Author Of 1 Presentation
P0470 - Initial findings from a dynamic cohort study of patients with multiple sclerosis: A proactive approach for safety and comparative effectiveness (ID 465)
Abstract
Background
A dynamic cohort (DC) study is a non-interventional, longitudinal study – based on healthcare claims data – that utilizes an open, cohort design to allow for new patients to enter over time and for additional follow-up to be accrued. In the setting of multiple sclerosis (MS), a DC study therefore allows for study of the natural history of disease, rates of pre-defined adverse events, relapses, and healthcare utilization, including the changing disease-modifying drug (DMD) landscape. Furthermore, ad hoc queries for new research questions can be rapidly implemented.
Objectives
To describe initial patient characteristics and treatment utilization in a DC study of patients with MS from the US MarketScan® Research Database.
Methods
Eligible patients (aged ≥18 years) had a database history of >1 year and were followed from the time of MS diagnosis through death, loss of enrollment coverage, or end of the current study period (2011 to 2017; annual data updates will continue until 2023). Cohorts of patients treated with DMDs, stratified by new users or switchers, were from the date of the first DMD prescription. Analysis of DMD usage patterns was limited to interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, fingolimod, alemtuzumab, natalizumab, and ocrelizumab.
Results
Overall, 77,015 patients with MS (median age 50 years, 76% female) were observed in the initial study period, of whom 27,988 were new (incident) MS patients. Among all MS patients, 49,964 (65%) used a DMD at any point in the study period. There were 12,647 new users of dimethyl fumarate, 8,195 of interferon beta-1a, 8,120 of natalizumab, 7,535 of fingolimod, 478 of alemtuzumab, and 292 of ocrelizumab; a majority had a prior history of treatment with interferons, glatiramer acetate, or daclizumab, and had received steroids in the previous year.
Conclusions
This DC study for MS is a key design for a proactive and expedited approach for continuous post-marketing safety and effectiveness monitoring of DMDs. Initial findings show that a large proportion of MS patients (35%) are not treated with a DMDs in the US. As additional data become available on an annual basis, with new MS patients added to the growing cumulative cohort, this study will continue to provide relevant information on the natural history of MS and its management with DMDs.