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Randomised controlled trials in systemic sclerosis: patient selection and endpoints for next generation trials
Francesco Del Galdo1, Collette Hartley1, Yannick Allanore2
1Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; National Institute of Health Research Biomedical Research Centre, Leeds Teaching Hospital Trust, Leeds, UK.
The Lancet. Rheumatology
|January 24, 2024
Summary
Systemic sclerosis trial designs are evolving. Recent successes target tissue damage, not just immune activation, prompting a re-evaluation of future clinical trial strategies for this complex autoimmune disease.
Area of Science:
- Rheumatology
- Immunology
- Clinical Trial Design
Background:
- Systemic sclerosis (SSc) exhibits significant heterogeneity in its natural history, complicating clinical management and research.
- Current SSc research often targets immune activation, reflecting its autoimmune nature.
- Recent successful Phase 3 trials have focused on pathways linked to tissue damage, not systemic immune responses.
Purpose of the Study:
- To review recent randomized controlled trials (RCTs) relevant to systemic sclerosis (SSc) strategies.
- To identify key considerations for designing future SSc clinical trials.
- To align trial design with advances in understanding SSc pathogenesis and natural history.
Main Methods:
- Review of randomized controlled trials (RCTs) from the past four years.
- Analysis of trial outcomes in relation to targeted pathways (immune activation vs. tissue damage).
- Synthesis of findings to inform future trial design strategies for SSc.
Main Results:
- Positive SSc trial results have emerged from targeting tissue damage pathways.
- This success suggests a potential selection bias in focusing solely on systemic immune activation.
- Approved therapies represent significant progress for this challenging autoimmune condition.
Conclusions:
- Future SSc trial design should consider targeting tissue damage pathways.
- A deeper understanding of SSc pathogenesis and natural history is crucial for effective trial development.
- The review highlights the need for adaptive and refined strategies in SSc clinical research.
