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The clinical effect of neutralizing antibodies against interferon-beta is independent of the type of interferon-beta used for patients with relapsing-remitting multiple sclerosis

Department of Neurology, Aarhus University Hospital in Aalborg, Denmark and The Danish MS Treatment Register, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark koch-henriksen{at}stofanet.dk

PS Sorensen

Danish Multiple Sclerosis Research Center, Department of Neurology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

K Bendtzen

Institute for Inflammation Research, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

EM Flachs

National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark;

Objective

To establish whether the clinical effect of neutralizing antibodies (NAbs) against interferon-beta (IFNβ) depends on the type of IFNβ (1a or 1b) used for treatment of patients with relapsing-remitting multiple sclerosis (MS).

Introduction

NAbs against IFNβ-1b appear faster and may be more evenly distributed on IgG subclasses, whereas NAbs against IFNβ-1a develop more slowly and may be devoid of IgG3. This might cause different clinical responses to NAbs.

Design/patients

All Danish MS-patients who had started first-time treatment with IFNβ-1a 22 µg s.c tiw (Rebif22) or IFNβ-1b 250 µg s.c. qod (Betaferon) before January 1st 2003 were included. Relapses were recorded at bi-annual visit.

Methods

We measured NAbs every 12 months using a clinically validated cytopathic effect assay. A blood sample with a neutralizing capacity of 20% or more was considered as NAb-positive. We used a mixed logistic regression analysis in which NAb-status (three levels), IFNβ-preparation, and time since treatment started were included as explanatory variables, and relapse rate as response variable.

Results

In 1,309 patients, who were observed for 21,958 months, 32.3% were classified as NAb-positive. The odds-ratio (OR) for relapses in NAb-positive months compared with NAb-negative months was 1.25; P = 0.02. The risk of relapses was higher with Betaferon than with Rebif22 (OR 1.26; P < 0.01). The effect of NAb-level on relapses was independent of whether the patients were treated with Betaferon or Rebif22 (P = 0.89) and of time (P = 0.80).

Conclusion

NAbs caused by IFNβ-1a s.c. do not differ from NAbs caused by IFNβ-1b in their detrimental clinical effect.

Key Words: interferon-beta • interferon-beta antibodies • multiple sclerosis • neutralizing antibodies • therapy • treatment effect

This version was published on May 1, 2009

Multiple Sclerosis, Vol. 15, No. 5, 601-605 (2009)
DOI: 10.1177/1352458508101946


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