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

Louise F Risnes, Margit Brottveit, Ida Robertsen, Jostein Ibsen, Lars Aabakken, Marie K Johannesen, Stine R Lund, Siv K B Furholm, Siv E H Isaksen, Anders Åsberg, Ludvig M Sollid, Knut E A Lundin

Journal: Alimentary pharmacology & therapeutics 2025;62(10):1027-1031

PMID: 41124699

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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.

Address: Norwegian Centre for Coeliac Disease Research, University of Oslo, Oslo, Norway.; Department of Immunology, Oslo University Hospital-Rikshospitalet, Oslo, Norway.; Department of Transplantation Medicine, Oslo University Hospital-Rikshospitalet, Oslo, Norway.; Department of Gastroenterology, Oslo University Hospital-Ullevål, Oslo, Norway.; Department of Pharmacy, University of Oslo, Oslo, Norway.; Norwegian Centre for Coeliac Disease Research, University of Oslo, Oslo, Norway.; Department of Transplantation Medicine, Oslo University Hospital-Rikshospitalet, Oslo, Norway.; Department of Transplantation Medicine, Oslo University Hospital-Rikshospitalet, Oslo, Norway.; Norwegian Centre for Coeliac Disease Research, University of Oslo, Oslo, Norway.; Department of Immunology, Oslo University Hospital-Rikshospitalet, Oslo, Norway.; Department of Transplantation Medicine, Oslo University Hospital-Rikshospitalet, Oslo, Norway.; Department of Pharmacy, University of Oslo, Oslo, Norway.

DOI: 10.1111/apt.70301

MeSH Terms: Humans, Nitriles, Celiac Disease, Hydroxybutyrates, Toluidines, Crotonates, Glutens, Male, Female, T-Lymphocytes, Adult, Middle Aged, Diet, Gluten-Free, Double-Blind Method