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Interim analysis results1

Tjalf Ziemssen, et al. Assessing the immune response to SARS-CoV-2 mRNA vaccines in siponimod-treated patients: a nonrandomized controlled clinical trial (AMA-VACC); Therapeutic Advances in Neurological Disorders, November 8, 2022;

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Data presented are for patients with evaluable antibody and T-cell assessments
  • AMA-VACC clinical trial was designed to characterize immune responses to SARS-CoV-2 mRNA vaccines in siponimod-treated SPMS patients
  • The study assessed the immune response in siponimod treated SPMS patients after initial and booster SARS-CoV-2 mRNA vaccination
  • Prospective, multicenter, open-label, three-cohort trial
  • 41 patients included in interim analysis (17 in cohort 1: ongoing siponimod treatment during vaccination; 4 in cohort 2: siponimod interrupted for vaccination; and 20 patients in cohort 3: first line DMT/no current treatment)
  • NAb at 1 week was reached by 52.9% in continuous siponimod treatment cohort, 75.0% in interrupted siponimod cohort and 90% of cohort 3  
  • Seroconversion at month 1 was observed in 56.3%, 100% and 95% in cohort 1, 2 and 3, respectively
  • One week after vaccination, 50%, 75% and 60% of the patients in cohort 1, 2 and 3, respectively, mounted SARS-CoV-2 specific T-cell response. After 1 month, T-cell reactivity was observed in 0.0%, 25% and 70% of cohort 1, 2 and 3, respectively.
  • Analysis of combined immune response (development of SARS-CoV-2-specific NAbs or T-cell reactivity or both) showed that 1 week after the second dose of vaccine, 71.4% of cohort 1, 75.0% of cohort 2, and 85.0% of cohort 3 were positive for either humoral or cellular response or both. One month after the second dose of vaccine, 56.3% of cohort 1, 100.0% of cohort 2, and 95.0% of cohort 3 were positive for either humoral or cellular response or both
  • No COVID-19 infection was reported, and no deaths were reported until the cut-off date

The interim analysis shows that majority of the siponimod treated patients mounts humoral and cellular response under continuous siponimod cohort.  

DMTs, disease-modifying therapies; SPMS, secondary progressive multiple sclerosis; SAEs, serious adverse events
* Indication varies in different countries. Current website is a global information resource. Local Prescribing Information/ Summary of Product Characteristics approved by individual country’s regulatory authority is the primary source of information for the indication of siponimod in the individual country.

The Pregnancy outcome Intensive Monitoring (PRIM) program is based on enhanced pharmacovigilance of the Novartis spontaneous reporting system. PRIM is an adverse event outcomes intensive monitoring program to collect information (targeted follow-up checklists) about pregnancy in patients exposed to siponimod immediately before or during pregnancy and infant outcomes 12 months after delivery.