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Risk of relapse after natalizumab withdrawal

2016; Wolters Kluwer; Volume: 3; Issue: 6 Linguagem: Inglês

10.1212/nxi.0000000000000297

2332-7812

Caroline Papeix, Sandra Vukusic, Romain Casey, Nadine Debard, Bruno Stankoff, S. Mrejen, Zoé Uhry, Éric Van Ganse, A Castot, Michel Clanet, Catherine Lubetzki, Christian Confavreux, Sandra Vukusic, Michel Clanet, Bertrand Fontaine, Thibault Moreau, Bruno Brochet, Jean Pelletier, de Sèze, François Cotton, Vincent Dousset, David Laplaud, Marc Debouvery, Gilles Edan, Caroline Papeix, Bruno Stankoff, Alain Créange, Yann Mickaeloff, Kumaran Deiva, Olivier Gout, Christine Lebrun‐Frénay, Vermersch Patrick, Giulles Defer, Éric Berger, Éric Thouvenot, Philippe CabreMD, Pierre Labauge, William Camu, Bertrand Bourre, Jean Philippe Candessanche, Laurent Magy, Abdellatif Al-Khedr, Ayman Tourbah, Olivier Casez, Anne‐Marie Guennoc, Jonathan Ciron,

Acute Lymphoblastic Leukemia research

To assess disease activity within 12 months after natalizumab (NZ) discontinuation in a large French postmarketing cohort.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.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).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.