Sjögren’s disease is an autoimmune disease affecting exocrine glands resulting in dryness of the eyes and the mouth with multiple systemic complications in different organs. In 30% to 50% of the patients, systemic and extra-glandular manifestations may develop and include fatigue, vasculitis, peripheral neuropathy, affected joint, kidney malfunction and interstitial lung disease. Moreover, Sjögren’s disease patients have a 10 to 20-fold higher risk of developing B cell lymphomas, conferring shorter life expectancy.

The negative impact on quality of life is prominent and Sjögren’s disease represents a significant health and economic burden. To date, there is no treatment with demonstrated efficacy for the systemic manifestations of Sjögren’s disease and only symptomatic treatments are commercially available. Classical immunosuppressive drugs are used in patients with severe organ involvement but with variable results.

There are several factors that may hamper the development of successful drugs for Sjögren’s disease. As a multi-organ disease, clinical manifestations and biological disturbances are considerably heterogeneous among individuals. Such heterogeneity provides a major challenge to designing clinical trials measuring the success of an intervention using a “one size fits all” outcome measure. Thus, it is of paramount importance to identify new sensitive clinical endpoints, define endotype-specific biomarkers and develop an original design for an innovative multi-arm clinical trial.