Key result
Sotatercept therapy in patients with pulmonary arterial hypertension was associated with multiple instances of clinically significant moderate to large pericardial effusions.
Why the study?
Pericardial effusions halted a trial of another activin signaling inhibitor, but were not significantly higher with sotatercept in landmark trials, prompting evaluation in real-world practice.
Does sotatercept therapy lead to pericardial effusions in patients with pulmonary arterial hypertension?
Case Report
Yes
Does sotatercept therapy lead to pericardial effusions in patients with pulmonary arterial hypertension?
This case series highlights a potential new safety signal of moderate to large pericardial effusions associated with real-world sotatercept use in PAH patients, an adverse event not significantly observed in its landmark trials.
Clinicians should monitor sotatercept-treated PAH patients for severe hypoxemia; leaves open whether telangiectasia-related shunting is causal.
Extract Sotatercept, an activin signaling inhibitor (ASI), was recently approved to treat pulmonary arterial hypertension (PAH)[1, 2]. Sotatercept improves exercise capacity and reduces morbidity and mortality[3–5]. Four common side effects associated with sotatercept use in the pivotal clinical trials[4] include polycythemia (6%), thrombocytopenia, (6%), telangiectasia (10%), and bleeding events (20%). Potentially related to telangiectasias, a rare but serious complication of severe hypoxemia and intrapulmonary shunting was recently reported [6]. A phase 2 trial (TROPOS) of cibotercept, another ASI, for the treatment of PAH, was recently halted due to multiple occurrences of unanticipated pericardial effusions in patients in the treatment arm[7]. However, development of pericardial effusions was not significantly higher with sotatercept therapy in the landmark trials[3–5]. In this multicenter case series, we report multiple instances of clinically significant moderate to large pericardial effusions in PAH patients treated with sotatercept.
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Sahay et al. (2025) conducted a case report in pulmonary arterial hypertension. Sotatercept was evaluated on clinically significant moderate to large pericardial effusions. Sotatercept therapy in patients with pulmonary arterial hypertension was associated with multiple instances of clinically significant moderate to large pericardial effusions.
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