S. Uebler
Merck Serono GmbHAuthor Of 1 Presentation
P0847 - Characterization of relapsing multiple sclerosis patients treated with cladribine tablets in Germany since marketing authorization (ID 376)
Abstract
Background
In 2017, cladribine tablets (CT) were approved for highly active relapsing multiple sclerosis (RMS) in the European Union. Data on real-world utilization of this novel disease modifying drug (DMD) can inform evidence-based treatment selection.
Objectives
To describe treatment and disease characteristics of RMS patients treated with CT in Germany since market authorization.
Methods
The German MS Registry (GMSR) captures data from more than 180 neurological centres. This study included all adult RMS patients newly treated with CT from August 2017 to September 18, 2019. We used descriptive statistics to summarize patient characteristics: age and sex, DMD history; and disease characteristics: relapse in the 12 months prior to CT initiation and Expanded Disability Status Scale (EDSS) score within the 90-days prior to or following CT initiation.
Results
A total of 141 patients who initiated CT were identified across 46 neurological centers. The median (25 percentile, 75 percentile) age was 39 (32, 49) years with most patients being female (71%). The majority (91%) had a relapsing-remitting multiple sclerosis (RRMS) diagnosis at CT initiation, with a median disease duration of 9.5 (5.0, 16.3) years. Among persons (68.8%) with a documented EDSS score within 90-days of CT initiation, median EDSS was 2.5 (1.5, 4). 15% of persons were naïve to DMDs. Dimethyl fumarate (16%), daclizumab (16%), and fingolimod (13%) were the most common DMDs prior to CT initiation. In the 12 months prior to CT initiation, 25% of patients experienced 1 relapse, and 9% of patients experienced ≥2 relapses.
Conclusions
In this German real-world neurological care setting, both DMD-naïve and DMD-experienced patients initiated CT. Median disability level indicated mild disability in one functional system or minimal disability in two functional systems. One third of patients had at least one relapse in the 12 months prior to CT initiation.