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Multiple Sclerosis => TREATMENTS => TYSABRI (natalizumab) => Topic started by: agate on November 16, 2016, 08:37:33 am

Title: (Abst.) Relapse risk after Tysabri withdrawal: results from large French study
Post by: agate on November 16, 2016, 08:37:33 am

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.

The abstract can be seen here (https://www.ncbi.nlm.nih.gov/pubmed/27844037).