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AMA-VACC

Interim analysis results1

Tjalf Ziemssen, et al.  Assessing the immune response to SARS-CoV-2 mRNA vaccines in patients with secondary progressive multiple sclerosis treated with siponimod (AMA-VACC clinical trial). Poster presentation at ECTRIMS. 2021;P810.

Humoral and cellular immune response on patient level

Humoral and cellular immune-v1
Note: Data presented are for patients with evaluable antibody and T-cell assessments
Number of evaluable patients (N): Siponimod continuously: N = 12; First-line / no treatment N = 16
Patients with no response (n [%]): Siponimod continuously: n = 4 [33.3%]; First-line / no treatment n = 2 [12.5%]
  • AMA-VACC clinical trial evaluated the immune response in siponimod treated SPMS patients with active disease one week after a complete cycle of a SARS-CoV-2 mRNA vaccination
  • Prospective, open-label, three-cohort trial
  • 41 patients included in interim analysis (17 in cohort 1: siponimod continuosly; 4 in cohort 2: siponimod interrupted for vaccination; and 20 patients in cohort 3: first line DMT/no current treatment)
  • Seroconversion rate in cohort 1 and 3 was 50 and 88%, respectively
  •  SARS-CoV-2 specific T-cell response was observed in 50%, 75% and 57% of cohort 1, 2 and 3, respectively
  • Humoral and or cellular response SARS-CoV-2 mRNA vaccine was observed in 66% of patients with continuous siponimod treatment
  • No relapses nor clinical significant findings were observed during the interim analysis, further no adverse events nor covid-19 infections occurred that led to permanent discontinuation of the study drug

The interim analysis shows that nearly 2 out of 3 patients with SPMS on siponimod develop an immune response to SARS-CoV-2 mRNA vaccines in population older than 56 in median age and with a long MS history

 (New) Interim analysis of AMA-VACC study

Abbreviations
DMTs, disease-modifying therapies; SPMS, secondary progressive multiple sclerosis; 
References
1. Ziemssen T, et al. Poster presentation at ECTRIMS. 2021;P810.
* 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.