Friday, 18 July 2014

Tysabri works in the real world outside of trials


Totaro R, Lugaresi A, Bellantonio P, Danni M, Costantino G, Gasperini C, Florio C, Pucci E, Maddestra M, Spitaleri D, Lus G, Ardito B, Farina D, Rossi M, Di Carmine C, Altobelli E, Maccarone B, Casalena A, De Luca G, Travaglini D, Di Ioia M, Di Tommaso V, Fantozzi R, Ruggieri S, Provinciali L, De Riso S, Mundi C, Fuiani A, Galgani S, Ruggieri S, Maniscalco GT, Giuliani G, Cartechini E, Petretta V, Fratta M, Alfieri G, Gatto M, Carolei A.
Natalizumab treatment in multiple sclerosis patients: a multicenter experience in clinical practice in Italy. Int J Immunopathol Pharmacol. 2014 Jul-Sep;27(2):147-54.

We evaluated efficacy of natalizumab in relapsing-remitting multiple sclerosis patients in a clinical practice setting. We report data on the first consecutive 343 patients receiving natalizumab in 12 multiple sclerosis (MS) Italian centres enrolled between April 2007 and November 2010. The main efficacy endpoints were the proportion of patients free from relapses, disease progression, combined clinical activity, defined as presence of relapse or disease progression, from MRI activity, and from any disease activity defined as the absence of any single or combined activity. At the end of follow-up, the cumulative proportion of patients free from relapses was 68%; the proportion of patients free from Expanded Disability Status Scale (EDSS) progression was 93%; the proportion of patients free from combined clinical activity was 65%; the proportion of patients free from MRI activity was 77%; and the proportion of patients free from any disease activity was 53%. Natalizumab was effective in reducing clinical and neuroradiological disease activity. Its effectiveness in clinical practice is higher than that reported in pivotal trials and was maintained over time.

It is clear that Tysabri can be a very effective drug however this has to be offset against the risk of developing consequences of tysabri treatment such as PML.

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