Treatment with sotatercept, a therapeutic fusion protein, is associated with significant benefits for patients with pulmonary arterial hypertension (PAH), according to a new study published in the New England Journal of Medicine.
The PULSAR trial tracked more than 100 adult patients who had already been receiving background medical therapy for PAH. For 24 weeks, participants were given either a dose of sotatercept or a placebo once every three weeks. The study’s primary endpoint was the change in pulmonary vascular resistance over the course of those 24 weeks.
Overall, adding treatment with sotatercept to ongoing background therapy was associated with a significant reduction in pulmonary vascular resistance. Improvements were also seen in each patient’s exercise capacity—measured by their six-minute walk distance—and NT-proBNP levels.
“Sotatercept was shown to reduce pulmonary vascular resistance in patients receiving background monotherapy, double therapy, or triple therapy, including those who were receiving prostacyclin infusion therapy,” wrote lead author Marc Humbert, MD, PhD, from the department of respiratory and intensive care medicine at Hôpital Bicêtre in Paris, and colleagues. “The decrease in pulmonary vascular resistance in the sotatercept groups was achieved by reducing the mean pulmonary artery pressure, without causing a substantial change in cardiac output or pulmonary artery wedge pressure. Preclinical evidence suggests that sotatercept has a direct effect on pulmonary vascular remodeling, which may explain its clinical effect on pulmonary artery pressure.”
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According to disclosure documents, Humbert and others involved in this research received grants and personal fees from Acceleron Pharma, the manufacturer behind sotatercept, over the course of the PHARMA trial.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.