ZENITH results published: sotatercept is effective for high-risk PAH patients

The ZENITH study examined whether adding sotatercept to people's ongoing therapies reduced the risk of death, lung transplantation, or hospitalizations for pulmonary arterial hypertension (PAH) in PAH patients in functional class III or IV at high risk of mortality.

A planned early analysis of the study data showed "overwhelming efficacy": patients in the sotatercept group had a "76% lower risk of a composite of death from any cause, lung transplantation, or hospitalization lasting over 24 hours for worsening pulmonary arterial hypertension."

These strongly positive results meant it was no longer ethical to give people a placebo instead of sotatercept. The trial was stopped early so all patients in the trial, including those in the placebo arm, could benefit from sotatercept. Patients in the trial (including those in the placebo group) will be able to receive sotatercept through the ongoing SOTERIA extension study.

Read the New England Journal of Medicine article here