Thomas Dörner, Martin Kaul, Antónia Szántó, Jui-Cheng Tseng, Athena S Papas, Ilona Pylvaenaeinen, Malika Hanser, Nasri Abdallah, Andrea Grioni, Aida Santos Da Costa, Enrico Ferrero, Peter Gergely, Rainer Hillenbrand, Alexandre Avrameas, Bruno Cenni, Richard M Siegel
OBJECTIVES: To evaluate the safety and efficacy of remibrutinib in patients with moderate-to-severe Sjögren's syndrome (SjS) in a phase 2 randomised, double-blind trial (NCT04035668; LOUiSSE (LOU064 in Sjögren's Syndrome) study). METHODS: Eligible patients fulfilling 2016 American College of Rheumatology/European League Against Rheumatism (EULAR) criteria for SjS, positive for anti-Ro/Sjögren's syndrome-related antigen A antibodies, with moderate-to-severe disease activity (EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) (based on weighted score) ≥ 5, EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) ≥ 5) received remibrutinib (100 mg) either one or two times a day, or placebo for the 24-week study treatment period...
November 6, 2023: Annals of the Rheumatic Diseases