Occurrence of antibodies against natalizumab in relapsing multiple sclerosis patients treated with natalizumab

Per Soelberg Sørensen; Poul Erik Hyldgaard Jensen; Aiden Haghikia; Malin Lundkvist; Christian Vedeler; Finn Sellebjerg; Nils Koch-Henriksen; Anna Fogdell-Hahn; Kjell-Morten Myhr; Jan Hillert; Ralf Gold

doi:10.1177/1352458511404271

Occurrence of antibodies against natalizumab in relapsing multiple sclerosis patients treated with natalizumab

Per Soelberg Sørensen, Poul Erik Hyldgaard Jensen, Aiden Haghikia, Malin Lundkvist, Christian Vedeler, Finn Sellebjerg, Nils Koch-Henriksen, Anna Fogdell-Hahn, Kjell-Morten Myhr, Jan Hillert, Ralf Gold

Institut for Klinisk Medicin

43 Citationer (Scopus)

Abstract

Background: In the clinical trials about 9% of natalizumab treated multiple sclerosis (MS) patients generated anti-natalizumab antibodies, of which 6% were persistent and 3% transient. The occurrence of antibodies reduced serum levels of natalizumab, decreased bio-efficacy, and abrogated the therapeutic efficacy.Objective: The objective was to assess the frequency of anti-natalizumab antibodies in an unselected cohort of patients from four different countries.Methods: We measured anti-natalizumab antibodies in a large cohort of 4881 unselected patients from four MS centres that systematically measured antibodies in patients treated with natalizumab. We applied the same ELISA assay developed by Biogen Idec and used in the pivotal trials of natalizumab.Results: Antibodies occurred in 4.5% (95% confidence interval, CI: 4.0-5.1%) of the patients, and were persistent in 3.5% (95% CI: 3.0-4.0%) and transient in 1.0% (95% CI: 0.7-1.3%) of the patients. The frequencies of permanently antibody positive patients did not show statistically significant differences between the four centres, whereas the frequencies of transiently antibody positive patients showed some variations.Conclusion: The frequencies of antibodies appeared to be of the same magnitude in the four centres, but might be less than in the pivotal studies of natalizumab.

Originalsprog	Engelsk
Tidsskrift	Multiple Sclerosis
Vol/bind	17
Udgave nummer	9
Sider (fra-til)	1074-8
Antal sider	5
ISSN	1352-4585
DOI	https://doi.org/10.1177/1352458511404271
Status	Udgivet - sep. 2011

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10.1177/1352458511404271

http://journals.sagepub.com/doi/pdf/10.1177/1352458511404271

Citationsformater

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title = "Occurrence of antibodies against natalizumab in relapsing multiple sclerosis patients treated with natalizumab",

abstract = "Background: In the clinical trials about 9% of natalizumab treated multiple sclerosis (MS) patients generated anti-natalizumab antibodies, of which 6% were persistent and 3% transient. The occurrence of antibodies reduced serum levels of natalizumab, decreased bio-efficacy, and abrogated the therapeutic efficacy.Objective: The objective was to assess the frequency of anti-natalizumab antibodies in an unselected cohort of patients from four different countries.Methods: We measured anti-natalizumab antibodies in a large cohort of 4881 unselected patients from four MS centres that systematically measured antibodies in patients treated with natalizumab. We applied the same ELISA assay developed by Biogen Idec and used in the pivotal trials of natalizumab.Results: Antibodies occurred in 4.5% (95% confidence interval, CI: 4.0-5.1%) of the patients, and were persistent in 3.5% (95% CI: 3.0-4.0%) and transient in 1.0% (95% CI: 0.7-1.3%) of the patients. The frequencies of permanently antibody positive patients did not show statistically significant differences between the four centres, whereas the frequencies of transiently antibody positive patients showed some variations.Conclusion: The frequencies of antibodies appeared to be of the same magnitude in the four centres, but might be less than in the pivotal studies of natalizumab.",

author = "S{\o}rensen, {Per Soelberg} and Jensen, {Poul Erik Hyldgaard} and Aiden Haghikia and Malin Lundkvist and Christian Vedeler and Finn Sellebjerg and Nils Koch-Henriksen and Anna Fogdell-Hahn and Kjell-Morten Myhr and Jan Hillert and Ralf Gold",

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TY - JOUR

T1 - Occurrence of antibodies against natalizumab in relapsing multiple sclerosis patients treated with natalizumab

AU - Sørensen, Per Soelberg

AU - Jensen, Poul Erik Hyldgaard

AU - Haghikia, Aiden

AU - Lundkvist, Malin

AU - Vedeler, Christian

AU - Sellebjerg, Finn

AU - Koch-Henriksen, Nils

AU - Fogdell-Hahn, Anna

AU - Myhr, Kjell-Morten

AU - Hillert, Jan

AU - Gold, Ralf

PY - 2011/9

Y1 - 2011/9

N2 - Background: In the clinical trials about 9% of natalizumab treated multiple sclerosis (MS) patients generated anti-natalizumab antibodies, of which 6% were persistent and 3% transient. The occurrence of antibodies reduced serum levels of natalizumab, decreased bio-efficacy, and abrogated the therapeutic efficacy.Objective: The objective was to assess the frequency of anti-natalizumab antibodies in an unselected cohort of patients from four different countries.Methods: We measured anti-natalizumab antibodies in a large cohort of 4881 unselected patients from four MS centres that systematically measured antibodies in patients treated with natalizumab. We applied the same ELISA assay developed by Biogen Idec and used in the pivotal trials of natalizumab.Results: Antibodies occurred in 4.5% (95% confidence interval, CI: 4.0-5.1%) of the patients, and were persistent in 3.5% (95% CI: 3.0-4.0%) and transient in 1.0% (95% CI: 0.7-1.3%) of the patients. The frequencies of permanently antibody positive patients did not show statistically significant differences between the four centres, whereas the frequencies of transiently antibody positive patients showed some variations.Conclusion: The frequencies of antibodies appeared to be of the same magnitude in the four centres, but might be less than in the pivotal studies of natalizumab.

AB - Background: In the clinical trials about 9% of natalizumab treated multiple sclerosis (MS) patients generated anti-natalizumab antibodies, of which 6% were persistent and 3% transient. The occurrence of antibodies reduced serum levels of natalizumab, decreased bio-efficacy, and abrogated the therapeutic efficacy.Objective: The objective was to assess the frequency of anti-natalizumab antibodies in an unselected cohort of patients from four different countries.Methods: We measured anti-natalizumab antibodies in a large cohort of 4881 unselected patients from four MS centres that systematically measured antibodies in patients treated with natalizumab. We applied the same ELISA assay developed by Biogen Idec and used in the pivotal trials of natalizumab.Results: Antibodies occurred in 4.5% (95% confidence interval, CI: 4.0-5.1%) of the patients, and were persistent in 3.5% (95% CI: 3.0-4.0%) and transient in 1.0% (95% CI: 0.7-1.3%) of the patients. The frequencies of permanently antibody positive patients did not show statistically significant differences between the four centres, whereas the frequencies of transiently antibody positive patients showed some variations.Conclusion: The frequencies of antibodies appeared to be of the same magnitude in the four centres, but might be less than in the pivotal studies of natalizumab.

U2 - 10.1177/1352458511404271

DO - 10.1177/1352458511404271

M3 - Journal article

SN - 1352-4585

VL - 17

SP - 1074

EP - 1078

JO - Multiple Sclerosis Journal

JF - Multiple Sclerosis Journal

IS - 9

ER -

Occurrence of antibodies against natalizumab in relapsing multiple sclerosis patients treated with natalizumab

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