학술논문
Long-Term Safety of Dupilumab in Patients With Moderate-to-Severe Asthma: TRAVERSE Continuation Study.
Document Type
Academic Journal
Author
Maspero JF; Fundación CIDEA, Buenos Aires, Argentina. Electronic address: jorge.maspero@fundacioncidea.org.ar.; Peters AT; Northwestern University Feinberg School of Medicine, Chicago, Ill.; Chapman KR; University of Toronto, Toronto, ON, Canada.; Domingo C; Corporació Sanitària Parc Taulí, Sabadell, Autonomous University of Barcelona, Barcelona, Spain.; Stewart J; Sanofi, Montreal, QC, Canada.; Hardin M; Sanofi, Cambridge, Mass.; Maroni J; Regeneron Pharmaceuticals, Inc., Tarrytown, NY.; Tawo K; Sanofi, Bridgewater, NJ.; Khokhar FA; Regeneron Pharmaceuticals, Inc., Tarrytown, NY.; Mortensen E; Regeneron Pharmaceuticals, Inc., Tarrytown, NY.; Laws E; Sanofi, Bridgewater, NJ.; Radwan A; Regeneron Pharmaceuticals, Inc., Tarrytown, NY.; Jacob-Nara JA; Sanofi, Bridgewater, NJ.; Deniz Y; Regeneron Pharmaceuticals, Inc., Tarrytown, NY.; Rowe PJ; Sanofi, Bridgewater, NJ.
Source
Publisher: Elsevier Inc Country of Publication: United States NLM ID: 101597220 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2213-2201 (Electronic) NLM ISO Abbreviation: J Allergy Clin Immunol Pract Subsets: MEDLINE
Subject
Language
English
Abstract
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.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)