6/29/23, 11:45 PM STELLAR Pathway Feedback Search Clinical Topics Home Studies STELLAR STELLAR Disease Pulmonary hypertension 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 N = 323 21.0% male 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; human immunodeficiency virus infection, or VOD 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 https://web.pathway.md/studies/rectWIu2sb5h0nA6E 1/2 6/29/23, 11:45 PM STELLAR Pathway Improvement in median 6-minute walk distance at week 24 34.4 m 34.4 25.8 m 17.2 m 8.6 m Significant increase 1 0.0 m Sotatercept Placebo Significant increase in 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 composite of multicomponent improvement of 6-minute walk distance, N- terminal pro-B-type natriuretic peptide level, and WHO functional class (38.9% vs. 10.1%; AD 28.8%, 95% CI 11.71 to 45.89) Significant increase in median reduction in 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) Significant increase in median reduction in N-terminal pro-B-type natriuretic peptide 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. Open reference URL https://web.pathway.md/studies/rectWIu2sb5h0nA6E 2/2