Sotatercept expected to raise life expectancy, lower hospitalizations in PAH
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Key takeaways:
- Life expectancy is projected to increase three-fold with sotatercept plus background therapy vs. background therapy alone.
- The treatment is expected to result in 683 fewer hospitalizations per 1,000 patients.
Patients with pulmonary arterial hypertension receiving sotatercept, a novel activin signaling inhibitor, plus background therapy are expected to live longer, according to a European Respiratory Society International Congress presentation.
Additional expected benefits of this treatment from a simulated model include less use of infused prostacyclin, fewer hospitalizations and fewer lung/heart-lung transplants, according to researchers.
“These data are encouraging and add another aspect to the data being generated for sotatercept in PAH,” Vallerie McLaughlin, MD, of the division of cardiovascular medicine in the department of internal medicine at University of Michigan, told Healio.
As Healio previously reported, the STELLAR trial found that sotatercept (Merck) reduced risk for death and clinical worsening by 84% in patients with PAH compared with placebo.
In the current study, McLaughlin and colleagues used data from STELLAR to create a population health model that would predict long-term PAH outcomes — including life expectancy, infused prostacyclin-free years, PAH hospitalizations and lung/heart-lung transplants over 30 years — based on use of background therapy alone or with sotatercept.
Specifically, they used the European Society of Cardiology/European Respiratory Society recommended 4-strata risk assessment approach to create a Markov-type model consisting of six health states: low risk, intermediate-low risk, intermediate-high risk, high risk, lung/heart-lung transplant and death. Based on transition probabilities derived from STELLAR, during each model of the cycle, patients could stay in their current health state or progress to one of the other states.
Researchers also obtained risk stratum-adjusted probabilities for death and lung/heart-lung transplants from the COMPERA PAH registry, and they evaluated existing literature for probabilities for death following transplantation.
When evaluating life expectancy, the model predicted that patients receiving background therapy alone had an expectancy of 5.1 years, whereas patients receiving sotatercept plus background therapy had an expectancy of 16.5 years.
“In this simulation model, adding sotatercept to background therapy increased life expectancy roughly three-fold,” McLaughlin told Healio.
Researchers continued to find better outcomes with the addition of sotatercept to background therapy as demonstrated by less need for infused prostacyclin (prostacyclin-free years, 14.7 years vs. 3.1 years).
Further, researchers observed 683 fewer PAH hospitalizations and four fewer transplants per 1,000 patients in the sotatercept plus background therapy group.
“For ethical reasons, it is not possible to perform long-term randomized controlled trials to assess mortality,” McLaughlin told Healio. “Simulation models such as this are hypothesis generating and need to be confirmed by long-term real-world observations.”
References:
- McLaughlin V, et al. Adis Journals. 2023;doi:10.6084/m9.figshare.24106863.v1.
- Merck presents new analyses supporting the promising potential of sotatercept, its investigational medicine for adults with pulmonary arterial hypertension (PAH). https://www.merck.com/news/merck-presents-new-analyses-supporting-the-promising-potential-of-sotatercept-its-investigational-medicine-for-adults-with-pulmonary-arterial-hypertension-pah/. Published Sept. 11, 2023. Accessed Sept. 11, 2023.