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The incidence and significance of anti-natalizumab antibodies: results from AFFIRM and SENTINEL.
Calabresi, P A; Giovannoni, G; Confavreux, C; Galetta, S L; Havrdova, E; Hutchinson, M; Kappos, L; Miller, D H; O'Connor, P W; Phillips, J T; Polman, C H; Radue, E-W; Rudick, R A; Stuart, W H; Lublin, F D; Wajgt, A; Weinstock-Guttman, B; Wynn, D R; Lynn, F; Panzara, M A.
Afiliación
  • Calabresi PA; Johns Hopkins Multiple Sclerosis Center, Baltimore, MD, USA. Calabresi@jhmi.edu
Neurology ; 69(14): 1391-403, 2007 Oct 02.
Article en En | MEDLINE | ID: mdl-17761550
OBJECTIVE: To determine the incidence and clinical effects of antibodies that develop during treatment with natalizumab. METHODS: In two randomized, double-blind, placebo-controlled studies (natalizumab safety and efficacy in relapsing remitting multiple sclerosis [MS, AFFIRM] and safety and efficacy of natalizumab in combination with interferon beta-1a [INF beta]1a] in patients with relapsing remitting MS [SENTINEL]) of patients with relapsing multiple sclerosis, blood samples were obtained at baseline and every 12 weeks to determine the presence of antibodies against natalizumab. Antibodies to natalizumab were measured using an ELISA. Patients were categorized as "transiently positive" if they had detectable antibodies (>or=0.5 microg/mL) at a single time point or "persistently positive" if they had antibodies at two or more time points >or=6 weeks apart. RESULTS: In the AFFIRM study, antibodies were detected in 57 of 625 (9%) of natalizumab-treated patients: Twenty (3%) were transiently positive and 37 (6%) were persistently positive. Persistently positive patients showed a loss of clinical efficacy as measured by disability progression (p
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Anticuerpos Bloqueadores / Esclerosis Múltiple Recurrente-Remitente / Anticuerpos Monoclonales Tipo de estudio: Clinical_trials / Incidence_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Neurology Año: 2007 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Buscar en Google
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Anticuerpos Bloqueadores / Esclerosis Múltiple Recurrente-Remitente / Anticuerpos Monoclonales Tipo de estudio: Clinical_trials / Incidence_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Neurology Año: 2007 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos