Brolucizumab 12- and 16-Week Fixed Dosing Potential in Neovascular AMD

Detalhes bibliográficos
Autor(a) principal: Singer, Michael
Data de Publicação: 2022
Outros Autores: Khanani, Arshad M., Wolf, Armin, Flores, Rita, Chhablani, Jay, B, Guruprasad B., Clemens, Andreas, Gedif, Kinfemichael, Liu, Xiaoxi, Mulyukov, Zufar, Querques, Giuseppe
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10362/143577
Resumo: Funding Information: Development of this publication was funded by Novartis Pharma AG including medical writing and editorial assistance. The sponsor participated in data analysis, interpretation of the data, and review of the manuscript. Publisher Copyright: © 2022 The Author(s). Published by S. Karger AG, Basel.
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spelling Brolucizumab 12- and 16-Week Fixed Dosing Potential in Neovascular AMDA post hoc Evaluation of Data from the HAWK and HARRIER TrialsAnti-vascular endothelial growth factorBrolucizumabFixed dosingNeovascular age-related macular degenerationMedicine(all)Funding Information: Development of this publication was funded by Novartis Pharma AG including medical writing and editorial assistance. The sponsor participated in data analysis, interpretation of the data, and review of the manuscript. Publisher Copyright: © 2022 The Author(s). Published by S. Karger AG, Basel.Introduction: This post hoc analysis applies a fixed dosing stratification approach to patient-level brolucizumab data from the phase III HAWK and HARRIER trials to determine the proportion of patients who would have been assigned to fixed dosing regimens with treatment intervals of 8, 12, or 16 weeks (q8w, q12w, or q16w) based on the presence/absence of disease activity (DA) following the loading phase. The analysis also simulates central subfield thickness (CSFT) data to estimate the anatomical outcomes if the patients had been thus assigned. Of note, the limitations of this analysis include the post hoc nature of the work and the inability to directly compare HAWK and HARRIER with TENAYA and LUCERNE due to the differences in design. Design: This study was a post hoc modelling analysis of patient-level data. Methods: Using patient-level data from HAWK and HARRIER, patients (n = 730) were allocated to a fixed q16w, q12w, or q8w regimen based on assessment of DA at weeks 16 and 20. Two definitions of DA were used: DA 1, based on a phase II study of faricimab, and DA 2, a definition derived from common clinical consideration including visual acuity and anatomical changes. CSFT simulations were performed using a pharmacokinetic/pharmacodynamic model describing CSFT response to anti-VEGF treatment. Outcome measures were modelled patient allocation to fixed regimens and mean CSFT reduction. Results: Using DA definitions 1 and 2, respectively, 78% and 76% of patients in the brolucizumab arm were allocated to a greater than or equal to q12w regimen, and 56% and 52% were allocated to a q16w regimen. Mean reduction in CSFT was similar between the two study drugs with both DA definition assumptions. Conclusions: This analysis demonstrates the potential durability of action and effectiveness of brolucizumab.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)Centro de Estudos de Doenças Crónicas (CEDOC)RUNSinger, MichaelKhanani, Arshad M.Wolf, ArminFlores, RitaChhablani, JayB, Guruprasad B.Clemens, AndreasGedif, KinfemichaelLiu, XiaoxiMulyukov, ZufarQuerques, Giuseppe2022-09-07T23:13:56Z2022-08-012022-08-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article8application/pdfhttp://hdl.handle.net/10362/143577eng0030-3755PURE: 46147846https://doi.org/10.1159/000524245info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-03-11T05:22:05Zoai:run.unl.pt:10362/143577Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:51:01.537901Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Brolucizumab 12- and 16-Week Fixed Dosing Potential in Neovascular AMD
A post hoc Evaluation of Data from the HAWK and HARRIER Trials
title Brolucizumab 12- and 16-Week Fixed Dosing Potential in Neovascular AMD
spellingShingle Brolucizumab 12- and 16-Week Fixed Dosing Potential in Neovascular AMD
Singer, Michael
Anti-vascular endothelial growth factor
Brolucizumab
Fixed dosing
Neovascular age-related macular degeneration
Medicine(all)
title_short Brolucizumab 12- and 16-Week Fixed Dosing Potential in Neovascular AMD
title_full Brolucizumab 12- and 16-Week Fixed Dosing Potential in Neovascular AMD
title_fullStr Brolucizumab 12- and 16-Week Fixed Dosing Potential in Neovascular AMD
title_full_unstemmed Brolucizumab 12- and 16-Week Fixed Dosing Potential in Neovascular AMD
title_sort Brolucizumab 12- and 16-Week Fixed Dosing Potential in Neovascular AMD
author Singer, Michael
author_facet Singer, Michael
Khanani, Arshad M.
Wolf, Armin
Flores, Rita
Chhablani, Jay
B, Guruprasad B.
Clemens, Andreas
Gedif, Kinfemichael
Liu, Xiaoxi
Mulyukov, Zufar
Querques, Giuseppe
author_role author
author2 Khanani, Arshad M.
Wolf, Armin
Flores, Rita
Chhablani, Jay
B, Guruprasad B.
Clemens, Andreas
Gedif, Kinfemichael
Liu, Xiaoxi
Mulyukov, Zufar
Querques, Giuseppe
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
Centro de Estudos de Doenças Crónicas (CEDOC)
RUN
dc.contributor.author.fl_str_mv Singer, Michael
Khanani, Arshad M.
Wolf, Armin
Flores, Rita
Chhablani, Jay
B, Guruprasad B.
Clemens, Andreas
Gedif, Kinfemichael
Liu, Xiaoxi
Mulyukov, Zufar
Querques, Giuseppe
dc.subject.por.fl_str_mv Anti-vascular endothelial growth factor
Brolucizumab
Fixed dosing
Neovascular age-related macular degeneration
Medicine(all)
topic Anti-vascular endothelial growth factor
Brolucizumab
Fixed dosing
Neovascular age-related macular degeneration
Medicine(all)
description Funding Information: Development of this publication was funded by Novartis Pharma AG including medical writing and editorial assistance. The sponsor participated in data analysis, interpretation of the data, and review of the manuscript. Publisher Copyright: © 2022 The Author(s). Published by S. Karger AG, Basel.
publishDate 2022
dc.date.none.fl_str_mv 2022-09-07T23:13:56Z
2022-08-01
2022-08-01T00:00:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10362/143577
url http://hdl.handle.net/10362/143577
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 0030-3755
PURE: 46147846
https://doi.org/10.1159/000524245
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 8
application/pdf
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
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reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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