Risk of relapse after natalizumab withdrawal: Results from the French TYSEDMUS cohort.
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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.
SUBMITTER: Papeix C
PROVIDER: S-EPMC5087255 | biostudies-literature | 2016 Dec
REPOSITORIES: biostudies-literature
Publications
Risk of relapse after natalizumab withdrawal: Results from the French TYSEDMUS cohort.
Papeix Caroline C Vukusic Sandra S Casey Romain R Debard Nadine N Stankoff Bruno B Mrejen Serge S Uhry Zoe Z Van Ganse Eric E Castot Anne A Clanet Michel M Lubetzki Catherine C Confavreux Christian C
Neurology(R) neuroimmunology & neuroinflammation 20161028 6
<h4>Objective</h4>To assess disease activity within 12 months after natalizumab (NZ) discontinuation in a large French postmarketing cohort.<h4>Methods</h4>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 poten ...[more]
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