Administration of siponimod in real clinical practice in Russia

Introduction . The study was driven by the prevalence of secondary progressive multiple sclerosis (SPMS) in Russia and the lack of data on siponimod in the real clinical practice (RCP). Aim. To collect and analyze data on the administration of siponimod in SPMS patients within Russia’s RCP as part of the EMBOSSES study (rEtrospective Multicenter oBservatiOnal Study Siponimod rEal-world Spms). Materials and methods . The study encompassed data of 606 SPMS patients from 11 centers who received siponimod for at least 6 months. The analysed data included demographic and clinical characteristics of patients, changes in the Expanded Disability Status Scale (EDSS) scores over time, percentage of patients with 6-month confirmed disability progression (6mCDP), annualized relapse rate (ARR) for MS, radiological signs of the disease activity and adverse events (AEs). Results. Among the study patients, women predominated (64.9%), while men accounted for 35.1%. The median age of patients was 49.5 (±8.9) years. 143 (23.6%) patients reported relapses during 2 years, whereas relapse-free SPMS was observed in 463 (76.4%) patients. The average EDSS scores remained stable, demonstrating minimal changes from 5.44 (±0.998) to 5.58 (±1.028) scores during the 2-year therapy. The percentage of patients free from 6mCDP was 85.5%. The KaplanMeier analysis revealed that 25% of patients achieved 6mCDP by Month 27 of therapy. The average ARR decreased from 0.14 to 0.032 at 12 months and remained low (0.062) after 2 years of treatment. The MRI showed a decrease in the percentage of patients with Gd+ T1 lesions to their complete absence over 2 years of therapy. Main AEs: lymphopenia, bradycardia, and elevated liver enzymes; serious AEs were observed in 3.3% of all cases. Conclusions. Siponimod demonstrated efficacy in controlling disability progression and inflammatory activity, as well as a favourable safety profile in patients with SPMS in the RCP setting. The results confirm the feasibility of using siponimod in patients with SPMS.