INTERIM findings from the ongoing SOTERIA study suggest that sotatercept provides a favourable long-term safety and efficacy profile for adults with pulmonary arterial hypertension (PAH), supporting its potential as an important add-on therapy.
The open-label study enrolled adults with PAH who had completed a prior sotatercept study without early discontinuation. Participants received subcutaneous sotatercept (≤0.7 mg·kg⁻¹ Q3W) while continuing stable background therapy. The primary objective was to assess safety and tolerability through adverse events (AEs), vital signs, and laboratory assessments. Secondary efficacy outcomes included 6-minute walk distance, N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, WHO functional class, clinical worsening events, and simplified French risk score. The data cutoff for this analysis was 8 November 2023.
A total of 426 participants were analysed, with a mean sotatercept exposure of 448.6 days (range 21–923 days; 523 patient-years). Of these, 90.8% experienced AEs, 3.5% discontinued treatment, and 30.3% reported serious AEs, although only 2.6% were considered treatment-related. There were 12 deaths (2.8%), with two linked to serious bleeding events but deemed unrelated to treatment. The most frequent AEs of interest were epistaxis (22.1%) and telangiectasia (16.9%), while 5.2% experienced serious bleeding events. Improvements in 6-minute walk distance, NT-proBNP, WHO functional class, and simplified French risk score observed from the study baseline were largely maintained at 1 year, including in participants who had previously received placebo.
These interim results support the favourable benefit-risk profile of sotatercept as an add-on therapy for PAH. Ongoing follow-up will provide further insights into its long-term efficacy and safety.
Ada Enesco, EMJ
Reference
Preston IR et al. A long-term follow-up study of sotatercept for treatment of pulmonary arterial hypertension: interim results of SOTERIA. Eur Respir J. 2025; DOI:10.1183/13993003.01435-2024.
