Therapeutic advances in respiratory disease · 2026
Clinical, hemodynamic, and safety outcomes of sotatercept in pulmonary arterial hypertension: a meta-analysis of randomized trials with time-to-event data.
СтатьяМетаанализСистематический обзорНазвание и аннотация: Перевод в очереди
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R Murad Mohamed, Awashra Ameer, S Elgendy Mohamed, Kasem Ahmed Wahdan, Shubietah Abdalhakim, Safi Fadi
Аннотация
BACKGROUND: Pulmonary arterial hypertension (PAH) remains progressive despite contemporary background therapy. Sotatercept is a novel activin signaling inhibitor that targets pulmonary vascular remodeling and may improve clinical and hemodynamic outcomes.
OBJECTIVES: To evaluate the efficacy, hemodynamic effects, and safety of sotatercept in patients with PAH.
DESIGN: Systematic review and meta-analysis of randomized controlled trials (RCTs).
DATA SOURCES AND METHODS: Five electronic databases were searched through October 2, 2025, for eligible RCTs. Time-to-event outcomes were analyzed using pooled individual patient data with hazard ratios (HRs), while secondary outcomes were assessed using random-effects risk ratios (RRs) and mean differences (MDs), with 95% confidence intervals (CI). Trial-sequential analysis (TSA) evaluated the conclusiveness of results.
RESULTS: In four RCTs (n = 889), sotatercept reduced clinical worsening or death by 77% (HR 0.23, 95% CI 0.16-0.32, p < 0.001) and prolonged event-free survival by ~40 weeks. World Health Organization (WHO) functional class improved in 40.3% vs 24.3% (RR 1.71, 95% CI 1.32-2.21), and 6-minute walk distance increased by MD 30.27 m (95% CI 13.45-47.08), while pulmonary vascular resistance (PVR) declined significantly (MD -247 dyn·s·cm-5, 95% CI -301.7; -192.2). Serious adverse events were slightly less frequent with sotatercept (26.2% vs 31.7%, RR 0.83); however, total bleeding (37.9% vs 18.7%, RR 2.00), epistaxis (26.7% vs 5.4%, RR 4.89), and telangiectasia (19.8% vs 6.4%, RR 3.24) were more common. TSA revealed conclusiveness in clinical worsening, WHO functional class, and PVR, as well as increases in bleeding events and epistaxis.
CONCLUSION: Sotatercept significantly improves clinical outcomes and extends event-free survival in PAH, with an acceptable safety profile; however, caution is warranted regarding bleeding events. These results support its role as an add-on therapy in PAH management.
TRIAL REGISTRATION: PROSPERO ID: CRD420251166414.
OBJECTIVES: To evaluate the efficacy, hemodynamic effects, and safety of sotatercept in patients with PAH.
DESIGN: Systematic review and meta-analysis of randomized controlled trials (RCTs).
DATA SOURCES AND METHODS: Five electronic databases were searched through October 2, 2025, for eligible RCTs. Time-to-event outcomes were analyzed using pooled individual patient data with hazard ratios (HRs), while secondary outcomes were assessed using random-effects risk ratios (RRs) and mean differences (MDs), with 95% confidence intervals (CI). Trial-sequential analysis (TSA) evaluated the conclusiveness of results.
RESULTS: In four RCTs (n = 889), sotatercept reduced clinical worsening or death by 77% (HR 0.23, 95% CI 0.16-0.32, p < 0.001) and prolonged event-free survival by ~40 weeks. World Health Organization (WHO) functional class improved in 40.3% vs 24.3% (RR 1.71, 95% CI 1.32-2.21), and 6-minute walk distance increased by MD 30.27 m (95% CI 13.45-47.08), while pulmonary vascular resistance (PVR) declined significantly (MD -247 dyn·s·cm-5, 95% CI -301.7; -192.2). Serious adverse events were slightly less frequent with sotatercept (26.2% vs 31.7%, RR 0.83); however, total bleeding (37.9% vs 18.7%, RR 2.00), epistaxis (26.7% vs 5.4%, RR 4.89), and telangiectasia (19.8% vs 6.4%, RR 3.24) were more common. TSA revealed conclusiveness in clinical worsening, WHO functional class, and PVR, as well as increases in bleeding events and epistaxis.
CONCLUSION: Sotatercept significantly improves clinical outcomes and extends event-free survival in PAH, with an acceptable safety profile; however, caution is warranted regarding bleeding events. These results support its role as an add-on therapy in PAH management.
TRIAL REGISTRATION: PROSPERO ID: CRD420251166414.