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.
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, multicentre, systematic data after NZ cessation in real-life settings.
This study indicates that natalizumab is keeping the cells that are driving relapsing disease in check and once drug is withdrawn disease will return and in many cases this will occur with the year.
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.
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, multicentre, systematic data after NZ cessation in real-life settings.
This study indicates that natalizumab is keeping the cells that are driving relapsing disease in check and once drug is withdrawn disease will return and in many cases this will occur with the year.