Contributions
Abstract: P363
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Epidemiology
Introduction: The Observatoire Français de la Sclérose En Plaques (OFSEP) is a French national cohort of patients with multiple sclerosis (MS) and related disorders (neuromyelitis optica spectrum disorders 'NMOSD'
), aiming at collecting clinical and MRI data and biological samples in a routine clinical setting, to foster clinical, basic and translational research in MS.
Objectives: To update the OFSEP description.
Methods: Patients are followed longitudinally by their neurologist involved in the OFSEP network, who collects clinical data in a computerized medical file, EDMUS. Since June 2013, this collection is standardized, including demographic and socioeconomic characteristics and disease and therapeutic description. Since April 2016, serious adverse events are also systematically collected. A standardized imaging protocol has been developed and is currently implemented in MRI centres nationwide; raw data are stored in a server interfaced with Shanoir software. Biological samples (blood, cerebrospinal fluid, urine and stool) are collected in seven specific subgroups of interest. OFSEP has implemented a strategy to improve the quality of its data and samples.
Results: On 15 December 2017, clinical data from all French MS expert centres and networks were aggregated: data from 59,477 patients were available (65% RRMS, 20% SPMS, 13% PPMS, 2% NMOSD) with mean disease duration of 13.6 ± 10.6 years. Standardized MRIs were produced by 24 MRIs centres and 12,482 cerebral (3D FLAIR, 17%; 2D DP T2, 17%; 3D T1 GADO, 12%) and 2,332 spinal sequences (SAG T2, 44%; SAG T1 GADO, 31%) from 856 patients were available with 319 (37%) patients with sequences at several temporal point. Biological samples were collected in 12 centres from 771 patients.
Conclusions: Over the last 7 years, OFSEP has improved his data quality and extended the patients followed and the variables collected. Its data and samples are open to physicians and researchers, public and private entities, in France and abroad. The ultimate goal of OFSEP is to answer questions about causes and mechanisms of MS, effectiveness of treatments, prognostic factors of disease progression, etc.
Disclosure: Romain Casey: nothing to disclose.
Nathalie Dufay: nothing to disclose.
Nadine Passante: nothing to disclose.
Jean-Christophe Brisset: nothing to disclose.
Bruno Brochet has received consulting and lecturing fees, travel grants and unconditional research support from Actelion, Biogen, Genzyme, Medday, Novartis, Merck Serono, Roche, Sanofi Aventis and Teva Pharma.
Michel Clanet: nothing to disclose.
François Cotton has received consulting and lecturing fees, travel grants and unconditional research support from Biogen, Novartis, Bracco imaging, Bayer Schering and Guerbet.
Jérôme De Sèze has no financial disclosure related to this project to declare.
Bertrand Fontaine has received a research grant from Biogen and is supported by funding from the Investment for the Future program ANR-10-IAIHU-06 and ANR-10-INBS-01-D1.
Francis Guillemin: Grants to my institution from Merck, Biogen and Novartis.
David-Axel Laplaud has received consulting and lecturing fees, travel grants and unconditional research support from Biogen, Genzyme, Novartis, Merck Serono, Roche, Sanofi Aventis and Teva Pharma.
Thibault Moreau has no financial disclosure related to this project to declare.
Jean Pelletier has received consulting and lecturing fees, travel grants and unconditional research support from Biogen, Genzyme, Novartis, Merck Serono, Roche, Sanofi Aventis and Teva Pharma.
Bruno Stankoff has no financial disclosure related to this project to declare.
Abdullatif Al Khedr has no financial disclosure related to this project to declare.
Eric Berger: Biogenidex, Genzyme-Sanofi, Teva, Novartis.
Bertrand Bourre serves on scientific advisory board for Merck Serono and has received funding for travel and honoraria from Biogen Idec, Merck Serono, Novartis, Sanofi-Genzyme and Teva.
David Brassat has no financial disclosure related to this project to declare.
Philippe Cabre has no financial disclosure related to this project to declare.
Jean-Philippe Camdessanché has no financial disclosure related to this project to declare.
Mathilde Camus-Jacqmin has no financial disclosure related to this project to declare.
Olivier Casez: Biogen, Novartis, Genzyme, Teva
Pierre Clavelou has no financial disclosure related to this project to declare.
Alain Créange has no financial disclosure related to this project to declare.
Marc Debouverie has received consulting and lecturing fees, travel grants and unconditional research support from Biogen, Genzyme, Novartis, Merck Serono, Roche, Sanofi Aventis and Teva Pharma.
Gilles Defer has no financial disclosure related to this project to declare.
Gilles Edan has no financial disclosure related to this project to declare.
Olivier Gout has no financial disclosure related to this project to declare.
Anne-Marie Guennoc has no financial disclosure related to this project to declare.
Olivier Heinzlef: Bayer Schering, Merck Serono, Teva, Genzyme, Novartis, Almirall, BiogenIdec.
Pierre Labauge has no financial disclosure related to this project to declare.
Céline Labeyrie has no financial disclosure related to this project to declare.
Christine Lebrun-Frenay has no financial disclosure related to this project to declare.
Laurent Magy has no financial disclosure related to this project to declare.
Eric Manchon has no financial disclosure related to this project to declare.
Jean-Philippe Neau has no financial disclosure related to this project to declare.
Chantal Nifle has no financial disclosure related to this project to declare.
Caroline Papeix has no financial disclosure related to this project to declare.
Ivania Patry: Novartis, Biogen, Merck Serono, Teva, Genzyme, Bayer.
Corinne Pottier has no financial disclosure related to this project to declare.
Eric Thouvenot has no financial disclosure related to this project to declare.
Ayman Tourbah has no financial disclosure related to this project to declare.
Patrick Vermersch has no financial disclosure related to this project to declare.
Sandra Vukusic has received consulting and lecturing fees, travel grants and unconditional research support from Biogen, Geneuro, Genzyme, Novartis, Merck Serono, Roche, Sanofi Aventis and Teva Pharma.
Abstract: P363
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Epidemiology
Introduction: The Observatoire Français de la Sclérose En Plaques (OFSEP) is a French national cohort of patients with multiple sclerosis (MS) and related disorders (neuromyelitis optica spectrum disorders 'NMOSD'
), aiming at collecting clinical and MRI data and biological samples in a routine clinical setting, to foster clinical, basic and translational research in MS.
Objectives: To update the OFSEP description.
Methods: Patients are followed longitudinally by their neurologist involved in the OFSEP network, who collects clinical data in a computerized medical file, EDMUS. Since June 2013, this collection is standardized, including demographic and socioeconomic characteristics and disease and therapeutic description. Since April 2016, serious adverse events are also systematically collected. A standardized imaging protocol has been developed and is currently implemented in MRI centres nationwide; raw data are stored in a server interfaced with Shanoir software. Biological samples (blood, cerebrospinal fluid, urine and stool) are collected in seven specific subgroups of interest. OFSEP has implemented a strategy to improve the quality of its data and samples.
Results: On 15 December 2017, clinical data from all French MS expert centres and networks were aggregated: data from 59,477 patients were available (65% RRMS, 20% SPMS, 13% PPMS, 2% NMOSD) with mean disease duration of 13.6 ± 10.6 years. Standardized MRIs were produced by 24 MRIs centres and 12,482 cerebral (3D FLAIR, 17%; 2D DP T2, 17%; 3D T1 GADO, 12%) and 2,332 spinal sequences (SAG T2, 44%; SAG T1 GADO, 31%) from 856 patients were available with 319 (37%) patients with sequences at several temporal point. Biological samples were collected in 12 centres from 771 patients.
Conclusions: Over the last 7 years, OFSEP has improved his data quality and extended the patients followed and the variables collected. Its data and samples are open to physicians and researchers, public and private entities, in France and abroad. The ultimate goal of OFSEP is to answer questions about causes and mechanisms of MS, effectiveness of treatments, prognostic factors of disease progression, etc.
Disclosure: Romain Casey: nothing to disclose.
Nathalie Dufay: nothing to disclose.
Nadine Passante: nothing to disclose.
Jean-Christophe Brisset: nothing to disclose.
Bruno Brochet has received consulting and lecturing fees, travel grants and unconditional research support from Actelion, Biogen, Genzyme, Medday, Novartis, Merck Serono, Roche, Sanofi Aventis and Teva Pharma.
Michel Clanet: nothing to disclose.
François Cotton has received consulting and lecturing fees, travel grants and unconditional research support from Biogen, Novartis, Bracco imaging, Bayer Schering and Guerbet.
Jérôme De Sèze has no financial disclosure related to this project to declare.
Bertrand Fontaine has received a research grant from Biogen and is supported by funding from the Investment for the Future program ANR-10-IAIHU-06 and ANR-10-INBS-01-D1.
Francis Guillemin: Grants to my institution from Merck, Biogen and Novartis.
David-Axel Laplaud has received consulting and lecturing fees, travel grants and unconditional research support from Biogen, Genzyme, Novartis, Merck Serono, Roche, Sanofi Aventis and Teva Pharma.
Thibault Moreau has no financial disclosure related to this project to declare.
Jean Pelletier has received consulting and lecturing fees, travel grants and unconditional research support from Biogen, Genzyme, Novartis, Merck Serono, Roche, Sanofi Aventis and Teva Pharma.
Bruno Stankoff has no financial disclosure related to this project to declare.
Abdullatif Al Khedr has no financial disclosure related to this project to declare.
Eric Berger: Biogenidex, Genzyme-Sanofi, Teva, Novartis.
Bertrand Bourre serves on scientific advisory board for Merck Serono and has received funding for travel and honoraria from Biogen Idec, Merck Serono, Novartis, Sanofi-Genzyme and Teva.
David Brassat has no financial disclosure related to this project to declare.
Philippe Cabre has no financial disclosure related to this project to declare.
Jean-Philippe Camdessanché has no financial disclosure related to this project to declare.
Mathilde Camus-Jacqmin has no financial disclosure related to this project to declare.
Olivier Casez: Biogen, Novartis, Genzyme, Teva
Pierre Clavelou has no financial disclosure related to this project to declare.
Alain Créange has no financial disclosure related to this project to declare.
Marc Debouverie has received consulting and lecturing fees, travel grants and unconditional research support from Biogen, Genzyme, Novartis, Merck Serono, Roche, Sanofi Aventis and Teva Pharma.
Gilles Defer has no financial disclosure related to this project to declare.
Gilles Edan has no financial disclosure related to this project to declare.
Olivier Gout has no financial disclosure related to this project to declare.
Anne-Marie Guennoc has no financial disclosure related to this project to declare.
Olivier Heinzlef: Bayer Schering, Merck Serono, Teva, Genzyme, Novartis, Almirall, BiogenIdec.
Pierre Labauge has no financial disclosure related to this project to declare.
Céline Labeyrie has no financial disclosure related to this project to declare.
Christine Lebrun-Frenay has no financial disclosure related to this project to declare.
Laurent Magy has no financial disclosure related to this project to declare.
Eric Manchon has no financial disclosure related to this project to declare.
Jean-Philippe Neau has no financial disclosure related to this project to declare.
Chantal Nifle has no financial disclosure related to this project to declare.
Caroline Papeix has no financial disclosure related to this project to declare.
Ivania Patry: Novartis, Biogen, Merck Serono, Teva, Genzyme, Bayer.
Corinne Pottier has no financial disclosure related to this project to declare.
Eric Thouvenot has no financial disclosure related to this project to declare.
Ayman Tourbah has no financial disclosure related to this project to declare.
Patrick Vermersch has no financial disclosure related to this project to declare.
Sandra Vukusic has received consulting and lecturing fees, travel grants and unconditional research support from Biogen, Geneuro, Genzyme, Novartis, Merck Serono, Roche, Sanofi Aventis and Teva Pharma.