Contributions
Abstract: EP1335
Type: ePoster
Abstract Category: Clinical aspects of MS - 5 Epidemiology
Background: Beta interferon, first disease-modifying therapy (DMT) for multiple sclerosis (MS), was approved in France in 1996. Twenty years later, 12 medications are available, improving the therapeutic arsenal regarding acceptance and tolerability (injectable, oral and infused medications) but first of all efficacy, despite potential adverse effects. Approval of natalizumab in 2007 and oral first-line treatments in 2014 were major steps in the therapeutic strategy. Increased availability of DMTs associated with better knowledge of their efficacy and their risks had consequences on therapeutic decisions made by neurologists in daily practice.
Objectives: To describe use of DMTs in relapsing-onset MS patients in France over the last 20 years, the therapeutic sequences and switches; to assess impact of the arrival of new drugs on the practices; to search for a period effect in DMTs use.
Methods: This national observational cohort study was based on data collected through the 'Observatoire Français de la Sclérose en Plaques' (OFSEP), the French MS registry that included more than 54,000 MS patients in December 2016. All patients with a relapsing-onset MS and alive in 1996 (to get a chance to be treated) were included. All treatments (including off-label drugs) were considered, whatever their duration. Treated patients were described, as well as the DMTs prescribed (type, dates and reasons of stopping) and all the potential switches (considering place in the strategy as well as way of administration). Analysis was done globally (and will be done by periods: before 1996, 1996-2007, 2007-2014, since 2014).
Results: As a whole, 41,952 patients were included; 30,341 (72.3%) received at least one DMT, accounting for a total of 73,012 DMT initiations over a mean (±SD) follow-up duration of 13.6±10.7 years from MS onset. First DMT was initiated after mean disease duration of 6.1±7.2 years and the cumulative treatment duration was 6.3±5.3 years, i.e. 49% of the follow-up duration. Injectable, oral, infused medications and off-label drugs concerned respectively 54.3%, 13.3%, 12.8% and 19.6% of DMTs. The most frequent switches were within first-line DMTs (n=10,874; 8,438 switches within injectable drugs and 1,837 switches from injectable to oral drugs), first to second-line DMTs (n=5,688), and within off-label drugs (n=1,918).
Conclusion: The OFSEP cohort offers the opportunity to describe therapeutic practices in France and their changes over time.
Disclosure: This work has been performed with the help of the French Observatoire of Multiple Sclerosis (OFSEP) which is supported by a grant provided by the French State and handled by the “Agence Nationale de la Recherche” within the framework of the “Investments for the Future” program, under the reference ANR-10-COHO-002.
Dr Leray reports personal fees as speaker or consultant from Novartis and Sanofi Genzyme, outside the submitted work, and travel grants from Novartis and Roche SAS. Sources of funding in the last year came from the French ARSEP Foundation, the French National Security Agency of Medicines and Health Products, the EDMUS Foundation, and donation from Roche SAS.
F. Rollot has nothing to disclose.
R. Casey has nothing to disclose.
Dr de Sèze received personal fees as speaker or consultant from Biogen, Merck Serono, Bayer, LFB, Sanofi-Aventis, Teva, Genzyme, Almiral, Alergan.
Dr Laplaud received honoraria and consulting fees from Biogen, Merck, Novartis, Sanofi-Genzyme and Roche, and grants from Biogen, Medday, Novartis, Roche and Sanofi-Genzyme.
Dr Vukusic received consultancy fees, speaker fees, research grants (non-personal) or honoraria from Biogen, Geneuro, Genzyme-Sanofi, Medday, Merck-Serono, Novartis, Roche and Teva.
Abstract: EP1335
Type: ePoster
Abstract Category: Clinical aspects of MS - 5 Epidemiology
Background: Beta interferon, first disease-modifying therapy (DMT) for multiple sclerosis (MS), was approved in France in 1996. Twenty years later, 12 medications are available, improving the therapeutic arsenal regarding acceptance and tolerability (injectable, oral and infused medications) but first of all efficacy, despite potential adverse effects. Approval of natalizumab in 2007 and oral first-line treatments in 2014 were major steps in the therapeutic strategy. Increased availability of DMTs associated with better knowledge of their efficacy and their risks had consequences on therapeutic decisions made by neurologists in daily practice.
Objectives: To describe use of DMTs in relapsing-onset MS patients in France over the last 20 years, the therapeutic sequences and switches; to assess impact of the arrival of new drugs on the practices; to search for a period effect in DMTs use.
Methods: This national observational cohort study was based on data collected through the 'Observatoire Français de la Sclérose en Plaques' (OFSEP), the French MS registry that included more than 54,000 MS patients in December 2016. All patients with a relapsing-onset MS and alive in 1996 (to get a chance to be treated) were included. All treatments (including off-label drugs) were considered, whatever their duration. Treated patients were described, as well as the DMTs prescribed (type, dates and reasons of stopping) and all the potential switches (considering place in the strategy as well as way of administration). Analysis was done globally (and will be done by periods: before 1996, 1996-2007, 2007-2014, since 2014).
Results: As a whole, 41,952 patients were included; 30,341 (72.3%) received at least one DMT, accounting for a total of 73,012 DMT initiations over a mean (±SD) follow-up duration of 13.6±10.7 years from MS onset. First DMT was initiated after mean disease duration of 6.1±7.2 years and the cumulative treatment duration was 6.3±5.3 years, i.e. 49% of the follow-up duration. Injectable, oral, infused medications and off-label drugs concerned respectively 54.3%, 13.3%, 12.8% and 19.6% of DMTs. The most frequent switches were within first-line DMTs (n=10,874; 8,438 switches within injectable drugs and 1,837 switches from injectable to oral drugs), first to second-line DMTs (n=5,688), and within off-label drugs (n=1,918).
Conclusion: The OFSEP cohort offers the opportunity to describe therapeutic practices in France and their changes over time.
Disclosure: This work has been performed with the help of the French Observatoire of Multiple Sclerosis (OFSEP) which is supported by a grant provided by the French State and handled by the “Agence Nationale de la Recherche” within the framework of the “Investments for the Future” program, under the reference ANR-10-COHO-002.
Dr Leray reports personal fees as speaker or consultant from Novartis and Sanofi Genzyme, outside the submitted work, and travel grants from Novartis and Roche SAS. Sources of funding in the last year came from the French ARSEP Foundation, the French National Security Agency of Medicines and Health Products, the EDMUS Foundation, and donation from Roche SAS.
F. Rollot has nothing to disclose.
R. Casey has nothing to disclose.
Dr de Sèze received personal fees as speaker or consultant from Biogen, Merck Serono, Bayer, LFB, Sanofi-Aventis, Teva, Genzyme, Almiral, Alergan.
Dr Laplaud received honoraria and consulting fees from Biogen, Merck, Novartis, Sanofi-Genzyme and Roche, and grants from Biogen, Medday, Novartis, Roche and Sanofi-Genzyme.
Dr Vukusic received consultancy fees, speaker fees, research grants (non-personal) or honoraria from Biogen, Geneuro, Genzyme-Sanofi, Medday, Merck-Serono, Novartis, Roche and Teva.