This post-hoc, exploratory pooled analysis, published on January 30, 2025, on the European Respiratory Journal, combines data from the Phase 2 PULSAR and Phase 3 STELLAR studies on sotatercept, both international, multicentre, randomised, double-blind, placebo-controlled trials in pulmonary arterial hypertension patients.
Out of 429 randomised patients, 237 received sotatercept and 192 placebo. After 24 weeks, sotatercept improved exercise capacity, pulmonary vascular resistance, WHO functional class, and delayed clinical worsening. Significant reductions in pulmonary and right heart pressures, improvements in right ventricle size and function were observed. The sotatercept group experienced more adverse events including increased haemoglobin, thrombocytopenia, and bleeding events.
This analysis confirms sotatercept’s therapeutic benefits and favorable safety profile, with longer follow-up needed to assess long-term outcomes.
Read more at this link on the European Respiratory Journal
Citation
Hoeper MM, Gomberg-Maitland M, Badesch DB, Gibbs JSR, Grünig E, Kopeć G, McLaughlin VV, Meyer G, Olsson KM, Preston IR, Rosenkranz S, Souza R, Waxman AB, Perchenet L, Strait J, Xing A, Manimaran S, Wang X, Miller B, Cornell AG, de Oliveira Pena J, Ghofrani HA, Humbert M. Efficacy and safety of the activin signalling inhibitor, sotatercept, in a pooled analysis of PULSAR and STELLAR studies. Eur Respir J. 2025 Jan 30:2401424. doi: 10.1183/13993003.01424-2024. Epub ahead of print. PMID: 39884760.