Renaud Felten, Valérie Devauchelle-Pensec, Raphaèle Seror, Pierre Duffau, David Saadoun, Eric Hachulla, Hatron Pierre Yves, Carine Salliot, Aleth Perdriger, Jacques Morel, Arsène Mékinian, Olivier Vittecoq, Jean-Marie Berthelot, Emanuelle Dernis, Veronique Le Guern, Philippe Dieudé, Claire Larroche, Christophe Richez, Thierry Martin, Charles Zarnitsky, Gilles Blaison, Pierre Kieffer, François Maurier, Azeddine Dellal, Stephanie Rist, Emmanuel Andres, Anne Contis, Emmanuel Chatelus, Christelle Sordet, Jean Sibilia, Cécile Arnold, Mira Y Tawk, Ouafaa Aberkane, Lise Holterbach, Patrice Cacoub, Alain Saraux, Xavier Mariette, Nicolas Meyer, Jacques-Eric Gottenberg
OBJECTIVES: No immunomodulatory drug has been approved for primary Sjögren's syndrome, a systemic autoimmune disease affecting 0.1% of the population. To demonstrate the efficacy of targeting interleukin 6 receptor in patients with Sjögren's syndrome-related systemic complications. METHODS: Multicentre double-blind randomised placebo-controlled trial between 24 July 2013 and 16 July 2018, with a follow-up of 44 weeks, involving 17 referral centres. Inclusion criteria were primary Sjögren's syndrome according to American European Consensus Group criteria and score ≥5 for the EULAR Sjögren's Syndrome Disease activity Index (ESSDAI, score of systemic complications)...
March 2021: Annals of the Rheumatic Diseases