LandmarkRCT

STELLAR

Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension

N Engl J Med, 2023 · Phase 3 multicenter double-blind randomized placebo-controlled trial (n=323)

Clinical question

Does add-on sotatercept improve exercise capacity in symptomatic PAH receiving stable background therapy?

Population: Adults with WHO functional class II-III pulmonary arterial hypertension on stable background therapy
Intervention: Subcutaneous sotatercept every 3 weeks in addition to background PAH therapy
Comparator: Placebo plus background PAH therapy
Primary outcome: Change from baseline in 6-minute walk distance at week 24
Result: Sotatercept improved 6-minute walk distance versus placebo, with a Hodges-Lehmann treatment difference of 40.8 m (95% CI 27.5 to 54.1; P<0.001), and improved multiple prespecified secondary endpoints. (+40.8 m in 6-minute walk distance, P<0.001)

What the trial found

Add-on sotatercept improved exercise capacity and several clinical/hemodynamic measures in symptomatic PAH on background therapy.

Current guideline position

Use according to contemporary PAH specialty guidance, regulatory labeling and risk-based treatment strategy; STELLAR is chronic PAH evidence, not an acute RV-crisis resuscitation trial.

Clinical interpretation

Introduced activin-signaling inhibition as an effective additional pathway for PAH therapy; monitor adverse effects including epistaxis/telangiectasia, increased hemoglobin, thrombocytopenia and blood-pressure effects.

Clinical Context & Relevant Topics (1)

Disease Reference

Pulmonary Hypertension & Acute Decompensation

Hemodynamic classification, right ventricular afterload reduction, selective pulmonary vasodilation, and pulmonary hypertensive crisis management.

View Topic Context →