Risk of relapse after natalizumab withdrawal: Results from the French TYSEDMUS cohort.
Neurol Neuroimmunol Neuroinflamm
; 3(6): e297, 2016 Dec.
Article
en En
| MEDLINE
| ID: mdl-27844037
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.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Prognostic_studies
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Risk_factors_studies
Idioma:
En
Revista:
Neurol Neuroimmunol Neuroinflamm
Año:
2016
Tipo del documento:
Article