Pulmonary vascular disease & thromboembolismRandomised controlled trial
Sotatercept for Pulmonary Arterial Hypertension within the First Year after Diagnosis
- Randomised controlled trial
- phase 3
- placebo-controlled
- stopped early
- Stopped early owing to loss of clinical equipoise after positive results from previous sotatercept trials
Authors' conclusion
Among adults with pulmonary arterial hypertension who had received the diagnosis less than 1 year earlier, the addition of sotatercept to background therapy resulted in a lower risk of clinical worsening than placebo.
Study context
- Population
- Adults with WHO functional class II or III pulmonary arterial hypertension diagnosed <1 year earlier, at intermediate or high risk of death, on double or triple background therapymedian follow-up 13.2 months
- Participants
- 320 adults
- Comparison
- Add-on sotatercept vs placebo
- Sotaterceptn = 160
- Placebon = 160reference
- Primary endpoint
- Clinical worsening (death from any cause, unplanned hospitalization ≥24 h for worsening PAH, atrial septostomy, lung transplantation, or deterioration in exercise testing due to PAH), time to first event
Primary result
Clinical worsening
Hazard ratio
0.24
95% CI 0.14–0.41
P < 0.001
Events by treatment group
Sotatercept vs Placebo
HR 0.24 (95% CI 0.14–0.41); P < 0.001
As reported in the abstract
Further findings
Deterioration in exercise testing due to PAH
Unplanned hospitalization for worsening PAH
Death from any cause
Atrial septostomy or lung transplantation
- No cases occurred
Safety
- Most common adverse events with sotatercept
- 31.9% · Epistaxis · Telangiectasia 26.2%
Original publication
Sotatercept for Pulmonary Arterial Hypertension within the First Year after Diagnosis. N Engl J Med. Published 30 September 2025. doi:10.1056/nejmoa2508170
Summarised from the published abstract; every number is checked against it