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Selected secondary endpoints

In STELLAR, a 24-week study of adults with PAH (WHO FC II or III) on background therapy:

See Study Design

MORE than 2x as many patients taking WINREVAIR improved by at least 1 WHO FC

29% of patients on WINREVAIR (n/N=48/163) improved by at least 1 WHO FC vs 14% of patients on placebo (n/N=22/159) at week 24 from baseline (P<0.001).
29% of patients on WINREVAIR (n/N=48/163) improved by at least 1 WHO FC vs 14% of patients on placebo (n/N=22/159) at week 24 from baseline (P<0.001).

At week 24 from baseline (P<0.001)

aOne patient in the group had missing data owing to COVID-19 and was excluded from the analysis.1

Hemodynamics and Cardiac Function

A greater decrease from baseline was observed with WINREVAIR vs placebo in 2 key measures of hemodynamics and cardiac function

PVR

-235 dynes*sec/cm5

Median treatment difference at week 24
(95% CI: -288, -181)

(-2.9 Wood units)

NT-proBNP

-442 pg/mL

Median treatment difference at week 24
(95% CI: -574, -310)

CI = confidence interval; PVR = pulmonary vascular resistance; NT-proBNP = N-terminal pro-B-type natriuretic peptide.

MORE time—WINREVAIRTM (sotatercept-csrk) substantially reduced the occurrence of death from any cause or PAH clinical worsening events vs placebo

Time to death from any cause or first occurrence of PAH clinical worsening event
This Kaplan-Meier Plot shows the time to death from any cause or first occurrence of a PAH clinical worsening event in the WINREVAIR and placebo groups in STELLAR. Time is on the X-axis with markers at 0, 10, 20, 30, 40, and 50. On the Y-axis, survival probability is shown from 0 to 1.0. The number of patients at risk at baseline and at weeks 10, 20, 30, 40, and 50 is shown below the plot. The line for the WINREVAIR group is solid magenta, and the line for the placebo group is a grey dashed line.
This Kaplan-Meier Plot shows the time to death from any cause or first occurrence of a PAH clinical worsening event in the WINREVAIR and placebo groups in STELLAR. Time is on the X-axis with markers at 0, 10, 20, 30, 40, and 50. On the Y-axis, survival probability is shown from 0 to 1.0. The number of patients at risk at baseline and at weeks 10, 20, 30, 40, and 50 is shown below the plot. The line for the WINREVAIR group is solid magenta, and the line for the placebo group is a grey dashed line.

(HR 0.16; 95% CI: 0.08, 0.35; P<0.001)

Nine of 163 (5.5%) patients on WINREVAIR experienced death or at least 1 PAH clinical worsening event, compared with 42 of 160 (26.3%) patients on placebo.

HR = hazard ratio.

Death from any cause or PAH clinical worsening eventsWINREVAIR
(n=163)
n (%)		Placebo
(n=160)
n (%)
Number of patients who experienced death or at least 1 clinical worsening event9 (5.5)42 (26.3)
Assessment of clinical worsening eventsb
Death2 (1.2)7 (4.4)
Worsening-related listing for lung and/or heart transplant1 (0.6)2 (1.3)
Need to initiate rescue therapy with an approved PAH therapy or the need to increase the dose of infusion prostacyclin by 10% or more2 (1.2)17 (10.6)
Need for atrial septostomy0 (0.0)0 (0.0)
PAH-specific hospitalization (≥24 hours)0 (0.0)8 (5.0)
Deterioration of PAHc4 (2.5)15 (9.4)

aThese outcomes were captured until the last patient completed the week 24 visit (median duration of exposure 33.6 weeks).


bA patient can have more than 1 assessment recorded for their clinical worsening.


cDeterioration of PAH 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: worsened WHO FC (II to III, III to IV, II to IV, etc.) and decrease in 6MWD by ≥15% (confirmed by two 6-minute walk tests at least 4 hours apart but no more than 1 week).


WINREVAIR may improve your patients’ disease trajectory by reducing the risk of clinical worsening events

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See Study Design

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.

Report exposure during pregnancy or lactation to the Merck Sharp & Dohme LLC Adverse Event reporting line at 1-877-888-4231

Indication

WINREVAIR is an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death.

Selected Safety Information

Erythrocytosis: WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required.

 

Severe Thrombocytopenia: WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm3. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required.

 

Serious Bleeding: In clinical studies, serious bleeding (e.g., gastrointestinal, intracranial hemorrhage) was reported in 4% vs 1% (STELLAR) and 7% vs 5% (ZENITH) of patients taking WINREVAIR vs placebo, respectively. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Advise patients about signs and symptoms of blood loss. Do not administer WINREVAIR if the patient is experiencing serious bleeding.

 

Embryo-Fetal Toxicity: WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment.

 

Impaired Fertility: Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility.

 

Adverse Reactions: The most common adverse reactions (≥10% for WINREVAIR and at least 5% more than placebo) occurring in the STELLAR phase 3 clinical trial were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.3%), and erythema (13.5% vs 3.1%). The most common adverse reactions in the ZENITH trial were infections (67.4% vs 44.2%), epistaxis (45.3% vs 9.3%), diarrhea (25.6% vs 17.4%), telangiectasia (25.6% vs 3.5%), increased hemoglobin (15.1% vs 1.2%), rash (10.5% vs 4.7%), erythema (10.5% vs 3.5%), and gingival bleeding (10.5% vs 2.3%).

 

Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose.

 

Before prescribing WINREVAIR, please read the accompanying Prescribing Information. The Patient Information and Instructions for Use (1-vial kit, 2-vial kit) also are available.

Indication
Selected Safety Information

WINREVAIR is an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death.

Selected Safety Information

Erythrocytosis: WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required.

 

Severe Thrombocytopenia: WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm3. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required.

 

Serious Bleeding: In clinical studies, serious bleeding (e.g., gastrointestinal, intracranial hemorrhage) was reported in 4% vs 1% (STELLAR) and 7% vs 5% (ZENITH) of patients taking WINREVAIR vs placebo, respectively. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Advise patients about signs and symptoms of blood loss. Do not administer WINREVAIR if the patient is experiencing serious bleeding.

 

Embryo-Fetal Toxicity: WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment.

 

Impaired Fertility: Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility.

 

Adverse Reactions: The most common adverse reactions (≥10% for WINREVAIR and at least 5% more than placebo) occurring in the STELLAR phase 3 clinical trial were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.3%), and erythema (13.5% vs 3.1%). The most common adverse reactions in the ZENITH trial were infections (67.4% vs 44.2%), epistaxis (45.3% vs 9.3%), diarrhea (25.6% vs 17.4%), telangiectasia (25.6% vs 3.5%), increased hemoglobin (15.1% vs 1.2%), rash (10.5% vs 4.7%), erythema (10.5% vs 3.5%), and gingival bleeding (10.5% vs 2.3%).

 

Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose.

 

Before prescribing WINREVAIR, please read the accompanying Prescribing Information. The Patient Information and Instructions for Use (1-vial kit, 2-vial kit) also are available.