Contributions
Abstract: EP1359
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Epidemiology
Context: For neurologists and patients with MS, one major unmet need is to better appreciate the causal factors of disease progression and to obtain reliable predictive tools that could apply on the individual level and at different key moments in the disease course (landmarks). Taking advantage of the existing network of neurologists collecting data in daily practice, the French MS registry (OFSEP) initiated a “high-definition” (HD) cohort. Its overarching objective is to determine, at specific landmarks over the disease course, the prognostic factors of the evolution of disability in MS and the care practices that can modify this predicted evolution in real-life settings.
Objective: To describe the OFSEP HD Cohort.
Methods: Patients with a diagnosis of MS and an EDSS score ≤ 7.0 followed in French expert centres will be included. Collection of data will include OFSEP core minimal clinical data (disability, neurological episode, treatment
), MFSC (T25FW, 9-HPT, CSCT), brain MRI, comorbidities, quality of life (EQ-5D, SF12, MusiQoL), socioeconomic indicators, alcohol and tobacco consumption, in addition to serum neurofilament light chains and biocollection at T0. Four landmarks will be studied: 1) the first visit when the diagnosis of MS is set; 2) the first visit when the diagnosis of progression (either primary or secondary) is set; 3) any visit with recent disease activity, defined by the occurrence of a relapse and/or MRI activity in the past 3 months; 4) any visit with absence of disease activity in the past 5 years. Patients will be followed annually and at the time of occurrence of a landmark of interest. Collected outcomes will be disability, MSFC, relapse, progression, death, lesion load, cerebral atrophy, patient-reported outcomes and combined outcomes including activity and progression, NEDA or OFSEP specific indicators.
Results: Inclusions will start in June 2018. We expect to include 5,000 patients up to 2020. The analyses will begin in 2020. The scientific program aims to deliver 1/ predictive tools that could identify subgroups of patients with a maximum expected disease progression free survival with good quality of life and 2/ economic assessments in a cost-of-illness and cost-effectiveness approach.
Discussion: For the first time in Europe a large cohort of MS patients with annual or targeted systematic extended collection of data will be open to researchers to improve knowledge on the disease.
Disclosure: Romain CASEY has no financial disclosure to declare.
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.
Emmanuelle LERAY has received consulting and lecture fees or travel grants from Biogen, Genzyme, MedDay Pharmaceuticals, Merck Serono Novartis and Roche.
Jonathan EPSTEIN has no financial disclosure related to this project to declare.
Yohann FOUCHER 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: EP1359
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Epidemiology
Context: For neurologists and patients with MS, one major unmet need is to better appreciate the causal factors of disease progression and to obtain reliable predictive tools that could apply on the individual level and at different key moments in the disease course (landmarks). Taking advantage of the existing network of neurologists collecting data in daily practice, the French MS registry (OFSEP) initiated a “high-definition” (HD) cohort. Its overarching objective is to determine, at specific landmarks over the disease course, the prognostic factors of the evolution of disability in MS and the care practices that can modify this predicted evolution in real-life settings.
Objective: To describe the OFSEP HD Cohort.
Methods: Patients with a diagnosis of MS and an EDSS score ≤ 7.0 followed in French expert centres will be included. Collection of data will include OFSEP core minimal clinical data (disability, neurological episode, treatment
), MFSC (T25FW, 9-HPT, CSCT), brain MRI, comorbidities, quality of life (EQ-5D, SF12, MusiQoL), socioeconomic indicators, alcohol and tobacco consumption, in addition to serum neurofilament light chains and biocollection at T0. Four landmarks will be studied: 1) the first visit when the diagnosis of MS is set; 2) the first visit when the diagnosis of progression (either primary or secondary) is set; 3) any visit with recent disease activity, defined by the occurrence of a relapse and/or MRI activity in the past 3 months; 4) any visit with absence of disease activity in the past 5 years. Patients will be followed annually and at the time of occurrence of a landmark of interest. Collected outcomes will be disability, MSFC, relapse, progression, death, lesion load, cerebral atrophy, patient-reported outcomes and combined outcomes including activity and progression, NEDA or OFSEP specific indicators.
Results: Inclusions will start in June 2018. We expect to include 5,000 patients up to 2020. The analyses will begin in 2020. The scientific program aims to deliver 1/ predictive tools that could identify subgroups of patients with a maximum expected disease progression free survival with good quality of life and 2/ economic assessments in a cost-of-illness and cost-effectiveness approach.
Discussion: For the first time in Europe a large cohort of MS patients with annual or targeted systematic extended collection of data will be open to researchers to improve knowledge on the disease.
Disclosure: Romain CASEY has no financial disclosure to declare.
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.
Emmanuelle LERAY has received consulting and lecture fees or travel grants from Biogen, Genzyme, MedDay Pharmaceuticals, Merck Serono Novartis and Roche.
Jonathan EPSTEIN has no financial disclosure related to this project to declare.
Yohann FOUCHER 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.