Research Communication: Teriflunomide Does Not Affect Gluten-Specific T-Cell Activity in Coeliac Disease-A Randomised, Placebo-Controlled Trial

Aliment Pharmacol Ther. 2025 Nov;62(10):1027-1031. doi: 10.1111/apt.70301. Epub 2025 Jul 27.

Abstract

Coeliac disease is an autoimmune disorder driven by gluten and managed through a strict gluten-free diet. We tested teriflunomide, a drug known for its ability to alter T-cell activity, in a phase 2a trial of 15 patients with coeliac disease. Participants received teriflunomide or placebo including a loading dose, followed by a 3-day oral gluten challenge to monitor T-cell responses. The main aim was to observe attenuation of gluten-specific T-cell activation markers after gluten exposure. We found no significant differences in T-cell activity between groups, concluding that teriflunomide is ineffective as a non-dietary treatment for coeliac disease.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Celiac Disease* / drug therapy
  • Celiac Disease* / immunology
  • Crotonates* / pharmacology
  • Crotonates* / therapeutic use
  • Diet, Gluten-Free
  • Double-Blind Method
  • Female
  • Glutens* / immunology
  • Humans
  • Hydroxybutyrates
  • Male
  • Middle Aged
  • Nitriles
  • T-Lymphocytes* / drug effects
  • T-Lymphocytes* / immunology
  • Toluidines* / pharmacology
  • Toluidines* / therapeutic use

Substances

  • Nitriles
  • teriflunomide
  • Hydroxybutyrates
  • Toluidines
  • Crotonates
  • Glutens