Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years

BACKGROUND: Benralizumab is an IL-5R alpha-directed monoclonal antibody indicated for patients with severe, uncontrolled eosinophilic asthma. OBJECTIVE: To evaluate the long-term safety and tolerability of benralizumab among adults treated for up to 5 years. METHODS: This analysis included adults tr...

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Autores: Korn, Stephanie, Bourdin, Arnaud, Chupp, Geoffrey, García-Cosío, Borja, Arbetter, Doug, Shah, Mihir, Garcia Gil, Esther
Tipo de recurso: artículo
Fecha de publicación:2021
País:España
Institución:Instituto de Salud Carlos III (ISCIII)
Repositorio:Repisalud
Idioma:inglés
OAI Identifier:oai:repisalud.isciii.es:20.500.12105/23188
Acceso en línea:https://hdl.handle.net/20.500.12105/23188
Access Level:acceso abierto
Palabra clave:Asthma
Exacerbation
Benralizumab
Integrated analysis
Eosinophils
Método Doble Ciego
Humanos
Antiasmáticos
Asma
Progresión de la Enfermedad
Eosinófilos
Anticuerpos Monoclonales Humanizados
Disease Progression
Anti-Asthmatic Agents
Humans
Antibodies, Monoclonal, Humanized
Double-Blind Method
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spelling Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 YearsKorn, StephanieBourdin, ArnaudChupp, GeoffreyGarcía-Cosío, BorjaArbetter, DougShah, MihirGarcia Gil, EstherAsthmaExacerbationBenralizumabIntegrated analysisEosinophilsMétodo Doble CiegoHumanosAntiasmáticosAsmaProgresión de la EnfermedadEosinófilosAnticuerpos Monoclonales HumanizadosAsthmaDisease ProgressionEosinophilsAnti-Asthmatic AgentsHumansAntibodies, Monoclonal, HumanizedDouble-Blind MethodBACKGROUND: Benralizumab is an IL-5R alpha-directed monoclonal antibody indicated for patients with severe, uncontrolled eosinophilic asthma. OBJECTIVE: To evaluate the long-term safety and tolerability of benralizumab among adults treated for up to 5 years. METHODS: This analysis included adults treated with placebo or subcutaneous benralizumab 30 mg every 4 or 8 weeks in the 48-week SIROCCO, 56-week CALIMA, and 28-week ZONDA pivotal trials, who were subsequently enrolled in the 56-week double-blind BORA extension and continued assigned regimens or initiated benralizumab (if previously on placebo) for 16 to 40 weeks, before entering the open-label MELTEMI extension. Safety was measured by adverse and serious adverse event rates. Exacerbations were evaluated in patients with blood eosinophils greater than or equal to 300 cells/mu L receiving high-dose inhaled corticosteroids at baseline. RESULTS: Overall, 446 received treatment and 384 (86.1%) completed the study; 157 (35.2%) received benralizumab for 4 or more years. Adverse and serious adverse event rates (28.5-32.4 and 6.3-8.4 per 100 patient-years, respectively) were low, stable over time, and did not increase with exposure; few (n = 8) discontinued because of adverse events. Serious infections and hypersensitivity event rates were consistent with those in previous studies. Among patients with blood eosinophils greater than or equal to 300 cells/mu L-high-dosage inhaled corticosteroids receiving benralizumab every 8 weeks, at least 75% had zero exacerbations annually during the integrated analysis period. CONCLUSIONS: In patients with severe, uncontrolled eosinophilic asthma, long-term benralizumab was safe and well tolerated for up to 5 years. There were no new safety signals, and exacerbations were eliminated in similar percentages of patients as in predecessor studies.Elsevier20242024-09-1820212021-12-0120212021-12-01research articlehttp://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articlehttps://hdl.handle.net/20.500.12105/23188reponame:Repisaludinstname:Instituto de Salud Carlos III (ISCIII)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:repisalud.isciii.es:20.500.12105/231882026-06-12T12:43:37Z
dc.title.none.fl_str_mv Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years
title Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years
spellingShingle Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years
Korn, Stephanie
Asthma
Exacerbation
Benralizumab
Integrated analysis
Eosinophils
Método Doble Ciego
Humanos
Antiasmáticos
Asma
Progresión de la Enfermedad
Eosinófilos
Anticuerpos Monoclonales Humanizados
Asthma
Disease Progression
Eosinophils
Anti-Asthmatic Agents
Humans
Antibodies, Monoclonal, Humanized
Double-Blind Method
title_short Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years
title_full Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years
title_fullStr Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years
title_full_unstemmed Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years
title_sort Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years
dc.creator.none.fl_str_mv Korn, Stephanie
Bourdin, Arnaud
Chupp, Geoffrey
García-Cosío, Borja
Arbetter, Doug
Shah, Mihir
Garcia Gil, Esther
author Korn, Stephanie
author_facet Korn, Stephanie
Bourdin, Arnaud
Chupp, Geoffrey
García-Cosío, Borja
Arbetter, Doug
Shah, Mihir
Garcia Gil, Esther
author_role author
author2 Bourdin, Arnaud
Chupp, Geoffrey
García-Cosío, Borja
Arbetter, Doug
Shah, Mihir
Garcia Gil, Esther
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv
dc.subject.none.fl_str_mv Asthma
Exacerbation
Benralizumab
Integrated analysis
Eosinophils
Método Doble Ciego
Humanos
Antiasmáticos
Asma
Progresión de la Enfermedad
Eosinófilos
Anticuerpos Monoclonales Humanizados
Asthma
Disease Progression
Eosinophils
Anti-Asthmatic Agents
Humans
Antibodies, Monoclonal, Humanized
Double-Blind Method
topic Asthma
Exacerbation
Benralizumab
Integrated analysis
Eosinophils
Método Doble Ciego
Humanos
Antiasmáticos
Asma
Progresión de la Enfermedad
Eosinófilos
Anticuerpos Monoclonales Humanizados
Asthma
Disease Progression
Eosinophils
Anti-Asthmatic Agents
Humans
Antibodies, Monoclonal, Humanized
Double-Blind Method
description BACKGROUND: Benralizumab is an IL-5R alpha-directed monoclonal antibody indicated for patients with severe, uncontrolled eosinophilic asthma. OBJECTIVE: To evaluate the long-term safety and tolerability of benralizumab among adults treated for up to 5 years. METHODS: This analysis included adults treated with placebo or subcutaneous benralizumab 30 mg every 4 or 8 weeks in the 48-week SIROCCO, 56-week CALIMA, and 28-week ZONDA pivotal trials, who were subsequently enrolled in the 56-week double-blind BORA extension and continued assigned regimens or initiated benralizumab (if previously on placebo) for 16 to 40 weeks, before entering the open-label MELTEMI extension. Safety was measured by adverse and serious adverse event rates. Exacerbations were evaluated in patients with blood eosinophils greater than or equal to 300 cells/mu L receiving high-dose inhaled corticosteroids at baseline. RESULTS: Overall, 446 received treatment and 384 (86.1%) completed the study; 157 (35.2%) received benralizumab for 4 or more years. Adverse and serious adverse event rates (28.5-32.4 and 6.3-8.4 per 100 patient-years, respectively) were low, stable over time, and did not increase with exposure; few (n = 8) discontinued because of adverse events. Serious infections and hypersensitivity event rates were consistent with those in previous studies. Among patients with blood eosinophils greater than or equal to 300 cells/mu L-high-dosage inhaled corticosteroids receiving benralizumab every 8 weeks, at least 75% had zero exacerbations annually during the integrated analysis period. CONCLUSIONS: In patients with severe, uncontrolled eosinophilic asthma, long-term benralizumab was safe and well tolerated for up to 5 years. There were no new safety signals, and exacerbations were eliminated in similar percentages of patients as in predecessor studies.
publishDate 2021
dc.date.none.fl_str_mv 2021
2021-12-01
2021
2021-12-01
2024
2024-09-18
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.12105/23188
url https://hdl.handle.net/20.500.12105/23188
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:Repisalud
instname:Instituto de Salud Carlos III (ISCIII)
instname_str Instituto de Salud Carlos III (ISCIII)
reponame_str Repisalud
collection Repisalud
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869402994217320448
score 15.812455

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