Effectiveness of Siponimod with Up to 2 Years of Treatment in a Real-World Setting in People with SPMS: Analysis from the Novartis Global Managed Access Program

Background: Limited real-world data exist on the effectiveness of siponimod in people living with secondary progressive multiple sclerosis (plwSPMS). Objective: To analyze the real-world data of patients receiving siponimod under a managed access program (MAP). Methods: The MAP was implemented in countries where siponimod was not approved and provision via MAP was permitted under local regulations. Data on the demographic/clinical characteristics and clinical outcomes of the cohort included in this MAP between February 2019 and April 2022, were collected from physicians using a Novartis database. Results: Among patients with evidence of starting siponimod treatment in the MAP (n=516), the mean EDSS at baseline was 5.2. Among those with post-baseline data available (n=423), the mean change from baseline in EDSS score at month 6 was − 0.04 (95% confidence interval [CI]: − 0.10, 0.01) and 0.03 (95% CI: − 0.03, 0.10) at month 24), and the annual relapse rate was 0.023. Cognition was stable or improved in patients for whom data was available. Among patients with ≥ 1 MRI assessment (n=165), 154 (93.3%) had no findings of disease activity. Conclusion: This real-world data set analysis provides data on the demographic/clinical characteristics of plwSPMS taking siponimod in clinical practice under MAP criteria and on the effectiveness that can be attained.