Sjögren disease (SjD) is a systemic autoimmune disorder affecting both children and adults, with a wide range of clinical phenotypes. It remains a challenging condition to recognise and diagnose early and manage effectively. The heterogeneous nature of the presentation, variable disease course and overlapping symptoms with other autoimmune conditions often result in delayed diagnosis. This, coupled with the lack of licensed effective therapies frequently leads to suboptimal patient outcomes. Improved outcome measures are crucial for advancing our understanding of SjD pathogenesis and developing effective treatments. They can help ensure that clinical trials are accurately capturing the impact of potential therapies on the disease and the quality of life of people with SjD. Further developments are needed in the areas of age and developmentally appropriate disease and patient-reported outcome measures, with adequate sensitivity to evaluate treatment efficacy, as well as predictor biomarkers for both treatment response and poor prognostic outcomes associated with SjD. Advancing these areas will help ensure that clinical trials adequately select the most suitable SjD cohorts to treat with a certain therapy, as well as accurately reflect the impact of a certain intervention on disease activity, progression, and quality of life, ultimately leading to better care for people with SjD.
Keywords: Sjögren disease; adults; children; clinical trials; outcome measures.