Study participants
vasculitis, pSS, myositis, renal, neurologic or cardiac involvement
VASCULITIS, DISEASE, SECONDARY, MYOSITIS, INTERSTITIAL LUNG DISEASE, DISEASE, COMPLICATIONS
We enrolled male and female adults (18–75 years) with moderate to severe pSS, previously diagnosed according to the revised American-European Consensus Group criteria. The study flow diagram is given in Flow chart of inclusion in the studyThe severity of disease activity was defined according to the EULAR SS Disease Activity Index (ESSDAI) score of ≥5. Patients also had to have a SS Patient Reported Index (ESSPRI) score of ≥5, and elevated serum titers of anti-SSA and/or anti-SSB antibodies at screening. We excluded patients with secondary SS, and those with severe complications of SS (including vasculitis with renal, neurologic or cardiac involvement; interstitial lung disease and severe myositis). Prohibited concomitant medications included: CS therapy exceeding the equivalent of 7.5 mg prednisone per day, anti-CD20 therapy (e.g. rituximab) or other B cell–depleting therapy within 6 months of screening, immunosuppressant therapy and CYC.