Abstract

Sjögren's syndrome is a disabling systemic autoimmune disease characterised by pain, fatigue, and mucosal dryness, with risk of systemic complications (joints, lungs, skin, and peripheral nerves being the most frequently involved) in 30–50% of patients.1 So far, there is no effective immunomodulatory treatment for disease-related systemic complications because most randomised controlled trials (RCTs) on Sjögren's syndrome done in the past two decades have been negative.2 Of note, the primary outcome criteria of most previous RCTs were based on patient-reported outcomes, such as pain, fatigue, or dryness visual analogue scales, and most trials included only a small proportion of patients with systemic complications.

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