Author Of 1 Presentation
P0839 - Baseline Characteristics of AMASIA: First Real World Data of Siponimod Treated Patients with Secondary Progressive Multiple Sclerosis (ID 692)
Abstract
Background
Hallmarks of secondary progressive multiple sclerosis (SPMS) are amongst others progressive motoric dysfunction and cognitive decline. Siponimod (Mayzent®), a selective sphingosine-1-phosphate receptor modulator, has been approved by the EMA for the treatment of active SPMS, evidenced by relapses or imaging features of inflammatory activity. AMASIA (ImpAct of Mayzent® (Siponimod) on secondAry progressive multiple Sclerosis patients in a long-term non-Iinterventional study in GermAny) is the first prospective non-interventional study to assess long-term effectiveness and safety of siponimod in clinical routine and the impact on quality of life and socioeconomic conditions.
Objectives
Characterization of the siponimod patient profile and SPMS diagnostic criteria based on clinical routine in Germany.
Methods
In AMASIA treatment effects of siponimod will be analyzed in 1,500 SPMS patients over 3 years. Disability progression and cognitive changes are evaluated every 6 months by the expanded disability status scale (EDSS) and the symbol digit modalities test (SDMT). Additional measures including MS activity by magnetic resonance imaging (MRI), assessments of functional domains, and questionnaires from patient’s, physician’s, and relatives’ perspectives of disability progression, cognitive worsening, and quality of life as well as socioeconomic aspects are analyzed.
Results
Results of the first interim analysis will be presented and will show patient characteristics of the first approx. 200 patients in Germany treated with siponimod in clinical routine. These data will include demography, but also all relevant clinical information including disease and therapy history, allowing for a comparison with data from phase II and III clinical studies with siponimod.
Conclusions
The combination of clinical parameters and patient reported outcomes including quality of life and socioeconomics allows a more detailed insight in the siponimod treated SPMS patient population in clinical routine in Germany. This will contribute to a better understanding of SPMS management in the medical community.