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.
