Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations.

2.50
Hdl Handle:
http://hdl.handle.net/10033/333596
Title:
Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations.
Authors:
Shankar, G; Arkin, S; Cocea, L; Devanarayan, V; Kirshner, S; Kromminga, A; Quarmby, V; Richards, S; Schneider, C K; Subramanyam, M; Swanson, S; Verthelyi, D; Yim, S
Abstract:
Immunogenicity is a significant concern for biologic drugs as it can affect both safety and efficacy. To date, the descriptions of product immunogenicity have varied not only due to different degrees of understanding of product immunogenicity at the time of licensing but also due to an evolving lexicon that has generated some confusion in the field. In recent years, there has been growing consensus regarding the data needed to assess product immunogenicity. Harmonization of the strategy for the elucidation of product immunogenicity by drug developers, as well as the use of defined common terminology, can benefit medical practitioners, health regulatory agencies, and ultimately the patients. Clearly, understanding the incidence, kinetics and magnitude of anti-drug antibody (ADA), its neutralizing ability, cross-reactivity with endogenous molecules or other marketed biologic drugs, and related clinical impact may enhance clinical management of patients treated with biologic drugs. To that end, the authors present terms and definitions for describing and analyzing clinical immunogenicity data and suggest approaches to data presentation, emphasizing associations of ADA development with pharmacokinetics, efficacy, and safety that are necessary to assess the clinical relevance of immunogenicity.
Affiliation:
Janssen Research & Development, LLC (Johnson & Johnson), 1400 McKean Road, P.O. Box 776, Spring House, Pennsylvania, 19477, USA, Gshanka3@its.jnj.com.
Citation:
Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations. 2014, 16 (4):658-73 AAPS J
Journal:
The AAPS journal
Issue Date:
Jul-2014
URI:
http://hdl.handle.net/10033/333596
DOI:
10.1208/s12248-014-9599-2
PubMed ID:
24764037
Type:
Article
Language:
en
ISSN:
1550-7416
Appears in Collections:
publications of the department of experimental infection research ([TC] EXPI)

Full metadata record

DC FieldValue Language
dc.contributor.authorShankar, Gen
dc.contributor.authorArkin, Sen
dc.contributor.authorCocea, Len
dc.contributor.authorDevanarayan, Ven
dc.contributor.authorKirshner, Sen
dc.contributor.authorKromminga, Aen
dc.contributor.authorQuarmby, Ven
dc.contributor.authorRichards, Sen
dc.contributor.authorSchneider, C Ken
dc.contributor.authorSubramanyam, Men
dc.contributor.authorSwanson, Sen
dc.contributor.authorVerthelyi, Den
dc.contributor.authorYim, Sen
dc.date.accessioned2014-11-03T15:42:28Z-
dc.date.available2014-11-03T15:42:28Z-
dc.date.issued2014-07-
dc.identifier.citationAssessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations. 2014, 16 (4):658-73 AAPS Jen
dc.identifier.issn1550-7416-
dc.identifier.pmid24764037-
dc.identifier.doi10.1208/s12248-014-9599-2-
dc.identifier.urihttp://hdl.handle.net/10033/333596-
dc.description.abstractImmunogenicity is a significant concern for biologic drugs as it can affect both safety and efficacy. To date, the descriptions of product immunogenicity have varied not only due to different degrees of understanding of product immunogenicity at the time of licensing but also due to an evolving lexicon that has generated some confusion in the field. In recent years, there has been growing consensus regarding the data needed to assess product immunogenicity. Harmonization of the strategy for the elucidation of product immunogenicity by drug developers, as well as the use of defined common terminology, can benefit medical practitioners, health regulatory agencies, and ultimately the patients. Clearly, understanding the incidence, kinetics and magnitude of anti-drug antibody (ADA), its neutralizing ability, cross-reactivity with endogenous molecules or other marketed biologic drugs, and related clinical impact may enhance clinical management of patients treated with biologic drugs. To that end, the authors present terms and definitions for describing and analyzing clinical immunogenicity data and suggest approaches to data presentation, emphasizing associations of ADA development with pharmacokinetics, efficacy, and safety that are necessary to assess the clinical relevance of immunogenicity.en
dc.language.isoenen
dc.titleAssessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations.en
dc.typeArticleen
dc.contributor.departmentJanssen Research & Development, LLC (Johnson & Johnson), 1400 McKean Road, P.O. Box 776, Spring House, Pennsylvania, 19477, USA, Gshanka3@its.jnj.com.en
dc.identifier.journalThe AAPS journalen

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