SAFETY OF OPHTHALMIC BIOLOGICS: A SYSTEMATIC REVIEW
Autor(a) principal: | |
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Data de Publicação: | 2015 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | https://doi.org/10.25756/rpf.v7i1.16 |
Resumo: | Objectives: The present study evaluates the safety of ophthalmic biologics.Methods: The website of European Medicines Agency was searched in order to identify the biologics with approved therapeutic indications in ophthalmology. MEDLINE, Cochrane Library and ClinicalTrials.gov databases were searched systematically, up to October 2014. The study was divided in two settings: pre- and postmarketing. Phase III and phase IV randomized controlled trials and their extension and follow-up studies were included. Cochrane collaboration risk of bias evaluation tool was used to assess methodological quality. Adverse events were classified as ocular (related and non-related with injection procedure) and non-ocular (related and non-related with systemic inhibition of vascular endothelial growth factor). Incidences of all adverse events were estimated.Results: Three biologics with therapeutic indications approved in ophthalmology were identified: pegaptanib, ranibizumab and aflibercept. Twenty-two studies were included, of which 14 considered the pre-marketing setting and 8 refer to the post-marketing setting. The most frequent ocular and non-ocular adverse events were common to all biologics studied. Ocular adverse events related with injection procedure were rare (≤1%). The incidence of non-ocular adverse events related with systemic inhibition of VEGF was superior in post-marketing compared to pre-marketing setting (1,0%-1,3% vs. 0,7-1,1%).Conclusions: Ophthalmic biologics’ safety profile was favorable. However, this study identified some adverse events, such as thromboembolic events, that deserve further research. |
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SAFETY OF OPHTHALMIC BIOLOGICS: A SYSTEMATIC REVIEWSEGURANÇA DOS MEDICAMENTOS BIOLÓGICOS OFTÁLMICOS: REVISÃO SISTEMÁTICAObjectives: The present study evaluates the safety of ophthalmic biologics.Methods: The website of European Medicines Agency was searched in order to identify the biologics with approved therapeutic indications in ophthalmology. MEDLINE, Cochrane Library and ClinicalTrials.gov databases were searched systematically, up to October 2014. The study was divided in two settings: pre- and postmarketing. Phase III and phase IV randomized controlled trials and their extension and follow-up studies were included. Cochrane collaboration risk of bias evaluation tool was used to assess methodological quality. Adverse events were classified as ocular (related and non-related with injection procedure) and non-ocular (related and non-related with systemic inhibition of vascular endothelial growth factor). Incidences of all adverse events were estimated.Results: Three biologics with therapeutic indications approved in ophthalmology were identified: pegaptanib, ranibizumab and aflibercept. Twenty-two studies were included, of which 14 considered the pre-marketing setting and 8 refer to the post-marketing setting. The most frequent ocular and non-ocular adverse events were common to all biologics studied. Ocular adverse events related with injection procedure were rare (≤1%). The incidence of non-ocular adverse events related with systemic inhibition of VEGF was superior in post-marketing compared to pre-marketing setting (1,0%-1,3% vs. 0,7-1,1%).Conclusions: Ophthalmic biologics’ safety profile was favorable. However, this study identified some adverse events, such as thromboembolic events, that deserve further research.Objetivos: Este estudo tem como objetivo avaliar a segurança dos medicamentos biológicos oftálmicos.Métodos: Os medicamentos biológicos oftálmicos foram identificados a partir do sítio Internet da Agência Europeia do Medicamento. Foi realizada uma pesquisa sistemática nas bases de dados MEDLINE, Cochrane Library e ClinicalTrials.gov, até outubro de 2014. O estudo foi dividido em dois períodos: pré e pós-comercialização. Foram incluídos ensaios clínicos aleatorizados e controlados de fase III e fase IV e os respetivos estudos de extensão, ou follow-up. A qualidade metodológica foi avaliada utilizando a ferramenta da Cochrane Collaboration. Foram avaliados os eventos adversos: oculares (relacionados e não relacionados com o procedimento de injeção) e os não oculares (relacionados e não relacionados com a inibição sistémica do fator de crescimento do endotélio vascular (VEGF)). Para cada evento adverso foi analisada a incidência.Resultados: Identificaram-se três medicamentos biológicos com aprovações em oftalmologia: pegaptanib, ranibizumab e aflibercept. Vinte e dois estudos foram incluídos: 14 referentes ao períodode pré-comercialização e oito ao período de pós-comercialização. Os eventos adversos oculares e não oculares mais frequentes foram comuns aos medicamentos avaliados. Os eventos adversosrelacionados com o procedimento de injeção foram raros (≤1%). A incidência dos eventos adversos relacionados com a inibição sistémica do VEGF foi superior no período de pós-comercialização,comparativamente ao período de pré-comercialização (1,0-1,3 por cento vs. 0,7-1,1 por cento).Conclusões: O perfil de segurança dos medicamentos biológicos é favorável. No entanto, este estudo permitiu identificar eventos adversos, tais como os eventos tromboembólicos, que necessitam de continuar a ser investigados.Formifarma2015-03-26info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttps://doi.org/10.25756/rpf.v7i1.16https://doi.org/10.25756/rpf.v7i1.16Revista Portuguesa de Farmacoterapia / Portuguese Journal of Pharmacotherapy; Vol 7 No 1 (2015): Janeiro; 25-41Revista Portuguesa de Farmacoterapia; v. 7 n. 1 (2015): Janeiro; 25-412183-73411647-354Xreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAPporhttp://revista.farmacoterapia.pt/index.php/rpf/article/view/16http://revista.farmacoterapia.pt/index.php/rpf/article/view/16/11Direitos de Autor (c) 2017 Revista Portuguesa de Farmacoterapiahttp://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessPenedones, AnaMendes, DiogoAlves, CarlosBatel Marques, Francisco2023-09-01T04:32:56Zoai:ojs.farmacoterapia.pt:article/16Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T15:11:29.847453Repositório 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 |
SAFETY OF OPHTHALMIC BIOLOGICS: A SYSTEMATIC REVIEW SEGURANÇA DOS MEDICAMENTOS BIOLÓGICOS OFTÁLMICOS: REVISÃO SISTEMÁTICA |
title |
SAFETY OF OPHTHALMIC BIOLOGICS: A SYSTEMATIC REVIEW |
spellingShingle |
SAFETY OF OPHTHALMIC BIOLOGICS: A SYSTEMATIC REVIEW Penedones, Ana |
title_short |
SAFETY OF OPHTHALMIC BIOLOGICS: A SYSTEMATIC REVIEW |
title_full |
SAFETY OF OPHTHALMIC BIOLOGICS: A SYSTEMATIC REVIEW |
title_fullStr |
SAFETY OF OPHTHALMIC BIOLOGICS: A SYSTEMATIC REVIEW |
title_full_unstemmed |
SAFETY OF OPHTHALMIC BIOLOGICS: A SYSTEMATIC REVIEW |
title_sort |
SAFETY OF OPHTHALMIC BIOLOGICS: A SYSTEMATIC REVIEW |
author |
Penedones, Ana |
author_facet |
Penedones, Ana Mendes, Diogo Alves, Carlos Batel Marques, Francisco |
author_role |
author |
author2 |
Mendes, Diogo Alves, Carlos Batel Marques, Francisco |
author2_role |
author author author |
dc.contributor.author.fl_str_mv |
Penedones, Ana Mendes, Diogo Alves, Carlos Batel Marques, Francisco |
description |
Objectives: The present study evaluates the safety of ophthalmic biologics.Methods: The website of European Medicines Agency was searched in order to identify the biologics with approved therapeutic indications in ophthalmology. MEDLINE, Cochrane Library and ClinicalTrials.gov databases were searched systematically, up to October 2014. The study was divided in two settings: pre- and postmarketing. Phase III and phase IV randomized controlled trials and their extension and follow-up studies were included. Cochrane collaboration risk of bias evaluation tool was used to assess methodological quality. Adverse events were classified as ocular (related and non-related with injection procedure) and non-ocular (related and non-related with systemic inhibition of vascular endothelial growth factor). Incidences of all adverse events were estimated.Results: Three biologics with therapeutic indications approved in ophthalmology were identified: pegaptanib, ranibizumab and aflibercept. Twenty-two studies were included, of which 14 considered the pre-marketing setting and 8 refer to the post-marketing setting. The most frequent ocular and non-ocular adverse events were common to all biologics studied. Ocular adverse events related with injection procedure were rare (≤1%). The incidence of non-ocular adverse events related with systemic inhibition of VEGF was superior in post-marketing compared to pre-marketing setting (1,0%-1,3% vs. 0,7-1,1%).Conclusions: Ophthalmic biologics’ safety profile was favorable. However, this study identified some adverse events, such as thromboembolic events, that deserve further research. |
publishDate |
2015 |
dc.date.none.fl_str_mv |
2015-03-26 |
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 |
https://doi.org/10.25756/rpf.v7i1.16 https://doi.org/10.25756/rpf.v7i1.16 |
url |
https://doi.org/10.25756/rpf.v7i1.16 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
http://revista.farmacoterapia.pt/index.php/rpf/article/view/16 http://revista.farmacoterapia.pt/index.php/rpf/article/view/16/11 |
dc.rights.driver.fl_str_mv |
Direitos de Autor (c) 2017 Revista Portuguesa de Farmacoterapia http://creativecommons.org/licenses/by-nc-nd/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Direitos de Autor (c) 2017 Revista Portuguesa de Farmacoterapia http://creativecommons.org/licenses/by-nc-nd/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Formifarma |
publisher.none.fl_str_mv |
Formifarma |
dc.source.none.fl_str_mv |
Revista Portuguesa de Farmacoterapia / Portuguese Journal of Pharmacotherapy; Vol 7 No 1 (2015): Janeiro; 25-41 Revista Portuguesa de Farmacoterapia; v. 7 n. 1 (2015): Janeiro; 25-41 2183-7341 1647-354X reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
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RCAAP |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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