Systemic sclerosis & Raynaud's
Expert viewpoint on endpoints in systemic sclerosis: current and future outlook
Authors' conclusion
Despite progress, significant unmet needs remain.
Study context
- Population
- Clinical trials in systemic sclerosis (SSc)
- Outcome
- Current landscape and future directions of clinical endpoints in SSc trials
Main finding
As reported in the abstract
- Three historical trial concepts: single-organ studies; single-organ primary endpoint with supportive secondary endpoints across other systems; studies designed to show disease modification through combined endpoints
- Growing importance of patient-reported outcomes, such as HAQ-DI and ScleroID
- Emergence of candidate composite endpoints, including the revised Composite Response Index in SSc, integrating clinical, functional and patient-centred measures
- Many endpoints assess damage at advanced stages; need for earlier indicators of disease progression
- Advocates time-to-event analyses, imaging and biomarker-based assessments, and refining composite endpoints to include continuous measures and vascular and gastrointestinal domains
Original publication
Expert viewpoint on endpoints in systemic sclerosis: current and future outlook. RMD Open. Published 15 July 2026. doi:10. 1136/ rmdopen-2026-006784
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