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Detection and kinetics of persistent neutralizing anti-interferon-beta antibodies in patients with multiple sclerosis. Results from the ABIRISK prospective cohort study

PEH. Jensen, C. Warnke, K. Ingenhoven, L. Piccoli, M. Gasis, C. Hermanrud, BM. Fernandez-Rodriguez, M. Ryner, D. Kramer, J. Link, R. Ramanujam, M. Auer, D. Buck, V. Grummel, E. Bertotti, N. Fissolo, B. Oliver-Martos, P. Nytrova, M. Khalil, M....

. 2019 ; 326 (-) : 19-27. [pub] 20181107

Jazyk angličtina Země Nizozemsko

Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie, pozorovací studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc19045133

Two validated assays, a bridging ELISA and a luciferase-based bioassay, were compared for detection of anti-drug antibodies (ADA) against interferon-beta (IFN-β) in patients with multiple sclerosis. Serum samples were tested from patients enrolled in a prospective study of 18 months. In contrast to the ELISA, when IFN-β-specific rabbit polyclonal and human monoclonal antibodies were tested, the bioassay was the more sensitive to detect IFN-β ADA in patients' sera. For clinical samples, selection of method of ELISA should be evaluated prior to the use of a multi-tiered approach. A titer threshold value is reported that may be used as a predictor for persistently positive neutralizing ADA.

Assistance Publique Hôpitaux de Paris Hôpital Paul Brousse Villejuif France

CESP INSERM UMR 1018 Faculty of Medicine Paris Sud University Paris Saclay University UVSQ Villejuif France

Clinic for Neurology 2 Kepler University Clinic Med Campus 3 Linz Austria

Danish Multiple Sclerosis Center Department of Neurology Rigshospitalet University of Copenhagen Copenhagen Denmark

Department of Clinical Neuroscience Karolinska Institutet Stockholm Sweden

Department of Neurology Medical University of Graz Graz Austria

Department of Neurology Technische Universität München Munich Germany

Department of Neurology University Hospital Köln Köln Germany

Departments of Biomedicine and Neurology University Hospital Basel and University of Basel Basel Switzerland

Drug Metabolism Pharmacokinetics Biologics Novartis Institutes for Biomedical Research Basel Switzerland

GlaxoSmithKline R and D Uxbridge Middlesex United Kingdom

Hospital Regional Universitario de Málaga Instituto de investigación Biomédica de Málaga Universidad de Málaga Málaga Spain

Hospital Universitari Vall d'Hebron Centre d'Esclerosi Múltiple de Catalunya Barcelona Spain

Innsbruck Medical University Innsbruck Austria

INSERM UMR 996 Univ Paris Sud Faculty of Pharmacy Université Paris Saclay Châtenay Malabry France

Ipsen Biopharm Ltd Berkshire United Kingdom

KTH Royal Institute of Technology Stockholm Sweden

Merck NBE Bioanalytics Ivrea Colleretto Giacosa Italy

MS Center Department of Neurology and Center Clinical Neuroscience Charles University Prague 1st Faculty of Medicine and General University Hospital Prague Czech Republic

Munich Cluster for systems Neurology Munich Germany

Sanofi Aventis Germany Frankfurt Am Main Germany

SciCross AB Skövde Sweden

Università della Svizzera italiana Faculty of Biomedical Sciences Institute for Research in Biomedicine Bellinzona Switzerland

University of Düsseldorf Medical Faculty Department of Neurology Düsseldorf Germany

Citace poskytuje Crossref.org

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$a Jensen, Poul Erik H $u Danish Multiple Sclerosis Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. Electronic address: poul.erik.h.jensen@regionh.dk.
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$a Detection and kinetics of persistent neutralizing anti-interferon-beta antibodies in patients with multiple sclerosis. Results from the ABIRISK prospective cohort study / $c PEH. Jensen, C. Warnke, K. Ingenhoven, L. Piccoli, M. Gasis, C. Hermanrud, BM. Fernandez-Rodriguez, M. Ryner, D. Kramer, J. Link, R. Ramanujam, M. Auer, D. Buck, V. Grummel, E. Bertotti, N. Fissolo, B. Oliver-Martos, P. Nytrova, M. Khalil, M. Guger, S. Rathmaier, C. Sievers-Stober, RLP. Lindberg, S. Hässler, D. Bachelet, O. Aktas, N. Donnellan, A. Lawton, B. Hemmer, EK. Havrdova, B. Kieseier, HP. Hartung, M. Comabella, X. Montalban, T. Derfuss, F. Sellebjerg, P. Dönnes, M. Pallardy, S. Spindeldreher, P. Broët, F. Deisenhammer, A. Fogdell-Hahn, PS. Sorensen, ABIRISK Consortium,
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$a Two validated assays, a bridging ELISA and a luciferase-based bioassay, were compared for detection of anti-drug antibodies (ADA) against interferon-beta (IFN-β) in patients with multiple sclerosis. Serum samples were tested from patients enrolled in a prospective study of 18 months. In contrast to the ELISA, when IFN-β-specific rabbit polyclonal and human monoclonal antibodies were tested, the bioassay was the more sensitive to detect IFN-β ADA in patients' sera. For clinical samples, selection of method of ELISA should be evaluated prior to the use of a multi-tiered approach. A titer threshold value is reported that may be used as a predictor for persistently positive neutralizing ADA.
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$a Warnke, Clemens $u Department of Neurology, University Hospital Köln, Köln, Germany; University of Düsseldorf, Medical Faculty, Department of Neurology, Düsseldorf, Germany. Electronic address: clemens.warnke@uk-koeln.de.
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$a Ingenhoven, Kathleen $u University of Düsseldorf, Medical Faculty, Department of Neurology, Düsseldorf, Germany. Electronic address: Kathleen.Ingenhoven@med.uni-duesseldorf.de.
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$a Piccoli, Luca $u Università della Svizzera italiana (USI), Faculty of Biomedical Sciences, Institute for Research in Biomedicine, Bellinzona, Switzerland. Electronic address: luca.piccoli@irb.usi.ch.
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$a Gasis, Marcia $u University of Düsseldorf, Medical Faculty, Department of Neurology, Düsseldorf, Germany. Electronic address: gasis@hhu.de.
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$a Hermanrud, Christina $u Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. Electronic address: christina.hermanrud@ki.se.
700    1_
$a Fernandez-Rodriguez, Blanca M $u Università della Svizzera italiana (USI), Faculty of Biomedical Sciences, Institute for Research in Biomedicine, Bellinzona, Switzerland. Electronic address: blanca.fernandez@irb.usi.ch.
700    1_
$a Ryner, Malin $u Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
700    1_
$a Kramer, Daniel $u Sanofi-Aventis Germany, Frankfurt Am Main, Germany. Electronic address: daniel.kramer@sanofi.com.
700    1_
$a Link, Jenny $u Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. Electronic address: jenny.link@ki.se.
700    1_
$a Ramanujam, Ryan $u Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; KTH - Royal Institute of Technology, Stockholm, Sweden. Electronic address: Ryan.Ramanujam@ki.se.
700    1_
$a Auer, Michael $u Innsbruck Medical University, Innsbruck, Austria. Electronic address: Michael.Auer@student.i-med.ac.at.
700    1_
$a Buck, Dorothea $u Department of Neurology, Technische Universität München, Munich, Germany. Electronic address: dorothea.buck@tum.de.
700    1_
$a Grummel, Verena $u Department of Neurology, Technische Universität München, Munich, Germany. Electronic address: v.grummel@tum.de.
700    1_
$a Bertotti, Elisa $u Merck NBE Bioanalytics Ivrea, Colleretto Giacosa, Italy. Electronic address: elisa.bertotti@merckgroup.com.
700    1_
$a Fissolo, Nicolas $u Hospital Universitari Vall d'Hebron, Centre d'Esclerosi Múltiple de Catalunya, Barcelona, Spain. Electronic address: nicolas.fissolo@vhir.org.
700    1_
$a Oliver-Martos, Begoña $u Hospital Regional Universitario de Málaga, Instituto de investigación Biomédica de Málaga (IBIMA), Universidad de Málaga, Málaga, Spain.
700    1_
$a Nytrova, Petra $u MS Center, Department of Neurology and Center Clinical Neuroscience, Charles University in Prague, 1st Faculty of Medicine and General University Hospital, Prague, Czech Republic. Electronic address: Petra.Nytrova@lf1.cuni.cz.
700    1_
$a Khalil, Michael $u Department of Neurology, Medical University of Graz, Graz, Austria. Electronic address: michael.khalil@medunigraz.at.
700    1_
$a Guger, Michael $u Clinic for Neurology 2, Kepler University Clinic, Med Campus III, Linz, Austria. Electronic address: Michael.Guger@kepleruniklinikum.at.
700    1_
$a Rathmaier, Sandra $u Clinic for Neurology 2, Kepler University Clinic, Med Campus III, Linz, Austria. Electronic address: Sandra.Rathmaier@kepleruniklinikum.at.
700    1_
$a Sievers-Stober, Claudia $u Departments of Biomedicine and Neurology, University Hospital Basel and University of Basel, Basel, Switzerland. Electronic address: claudia.sievers-stober@unibas.ch.
700    1_
$a Lindberg, Raija L P $u Departments of Biomedicine and Neurology, University Hospital Basel and University of Basel, Basel, Switzerland. Electronic address: Raija.Lindberg@unibas.ch.
700    1_
$a Hässler, Signe $u CESP, INSERM UMR 1018, Faculty of Medicine, Paris-Sud University, Paris-Saclay, University UVSQ, Villejuif, France. Electronic address: signe.hassler@inserm.fr.
700    1_
$a Bachelet, Delphine $u CESP, INSERM UMR 1018, Faculty of Medicine, Paris-Sud University, Paris-Saclay, University UVSQ, Villejuif, France. Electronic address: delphine.bachelet@inserm.fr.
700    1_
$a Aktas, Orhan $u University of Düsseldorf, Medical Faculty, Department of Neurology, Düsseldorf, Germany. Electronic address: orhan.aktas@uni-duesseldorf.de.
700    1_
$a Donnellan, Naoimh $u Ipsen Biopharm Ltd., Berkshire, United Kingdom.
700    1_
$a Lawton, Andy $u GlaxoSmithKline R&D, Uxbridge, Middlesex, United Kingdom. Electronic address: andy.m.lawton@gsk.com.
700    1_
$a Hemmer, Bernhard $u Department of Neurology, Technische Universität München, Munich, Germany; Munich Cluster for systems Neurology (SyNergy), Munich, Germany. Electronic address: hemmer@lrz.tu-muenchen.de.
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$a Havrdova, Eva Kubala $u MS Center, Department of Neurology and Center Clinical Neuroscience, Charles University in Prague, 1st Faculty of Medicine and General University Hospital, Prague, Czech Republic. Electronic address: eva.havrdova@lf1.cuni.cz.
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$a Kieseier, Bernd $u University of Düsseldorf, Medical Faculty, Department of Neurology, Düsseldorf, Germany. Electronic address: Bernd.Kieseier@uni-duesseldorf.de.
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$a Hartung, Hans-Peter $u University of Düsseldorf, Medical Faculty, Department of Neurology, Düsseldorf, Germany. Electronic address: hans-peter.hartung@uni-duesseldorf.de.
700    1_
$a Comabella, Manuel $u Hospital Universitari Vall d'Hebron, Centre d'Esclerosi Múltiple de Catalunya, Barcelona, Spain. Electronic address: manuel.comabella@vhir.org.
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$a Derfuss, Tobias $u Departments of Biomedicine and Neurology, University Hospital Basel and University of Basel, Basel, Switzerland. Electronic address: Tobias.Derfuss@usb.ch.
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$a Sellebjerg, Finn $u Danish Multiple Sclerosis Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. Electronic address: finn.thorup.sellebjerg@regionh.dk.
700    1_
$a Dönnes, Pierre $u SciCross AB, Skövde, Sweden. Electronic address: pierre@scicross.com.
700    1_
$a Pallardy, Marc $u INSERM UMR 996, Univ. Paris-Sud, Faculty of Pharmacy, Université Paris-Saclay, Châtenay-Malabry, France. Electronic address: marc.pallardy@u-psud.fr.
700    1_
$a Spindeldreher, Sebastian $u Drug Metabolism Pharmacokinetics-Biologics, Novartis Institutes for Biomedical Research, Basel, Switzerland. Electronic address: sebastian.spindeldreher@novartis.com.
700    1_
$a Broët, Philippe $u CESP, INSERM UMR 1018, Faculty of Medicine, Paris-Sud University, Paris-Saclay, University UVSQ, Villejuif, France; Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse, Villejuif, France. Electronic address: philippe.broet@inserm.fr.
700    1_
$a Deisenhammer, Florian $u Innsbruck Medical University, Innsbruck, Austria. Electronic address: Florian.Deisenhammer@tirol-kliniken.at.
700    1_
$a Fogdell-Hahn, Anna $u Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. Electronic address: Anna.Fogdell-Hahn@ki.se.
700    1_
$a Sorensen, Per Soelberg $u Danish Multiple Sclerosis Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. Electronic address: Per.Soelberg.Soerensen@regionh.dk.
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