How do patients with secondary progressive multiple sclerosis enrolled in the EXPAND randomized controlled trial compare with those seen in German clinical practice in the NeuroTransData multiple sclerosis registry?
multiple sclerosis
observational study
randomized clinical trial
real-world population
secondary progressive multiple sclerosis
Journal
Journal of central nervous system disease
ISSN: 1179-5735
Titre abrégé: J Cent Nerv Syst Dis
Pays: United States
ID NLM: 101595026
Informations de publication
Date de publication:
2022
2022
Historique:
received:
30
07
2021
accepted:
04
07
2022
entrez:
12
8
2022
pubmed:
13
8
2022
medline:
13
8
2022
Statut:
epublish
Résumé
In EXPAND (NCT01665144), a phase 3 randomized clinical trial, siponimod reduced disability progression versus placebo in patients with secondary progressive multiple sclerosis (SPMS). To understand how a real-world population with SPMS relates to that in EXPAND, we conducted a retrospective, observational cohort study using the German NeuroTransData (NTD) multiple sclerosis (MS) registry. The NTD MS registry is run by a Germany-wide network of physicians. Two cross-sectional analyses were performed using the NTD MS registry. The first included patients with SPMS, as recorded in the registry, and compared their characteristics between 1 January 2018 and 31 December 2018 with patients in EXPAND. The second described the characteristics of patients in the registry at the time of diagnosis of SPMS between 1 January 2010 and 31 December 2018. The first analysis included 773 patients: patients were older in the NTD MS registry than in EXPAND (mean age, 57.9 vs 48.0 years) and had a longer duration of SPMS (mean, 6.2 vs 3.8 years). In the NTD MS registry, median Expanded Disability Status Scale (EDSS) scores were comparable to EXPAND (6.0 The population in the NTD MS registry was older to that in EXPAND, but were similar in terms of disability. Differences likely reflect the inclusion criteria of EXPAND but also highlight that real-world populations encompass a wider range of patient characteristics.
Sections du résumé
Background
UNASSIGNED
In EXPAND (NCT01665144), a phase 3 randomized clinical trial, siponimod reduced disability progression versus placebo in patients with secondary progressive multiple sclerosis (SPMS).
Aim
UNASSIGNED
To understand how a real-world population with SPMS relates to that in EXPAND, we conducted a retrospective, observational cohort study using the German NeuroTransData (NTD) multiple sclerosis (MS) registry.
Methods
UNASSIGNED
The NTD MS registry is run by a Germany-wide network of physicians. Two cross-sectional analyses were performed using the NTD MS registry. The first included patients with SPMS, as recorded in the registry, and compared their characteristics between 1 January 2018 and 31 December 2018 with patients in EXPAND. The second described the characteristics of patients in the registry at the time of diagnosis of SPMS between 1 January 2010 and 31 December 2018.
Results
UNASSIGNED
The first analysis included 773 patients: patients were older in the NTD MS registry than in EXPAND (mean age, 57.9 vs 48.0 years) and had a longer duration of SPMS (mean, 6.2 vs 3.8 years). In the NTD MS registry, median Expanded Disability Status Scale (EDSS) scores were comparable to EXPAND (6.0
Conclusion
UNASSIGNED
The population in the NTD MS registry was older to that in EXPAND, but were similar in terms of disability. Differences likely reflect the inclusion criteria of EXPAND but also highlight that real-world populations encompass a wider range of patient characteristics.
Identifiants
pubmed: 35958354
doi: 10.1177/11795735221115912
pii: 10.1177_11795735221115912
pmc: PMC9358581
doi:
Types de publication
Journal Article
Langues
eng
Pagination
11795735221115912Informations de copyright
© The Author(s) 2022.
Déclaration de conflit d'intérêts
Declaration of conflicting interests: SB has received honoraria for consulting, clinical studies and lecturing from Biogen, CSL Behring, Merck, NeuroTransData, Novartis, Octapharma and Roche. AB has received consulting fees for advisory board/speaker/other activities from NeuroTransData, and for project management/clinical studies and travel expenses from Novartis and Servier. VB and NA are employees of Novartis Pharma AG.
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