New Data Bolsters Case for Sotatercept as Add-on Therapy in Pulmonary Arterial Hypertension
New Orleans, louisiana – Presented at the 2025 american Heart Association Scientific Sessions (November 7-10), pooled analysis from the PULSAR, STELLAR, and ZENITH trials demonstrates critically important benefit from adding sotatercept (Winrevair) to existing therapies for pulmonary arterial hypertension (PAH), even in patients already heavily pretreated. The findings suggest sotatercept addresses limitations of current PAH treatments and offers a potential pathway to improved outcomes for a broader patient population.
Despite decades of advances in PAH treatment with therapies targeting three distinct pathways,significant mortality remains a challenge. Sotatercept, a first-in-class activin signaling inhibitor, has shown promise in clinical trials by improving right ventricular function and exercise capacity when added to background PAH therapy. Vallerie McLaughlin, MD, highlighted the importance of this addition, stating, ”We still lose far too many patients to this disease… [and] patients in these trials where very highly pretreated with those other conventional therapies and still experienced a benefit from the addition of sotatercept.”
The analysis presented by Dr. McLaughlin indicates sotatercept may benefit patients across the risk spectrum. While acknowledging the importance of risk stratification, she emphasized considering the therapy even for those classified as low-risk. “Certainly, patients who aren’t achieving low-risk [status] need additional therapy, and we consider sotatercept in those patients. But there are many patients who technically meet low-risk [status] but still have a high burden of disease, still have bad RV [right ventricular] dysfunction that we also consider it in.”
Dr. McLaughlin underscored a proactive approach to patient care,stating,”Every time I see a patient,no matter what the risk category is,I think,’how can I optimize this patient’s long-term outcomes?’ and I’m frequently enough thinking about whether or not sotatercept is an appropriate therapy in that patient.” This suggests a shift towards earlier consideration of sotatercept as a means of maximizing long-term benefits for individuals living with PAH.
