- Question
- Does adding sotatercept to background therapy improve exercise capacity in patients with pulmonary arterial hypertension?
- Design
- Phase 3, multicenter, randomized 1:1, double-blind, placebo-controlled trial; the registry lists 324 participants. Study drug was given subcutaneously every 3 weeks.
- Population
- Adults with pulmonary arterial hypertension in WHO functional class II or III receiving stable background therapy.
- Intervention
- Subcutaneous sotatercept with a starting dose of 0.3 mg per kilogram of body weight and a target dose of 0.7 mg per kilogram every 3 weeks, added to background therapy.
- Control
- Subcutaneous placebo every 3 weeks, added to background therapy.
- Primary outcome
- Change from baseline at week 24 in 6-minute walk distance.
- Results
- The median change in 6-minute walk distance was 34.4 m (95% CI, 33.0 to 35.5) with sotatercept and 1.0 m (95% CI, -0.3 to 3.5) with placebo; the Hodges-Lehmann estimate of the difference was 40.8 m (95% CI, 27.5 to 54.1; P<0.001). Eight of the nine hierarchically tested secondary end points were significantly improved, the exception being the PAH-SYMPACT Cognitive/Emotional Impacts domain score.
- Safety
- Epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure occurred more frequently with sotatercept.
- Conclusion
- In patients with pulmonary arterial hypertension on stable background therapy, sotatercept improved exercise capacity more than placebo.
- Why it matters
- It introduced a new class of treatment acting on the activin and growth-factor signaling pathway, added on top of background vasodilator therapy in pulmonary arterial hypertension.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026