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Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): open-label, long-term extension of
Oliver Distler1, Yannick Allanore2, Christopher P Denton3
1Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
The Lancet. Rheumatology
|January 22, 2024
Summary
Long-term riociguat treatment in early diffuse cutaneous systemic sclerosis showed no new safety concerns. This extension study evaluated safety and treatment effects over an additional year.
Area of Science:
- Rheumatology
- Cardiology
- Pulmonology
Background:
- The Riociguat Safety and Efficacy in Patients with Diffuse Cutaneous Systemic Sclerosis (RISE-SSc) trial assessed riociguat in early diffuse cutaneous systemic sclerosis.
- A long-term extension evaluated the safety and exploratory treatment effects of riociguat for an additional year.
Purpose of the Study:
- To evaluate the long-term safety of riociguat in patients with early diffuse cutaneous systemic sclerosis.
- To explore potential treatment effects of riociguat over an extended period.
Main Methods:
- Patients completing the 52-week RISE-SSc trial were eligible for the long-term extension.
- Participants received riociguat, with dose adjustments over 10 weeks, followed by an open-label phase.
- Safety assessments included adverse events and serious adverse events.
Main Results:
- 87 patients entered the extension (42 riociguat-riociguat, 45 placebo-riociguat).
- 94% of patients experienced adverse events, mostly mild to moderate.
- No increase in pulmonary-related serious adverse events was observed in patients with interstitial lung disease.
Conclusions:
- Long-term riociguat administration did not reveal new safety signals in this patient population.
- The open-label nature of the extension and lack of a comparator group are study limitations.
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