Sotatercept Reduces Risk for Clinical Worsening in Adults With Recently Diagnosed PAH

THURSDAY, Oct. 9, 2025 (HealthDay News) -- The addition of sotatercept, an activin-signaling inhibitor, to background therapy results in a lower risk for clinical worsening among adults with pulmonary arterial hypertension (PAH) who were diagnosed less than a year earlier, according to a study published online Sept. 30 in the New England Journal of Medicine.Vallerie V. McLaughlin, M.D., from the University of Michigan Medical School in Ann Arbor, and colleagues enrolled adults with World Health Organization functional class II or III PAH who had received a diagnosis less than one year earlier, had an intermediate or high risk for death, and were receiving double or triple background therapy in a phase 3 trial. Patients were randomly assigned to receive add-on therapy with subcutaneous sotatercept or placebo every 21 days.After the reporting of positive results from previous sotatercept trials, the trial was stopped early due to loss of clinical equipoise. Overall, 320 patients were included -- 160 each in the sotatercept and placebo groups -- and were followed for a median of 13.2 months. The researchers found that at least one primary end point event (clinical worsening, a composite of death from any cause, unplanned hospitalization lasting at least 24 hours for worsening of PAH, atrial septostomy, lung transplantation, or deterioration in performance in exercise testing due to PAH) occurred in 10.6 and 36.9 percent in the sotatercept and placebo groups, respectively (hazard ratio, 0.24)."These results are incredibly promising for patients early in their journey with pulmonary arterial hypertension, which still has limited treatment options," McLaughlin said in a statement.Several authors disclosed ties to pharmaceutical companies, including Merck, which manufactures sotatercept and funded the study.Abstract/Full Text (subscription or payment may be required).Sign up for our weekly HealthDay newsletter