2026-04-14T05:34:28Zhttps://recercat.cat/oai/request

oai:recercat.cat:2072/4754742024-11-08T04:45:11Zcom_2072_98col_2072_378192

00925njm 22002777a 4500 dc Maspero, Jorge author Peters, Anju T. author Chapman, Kenneth R. author Domingo, Christian author Stewart, John author Hardin, Megan author Maroni, Jaman author Tawo, Kelsei author Khokhar, Faisal A. author Mortensen, Eric author Laws, Elizabeth author Radwan, Amr author Jacob-Nara, Juby A. author Deniz, Yamo author Rowe, Paul J. author Universitat Autònoma de Barcelona. Departament de Medicina author 2024 Altres ajuts: Sanofi and Regeneron Pharmaceuticals, Inc (NCT02134028 and NCT03620747) Background: Previous clinical trials have demonstrated dupilumab efficacy and safety in adults and adolescents with moderate to severe asthma for up to 3 years. Objective: The TRAVERSE continuation study (NCT03620747), a single-arm, open-label study, assessed safety and tolerability of dupilumab 300 mg every 2 weeks up to an additional 144 weeks (∼3 years) in patients with moderate to severe asthma who previously completed TRAVERSE (NCT02134028). Methods: Primary end points were incidence and event rates per 100 patient-years of treatment-emergent adverse events (TEAEs). Secondary end points included adverse events (AEs) of special interest, serious AEs, and AEs leading to study discontinuation. Results: A total of 393 patients participated in the TRAVERSE continuation study (cumulative dupilumab exposure, 431.7 patient-years; median treatment duration, 309 days). A total of 29 patients (7.4%) received more than 958 days of treatment. A total of 214 (54.5%) patients reported at least 1 TEAE (event rate: 171.4); 37 (9.4%) experienced at least 1 treatment-related TEAE, none of which were considered severe; 2 patients reported 6 TEAEs of moderate intensity. A total of 22 (5.6%) patients reported serious AEs (event rate: 6.9). AEs of special interest were reported in 24 patients (6.1%; event rate: 6.0). Five (1.3%) deaths occurred (event rate: 1.2) following serious AEs of coronavirus disease 2019 (COVID-19)-related pneumonia (3 patients), pancreatitis (1 patient), and pulmonary embolism (1 patient). None of the TEAEs leading to death were considered treatment-related. Conclusions: Dupilumab treatment was well tolerated for up to an additional 3 years. Safety findings were consistent with the known safety profile of dupilumab. These findings further support the long-term use of dupilumab in patients with moderate to severe asthma. Asthma control Moderate to severe Long-term Safety Adverse events Dupilumab Long-Term Safety of Dupilumab in Patients With Moderate-to-Severe Asthma : TRAVERSE Continuation Study