Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc)

The Phase 2b RISE-SSc trial investigated the safety and efficacy of Riociguat compared to a placebo in early diffuse cutaneous systemic sclerosis. A long-term extension of the study followed patients for an additional year. Out of 121 patients, 87 (72%) continued into the long-term extension. Most patients experienced mild to moderate adverse events, and there was no increase in serious lung-related adverse events in patients with interstitial lung disease. The study found no new safety concerns with long-term Riociguat treatment for early diffuse cutaneous systemic sclerosis, although it lacked a comparator group in its open-label extension.