For patients receiving background therapy for pulmonary arterial hypertension, treatment with sotatercept results in a reduction in pulmonary vascular resistance, according to a study published in the April 1 issue of the New England Journal of Medicine.
Marc Humbert, M.D., Ph.D., from Hôpital Bicêtre in Paris, and colleagues conducted the 24-week placebo-controlled period of a multicenter phase 2 trial in which 106 adults receiving background therapy for pulmonary arterial hypertension were randomly assigned to receive subcutaneous sotatercept at a dose of 0.3 or 0.7 mg/kg body weight every three weeks or placebo. An 18-month active-drug extension period for this trial is currently ongoing.
The researchers found that the least-squares mean difference in the change from baseline to week 24 in pulmonary vascular resistance between the sotatercept 0.3-mg group and the placebo group was −145.8 dyn/sec/cm-5; the corresponding difference between the sotatercept 0.7-mg group and the placebo group was −239.5 dyn/sec/cm-5. At 24 weeks, the least-squares mean difference in the change from baseline in six-minute walk distance between the sotatercept 0.3-mg and placebo groups was 29.4 m; the corresponding difference between the sotatercept 0.7-mg and placebo groups was 21.4 m. There was also an association seen for sotatercept with a decrease in N-terminal pro-B-type natriuretic peptide levels. The most common hematologic adverse events were thrombocytopenia and an increased hemoglobin level.
“Treatment with sotatercept reduced pulmonary vascular resistance among patients with pulmonary arterial hypertension who were receiving stable background therapy, including prostacyclin infusion therapy,” the authors write.
The study was funded by Acceleron Pharma, the manufacturer of sotatercept.