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Journal of Neurology

Erschienen in:

01.06.2013 | Original Communication

The impact of neutralizing antibodies on the risk of disease worsening in interferon β–treated relapsing multiple sclerosis: a 5 year post-marketing study

verfasst von: D. Paolicelli, M. D’Onghia, F. Pellegrini, V. Direnzo, P. Iaffaldano, V. Lavolpe, M. Trojano

Erschienen in: Journal of Neurology | Ausgabe 6/2013

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Abstract

The impact of neutralizing antibodies (NAbs) on interferon β (IFNβ) efficacy in MS patients is still an object of controversy. To evaluate the clinical response to IFNβ during NAb-positive (NAb+) and NAb-negative (NAb−) statuses on a large population of relapsing remitting (RR) MS patients were followed up to 5 years. Sera from 567 RR MS patients treated with IFNβ for 2–5 years were collected every 6–12 months and evaluated for NAb presence by a cytopathic effect assay. The relapse rate and expanded disability status scale (EDSS) score were assessed at baseline and every 6 months for each patient. A NAb+ status was defined after two consecutive positive titers of NAbs >/= 20 neutralizing units (NU)/mL. Multivariate models were used to analyze the relapse rate, the time to first relapse, the time to confirmed EDSS score 4 during NAb+ and NAb− statuses. A propensity score (PS) matching analysis was performed to assess the robustness of the multivariate models. Fourteen percent of patients became NAb+ during the follow-up. A significant increase of the relapse rate (IRR = 1.38; p = 0.0247) and decrease of the time to 1st relapse (IRR = 1.51; p = 0.0111) were found during NAb+ periods. The PS matching analysis, in a selected cohort of patients, demonstrated a negative trend of NAbs on the time to reach the milestone EDSS 4 (IRR = 2.94; p = 0.0879). This long-term post-marketing observational study further confirms that the occurrence of NAbs significantly affects the risk of disease worsening in IFNβ- treated RRMS.

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Titel: The impact of neutralizing antibodies on the risk of disease worsening in interferon β–treated relapsing multiple sclerosis: a 5 year post-marketing study
verfasst von: D. Paolicelli
M. D’Onghia
F. Pellegrini
V. Direnzo
P. Iaffaldano
V. Lavolpe
M. Trojano
Publikationsdatum: 01.06.2013
Verlag: Springer-Verlag
Erschienen in: Journal of Neurology / Ausgabe 6/2013
Print ISSN: 0340-5354
Elektronische ISSN: 1432-1459
DOI: https://doi.org/10.1007/s00415-012-6829-3

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The impact of neutralizing antibodies on the risk of disease worsening in interferon β–treated relapsing multiple sclerosis: a 5 year post-marketing study

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