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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorLink, Jenny
dc.contributor.authorRamanujam, Ryan
dc.contributor.authorAuer, Michael
dc.contributor.authorRyner, Malin
dc.contributor.authorHassler, Signe
dc.contributor.authorBachelet, Delphine
dc.contributor.authorMontalban Gairín, Xavier
dc.contributor.authorComabella Lopez, Manuel
dc.contributor.authorFissolo, Nicolás Miguel
dc.date.accessioned2019-03-22T07:20:48Z
dc.date.available2019-03-22T07:20:48Z
dc.date.issued2017-02-07
dc.identifier.citationLink J, Ramanujam R, Auer M, Ryner M, Hässler S, Bachelet D, et al. Clinical practice of analysis of anti-drug antibodies against interferon beta and natalizumab in multiple sclerosis patients in Europe: A descriptive study of test results. PLoS One. 2017;12(2):e0170395.
dc.identifier.issn1932-6203
dc.identifier.urihttps://hdl.handle.net/11351/3857
dc.descriptionAntibodies; Interferon beta; Multiple sclerosis
dc.description.abstractAntibodies against biopharmaceuticals (anti-drug antibodies, ADA) have been a well-integrated part of the clinical care of multiple sclerosis (MS) in several European countries. ADA data generated in Europe during the more than 10 years of ADA monitoring in MS patients treated with interferon beta (IFNβ) and natalizumab have been pooled and characterized through collaboration within a European consortium. The aim of this study was to report on the clinical practice of ADA testing in Europe, considering the number of ADA tests performed and type of ADA assays used, and to determine the frequency of ADA testing against the different drug preparations in different countries. A common database platform (tranSMART) for querying, analyzing and storing retrospective data of MS cohorts was set up to harmonize the data and compare results of ADA tests between different countries. Retrospective data from six countries (Sweden, Austria, Spain, Switzerland, Germany and Denmark) on 20,695 patients and on 42,555 samples were loaded into tranSMART including data points of age, gender, treatment, samples, and ADA results. The previously observed immunogenic difference among the four IFNβ preparations was confirmed in this large dataset. Decreased usage of the more immunogenic preparations IFNβ-1a subcutaneous (s.c.) and IFNβ-1b s.c. in favor of the least immunogenic preparation IFNβ-1a intramuscular (i.m.) was observed. The median time from treatment start to first ADA test correlated with time to first positive test. Shorter times were observed for IFNβ-1b-Extavia s.c. (0.99 and 0.94 years) and natalizumab (0.25 and 0.23 years), which were introduced on the market when ADA testing was already available, as compared to IFNβ-1a i.m. (1.41 and 2.27 years), IFNβ-1b-Betaferon s.c. (2.51 and 1.96 years) and IFNβ-1a s.c. (2.11 and 2.09 years) which were available years before routine testing began. A higher rate of anti-IFNβ ADA was observed in test samples taken from older patients. Testing for ADA varies between different European countries and is highly dependent on the policy within each country. For drugs where routine monitoring of ADA is not in place, there is a risk that some patients remain on treatment for several years despite ADA positivity. For drugs where a strategy of ADA testing is introduced with the release of the drug, there is a reduced risk of having ADA positive patients and thus of less efficient treatment. This indicates that potential savings in health cost might be achieved by routine analysis of ADA.
dc.language.isoeng
dc.publisherPublic Library of Science
dc.relation.ispartofseriesPLoS ONE;12(2)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectEsclerosi múltiple
dc.subjectInterferó - Immunologia
dc.subjectAntígens - Immunologia
dc.subject.meshMultiple Sclerosis
dc.subject.meshInterferon-beta
dc.subject.meshNatalizumab
dc.subject.meshAntibodies
dc.subject.mesh/immunology
dc.subject.meshEurope
dc.titleClinical practice of analysis of anti-drug antibodies against interferon beta and natalizumab in multiple sclerosis patients in Europe: A descriptive study of test results
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1371/journal.pone.0170395
dc.subject.decsesclerosis múltiple
dc.subject.decsinterferón beta
dc.subject.decsnatalizumab
dc.subject.decsanticuerpos
dc.subject.decs/inmunología
dc.subject.decsEuropa (continente)
dc.relation.publishversionhttps://journals.plos.org/plosone/article?id=10.1371/journal.pone.0170395
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Link J] Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. [Ramanujam R] Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. KTH - Royal Institute of Technology, Stockholm, Sweden. [Auer M] Innsbruck Medical University, Innsbruck, Austria. [Ryner M] Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. [Hässler S, Bachelet D] CESP, Université Paris-Sud, UVSQ, INSERM, Université Paris-Saclay, Villejuif, France. [Fissolo N, Comabella M, Montalban X] Centre d'Esclerosi Múltiple de Catalunya, Barcelona, Spain. Hospital Universitari Vall d'Hebron, Barcelona, Spain.
dc.identifier.pmid28170401
dc.identifier.wosWOS:000393705500005
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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