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Risk of relapse after natalizumab withdrawal: Results from the French TYSEDMUS cohort.
Papeix, Caroline; Vukusic, Sandra; Casey, Romain; Debard, Nadine; Stankoff, Bruno; Mrejen, Serge; Uhry, Zoe; Van Ganse, Eric; Castot, Anne; Clanet, Michel; Lubetzki, Catherine; Confavreux, Christian.
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  • Papeix C; Neurology Department (C.P., S.M., C.L.), Pitié-Salpêtrière Hospital, Paris; Service de Neurologie A, Hôpital Neurologique Pierre Wertheimer (S.V., C.C.), and Neuro-epidemiology and Pharmaco-epidemiology (E.V.G.), Hospices Civils de Lyon, Lyon/Bron; Centre des Neurosciences de Lyon (S.V., C.C.), INSE
  • Vukusic S; Neurology Department (C.P., S.M., C.L.), Pitié-Salpêtrière Hospital, Paris; Service de Neurologie A, Hôpital Neurologique Pierre Wertheimer (S.V., C.C.), and Neuro-epidemiology and Pharmaco-epidemiology (E.V.G.), Hospices Civils de Lyon, Lyon/Bron; Centre des Neurosciences de Lyon (S.V., C.C.), INSE
  • Casey R; Neurology Department (C.P., S.M., C.L.), Pitié-Salpêtrière Hospital, Paris; Service de Neurologie A, Hôpital Neurologique Pierre Wertheimer (S.V., C.C.), and Neuro-epidemiology and Pharmaco-epidemiology (E.V.G.), Hospices Civils de Lyon, Lyon/Bron; Centre des Neurosciences de Lyon (S.V., C.C.), INSE
  • Debard N; Neurology Department (C.P., S.M., C.L.), Pitié-Salpêtrière Hospital, Paris; Service de Neurologie A, Hôpital Neurologique Pierre Wertheimer (S.V., C.C.), and Neuro-epidemiology and Pharmaco-epidemiology (E.V.G.), Hospices Civils de Lyon, Lyon/Bron; Centre des Neurosciences de Lyon (S.V., C.C.), INSE
  • Stankoff B; Neurology Department (C.P., S.M., C.L.), Pitié-Salpêtrière Hospital, Paris; Service de Neurologie A, Hôpital Neurologique Pierre Wertheimer (S.V., C.C.), and Neuro-epidemiology and Pharmaco-epidemiology (E.V.G.), Hospices Civils de Lyon, Lyon/Bron; Centre des Neurosciences de Lyon (S.V., C.C.), INSE
  • Mrejen S; Neurology Department (C.P., S.M., C.L.), Pitié-Salpêtrière Hospital, Paris; Service de Neurologie A, Hôpital Neurologique Pierre Wertheimer (S.V., C.C.), and Neuro-epidemiology and Pharmaco-epidemiology (E.V.G.), Hospices Civils de Lyon, Lyon/Bron; Centre des Neurosciences de Lyon (S.V., C.C.), INSE
  • Uhry Z; Neurology Department (C.P., S.M., C.L.), Pitié-Salpêtrière Hospital, Paris; Service de Neurologie A, Hôpital Neurologique Pierre Wertheimer (S.V., C.C.), and Neuro-epidemiology and Pharmaco-epidemiology (E.V.G.), Hospices Civils de Lyon, Lyon/Bron; Centre des Neurosciences de Lyon (S.V., C.C.), INSE
  • Van Ganse E; Neurology Department (C.P., S.M., C.L.), Pitié-Salpêtrière Hospital, Paris; Service de Neurologie A, Hôpital Neurologique Pierre Wertheimer (S.V., C.C.), and Neuro-epidemiology and Pharmaco-epidemiology (E.V.G.), Hospices Civils de Lyon, Lyon/Bron; Centre des Neurosciences de Lyon (S.V., C.C.), INSE
  • Castot A; Neurology Department (C.P., S.M., C.L.), Pitié-Salpêtrière Hospital, Paris; Service de Neurologie A, Hôpital Neurologique Pierre Wertheimer (S.V., C.C.), and Neuro-epidemiology and Pharmaco-epidemiology (E.V.G.), Hospices Civils de Lyon, Lyon/Bron; Centre des Neurosciences de Lyon (S.V., C.C.), INSE
  • Clanet M; Neurology Department (C.P., S.M., C.L.), Pitié-Salpêtrière Hospital, Paris; Service de Neurologie A, Hôpital Neurologique Pierre Wertheimer (S.V., C.C.), and Neuro-epidemiology and Pharmaco-epidemiology (E.V.G.), Hospices Civils de Lyon, Lyon/Bron; Centre des Neurosciences de Lyon (S.V., C.C.), INSE
  • Lubetzki C; Neurology Department (C.P., S.M., C.L.), Pitié-Salpêtrière Hospital, Paris; Service de Neurologie A, Hôpital Neurologique Pierre Wertheimer (S.V., C.C.), and Neuro-epidemiology and Pharmaco-epidemiology (E.V.G.), Hospices Civils de Lyon, Lyon/Bron; Centre des Neurosciences de Lyon (S.V., C.C.), INSE
  • Confavreux C; Neurology Department (C.P., S.M., C.L.), Pitié-Salpêtrière Hospital, Paris; Service de Neurologie A, Hôpital Neurologique Pierre Wertheimer (S.V., C.C.), and Neuro-epidemiology and Pharmaco-epidemiology (E.V.G.), Hospices Civils de Lyon, Lyon/Bron; Centre des Neurosciences de Lyon (S.V., C.C.), INSE
Neurol Neuroimmunol Neuroinflamm ; 3(6): e297, 2016 Dec.
Article en En | MEDLINE | ID: mdl-27844037
ABSTRACT

OBJECTIVE:

To assess disease activity within 12 months after natalizumab (NZ) discontinuation in a large French postmarketing cohort.

METHODS:

In France, patients exposed at least once to NZ were included in the TYSEDMUS observational and multicenter cohort, part of the French NZ Risk Management Plan. Clinical disease activity during the year following NZ discontinuation was assessed in this cohort. Time to first relapse after NZ stop was analyzed using Kaplan-Meier method and potentially associated factors were studied using a multivariate Cox model.

RESULTS:

Out of the 4,055 patients with multiple sclerosis (MS) included in TYSEDMUS, 1,253 discontinued NZ and 715 of them had relevant data for our study. The probability of relapse within the year after NZ stop was estimated at 45% (95% confidence interval 0.41-0.49).

CONCLUSIONS:

This large and systematic survey of patients with MS after NZ withdrawal allows quantifying the risk of increased disease activity following treatment discontinuation. This study provides large-scale, multicenter, systematic data after NZ cessation in real-life settings.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Idioma: En Revista: Neurol Neuroimmunol Neuroinflamm Año: 2016 Tipo del documento: Article
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Idioma: En Revista: Neurol Neuroimmunol Neuroinflamm Año: 2016 Tipo del documento: Article