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Title: | Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension |
Authors: | HUMBERT, Marc; MCLAUGHLIN, Vallerie; GIBBS, J. Simon R.; GOMBERG-MAITLAND, Mardi; HOEPER, Marius M.; PRESTON, Ioana R.; SOUZA, Rogerio; WAXMAN, Aaron B.; GHOFRANI, Hossein-Ardeschir; SUBIAS, Pilar Escribano; FELDMAN, Jeremy; MEYER, Gisela; MONTANI, David; OLSSON, Karen M.; MANIMARAN, Solaiappan; PENA, Janethe de Oliveira; BADESCH, David B. |
Citation: | EUROPEAN RESPIRATORY JOURNAL, v.61, n.1, article ID 2201347, 12p, 2023 |
Abstract: | Background In participants with pulmonary arterial hypertension, 24 weeks of sotatercept resulted in a significantly greater reduction from baseline in pulmonary vascular resistance than placebo. This report characterises the longer-term safety and efficacy of sotatercept in the PULSAR open-label extension. We report cumulative safety, and efficacy at months 18-24, for all participants treated with sotatercept. Methods PULSAR was a phase 2, randomised, double-blind, placebo-controlled study followed by an open-label extension, which evaluated sotatercept on top of background pulmonary arterial hypertension therapy in adults. Participants originally randomised to placebo were re-randomised 1:1 to sotatercept 0.3 or 0.7 mg center dot kg(-1) ( placebo-crossed group); those initially randomised to sotatercept continued the same sotatercept dose (continued-sotatercept group). Safety was evaluated in all participants who received >= 1 dose of sotatercept. The primary efficacy endpoint was change from baseline to months 18-24 in pulmonary vascular resistance. Secondary endpoints included 6-min walk distance and functional class. Two prespecified analyses, placebo-crossed and delayed-start, evaluated efficacy irrespective of dose. Results Of 106 participants enrolled in the PULSAR study, 97 continued into the extension period. Serious treatment-emergent adverse events were reported in 32 (30.8%) participants; 10 (9.6%) reported treatment-emergent adverse events leading to study discontinuation. Three (2.9%) participants died, none considered related to study drug. The placebo-crossed group demonstrated significant improvement across primary and secondary endpoints and clinical efficacy was maintained in the continued-sotatercept group. Conclusion These results support the longer-term safety and durability of clinical benefit of sotatercept for pulmonary arterial hypertension. |
Appears in Collections: | Artigos e Materiais de Revistas Científicas - FM/MCP Artigos e Materiais de Revistas Científicas - HC/InCor Artigos e Materiais de Revistas Científicas - LIM/09 Artigos e Materiais de Revistas Científicas - ODS/03 |
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