Long-Term Safety of Dupilumab in Patients With Moderate-to-Severe Asthma : TRAVERSE Continuation Study
Maspero, Jorge (Fundación CIDEA, Buenos Aires, Argentina)
Peters, Anju T. (Northwestern University Feinberg School of Medicine, Chicago, USA)
Chapman, Kenneth R. (University of Toronto)
Domingo, Christian (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Stewart, John (Sanofi, Montreal, QC, Canada)
Hardin, Megan (Sanofi (Cambridge, Estats Units d'Amèrica))
Maroni, Jaman (Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA)
Tawo, Kelsei (Sanofi, Bridgewater, NJ)
Khokhar, Faisal A. (Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA)
Mortensen, Eric (Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA)
Laws, Elizabeth (Sanofi, Bridgewater, NJ)
Radwan, Amr (Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA)
Jacob-Nara, Juby A. (Sanofi, Bridgewater, NJ)
Deniz, Yamo (Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA)
Rowe, Paul Jonathan (Sanofi, Bridgewater, NJ)
Universitat Autònoma de Barcelona. Departament de Medicina

Data:	2024
Resum:	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.
Nota:	Altres ajuts: Sanofi and Regeneron Pharmaceuticals, Inc (NCT02134028 and NCT03620747)
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Asthma control ; Moderate to severe ; Long-term ; Safety ; Adverse events ; Dupilumab
Publicat a:	Journal of Allergy and Clinical Immunology: In Practice, Vol. 12 Núm. 4 (april 2024) , p. 991-997.e6, ISSN 2213-2198

DOI: 10.1016/j.jaip.2023.12.043

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