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Revolution in PAH therapy: Sotatercept reduces risk of death by 76%!
Sotatercept, a newly approved drug for the treatment of PAH, shows promising results. Prof. Dr. Hoeper from UNI Med Hannover was involved in the crucial studies.
Revolution in PAH therapy: Sotatercept reduces risk of death by 76%!
The recently accepted drug sotatercept offers new hope for patients with pulmonary arterial hypertension (PAH), a potentially life-threatening disease characterized by the narrowing of small pulmonary arteries. According to the Hannover Medical School the innovative therapy shows promising results in the treatment of advanced PAH, which carries a high risk of death.
The ZENITH clinical study, published in the renowned New England Journal of Medicine, examined the effects of sotatercept. In the study, which was led by Prof. Dr. Marius Hoeper from the Hannover Medical School, a group of 172 patients with WHO functional classes III or IV PAH received either the substance sotatercept or a placebo.
Admission and clinical results
Sotatercept was approved in September 2024 and is administered subcutaneously. It acts as a “ligand trap” and blocks the function of the protein activin, which is responsible for the formation of new endothelial cells. The effectiveness of the drug was also tested in the international STELLAR study. In the ZENITH study, the risk of worsening PAH, which includes hospitalizations, lung transplants and death, fell by more than 75% in the sotatercept group compared to the placebo group, as the American College of Cardiology reported.
The data shows that only 8.1% of patients in the sotatercept group died, compared to 15.1% in the placebo group. Additionally, there were only 9.3% hospitalizations due to worsening PAH in the sotatercept group compared to 50.0% in the placebo group. These promising results led to the early termination of the placebo group for ethical reasons.
Patient profile and symptoms
The study included patients with an average age of 54 years, with 77% being women. PAH occurs primarily in women between the ages of 30 and 60 and causes symptoms such as shortness of breath, fatigue, swollen feet and chest pain. In the worst case, these symptoms can lead to right heart failure and a significantly reduced life expectancy.
The ZENITH study also found that there were fewer serious adverse events in the sotatercept group compared to the placebo group. While most side effects in the sotatercept group consisted of epistaxis and telangiectasia, the therapy overall led to an improvement in the patients' quality of life and physical resilience.
Additionally emphasizes the Pharmaceutical newspaper, that the inflammatory component associated with elevated cytokine and chemokine levels also likely contributes to the worsening of PAH. Thus, sotatercept is likely to contribute significantly to the treatment of this complex disease not only through its effect on endothelial cell growth, but also by improving the ratio between growth-promoting and growth-inhibiting factors.
Overall, the results of sotatercept to date show promising potential for improving patient care in the treatment of pulmonary arterial hypertension, especially in a patient group that has previously been difficult to treat.