Efficacy and safety of induction therapy with calcineurin inhibitors followed by vedolizumab maintenance in 71 patients with severe steroid-refractory ulcerative colitis

Aliment Pharmacol Ther. 2020 Mar;51(6):637-643. doi: 10.1111/apt.15616. Epub 2019 Dec 25.

Abstract

Background: Following induction therapy with a calcineurin inhibitor (CNI) in severe ulcerative colitis, transitioning to vedolizumab as maintenance therapy could be an option.

Aim: To report on the largest cohort of patients successfully induced with CNIs who were transitioned to vedolizumab maintenance therapy.

Methods: This is a retrospective observational study of adult patients with severe steroid-refractory ulcerative colitis. Patients were included if they were induced with a CNI followed by maintenance therapy with vedolizumab between January 2014 and December 2018. The primary endpoint was colectomy-free survival. Secondary endpoints included survival without vedolizumab discontinuation as well as clinical, steroid-free and biochemical remission at week 14.

Results: A total of 71 patients (59% male) were treated with vedolizumab after induction therapy with CNIs for severe steroid-refractory colitis. Patients were followed for a median time of 25 months (IQR 16-36). Colectomy-free survival rates from vedolizumab initiation were 93% at 3 months, 67% at 1 year and 55% at 2 years. At the end of induction with vedolizumab at week 14, 50% of patients were in clinical remission, and 62% of patients had a normal CRP. At 1 and 2 years following vedolizumab initiation, 43% and 28% of patients were still on vedolizumab respectively. Vedolizumab was dose escalated to infusions every 4 weeks in 44% of patients. The median time to dose escalation was 5.6 months (IQR 4.1-8.2). No serious adverse events were recorded in our patient cohort.

Conclusions: Transitioning to vedolizumab following induction of remission with CNIs is effective and safe.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Calcineurin Inhibitors / administration & dosage*
  • Calcineurin Inhibitors / adverse effects
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / epidemiology
  • Colitis, Ulcerative / pathology
  • Drug Administration Schedule
  • Drug Resistance / drug effects*
  • Female
  • Follow-Up Studies
  • Humans
  • Induction Chemotherapy / methods*
  • Maintenance Chemotherapy / methods*
  • Male
  • Progression-Free Survival
  • Retrospective Studies
  • Severity of Illness Index
  • Steroids / therapeutic use*
  • Treatment Outcome
  • Young Adult

Substances

  • Antibodies, Monoclonal, Humanized
  • Calcineurin Inhibitors
  • Steroids
  • vedolizumab