Systemic sclerosis & Raynaud's
Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): open-label, long-term extension of a phase 2b, randomised, placebo-controlled trial
Authors' conclusion
No new safety signals were observed with long-term riociguat in patients with early diffuse cutaneous systemic sclerosis.
Study context
- Population
- Patients with early dcSSc who completed the 52-week double-blind phase of RISE-SScof 121 in main study
- Participants
- 87 patients
- Comparison
- Riociguat continued vs switched from placebo to riociguat
- Riociguat-riociguatn = 42
- Placebo-riociguatn = 45
- Primary endpoint
- Safety, including adverse events and serious adverse events
- Follow-up
- Additional year
Methodological details10-week double-blind dose-adjustment phase, descriptive statistical analyses, Enrolment to RISE-SSc between Jan 15, 2015, and Dec 8, 2016
- 10-week double-blind dose-adjustment phase
- Descriptive statistical analyses
- Enrolment to RISE-SSc between Jan 15, 2015, and Dec 8, 2016
Primary result
As reported in the abstract
Patients with an adverse event
Patients with an adverse event (overall)
82 (94%) of 87
Safety
Adverse events of mild to moderate severity
- Mild to moderate adverse events (overall)
- 66 [76%] of 87
Pulmonary-related serious adverse events in patients with ILD
- No increase
Original publication
Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): open-label, long-term extension of a phase 2b, randomised, placebo-controlled trial. Lancet Rheumatol. Published November 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →