STELLAR
Trial question
What is the role of sotatercept in patients with pulmonary arterial hypertension?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
79.0% female
21.0% male
N = 323
323 patients (256 female, 67 male).
Inclusion criteria: adult patients with pulmonary arterial hypertension who were receiving stable background therapy.
Key exclusion criteria: pulmonary arterial hypertension subtypes associated with portopulmonary disease; schistosomiasis; HIV infection, or veno-occlusive disease.
Interventions
N=163 sotatercept (a subcutaneous starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks).
N=160 placebo (matching placebo every 3 weeks).
Primary outcome
Improvement in median 6-minute walk distance at week 24
34.4 m
1 m
34.4 m
25.8 m
17.2 m
8.6 m
0.0 m
Sotatercept
Placebo
Significant
increase ▲
Significantly greater improvement in the median 6-minute walk distance at week 24 (34.4 m vs. 1 m; AD 33.4 m, 95% CI 13.58 to 53.22).
Secondary outcomes
Significant increase in 6-improvement of a multicomponent endpoint capturing change in 6-minute walk distance, N-terminal pro-BNP level, and WHO functional class (38.9% vs. 10.1%; AD 28.8%, 95% CI 11.71 to 45.89).
Significantly greater reduction in median pulmonary vascular resistance at week 24 (165.1 dyn.sec.cm-5 vs. -32.8 dyn.sec.cm-5; AD 197.9 dyn.sec.cm-5, 95% CI 80.47 to 315.33).
Significantly greater reduction in median N-terminal pro-BNP level at week 24 (230.3 pg/mL vs. -58.6 pg/mL; AD 288.9 pg/mL, 95% CI 117.48 to 460.32).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept was superior to placebo with respect to improvement in the median 6-minute walk distance at week 24.
Reference
Marius M Hoeper, David B Badesch, H Ardeschir Ghofrani et al. Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2023 Apr 20;388(16):1478-1490.
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