Compared with placebo, the fusion protein sotatercept improved exercise capacity in patients with pulmonary arterial hypertension who were receiving stable background therapy, the STELLAR trial shows. “Improvements were also observed in pulmonary vascular resistance, WHO functional class, [N-terminal pro–B-type natriuretic peptide] levels, risk of death assessed by means of the simplified French risk model, and the Physical Impacts and Cardiopulmonary Symptoms domain scores of the PAH-SYMPACT quality-of-life tool,” the authors write. “The risk of death or nonfatal clinical worsening events, assessed up to the end of the trial, was 84% lower with sotatercept than with placebo.”
The multicenter, double-blind, phase 3 trial included 163 adults with pulmonary arterial hypertension (WHO functional class II or III) receiving stable background therapy. After random assignment to subcutaneous sotatercept or placebo every 3 weeks, these changes were observed in a primary endpoint of the change from baseline at week 24 in the 6-minute walk distance: “The median change from baseline at week 24 in the 6-minute walk distance was 34.4 m (95% confidence interval [CI], 33.0 to 35.5) in the sotatercept group and 1.0 m (95% CI, −0.3 to 3.5) in the placebo group. The Hodges–Lehmann estimate of the difference between the sotatercept and placebo groups in the change from baseline at week 24 in the 6-minute walk distance was 40.8 m (95% CI, 27.5 to 54.1; P <0.001). The first eight secondary endpoints were significantly improved with sotatercept as compared with placebo, whereas the PAH-SYMPACT Cognitive/Emotional Impacts domain score was not. Adverse events that occurred more frequently with sotatercept than with placebo included epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure.”
Editorial: “The STELLAR trial provides encouraging data for a new direction in therapeutic strategies for pulmonary arterial hypertension, and it forces us to ask whether a new treatment era for the disorder has arrived,” editorialists write. “It’s too soon to know. But one thing is clear: the era of remarkable progress in the care of patients with this devastating disease has not come to an end.”