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   DIR Return to: TYSABRI (natalizumab)
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       #Post#: 1455--------------------------------------------------
       (Abst.) Relapse risk after Tysabri withdrawal: results from
       large French study
   DIR 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.
       --- End Quote ---
       The abstract can be seen here
  HTML https://www.ncbi.nlm.nih.gov/pubmed/27844037.
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