Real-world report links Winrevair to better outcomes in PAH patients
Data suggest lower mortality and reduced need for lung transplant
In people with pulmonary arterial hypertension (PAH), adding Winrevair (sotatercept-csrk) to standard therapy was linked to longer survival, fewer safety events, and a lower need for lung transplant compared with standard therapy alone, according to new real-world data.
“These findings extend clinical trial evidence, suggesting sotatercept [Winrevair] offers meaningful survival and safety benefits in routine practice,” the researchers wrote.
The study, “Durability of sotatercept response in pulmonary hypertension: Insights from extended real-world follow-up,” was published in the International Journal of Cardiology.
How PAH damages blood vessels in the lungs
In PAH, cells in the walls of the lung’s blood vessels grow abnormally. Over time, this can narrow the vessels, make it harder for blood to move through the lungs, and raise pressure in the pulmonary arteries. Common symptoms include shortness of breath, fatigue, and chest pain.
Merck‘s Winrevair, which is approved for adults with PAH, is designed to target biological signaling involved in abnormal blood vessel changes, also called vascular remodeling. The goal is to help slow or reverse these harmful changes in the lungs’ blood vessels.
In clinical trials, adding Winrevair to standard PAH therapy improved exercise capacity and other measures of heart-lung strain, and reduced the risk of clinical worsening in people with PAH.
Still, the researchers noted that long-term real-world data remain limited. “Given the robust efficacy data and the unmet need in PH, increased use of [Winrevair] is expected in the future,” the team of U.S. scientists wrote. “This anticipated uptake, combined with the need to understand long-term safety, durability of benefit, and cost-effectiveness, highlights why there is a critical need to explore outcomes in diverse patient populations.”
Researchers compare real-world outcomes with and without Winrevair
To explore this question, researchers ran a retrospective study using data from the TriNetX Global Collaborative Network, which includes 102 healthcare organizations. They compared people with PAH who received Winrevair with similar patients who did not.
The analysis included 346 Winrevair-treated patients (mean age 55.6, and 74% were women) matched to 346 similar patients who did not receive the therapy. Rates of other health conditions were broadly similar between groups, including heart failure, obstructive sleep apnea, and connective tissue disorders.
Both groups also used standard PAH medications at similar rates. These included phosphodiesterase-5 inhibitors, such as tadalafil (available as Adcirca or generics) and sildenafil (Revatio and generics), endothelin receptor antagonists, including ambrisentan (Letairis and generics) and macitentan (Opsumit and generics), and therapies that work in the prostacyclin pathway to help blood vessels relax.
On average, patients were followed for about eight months in the control group and about six months in the Winrevair group.
During follow-up, overall survival was significantly higher among people who received Winrevair. Eleven patients (3.2%) in the Winrevair group died from any cause, compared with 104 patients (30.4%) in the control group. That difference equals an absolute risk reduction of 27.2 percentage points favoring Winrevair.
Survival analyses also showed a higher chance of being alive at the end of follow-up for people receiving Winrevair. The probability of survival was 95.5% in the Winrevair group versus 45.2% for controls.
Winrevair was also linked with a lower need for lung transplant during the study period. No patients in the Winrevair group received a transplant, compared with 12 people (3.5%) in the control group.
Winrevair tied to fewer safety endpoint events in follow-up
In terms of safety, Winrevair was also linked to fewer events in a composite safety endpoint. These safety events occurred in 10.2% of Winrevair-treated patients compared with 26.9% of controls.
The composite endpoint included issues such as low platelet counts, higher-than-normal red blood cell levels, severe episodes of high blood pressure, nosebleeds, and blood clots.
Overall, Winrevair-treated patients had fewer adverse events per person on average, though this difference was not statistically significant in the analysis.
Taken together, the researchers concluded that Winrevair was “associated with significantly lower mortality, fewer adverse events, and reduced need for lung transplantation compared with standard therapy in long term follow up.”
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