In this segment, the panel examines why no disease-modifying therapies (DMTs) have yet been approved for Sjögren’s Disease (SjD), despite multiple promising agents in clinical trials. A major challenge is the heterogeneity of SjD: patients differ widely in symptoms, disease mechanisms, and organ involvement, making it difficult to identify uniform trial populations. Additionally, there is ongoing debate over the best clinical endpoints to measure meaningful improvement. Many current outcome tools emphasize subjective symptoms, such as dryness or fatigue, which are influenced by numerous factors and may not correlate directly with biological disease activity.

The panel also notes that disease often progresses slowly, which requires longer trial durations and increases cost and complexity. Identifying patients earlier, when glandular function is still recoverable, may improve the success of future therapies. Ultimately, advancing DMT development will depend on refined patient selection, improved biomarkers, and targeted approaches that address the underlying immune mechanisms driving SjD.