Ulcerative* / drug therapy
  • Female
  • Humans
  • Immunosuppressive Agents* / administration & dosage
  • Immunosuppressive Agents* / therapeutic use
  • Induction Chemotherapy
  • Male
  • Mesalamine / administration & dosage
  • Mesalamine / therapeutic use
  • Middle Aged
  • Remission Induction*
  • Retrospective Studies
  • Severity of Illness Index
  • Tacrolimus* / administration & dosage
  • Tacrolimus* / therapeutic use
  • Treatment Outcome

Substances

  • Tacrolimus
  • Immunosuppressive Agents
  • Mesalamine