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Randomised controlled trial

Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension

N Engl J MedPublished

  • Randomised controlled trial
  • multicentre
  • double-blind
  • phase 3
  • placebo-controlled
Read the original article ↗

Authors' conclusion

In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo.

Study context

Population
Adults with pulmonary arterial hypertension (WHO functional class II or III) on stable background therapy
Participants
163 vs 160
Comparison
Sotatercept vs placebo
  • Sotaterceptn = 163
  • Placebon = 160reference
Primary endpoint
Change from baseline in 6-minute walk distance
Follow-up
Week 24

Primary result

As reported in the abstract

Hodges-Lehmann estimate of the difference

40.8 m

95% CI 27.5–54.1

P < 0.001

By group

Sotatercept vs Placebo
Hodges-Lehmann estimate of the difference 40.8 m (95% CI 27.5–54.1); P < 0.001

Secondary outcomes

First eight hierarchically tested secondary end points (multicomponent improvement, pulmonary vascular resistance, NT-proBNP, WHO functional class, time to death or clinical worsening, French risk score, PAH-SYMPACT Physical Impacts and Cardiopulmonary Symptoms) · week 24

Significantly improved with sotatercept vs placebo

PAH-SYMPACT Cognitive/Emotional Impacts domain score · week 24

Not significantly improved with sotatercept vs placebo

Original publication

Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. N Engl J Med. Published 6 March 2023. doi:10.1056/nejmoa2213558
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Summarised from the published abstract; every number is checked against it