Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension

中止 安慰剂 医学 临床终点 不利影响 肺动脉高压 临床试验 意向治疗分析 内科学 外科 替代医学 病理
作者
Marc Humbert,Vallerie V. McLaughlin,J. Simon R. Gibbs,Mardi Gomberg‐Maitland,Marius M. Hoeper,Ioana R. Preston,Rogério Souza,Aaron B. Waxman,Hossein Ardeschir Ghofrani,Pilar Escribano,Jeremy Feldman,G. Meyer,David Montani,Karen M. Olsson,Solaiappan Manimaran,Janethe de Oliveira Pena,David B. Badesch
出处
期刊:The European respiratory journal [European Respiratory Society]
卷期号:61 (1): 2201347-2201347 被引量:42
标识
DOI:10.1183/13993003.01347-2022
摘要

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.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·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.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.These results support the longer-term safety and durability of clinical benefit of sotatercept for pulmonary arterial hypertension.
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