6/29/23, 1:45 AM PULSAR (low-dose sotatercept) Pathway Feedback Search Clinical Topics Home Studies PULSAR (low-dose sotatercept) PULSAR (low-dose sotatercept) Disease Pulmonary hypertension Trial question What is the role of low-dose sotatercept in patients with pulmonary arterial hypertension? Study design Multi-center Double blinded RCT Population Characteristics of study participants 86.0% female N = 64 14.0% male 64 patients (55 female, 9 male) Inclusion criteria: adults who were receiving background therapy for pulmonary arterial hypertension Key exclusion criteria: portopulmonary disease; schistosomiasis; and human immunodeficiency virus infection-associated pulmonary arterial hypertension; portal hypertension or chronic liver disease Interventions N=32 low-dose sotatercept (subcutaneous dose of 0.3 mg/kg every 3 weeks for 24 weeks) N=32 placebo (matching placebo every 3 weeks for 24 weeks) Primary outcome https://web.pathway.md/studies/recEgbg5w6SnRUMwg 1/2 6/29/23, 1:45 AM PULSAR (low-dose sotatercept) Pathway Pulmonary vascular resistance reduction at week 24 162.2 dyn s/ 162.2 121.6 dyn s/ 81.1 dyn s/ 40.5 dyn s/ Significant increase 16.4 0.0 dyn s/ Low-dose sotatercept Placebo Significant increase in pulmonary vascular resistance reduction at week 24 (162.2 dyn s/cm vs. 16.4 dyn s/cm ; AD 145.8 dyn s/cm , 95% CI 50.6 to 241) Secondary outcomes Significant increase in improvement in 6-minute walk distance at week 24 (58.1 m vs. 28.7 m; AD 29.4 m, 95% CI 3.8 to 55) Significant increase in N-terminal pro-BNP level reduction at week 24 (621.1 pg/mL vs. -310.4 pg/mL; AD 931.5 pg/mL, 95% CI 509.7 to 1353.2) Safety outcomes No significant difference in any adverse event. Significant difference in thrombocytopenia (6% vs. 0%). Conclusion In adults who were receiving background therapy for pulmonary arterial hypertension, low-dose sotatercept was superior to placebo with respect to pulmonary vascular resistance reduction at week 24. Reference Marc Humbert, Vallerie McLaughlin, J Simon R Gibbs et al. Sotatercept for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2021 Apr 1;384(13):1204-1215. Open reference URL https://web.pathway.md/studies/recEgbg5w6SnRUMwg 2/2