PT  - JOURNAL ARTICLE
AU  - Papeix, Caroline
AU  - Vukusic, Sandra
AU  - Casey, Romain
AU  - Debard, Nadine
AU  - Stankoff, Bruno
AU  - Mrejen, Serge
AU  - Uhry, Zoe
AU  - Van Ganse, Eric
AU  - Castot, Anne
AU  - Clanet, Michel
AU  - Lubetzki, Catherine
AU  - Confavreux, Christian
AU  - ,
TI  - Risk of relapse after natalizumab withdrawal
AID  - 10.1212/NXI.0000000000000297
DP  - 2016 Dec 01
TA  - Neurology - Neuroimmunology Neuroinflammation
PG  - e297
VI  - 3
IP  - 6
4099  - http://nn.neurology.org/content/3/6/e297.short
4100  - http://nn.neurology.org/content/3/6/e297.full
SO  - Neurol Neuroimmunol Neuroinflamm2016 Dec 01; 3
AB  - 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.AE=adverse event; ARR=annualized relapse rate; CI=confidence interval; DMD=disease-modifying drug; EDSS=Expanded Disability Status Scale; HR=hazard ratio; IM=immunomodulatory treatment; IS=immunosuppressants; JCV=JC virus; MS=multiple sclerosis; NZ=natalizumab; PML=progressive multifocal leukoencephalopathy; SAE=serious adverse event