Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension.

ABSTRACT:

Background

In participants with pulmonary arterial hypertension, 24 weeks of sotatercept resulted in a significantly greater reduction from baseline in pulmonary vascular resistance than placebo. This report characterises the longer-term safety and efficacy of sotatercept in the PULSAR open-label extension. We report cumulative safety, and efficacy at months 18-24, for all participants treated with sotatercept.

Methods

PULSAR was a phase 2, randomised, double-blind, placebo-controlled study followed by an open-label extension, which evaluated sotatercept on top of background pulmonary arterial hypertension therapy in adults. Participants originally randomised to placebo were re-randomised 1:1 to sotatercept 0.3 or 0.7 mg·kg^-1 (placebo-crossed group); those initial

SUBMITTER: Humbert M 

PROVIDER: S-EPMC9816418 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature