Phase IV Tysabri data

#MS Research # MSBlog Effect of Tysabri

Outteryck O, Ongagna JC, Brochet B, Rumbach L, Lebrun-Frenay C, Debouverie M, Zéphir H, Ouallet JC, Berger E, Cohen M, Pittion S, Laplaud D, Wiertlewski S, Cabre P, Pelletier J, Rico A, Defer G, Derache N, Camu W, Thouvenot E, Moreau T, Fromont A, Tourbah A, Labauge P, Castelnovo G, Clavelou P, Casez O, Hautecoeur P, Papeix C, Lubetzki C, Fontaine B, Couturier N, Bohossian N, Clanet M, Vermersch P, de Sèze J, Brassat D; BIONAT network, and CFSEP. A prospective observational post-marketing study of natalizumab-treated multiple sclerosispatients: clinical, radiological and biological features and adverse events. The BIONAT cohort. Eur J Neurol. 2013 Jun 12. doi: 10.1111/ene.12204. [Epub ahead of print]

BIONAT is a French multicentric phase IV study of natalizumab (NTZ)-treated relapsing-remitting multiple sclerosis(MS) patients. The purpose of this study was to collect clinical, radiological and biological data on 1204 patients starting NTZ, and to evaluate the clinical/radiological response to NTZ after 2 years of treatment.
METHODS:Patients starting NTZ at 18 French MS centres since June 2007 were included. Good response to NTZ was defined by the absence of clinical and radiological activity. Data analysed in this first report on the BIONAT study focus on patients who started NTZ at least 2 years ago (n = 793; BIONAT2Y ).
RESULTS:NTZ was discontinued in 17.78% of BIONAT2Y . The proportion of patients without combined disease activity was 45.59% during the first two successive years of treatment. Systematic dosage of anti-NTZ ntibodies (Abs) detected only two supplementary patients with anti-NTZ Abs compared with strict application of recommendations. A significant decrease of IgG,M concentrations at 2 years of treatment was found.
CONCLUSIONS: The efficacy of NTZ therapy on relapsing-remitting MS in a real life setting is confirmed in the BIONAT cohort. The next step will be the identification of biomarkers predicting response to NTZ therapy and adverse events.
Phase IV is the post-licensing phase of drug development, when people start to take drug in a less constrained fashion than in clinical trials. This is where rare adverse events begin to crop up.

This study shows that tysabri is efficacious…the question is the risk benefit ratio. So keep checking profGs risk update so you can make more informed choices

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