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Study Design and Clinical Data

STELLAR study

The efficacy of WINREVAIR was evaluated in adult patients with PAH in STELLAR, a 24-week, global, double-blind, placebo-controlled, multicenter, parallel-group clinical trial.

aAll patients were on stable doses of background therapy for PAH for ≥90 days before enrollment and continued receiving background therapy throughout the trial.1

SC = subcutaneous; Q3W = every 3 weeks.

The STELLAR trial excluded patients diagnosed with HIV-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH, and pulmonary veno-occlusive disease.


Efficacy endpoints


Primary endpoint

  • Change from baseline in 6-minute walk distance (6MWD) at week 24


Secondary endpoints

  • Proportion of patients achieving multicomponent improvement (MCI) from baseline at week 24, defined as satisfying all 3 of the following criteria:
    • Improvement in 6MWD (increase ≥30 m)
    • Improvement in N-terminal pro-B-type natriuretic peptide (NT-proBNP) (decrease in NT-proBNP ≥30% or maintenance/achievement of NT-proBNP level <300 pg/mL)
    • Improvement in World Health Organization (WHO) functional class (FC) or maintenance of WHO FC II
  • Change from baseline pulmonary vascular resistance (PVR) at week 24
  • Change from baseline NT-proBNP levels at week 24
  • Proportion of patients who improve WHO FC from baseline at week 24
  • Time to death or the first occurrence of a clinical worsening event
    • Clinical worsening events included: a) worsening-related listing for lung and/or heart transplant; b) need to initiate rescue therapy with an approved background PAH therapy or the need to increase the dose of infusion prostacyclin by 10% or more; c) need for atrial septostomy; d) hospitalization for worsening of PAH (≥24 hours); e) deterioration of PAH defined by both of the following events occurring at any time (even if they began at different times) as compared to their baseline values: worsened WHO FC (II to III, III to IV, II to IV, etc.) and decrease in 6MWD by ≥15% confirmed by 2 tests at least 4 hours apart but no more than 1 week.
  • Proportion of patients who maintained or achieved a low risk score using the French risk score calculator at week 24 vs baseline
  • Change from baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT®) at week 24
  • Change from baseline in the Cardiopulmonary Symptoms Domain Score of PAH-SYMPACT® at week 24
  • Change from baseline in the Cognitive/Emotional Impacts Domain Score of PAH-SYMPACT® at week 24

Select baseline characteristics

The demographic and baseline clinical levels were generally similar between the WINREVAIR and placebo groups.

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Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vestibulum in nu Ila odio. Donec vitae libero hendrerit, tincidunt erat a, aliquam arcu. Proin vel dictum risus. Nunc aliquam pellentesque magna, ut dignissim mi viverra sed. Nunc eget dolor quis erat rhoncus varius ut vel urna. Etiam commodo odio felis, nee mattis ex lobortis quis. Nulla eleifend eleifendjusto. Phasellus varius tempor lacinia. Suspendisse lacus ante, consequat nee orci et, congue dictum lectus. Phasellus lectus nisi, maximus ac sem ut, varius blandit sapien. Nam efficitur sapien sed dui mattis, nee varius elit egestas. Mauris commodo nee neque sit amet sodales.

Ut congue imperdiet diam, non faucibus sapien finibus non. Maecenas lacus mi, sodales non convallis non, malesuada at mi. Maecenas risus eras, luctus eget dapibus quis, semper vel massa. Phasellus euismod tortor id tortor interdum maxim us. Etiam sodales erat sit amet quam sollicitudin hendrerit. Sed sollicitudin lectus ut mi lobortis, vel efficitur arcu ullamcorper. Nam aliquam eget ligula sit amet feugiat. Sed vulputate, arcu et cursus ultrices, velit nisl feugiat mauris, ut eleifend ante dolor vitae massa. Praesent lacinia purus leo, quis porta ipsum commodo in. Donec pretium leo ante, id faucibus purus bibendum id. Donec iaculis augue augue, aliquet pulvinar mi vehicula in. Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas. Phasellus enim massa, tempor non elit congue, rutrum rhoncus nulla. Donec finibus eu ipsum vitae porttitor. Vestibulum tincidunt tincidunt quam, id lobortis eras luctus ac. Pellentesque faucibus lacus vel elit viverra fringilla.


Reference:
1. Hoeper MM, Badesch DB, Ghofrani HA, et al; STELLAR Trial Investigators. Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. N Engl J Med. 2023;388(16):1478-1490.

Click the drop down below to learn more about the primary efficacy endpoint

In STELLAR, a 24-week study of adult patients with PAH on stable background therapy1:

WINREVAIR significantly increased exercise capacity, as measured by an improvement in
6-minute walk distance (6MWD) from baseline

aHodges-Lehmann location shift from placebo estimate (median of the placebo-adjusted change from baseline at week 24).

Change from baseline in 6MWD at week 24 for subjects who died was assigned a value of -2000 meters to receive the worst rank. Change from baseline in 6MWD at week 24 for subjects who have missing data due to a non-fatal clinical worsening event was imputed to -1000 meters to receive the next-worst rank.


Placebo-adjusted change from baseline in 6MWD (meters) at week 24 in subgroups

aHodges-Lehmann location shift from placebo estimate (median of the placebo-adjusted change from baseline at week 24).

Change from baseline in 6MWD at week 24 for subjects who died was assigned a value of -2000 meters to receive the worst rank. Change from baseline in 6MWD at week 24 for subjects who have missing data due to a non-fatal clinical worsening event was imputed to -1000 meters to receive the next-worst rank.

ASE = asymptotic standard error; CHD = congenital heart disease; HL = Hodges-Lehmann; s/p = systemic-to-pulmonary.


STELLAR primary endpoint: Change in 6MWD from baseline at 24 weeks1

While the primary endpoint in the STELLAR trial was the placebo-adjusted median change increase in 6MWD at 24 weeks, this graph shows the observed mean change in 6MWD (in meters, 95% CI). Walking distance was recorded at prespecified trial visits (weeks 0, 3, 12, and 24) during the first 24 weeks of the trial.a

The confidence intervals have not been adjusted for multiplicity and cannot be used to infer definitive treatment effects.

aThe data shown are for patients with available data (observed) over time.

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Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vestibulum in nu Ila odio. Donec vitae libero hendrerit, tincidunt erat a, aliquam arcu. Proin vel dictum risus. Nunc aliquam pellentesque magna, ut dignissim mi viverra sed. Nunc eget dolor quis erat rhoncus varius ut vel urna. Etiam commodo odio felis, nee mattis ex lobortis quis. Nulla eleifend eleifendjusto. Phasellus varius tempor lacinia. Suspendisse lacus ante, consequat nee orci et, congue dictum lectus. Phasellus lectus nisi, maximus ac sem ut, varius blandit sapien. Nam efficitur sapien sed dui mattis, nee varius elit egestas. Mauris commodo nee neque sit amet sodales.

Ut congue imperdiet diam, non faucibus sapien finibus non. Maecenas lacus mi, sodales non convallis non, malesuada at mi. Maecenas risus eras, luctus eget dapibus quis, semper vel massa. Phasellus euismod tortor id tortor interdum maxim us. Etiam sodales erat sit amet quam sollicitudin hendrerit. Sed sollicitudin lectus ut mi lobortis, vel efficitur arcu ullamcorper. Nam aliquam eget ligula sit amet feugiat. Sed vulputate, arcu et cursus ultrices, velit nisl feugiat mauris, ut eleifend ante dolor vitae massa. Praesent lacinia purus leo, quis porta ipsum commodo in. Donec pretium leo ante, id faucibus purus bibendum id. Donec iaculis augue augue, aliquet pulvinar mi vehicula in. Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas. Phasellus enim massa, tempor non elit congue, rutrum rhoncus nulla. Donec finibus eu ipsum vitae porttitor. Vestibulum tincidunt tincidunt quam, id lobortis eras luctus ac. Pellentesque faucibus lacus vel elit viverra fringilla.

Reference:

1. Hoeper MM, Badesch DB, Ghofrani HA, et al; STELLAR Trial Investigators. Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. N Engl J Med. 2023;388(16):1478-1490.

Click the drop downs below to learn more about each secondary efficacy endpoint

In STELLAR, a 24-week study of adult patients with PAH on stable background therapy1:

Patients taking WINREVAIR experienced significant multicomponent improvement (MCI) vs placebo

MCI was defined as the proportion of patients who satisfied all 3 of the following criteria at week 24 relative to baseline:

  • Improvement in 6MWD (increase ≥30 m)
  • Improvement in NT-proBNP (decrease in ≥30% or maintenance/achievement of NT-proBNP level <300 pg/mL)
  • Improvement in WHO FC or maintenance of WHO FC II

aA missing result at week 24 not due to COVID-19 was considered a nonresponder. Subjects who missed assessments due to COVID-19 were removed from the denominator.
bComparison with placebo uses Cochran-Mantel-Haenszel method stratified by randomization factors.

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Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vestibulum in nu Ila odio. Donec vitae libero hendrerit, tincidunt erat a, aliquam arcu. Proin vel dictum risus. Nunc aliquam pellentesque magna, ut dignissim mi viverra sed. Nunc eget dolor quis erat rhoncus varius ut vel urna. Etiam commodo odio felis, nee mattis ex lobortis quis. Nulla eleifend eleifendjusto. Phasellus varius tempor lacinia. Suspendisse lacus ante, consequat nee orci et, congue dictum lectus. Phasellus lectus nisi, maximus ac sem ut, varius blandit sapien. Nam efficitur sapien sed dui mattis, nee varius elit egestas. Mauris commodo nee neque sit amet sodales.

Ut congue imperdiet diam, non faucibus sapien finibus non. Maecenas lacus mi, sodales non convallis non, malesuada at mi. Maecenas risus eras, luctus eget dapibus quis, semper vel massa. Phasellus euismod tortor id tortor interdum maxim us. Etiam sodales erat sit amet quam sollicitudin hendrerit. Sed sollicitudin lectus ut mi lobortis, vel efficitur arcu ullamcorper. Nam aliquam eget ligula sit amet feugiat. Sed vulputate, arcu et cursus ultrices, velit nisl feugiat mauris, ut eleifend ante dolor vitae massa. Praesent lacinia purus leo, quis porta ipsum commodo in. Donec pretium leo ante, id faucibus purus bibendum id. Donec iaculis augue augue, aliquet pulvinar mi vehicula in. Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas. Phasellus enim massa, tempor non elit congue, rutrum rhoncus nulla. Donec finibus eu ipsum vitae porttitor. Vestibulum tincidunt tincidunt quam, id lobortis eras luctus ac. Pellentesque faucibus lacus vel elit viverra fringilla.

Reference:
1. Hoeper MM, Badesch DB, Ghofrani HA, et al; STELLAR Trial Investigators. Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. N Engl J Med. 2023;388(16):1478-1490.

In STELLAR, a 24-week study of adult patients with PAH on stable background therapy1:

WINREVAIR demonstrated significant improvement in pulmonary vascular resistance (PVR) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) vs placebo

aHodges-Lehmann location shift from placebo estimate (median of the placebo-adjusted change from baseline at week 24).
bChange from baseline in PVR at week 24 for subjects who died was assigned as 20000 to receive the worst rank. Change from baseline in PVR at week 24 for subjects who had missing data due to a non-fatal clinical worsening event was imputed as 15000 to receive the next-worst rank.
cChange from baseline in NT-proBNP at week 24 for subjects who died was assigned as 200000 to receive the worst rank. Change from baseline in NT-proBNP at week 24 for subjects who had missing data due to a non-fatal clinical worsening event was imputed as 150000 to receive the next-worst rank.
dThere were 3 placebo participants with no NT-proBNP samples at any timepoint. In such cases, missing data were not imputed.
eWilcoxon p-value refers to p-value from the aligned rank-stratified Wilcoxon test with randomization factors as strata.


In STELLAR, a 24-week study of adult patients with PAH on stable background therapy1:

Prespecified subgroup analyses of select PAH etiologies in patients taking WINREVAIR vs placebo2,a

LIMITATIONS: STELLAR was not powered to detect differences in treatment effect in these subgroups, and the confidence intervals have not been adjusted for multiplicity. These subgroups contain modest and imbalanced patient numbers across treatment arms. Results from these prespecified subgroup analyses should be interpreted with caution.

  • aMedian change in PVR and NT-proBNP from baseline at week 24 for drug/toxin-induced PAH (WINREVAIR, n/N=7/163; placebo, n/N=4/160) and congenital heart disease with s/p shunt repair (WINREVAIR, n/N=9/163; placebo, n/N=7/160) were also included as part of this subgroup analysis.
    bThe graph plots the Hodges-Lehmann location shift point estimates (95% CI) for the median of the placebo-adjusted change from baseline at week 24 for each subgroup.
    cPatients with missing values due to death or non-fatal clinical worsening event were assigned worst and second-worst rank scores, respectively. Missing values due to reasons other than death or a non-fatal clinical worsening event were imputed using a fully conditional specification regression model, which assumed the data were missing at random.

Mean change from baseline at week 24 in mean pulmonary arterial pressure (mPAP)2,4

LIMITATIONS: This analysis was exploratory in nature and has not been adjusted for multiplicity. It cannot be used to establish definitive causal relationships or treatment effects. Results should be interpreted with caution.

  • aDerived from analysis of covariance (ANCOVA) model with treatment, randomization stratification factors of background therapy (monotherapy or double therapy vs triple therapy), and baseline WHO FC (II vs III) as fixed factors and the baseline parameter under evaluation as the covariate.
  • PVR = (mPAP-pulmonary arterial wedge pressure)/cardiac output.3
  • RHC = right heart catheterization.
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Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vestibulum in nu Ila odio. Donec vitae libero hendrerit, tincidunt erat a, aliquam arcu. Proin vel dictum risus. Nunc aliquam pellentesque magna, ut dignissim mi viverra sed. Nunc eget dolor quis erat rhoncus varius ut vel urna. Etiam commodo odio felis, nee mattis ex lobortis quis. Nulla eleifend eleifendjusto. Phasellus varius tempor lacinia. Suspendisse lacus ante, consequat nee orci et, congue dictum lectus. Phasellus lectus nisi, maximus ac sem ut, varius blandit sapien. Nam efficitur sapien sed dui mattis, nee varius elit egestas. Mauris commodo nee neque sit amet sodales.

Ut congue imperdiet diam, non faucibus sapien finibus non. Maecenas lacus mi, sodales non convallis non, malesuada at mi. Maecenas risus eras, luctus eget dapibus quis, semper vel massa. Phasellus euismod tortor id tortor interdum maxim us. Etiam sodales erat sit amet quam sollicitudin hendrerit. Sed sollicitudin lectus ut mi lobortis, vel efficitur arcu ullamcorper. Nam aliquam eget ligula sit amet feugiat. Sed vulputate, arcu et cursus ultrices, velit nisl feugiat mauris, ut eleifend ante dolor vitae massa. Praesent lacinia purus leo, quis porta ipsum commodo in. Donec pretium leo ante, id faucibus purus bibendum id. Donec iaculis augue augue, aliquet pulvinar mi vehicula in. Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas. Phasellus enim massa, tempor non elit congue, rutrum rhoncus nulla. Donec finibus eu ipsum vitae porttitor. Vestibulum tincidunt tincidunt quam, id lobortis eras luctus ac. Pellentesque faucibus lacus vel elit viverra fringilla.

References:
1. Hoeper MM, Badesch DB, Ghofrani HA, et al. Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. N Engl J Med. 2023;388(16):1478-1490. 2. Hoeper MM, Badesch DB, Ghofrani HA, et al; STELLAR Trial Investigators. Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. N Engl J Med. 2023;388(16)(suppl):S1-S69. 3. Simmoneau G, Montani D, Celermajer DS, et al. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019;53(1):1801913. 4. Humbert M, Kovacs G, Hoeper MM, et al. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Heart J. 2022;43(38):3618-3731. 

In STELLAR, a 24-week study of adult patients with PAH on stable background therapy1:

Significantly more patients taking WINREVAIR improved their World Health Organization (WHO) functional class (FC) vs placebo

aA missing result at week 24 not due to COVID-19 was considered a nonresponder. Subjects who missed assessments due to COVID-19 were removed from the denominator.
bComparison with placebo uses Cochran-Mantel-Haenszel method stratified by randomization factors.

[SSI PLACEHOLDER]

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vestibulum in nu Ila odio. Donec vitae libero hendrerit, tincidunt erat a, aliquam arcu. Proin vel dictum risus. Nunc aliquam pellentesque magna, ut dignissim mi viverra sed. Nunc eget dolor quis erat rhoncus varius ut vel urna. Etiam commodo odio felis, nee mattis ex lobortis quis. Nulla eleifend eleifendjusto. Phasellus varius tempor lacinia. Suspendisse lacus ante, consequat nee orci et, congue dictum lectus. Phasellus lectus nisi, maximus ac sem ut, varius blandit sapien. Nam efficitur sapien sed dui mattis, nee varius elit egestas. Mauris commodo nee neque sit amet sodales.

Ut congue imperdiet diam, non faucibus sapien finibus non. Maecenas lacus mi, sodales non convallis non, malesuada at mi. Maecenas risus eras, luctus eget dapibus quis, semper vel massa. Phasellus euismod tortor id tortor interdum maxim us. Etiam sodales erat sit amet quam sollicitudin hendrerit. Sed sollicitudin lectus ut mi lobortis, vel efficitur arcu ullamcorper. Nam aliquam eget ligula sit amet feugiat. Sed vulputate, arcu et cursus ultrices, velit nisl feugiat mauris, ut eleifend ante dolor vitae massa. Praesent lacinia purus leo, quis porta ipsum commodo in. Donec pretium leo ante, id faucibus purus bibendum id. Donec iaculis augue augue, aliquet pulvinar mi vehicula in. Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas. Phasellus enim massa, tempor non elit congue, rutrum rhoncus nulla. Donec finibus eu ipsum vitae porttitor. Vestibulum tincidunt tincidunt quam, id lobortis eras luctus ac. Pellentesque faucibus lacus vel elit viverra fringilla.

Reference:
1. Hoeper MM, Badesch DB, Ghofrani HA, et al. Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. N Engl J Med. 2023;388(16):1478-1490.

In STELLAR, a 24-week study of adult patients with PAH on stable background therapy1:

WINREVAIR significantly reduced the occurrence of death or clinical worsening events vs placebo

Nine of 163 (5.5%) patients in the WINREVAIR group experienced death or at least one clinical worsening event, compared with 42 of 160 (26.3%) patients in the placebo group.

Clinical worsening events and death were captured until the last patient completed the week 24 visit (data up to the data cutoff). The median duration of exposure was 33.6 weeks.

aTime to death or the first occurrence of any of the following clinical worsening events: a) worsening-related listing for lung and/or heart transplant; b) need to initiate rescue therapy with an approved background PAH therapy or the need to increase the dose of infusion prostacyclin by 10% or more; c) need for atrial septostomy; d) hospitalization for worsening of PAH (≥24 hours); e) deterioration of PAH defined by both of the following events occurring at any time (even if they began at different times) as compared to their baseline values: worsened WHO FC (II to III, III to IV, II to IV, etc.) and decrease in 6MWD by ≥15% confirmed by 2 tests at least 4 hours apart but no more than one week.
bLog-rank test comparison with placebo stratified by the randomization factors.
cThe hazard ratio (HR) (WINREVAIR/placebo) was derived from a Cox proportional hazard model with treatment group as the covariate stratified by the randomization factors.
dA subject can have more than one assessment recorded for their first event of clinical worsening. There were 3 placebo subjects and 0 WINREVAIR subjects who had more than one assessment recorded for their first event of clinical worsening.
eDeterioration of PAH therapy is defined by both of the following events occurring at any time, even if they began at different times, as compared to their baseline values: (a) worsened WHO functional class (II to III, III to IV, II to IV, etc.); and (b) decrease in 6MWD by ≥15% (confirmed by two 6-minute walk tests at least 4 hours apart but no more than one week).

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Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vestibulum in nu Ila odio. Donec vitae libero hendrerit, tincidunt erat a, aliquam arcu. Proin vel dictum risus. Nunc aliquam pellentesque magna, ut dignissim mi viverra sed. Nunc eget dolor quis erat rhoncus varius ut vel urna. Etiam commodo odio felis, nee mattis ex lobortis quis. Nulla eleifend eleifendjusto. Phasellus varius tempor lacinia. Suspendisse lacus ante, consequat nee orci et, congue dictum lectus. Phasellus lectus nisi, maximus ac sem ut, varius blandit sapien. Nam efficitur sapien sed dui mattis, nee varius elit egestas. Mauris commodo nee neque sit amet sodales.

Ut congue imperdiet diam, non faucibus sapien finibus non. Maecenas lacus mi, sodales non convallis non, malesuada at mi. Maecenas risus eras, luctus eget dapibus quis, semper vel massa. Phasellus euismod tortor id tortor interdum maxim us. Etiam sodales erat sit amet quam sollicitudin hendrerit. Sed sollicitudin lectus ut mi lobortis, vel efficitur arcu ullamcorper. Nam aliquam eget ligula sit amet feugiat. Sed vulputate, arcu et cursus ultrices, velit nisl feugiat mauris, ut eleifend ante dolor vitae massa. Praesent lacinia purus leo, quis porta ipsum commodo in. Donec pretium leo ante, id faucibus purus bibendum id. Donec iaculis augue augue, aliquet pulvinar mi vehicula in. Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas. Phasellus enim massa, tempor non elit congue, rutrum rhoncus nulla. Donec finibus eu ipsum vitae porttitor. Vestibulum tincidunt tincidunt quam, id lobortis eras luctus ac. Pellentesque faucibus lacus vel elit viverra fringilla.

Reference:
1. Hoeper MM, Badesch DB, Ghofrani HA, et al. Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. N Engl J Med. 2023;388(16):1478-1490.

In STELLAR, a 24-week study of adult patients with PAH on stable background therapy1:

Significantly more patients taking WINREVAIR maintained or achieved a low French risk score vs placebo

aComparison with placebo uses Cochran-Mantel-Haenszel method stratified by randomization factors.

[SSI PLACEHOLDER]

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vestibulum in nu Ila odio. Donec vitae libero hendrerit, tincidunt erat a, aliquam arcu. Proin vel dictum risus. Nunc aliquam pellentesque magna, ut dignissim mi viverra sed. Nunc eget dolor quis erat rhoncus varius ut vel urna. Etiam commodo odio felis, nee mattis ex lobortis quis. Nulla eleifend eleifendjusto. Phasellus varius tempor lacinia. Suspendisse lacus ante, consequat nee orci et, congue dictum lectus. Phasellus lectus nisi, maximus ac sem ut, varius blandit sapien. Nam efficitur sapien sed dui mattis, nee varius elit egestas. Mauris commodo nee neque sit amet sodales.

Ut congue imperdiet diam, non faucibus sapien finibus non. Maecenas lacus mi, sodales non convallis non, malesuada at mi. Maecenas risus eras, luctus eget dapibus quis, semper vel massa. Phasellus euismod tortor id tortor interdum maxim us. Etiam sodales erat sit amet quam sollicitudin hendrerit. Sed sollicitudin lectus ut mi lobortis, vel efficitur arcu ullamcorper. Nam aliquam eget ligula sit amet feugiat. Sed vulputate, arcu et cursus ultrices, velit nisl feugiat mauris, ut eleifend ante dolor vitae massa. Praesent lacinia purus leo, quis porta ipsum commodo in. Donec pretium leo ante, id faucibus purus bibendum id. Donec iaculis augue augue, aliquet pulvinar mi vehicula in. Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas. Phasellus enim massa, tempor non elit congue, rutrum rhoncus nulla. Donec finibus eu ipsum vitae porttitor. Vestibulum tincidunt tincidunt quam, id lobortis eras luctus ac. Pellentesque faucibus lacus vel elit viverra fringilla.

Reference:
1. Hoeper MM, Badesch DB, Ghofrani HA, et al. Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. N Engl J Med. 2023;388(16):1478-1490.

In STELLAR, a 24-week study of adult patients with PAH on stable background therapy1:

WINREVAIR significantly improved patients’ PAH-SYMPACT® Physical Impacts and Cardiopulmonary Symptoms Domain Scores vs placebo

The change from baseline in the Cognitive/Emotional Impacts Domain Score of Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT®) of WINREVAIR vs placebo at week 24 was not statistically significant (-0.16a,b; 95% Cl: -0.399, 0.084; p=0.156c).

PAH-SYMPACT® is a disease-specific patient-reported outcome instrument. Domain scores range from 0 to 4 with higher scores indicating greater severity of symptoms.1

aHodges-Lehmann location shift from placebo estimate (median of the placebo-adjusted change from baseline at week 24).
bChange from baseline in SYMPACT scores at week 24 for subjects who died was assigned as 200 to receive the worst rank. Change from baseline in SYMPACT scores at week 24 for subjects who had missing data due to a non-fatal clinical worsening event was imputed as 150 to receive the next-worst rank.
cWilcoxon p-value refers to p-value from the aligned rank-stratified Wilcoxon test with randomization factors as strata.

[SSI PLACEHOLDER]

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Reference: 1. Hoeper MM, Badesch DB, Ghofrani HA, et al; STELLAR Trial Investigators. Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. N Engl J Med. 2023;388(16):1478-1490.

WINREVAIR delivered improvement across 8 of 9 secondary endpoints