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Neutralizing antibodies on Interferon beta in Multiple Sclerosis

Neutralizing antibodies on Interferon beta in Multiple Sclerosis

Objective

Nearly all biopharmaceuticals induce antibodies. Although the impact of these antibodies varies widely, it is clear that the immunogenicity of biopharmaceuticals may hamper optimum treatment strategies. The effectiveness of interferon beta (IFNb) is well established in relapsing-remitting multiple sclerosis (MS). Nevertheless, the use of this drug in clinical practice is complex, especially because it may induce neutralising antibodies (NABs). These NABs cause a reduction in IFNb bioavailability as measured by reduced levels of biomarkers. Moreover, there is evidence that persistent NABs reduce therapeutic efficacy. Because a standardised assay is lacking, the relevant clinical and biological level of NABs has not yet been defined. We here propose to setup a European wide network to provide standardised testing and to define the titres which are clinically relevant. We also want to develop in-vitro and in-vivo assays and models that predict immunogenicity, allowing strategies to prevent or modulate the induction of NABs. This project will increase the efficient use of IFNb in MS and safe money (approximately 100 million Euros per year) for the EU health systems by avoiding the use of this expensive treatment in patients in whom the drug is not effective. We want to achieve these goals by: 1 Validation and standardisation of a recently CHMP approved common assay for the detection of NABs. 2 Developing new assays. 3 Evaluating clinical effects in large cohorts of patients. 4 Studying bio-activity markers. 5 Studying immunogenicity. This research may lead to an evidence-based approach for dealing with the clinical problems of NABs and to improve care of MS patients by deciding what a clinically significant level of NABs is and recommending a strategy that will reduce clinical sequelae. Moreover, these studies may lead to data that can be applied more generally on the induction of antibodies by other biopharmaceuticals.

Coordinator

VU UNIVERSITY MEDICAL CENTRE

Address

De Boelelaan 1117, 1081 Hv
Amsterdam

Netherlands

Administrative Contact

Chris POLMAN (Professor)

Participants (14)

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UTRECHT UNIVERSITY

Netherlands

HEINRICH-HEINE-UNIVERSITAET DUESSELDORF

Germany

OSPEDALE UNIVERSITARIO SAN LUIGI

Italy

UNIVERSITY COLLEGE LONDON

United Kingdom

INNSBRUCK MEDICAL UNIVERSITY

Austria

COPENHAGEN UNIVERSITY HOSPITAL RIGSHOSPITALET

Denmark

HOSPITAL UNIVERSITARI VALL D'HEBRON

Spain

KAROLINSKA INSTITUTE

Sweden

BIOMONITOR

Denmark

NOVOZYMES AS

Denmark

LAB 21 LIMITED

United Kingdom

UNIVERSITY HOSPITAL BASEL

Switzerland

QUEEN MARY AND WESTFIELD COLLEGE, UNIVERSITY OF LONDON

United Kingdom

GENERAL CHARLES UNIVERISTY FIRST SCHOOL OF MEDICINE

Czechia

Project information

Grant agreement ID: 18926

  • Start date

    1 January 2006

  • End date

    30 June 2009

Funded under:

FP6-LIFESCIHEALTH

  • Overall budget:

    € 3 911 064

  • EU contribution

    € 3 500 000

Coordinated by:

VU UNIVERSITY MEDICAL CENTRE

Netherlands