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Early Real-World Experience With Sotatercept in High-Risk Pulmonary Arterial Hypertension: A Five-Patient Case Series
Session:
Sessão de Posters 27 - Abordagem e avanços terapêuticos na hipertensão pulmonar
Speaker:
Leonor Magalhães
Congress:
CPC 2026
Topic:
F. Valvular, Myocardial, Pericardial, Pulmonary, Congenital Heart Disease
Theme:
21. Pulmonary Circulation, Pulmonary Embolism, Right Heart Failure
Subtheme:
21.4 Pulmonary Circulation, Pulmonary Embolism, Right Heart Failure - Treatment
Session Type:
Posters Eletrónicos
FP Number:
---
Authors:
Leonor Magalhães; Julien Lopes; Ana Clara Félix; Sara Varão; Bárbara Lacerda Teixeira; Luís Almeida Morais; Ana Galrinho; Rui Cruz Ferreira
Abstract
<p><strong>Introduction:</strong>Pulmonary arterial hypertension (PAH) is a progressive disease caused by pulmonary vascular remodeling. Sotatercept, the first approved activin signalling inhibitor, offers a novel non-vasodilator therapeutic approach. Based on RCT, it is used as add-on therapy after 3 months therapy in symptomatic patients. <strong>Methods: </strong>Descriptive observational case series of WHO group 1 PAH patients (P) who started sotatercept in a tertiary referral centre in 2025. <strong>Results</strong>: 5 consecutive P were included [2 idiopathic PAH, 2 heritable PAH (BMPR2), and 1 connective tissue disease–associated PAH] with a median time of diagnosis of 18 months (3–60). All patients were under optimised triple therapy for a median of 25 months (2–40). Patients presented WHO functional class II–III and intermediate–high risk (REVEAL Lite 2 score 6-8). The median 6-minute walk distance was 369m and NT-proBNP was 252pg/mL (53.9–871). Right heart catheterization showed a median mean pulmonary artery pressure (mPAP) of 42mmHg (33–52), right atrial pressure 5.16 mmHg (3.93–6.23), and cardiac index of 3.11L/min/m² (2.57–3.23). On baseline echocardiography, all P presented systolic D-shaped left ventricle and 3 of 5P presented reduced right ventricular (RV) longitudinal strain [median Free wall strain of 15.9% (7.5–24.1) and global longitudinal strain of 15% (8-22)]; TAPSE of 21mm (10–27) and RV fractional area change of 39% (29–42). On cardiac magnetic resonance, the median RV Ejection Fraction was 54% (40–57), RV end-systolic volume index of 44.5 mL/m² (36–55), and stroke volume index of 49 mL/m² (37–61). Sotatercept was initiated on a day care unit regime with structured revaluations. The follow-up remains limited, only two completed 24weeks (w) after first dose. All reached 12w after administration. Preliminary NT-proBNP analysis showed a 62.5% reduction at 3w and, by 12w, 3P reached <50 pg/mL. Regarding adverse effects, 3P experienced hemoglobin (Hb) increase of >2 g/dL (at 12w), but only 1 required one dose omission (Hb 14 > 18.4 g/dL), with subsequent stabilization and drug resume. 4 in 5 P maintain the same level of platelets during the FUP (all >220 000x10e3L); 1P with previous known thrombocytopenia (89 000x10e3/uL) improved to 97 000x10e3/uL, at 12w. 1P experienced two episodes of mild, self-limited epistaxis on the first month. Another patient had a 72hours hospitalization non related to sotatercept (prostacyclin overdosage). No major events led to permanent treatment discontinuations. <br /> Using a novel strategy, 3P were monitored with CardioMEMS, enabling real-time documentation of progressive reduction in mPAP.<br /> <strong>Conclusion</strong>: In our small cohort, sotatercept seems to be associated with early and sustained reductions in NT-proBNP and mPAP on remote monitoring, with hematologic safety and no major adverse events. These early real-world data mark the first step on novel disease-modifying strategy in PAH. </p>
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