BACKGROUND AND PURPOSE: 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-NTZantibodies (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.
BACKGROUND AND PURPOSE: 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-NTZantibodies (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.
Authors: Roderick P P W M Maas; Annemarie H G Muller-Hansma; Rianne A J Esselink; Jean-Luc Murk; Clemens Warnke; Joep Killestein; Mike P Wattjes Journal: J Neurol Date: 2016-07-11 Impact factor: 4.849
Authors: Patrick Ostkamp; Anke Salmen; Béatrice Pignolet; Dennis Görlich; Till F M Andlauer; Andreas Schulte-Mecklenbeck; Gabriel Gonzalez-Escamilla; Florence Bucciarelli; Isabelle Gennero; Johanna Breuer; Gisela Antony; Tilman Schneider-Hohendorf; Nadine Mykicki; Antonios Bayas; Florian Then Bergh; Stefan Bittner; Hans-Peter Hartung; Manuel A Friese; Ralf A Linker; Felix Luessi; Klaus Lehmann-Horn; Mark Mühlau; Friedemann Paul; Martin Stangel; Björn Tackenberg; Hayrettin Tumani; Clemens Warnke; Frank Weber; Brigitte Wildemann; Uwe K Zettl; Ulf Ziemann; Bertram Müller-Myhsok; Tania Kümpfel; Luisa Klotz; Sven G Meuth; Frauke Zipp; Bernhard Hemmer; Reinhard Hohlfeld; David Brassat; Ralf Gold; Catharina C Gross; Carsten Lukas; Sergiu Groppa; Karin Loser; Heinz Wiendl; Nicholas Schwab Journal: Proc Natl Acad Sci U S A Date: 2021-01-05 Impact factor: 11.205
Authors: Tilman Schneider-Hohendorf; Lisa Ann Gerdes; Béatrice Pignolet; Roland Liblau; Heinz Wiendl; Nicholas Schwab; Rachel Gittelman; Patrick Ostkamp; Florian Rubelt; Catarina Raposo; Björn Tackenberg; Marianne Riepenhausen; Claudia Janoschka; Christian Wünsch; Florence Bucciarelli; Andrea Flierl-Hecht; Eduardo Beltrán; Tania Kümpfel; Katja Anslinger; Catharina C Gross; Heidi Chapman; Ian Kaplan; David Brassat; Hartmut Wekerle; Martin Kerschensteiner; Luisa Klotz; Jan D Lünemann; Reinhard Hohlfeld Journal: J Exp Med Date: 2022-09-01 Impact factor: 17.579