Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview

28 páginas

Autores:: Rodríguez, Sandra
Muñoz, Andrés
Bustos, Rosa Helena
Jaimes, Diego

Tipo de recurso:

Fecha de publicación:: 2020

Institución:: Universidad de la Sabana

Repositorio:: Repositorio Universidad de la Sabana

Idioma:: eng

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spelling	Rodríguez, SandraMuñoz, AndrésBustos, Rosa HelenaJaimes, Diego8/1/2021 20:492021-08-02T01:49:37Z2020-08-23Rodríguez S., Muñoz A., Bustos R.H., Jaimes D. (2020) Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview. Biomedicines, 8, 303. p.p. 1-28. https://www.mdpi.com/2227-9059/8/9/3032227-9059https://www.mdpi.com/2227-9059/8/9/303http://hdl.handle.net/10818/4808010.3390/biomedicines809030328 páginasSince we have gained an understanding of the immunological pathophysiology of rheumatic diseases such as rheumatoid arthritis and systemic lupus erythematosus, treatment based on biological drugs has become a fundamental axis. These therapies are oriented towards the regulation of cytokines such as tumour necrosis factor-alpha (TNF-α), interleukin (IL)-6, IL-1, and the modulation of cell-mediated immunity (B cells and T cells) by anti CD20 or anti CTAL-4 agents, and can increase the risk of associated infections or adverse events (AE). In this context, the entry of biotherapeutics represented a challenge for pharmacovigilance, risk management and approval by the main global regulatory agencies regarding biosimilars, where efficacy and safety are based on comparability exercises without being an exact copy in terms of molecular structure. The objective of this review is divided into three fundamental aspects: (i) to illustrate the evolution and focus of pharmacovigilance at the biopharmaceutical level, (ii) to describe the different approved recommendations of biopharmaceuticals (biological and biosimilars) and their use in rheumatic diseases (RDs) such as rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE) and other less frequent RD like cryopyrin-associated autoinflammatory syndromes (CAPS), and (iii) to identify the main AE reported in the post-marketing phase of RD biopharmaceuticals.application/pdfengBiomedicinesBiomedicines 2020, 8(9), 303Attribution-NonCommercial-NoDerivatives 4.0 Internacionalhttp://creativecommons.org/licenses/by-nc-nd/4.0/http://purl.org/coar/access_right/c_abf2Universidad de La SabanaIntellectum Repositorio Universidad de La SabanaBiopharmaceuticalsBiologicsMonoclonal antibodiesPharmacovigilanceRheumatologic diseasesBiosimilarsPharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An OverviewarticlepublishedVersionhttp://purl.org/coar/version/c_970fb48d4fbd8a85http://purl.org/coar/resource_type/c_6501CC-LICENSElicense_rdflicense_rdfapplication/rdf+xml; charset=utf-8805https://intellectum.unisabana.edu.co/bitstream/10818/48080/2/license_rdf4460e5956bc1d1639be9ae6146a50347MD52LICENSElicense.txtlicense.txttext/plain; charset=utf-8498https://intellectum.unisabana.edu.co/bitstream/10818/48080/3/license.txtf52a2cfd4df262e08e9b300d62c85cabMD5310818/48080oai:intellectum.unisabana.edu.co:10818/480802022-05-10 05:21:23.877Intellectum Universidad de la Sabanacontactointellectum@unisabana.edu.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
dc.title.es_CO.fl_str_mv	Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview
title	Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview
spellingShingle	Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview Biopharmaceuticals Biologics Monoclonal antibodies Pharmacovigilance Rheumatologic diseases Biosimilars
title_short	Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview
title_full	Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview
title_fullStr	Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview
title_full_unstemmed	Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview
title_sort	Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview
dc.creator.fl_str_mv	Rodríguez, Sandra Muñoz, Andrés Bustos, Rosa Helena Jaimes, Diego
dc.contributor.author.none.fl_str_mv	Rodríguez, Sandra Muñoz, Andrés Bustos, Rosa Helena Jaimes, Diego
dc.subject.es_CO.fl_str_mv	Biopharmaceuticals Biologics Monoclonal antibodies Pharmacovigilance Rheumatologic diseases Biosimilars
topic	Biopharmaceuticals Biologics Monoclonal antibodies Pharmacovigilance Rheumatologic diseases Biosimilars
description	28 páginas
publishDate	2020
dc.date.issued.none.fl_str_mv	2020-08-23
dc.date.available.none.fl_str_mv	2021-08-02T01:49:37Z
dc.date.accessioned.none.fl_str_mv	8/1/2021 20:49
dc.type.en.fl_str_mv	article
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dc.identifier.citation.es_CO.fl_str_mv	Rodríguez S., Muñoz A., Bustos R.H., Jaimes D. (2020) Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview. Biomedicines, 8, 303. p.p. 1-28. https://www.mdpi.com/2227-9059/8/9/303
dc.identifier.issn.none.fl_str_mv	2227-9059
dc.identifier.other.none.fl_str_mv	https://www.mdpi.com/2227-9059/8/9/303
dc.identifier.uri.none.fl_str_mv	http://hdl.handle.net/10818/48080
dc.identifier.doi.none.fl_str_mv	10.3390/biomedicines8090303
identifier_str_mv	Rodríguez S., Muñoz A., Bustos R.H., Jaimes D. (2020) Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview. Biomedicines, 8, 303. p.p. 1-28. https://www.mdpi.com/2227-9059/8/9/303 2227-9059 10.3390/biomedicines8090303
url	https://www.mdpi.com/2227-9059/8/9/303 http://hdl.handle.net/10818/48080
dc.language.iso.es_CO.fl_str_mv	eng
language	eng
dc.relation.ispartofseries.none.fl_str_mv	Biomedicines 2020, 8(9), 303
dc.rights.*.fl_str_mv	Attribution-NonCommercial-NoDerivatives 4.0 Internacional
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Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview

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