Primary Sjögren's syndrome: new beginning for evidence-based trials

Primary Sjögren's syndrome is a heterogeneous disease that impairs quality of life, mainly because of sicca, pain, and fatigue, and 15–90% of patients also have systemic manifestations. 1 Brito-Zerón P Acar-Denizli N Ng W-F et al. Epidemiological profile and north–south gradient driving baseline systemic involvement of primary Sjögren's syndrome. Rheumatology. 2020; 59: 2350-2359 Crossref PubMed Scopus (24) Google Scholar Most patients, even without systemic manifestations, are willing to try new treatments, including biologics. 2 Cornec D Devauchelle-Pensec V Mariette X et al. Severe health-related quality of life impairment in active primary Sjögren's syndrome and patient-reported outcomes: data from a large therapeutic trial. Arthritis Care Res. 2017; 69: 528-535 Crossref PubMed Scopus (48) Google Scholar It would be important that primary endpoints for therapeutic trials should include the cardinal primary Sjögren's syndrome symptoms, which are dryness, fatigue, and pain. Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjögren's syndrome: a randomised, double-blind, placebo-controlled, phase 2b dose-finding trialThe study met its primary objective, showing a dose-related decrease in disease activity as measured by ESSDAI at week 24. Overall, ianalumab was well tolerated and safe, with no increase in infections. To our knowledge, this is the first large, randomised, controlled trial in primary Sjögren's syndrome that met its primary endpoint, and its results mean there is potential for more studies of this mechanism in the future. Full-Text PDF