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   DIR Return to: TYSABRI (natalizumab)
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       #Post#: 1455--------------------------------------------------
       (Abst.) Relapse risk after Tysabri withdrawal: results from larg
       e French study
       By: agate Date: November 16, 2016, 12:37 pm
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       From PubMed, November 17, 2016:
       [quote]Neurol Neuroimmunol Neuroinflamm. 2016 Oct 28;3(6)
       Risk of relapse after natalizumab withdrawal: Results from the
       French TYSEDMUS cohort.
       Papeix C1, Vukusic S1, Casey R1, Debard N1, Stankoff B1, Mrejen
       S1, Uhry Z1, Van Ganse E1, Castot A1, Clanet M1, Lubetzki C1,
       Confavreux C1; TYSEDMUS and OFSEP Group.
       Author information
       1Neurology 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.), INSERM
       1028 et CNRS UMR5292, Equipe Neuro-oncologie et
       Neuro-inflammation; Université de Lyon (S.V., C.C.);
       Observatoire Français de la Sclérose en Plaques (R.C., N.D.,
       Z.U.), Bron; Neurology Department (B.S.), Saint Antoine
       Hospital, Paris; Agence Nationale de Sécurité des Médicaments
       (ANSM, formerly Agence Française de Sécurité Sanitaire des
       Produits de Santé-AFSSAPS) (A.C.), Saint-Denis; and Neurology
       Department (M.C.), Purpan Hospital, Toulouse, France.
       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.[/quote]
       The abstract can be seen here
  HTML https://www.ncbi.nlm.nih.gov/pubmed/27844037.
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