Systemic sclerosis & Raynaud's
Biomarker analysis from the phase 2b randomized placebo-controlled trial of riociguat in early diffuse cutaneous systemic sclerosis
Authors' conclusion
Plasma cGMP increased with riociguat, suggesting engagement with the nitric oxide-soluble guanylate cyclase-cGMP pathway. Riociguat was associated with a significant reduction in sPECAM-1 (an angiogenic biomarker) vs placebo.
Study context
- Population
- Patients with early dcSSc in the RISE-SSc trial
- Participants
- 60 vs 61
- Comparison
- Riociguat vs placebo for 52 weeks
- Riociguatn = 60
- Placebon = 61reference
- Primary endpoint
- Change in plasma cyclic guanosine monophosphate (cGMP) (target engagement biomarker)
- Follow-up
- Week 14
Methodological detailsphase 2b, placebo-controlled, biomarker analysis
- Phase 2b
- Placebo-controlled
- Biomarker analysis
Primary result
As reported in the abstract
Plasma cGMP increase
P < 0.001
Further findings
| Outcome | P value |
|---|---|
| Serum sPECAM-1 · week 14Decreased with riociguat vs placebo | P = 0.004 |
| Serum CXCL-4 · week 14Decreased with riociguat vs placebo | P = 0.008 |
Skin collagen markers · week 14
- No differences between the two groups
Higher baseline serum sPECAM-1 and larger mRSS reduction with riociguat vs placebo · week 52
- Interaction P-value
- 0.004
αSMA-positive cells in baseline skin biopsies and larger mRSS reduction with riociguat vs placebo · week 52
- Interaction P-value
- 0.02
Original publication
Biomarker analysis from the phase 2b randomized placebo-controlled trial of riociguat in early diffuse cutaneous systemic sclerosis. Rheumatology (Oxford). Published 9 March 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →