The non-interventional AMASIA study aims to provide real-world evidence on the long-term effectiveness and safety of siponimod on patients suffering from active secondary progressive multiple sclerosis (SPMS). Furthermore, the impact of siponimod-treatment on quality of life is also investigated.

The selective sphingosine-1-phosphate receptor modulator siponimod is approved for the treatment of relapsing forms of MS in the US and for the treatment of active SPMS in the EU. Real-word insights on the long-term effectiveness and safety of siponimod will support treatment decisions.

In this ongoing non-interventional study in Germany, siponimod treated active SPMS patients are followed over 3 years. Every 6 months, disability progression and cognitive changes are evaluated by EDSS, FSMC and SDMT. Questionnaires from the perspective of patients, physicians, and relatives on disability progression, cognitive worsening and quality of life are documented. The results correspond to the interim analyses as of June 2022 and February 2023.

Data collected from more than 600 active SPMS-patients receiving siponimod for the first time give an insight into the real-world clinical practice in Germany. Subgroup analyses by patient age, EDSS and time between diagnosis of MS and inclusion into this study indicate that siponimod exhibits a sustained effectiveness over the time studied (i.e. 18 months) in regard to preventing further progression of the disease as measured by EDSS, FSMC and SDMT. Younger patients and patients who start siponimod treatment earlier after the onset of their disease benefit slightly more. Regardless of age, TSQM scores “Effectiveness”, “Convenience”, and “Global Satisfaction” are at a high level throughout the observational period to date.

AMASIA provides real-world evidence on the use of siponimod in the treatment of active SPMS patients in Germany, indicating a particular benefit for younger patients and patients who are treated early after the onset of the disease.