RT Journal Article
SR Electronic
T1 Prognostic factors of disability progression in multiple sclerosis in real life: the OFSEP-high definition (OFSEP-HD) prospective cohort in France
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e094688
DO 10.1136/bmjopen-2024-094688
VO 15
IS 4
A1 Francis, Guillemin
A1 Romain, Casey
A1 Jonathan, Epstein
A1 Yohann, Foucher
A1 David, Laplaud
A1 Hamza, Achit
A1 Fabien, Rollot
A1 Emmanuelle, Leray
A1 Sandra, Vukusic
A1 
YR 2025
UL http://bmjopen.bmj.com/content/15/4/e094688.abstract
AB Purpose To determine prognostic factors of disability in multiple sclerosis (MS), that is, (1) identify determinants of the dynamics of disability progression; (2) study the effectiveness of disease-modifying treatments (DMTs); (3) merge determinants and DMTs for creating patient-centred prognostic tools and (4) conduct an economic analysis.Participants Individuals registered in the French Observatoire Français de la Sclérose en Plaques (OFSEP) database were included in this OFSEP-high definition cohort if they had a diagnosis of MS, were ≥15 years old and had an Expanded Disability Status Scale (EDSS) score <7. The outcomes will be assessed annually: (1) time to reach irreversible EDSS scores of 4, 6 and 7; (2) relapses and disease progression; (3) MRI-based progression, patient-reported outcomes, social consequences; and (4) combined outcomes on activity and progression. Clinical and quality-of-life data, MRI results and biological (blood, serum) samples will be collected at each follow-up.Findings to date A cohort of 2842 individuals, 73.4% women, mean (SD) age of 42.7 (11.6) years, median disease duration of 8.8 years, has been recruited from July 2018 to September 2020. The course of MS was relapsing remitting in 67.7%, secondary progressive in 11.9%. The mean annual relapse rate was 0.98. The disease-modifying treatment received was highly effective therapy in 50.3% and moderately effective therapy in 30.7%.Future plans The participants will be followed until December 2026. Disease course up to four landmarks will be examined as predictors of disease progression: (1) diagnosis of MS; (2) relapse activity worsening and independent progression; (3) any recent disease activity and (4) any visit with absence of disease activity in the past 5 years. The marginal effectiveness and tolerability of treatments will be assessed. Stratified algorithms will be proposed for medical decision-making. Economic evaluation of disease cost and cost-effectiveness of new DMTs will be conducted from a public payer perspective.Trial registration number NCT03603457.Data are available upon reasonable request. Data will be available upon reasonable request to the scientific committee. Its availability will follow the rules previously established for the OFSEP project in general, meeting the ANR (funding body) requirements of wide access to the international research community.