An article published in the New England Journal of Medicine on March 31 titled “Sotatercept in Patients with Pulmonary Arterial Hypertension at High Risk for Death” reports on the findings of ZENITH, a phase 3 trial which evaluated sotatercept as an add-on therapy for high-risk pulmonary arterial hypertension patients (functional class II-IV) already on maximum tolerated background therapy. The study randomly assigned 172 patients (86 per group) to receive either sotatercept or placebo every 3 weeks.
Among the high-risk adults with pulmonary arterial hypertension treatment with sotatercept resulted in a lower risk of death from any cause, lung transplantation, or hospitalization (≥24 hours) versus the group with placebo. The trial was stopped early due to clear efficacy demonstrated in a planned interim analysis.
Looking at the individual components:
- Deaths: 7 (8.1%) with sotatercept vs 13 (15.1%) with placebo
- Lung transplantations: 1 (1.2%) with sotatercept vs 6 (7.0%) with placebo
- Hospitalizations: 8 (9.3%) with sotatercept vs 43 (50.0%) with placebo
The most common adverse events associated with sotatercept treatment were epistaxis (nosebleeds) and telangiectasia (small dilated blood vessels near the skin surface).
Read more at this link on the NIH Library of Medicine
Citation
Humbert M, McLaughlin VV, Badesch DB, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, Preston IR, Souza R, Waxman AB, Moles VM, Savale L, Vizza CD, Rosenkranz S, Shi Y, Miller B, Mackenzie HS, Kim SS, Loureiro MJ, Patel MJ, Koglin J, Cornell AG, Hoeper MM; ZENITH Trial Investigators. Sotatercept in Patients with Pulmonary Arterial Hypertension at High Risk for Death. N Engl J Med. 2025 Mar 31. doi: 10.1056/NEJMoa2415160. Epub ahead of print. PMID: 40167274.CopyDownload .nbib