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Important sources of variability in clinical studies of neutralizing antibodies against interferon beta.

Publication ,  Journal Article
Hurwitz, BJ
Published in: J Neurol Sci
September 15, 2008

Interferon (IFN) beta treatment of relapsing-remitting multiple sclerosis (RRMS) stimulates production of neutralizing antibodies (NAbs) in some patients. However, clinical data supporting the hypothesis that NAbs to IFN beta adversely affect patient outcomes are not consistent across multiple studies or different forms of IFN beta. Only the PRISMS trial has produced data showing a negative impact of NAbs to IFN beta-1a (Rebif) across multiple study endpoints. No such data are available for IFN beta-1b (Betaseron) despite completion of a large registry study. Biological factors affecting the development of NAbs to IFN beta include protein structure, product formulation, administration frequency and/or dosing, and patients' immunological responses. Technical factors affecting interpretation of clinical trial data on NAbs include inadequate randomization; differences in the methods used to measure NAbs and in definitions of NAb positivity; selection of NAb-positive patient subpopulations according to titer and duration of NAb response; lack of power to detect differences in patient subgroups; and different trial durations. Given the complexity of NAb studies, it is not possible to generalize from current data regarding the potential impact of NAbs on the clinical efficacy of all IFN beta therapies. Differences between IFN beta products and their specific trials should be considered when evaluating the evidence on this topic.

Duke Scholars

Published In

J Neurol Sci

DOI

ISSN

0022-510X

Publication Date

September 15, 2008

Volume

272

Issue

1-2

Start / End Page

8 / 19

Location

Netherlands

Related Subject Headings

  • Multiple Sclerosis, Relapsing-Remitting
  • Interferon-beta
  • Interferon beta-1b
  • Humans
  • Clinical Trials as Topic
  • Antibody Formation
  • Antibodies
  • 5202 Biological psychology
  • 3209 Neurosciences
  • 3202 Clinical sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Hurwitz, B. J. (2008). Important sources of variability in clinical studies of neutralizing antibodies against interferon beta. J Neurol Sci, 272(1–2), 8–19. https://doi.org/10.1016/j.jns.2008.05.004
Hurwitz, B. J. “Important sources of variability in clinical studies of neutralizing antibodies against interferon beta.J Neurol Sci 272, no. 1–2 (September 15, 2008): 8–19. https://doi.org/10.1016/j.jns.2008.05.004.
Hurwitz, B. J. “Important sources of variability in clinical studies of neutralizing antibodies against interferon beta.J Neurol Sci, vol. 272, no. 1–2, Sept. 2008, pp. 8–19. Pubmed, doi:10.1016/j.jns.2008.05.004.
Journal cover image

Published In

J Neurol Sci

DOI

ISSN

0022-510X

Publication Date

September 15, 2008

Volume

272

Issue

1-2

Start / End Page

8 / 19

Location

Netherlands

Related Subject Headings

  • Multiple Sclerosis, Relapsing-Remitting
  • Interferon-beta
  • Interferon beta-1b
  • Humans
  • Clinical Trials as Topic
  • Antibody Formation
  • Antibodies
  • 5202 Biological psychology
  • 3209 Neurosciences
  • 3202 Clinical sciences