Comparative efficacy and safety of vedolizumab and infliximab in ulcerative colitis after failure of a first subcutaneous anti-TNF agent: a multicentre cohort study

Aliment Pharmacol Ther. 2020 May;51(9):852-860. doi: 10.1111/apt.15680. Epub 2020 Mar 22.

Abstract

Background: Few data exist to help select a second biologic agent in patients with refractory ulcerative colitis (UC).

Aim: To compare the efficacy of infliximab (IFX) and vedolizumab (VDZ) in UC patients who failed a first subcutaneous anti-tumor necrosing factor (TNF) agent.

Methods: Consecutive UC patients from 12 French centres starting IFX or VDZ after at least one injection of adalimumab or golimumab have been included in a retrospective study. Outcomes were clinical remission at week 14, survival without treatment discontinuation and survival without UC-related event.

Results: Among the 225 patients included, clinical remission at week 14 was achieved in 40/154 (26%) patients treated with IFX and in 35/71 (49%) treated with VDZ (P = 0.001). After a propensity score matching analysis, this difference remained significant (odds ratio: 1.67; 95% confidence interval: 1.08-2.56; P = 0.02). With a median follow-up of 117 weeks, survival rates without treatment discontinuation at years 1 and 3 were 50% and 29% with IFX, and 80% and 55% with VDZ, respectively (P < 0.001). Regarding survival without UC-related event, they were 49% and 27% with IFX, and 74% and 52% with VDZ (P < 0.01).

Conclusion: After failure of a first subcutaneous anti-TNF agent, UC patients were more likely to achieve clinical remission with VDZ than those treated with IFX. Although due to prescription habits patients in the IFX group had a significantly more severe disease, these differences remained after adjustments and subgroup analyses. Such results have to be confirmed prospectively and warrant dedicated head-to-head trials.

Publication types

  • Comparative Study
  • Multicenter Study
  • Observational Study

MeSH terms

  • Adalimumab / administration & dosage*
  • Adalimumab / adverse effects
  • Adult
  • Antibodies, Monoclonal / administration & dosage*
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Biological Factors / administration & dosage
  • Biological Factors / adverse effects
  • Cohort Studies
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / pathology
  • Comparative Effectiveness Research
  • Drug Substitution
  • Female
  • Humans
  • Infliximab / adverse effects
  • Infliximab / therapeutic use*
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Recurrence
  • Retrospective Studies
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors
  • Young Adult

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Biological Factors
  • Tumor Necrosis Factor-alpha
  • golimumab
  • vedolizumab
  • Infliximab
  • Adalimumab