Adverse events/mode of action relationship of monoclonal antibodies-based therapies : overview of marketed produts in the European Union

Detalhes bibliográficos
Autor(a) principal: Lemos, Francisca Mendes
Data de Publicação: 2014
Tipo de documento: Dissertação
Idioma: por
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10451/18333
Resumo: Tese de mestrado, Ciências Biofarmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2014
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spelling Adverse events/mode of action relationship of monoclonal antibodies-based therapies : overview of marketed produts in the European UnionBiopharmaceuticalsMonoclonal AntibodiesmAbs Adverse EventsmAbs Mechanism of Actionanti-TNF alpha mAbsanti-VEGF mAbsanti-CD20 mAbsTeses de mestrado - 2014Tese de mestrado, Ciências Biofarmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2014In the past few years, great discoveries and improvements have been done in drug development field and a market that was previously populated just by chemical drugs is now growing to include the so called biopharmaceuticals. As biotechnologically-derived drugs rely on the fundamental understanding of the related disease, it can be predicted that they will play a major – if not dominant – role in the drug development arena of the next decades. Following the success of recombinant proteins, therapeutic Monoclonal Antibodies (mAbs) represent the second wave of innovation created by the biotechnology industry. Overcoming the problems initially raised by these biopharmaceuticals, the recent generations of mAbs have managed to reduce some of the immunogenicity problems observed with murine mAbs. Other concerns remain, however, and the adverse events arising during the long-life experience will continue to be an important factor to monitor. The target specificity of mAbs associated to the fact that they are large protein molecules make the emergence of off-target or metabolite–related toxicities less probable, being immunogenicity and target-mediated effects the most relevant determinants of toxicity. This project focus was in the correlation and comparison of mAbs’ adverse events with their specific mechanism of action. The data here analysed comprises mainly European data (EMA) but also some United States data [1]. Due to the large diversity of mechanisms for the marketed mAbs, the analysis has been restricted to three pharmacological classes of mAbs: anti-TNFα, anti-VGEF and anti-CD20 mAbs. Adverse events were compared within each mAb class and then compared through all mAbs classes. There were antibody-related adverse events reported transversally for all mAbs but there were also some class-related adverse events which were only reported in specific classes, with specific mechanisms of action. For class-related adverse events it was observed that additional key factors – like administration routes, mAbs structural configurations and profile of patients receiving those mAbs – may also impact the adverse events and cannot be excluded in safety profile characterisation. It was confirmed that the adverse events reported for all mAbs analysed were strictly related to mAbs’ mechanism of action. Hence, characterisation of each mAb specifities together with a precise understanding of the mAbs mechanism of action is crucial for mAbs safety profile characterisation.Lima, BeatrizLobato, RosárioRepositório da Universidade de LisboaLemos, Francisca Mendes2017-12-22T01:30:22Z201420142014-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisapplication/pdfhttp://hdl.handle.net/10451/18333TID:201251256porinfo:eu-repo/semantics/embargoedAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-11-08T16:04:35Zoai:repositorio.ul.pt:10451/18333Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T21:37:55.726812Repositório 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 Adverse events/mode of action relationship of monoclonal antibodies-based therapies : overview of marketed produts in the European Union
title Adverse events/mode of action relationship of monoclonal antibodies-based therapies : overview of marketed produts in the European Union
spellingShingle Adverse events/mode of action relationship of monoclonal antibodies-based therapies : overview of marketed produts in the European Union
Lemos, Francisca Mendes
Biopharmaceuticals
Monoclonal Antibodies
mAbs Adverse Events
mAbs Mechanism of Action
anti-TNF alpha mAbs
anti-VEGF mAbs
anti-CD20 mAbs
Teses de mestrado - 2014
title_short Adverse events/mode of action relationship of monoclonal antibodies-based therapies : overview of marketed produts in the European Union
title_full Adverse events/mode of action relationship of monoclonal antibodies-based therapies : overview of marketed produts in the European Union
title_fullStr Adverse events/mode of action relationship of monoclonal antibodies-based therapies : overview of marketed produts in the European Union
title_full_unstemmed Adverse events/mode of action relationship of monoclonal antibodies-based therapies : overview of marketed produts in the European Union
title_sort Adverse events/mode of action relationship of monoclonal antibodies-based therapies : overview of marketed produts in the European Union
author Lemos, Francisca Mendes
author_facet Lemos, Francisca Mendes
author_role author
dc.contributor.none.fl_str_mv Lima, Beatriz
Lobato, Rosário
Repositório da Universidade de Lisboa
dc.contributor.author.fl_str_mv Lemos, Francisca Mendes
dc.subject.por.fl_str_mv Biopharmaceuticals
Monoclonal Antibodies
mAbs Adverse Events
mAbs Mechanism of Action
anti-TNF alpha mAbs
anti-VEGF mAbs
anti-CD20 mAbs
Teses de mestrado - 2014
topic Biopharmaceuticals
Monoclonal Antibodies
mAbs Adverse Events
mAbs Mechanism of Action
anti-TNF alpha mAbs
anti-VEGF mAbs
anti-CD20 mAbs
Teses de mestrado - 2014
description Tese de mestrado, Ciências Biofarmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2014
publishDate 2014
dc.date.none.fl_str_mv 2014
2014
2014-01-01T00:00:00Z
2017-12-22T01:30:22Z
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status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10451/18333
TID:201251256
url http://hdl.handle.net/10451/18333
identifier_str_mv TID:201251256
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