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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 AAN 2022

Combined immune response to SARS-COV-2 mRNA vaccines

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Data presented are for patients with evaluable antibody and T-cell assessments
 
  • AMA-VACC clinical trial evaluated the data on SARS-CoV-2 vaccinations in siponimod treated SPMS patients with an aim to offer a guidance to treating physicians and patients for the coordination of MS treatment and vaccination
  • The study assessed the immune response in siponimod treated SPMS patients after initial and booster SARS-CoV-2 mRNA vaccination
  • Prospective, 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 could be detected some point (at either one week or one month or both time points) in 65% of continuously treated siponimod patients and 95% of patients on first line DMTs.
  • SARS-CoV-2 specific T-cell response was observed in 50%, 75% and 60% of cohort 1, 2 and 3, respectively (data not shown)
  • Taken together > 70% of patients with continuous siponimod treatment developed an immune response (i. e. humoral or cellular response or both) towards SARS-CoV-2 mRNA vaccines as soon as 1 week after full vaccination.
  • Until the cut-off date of this interim analysis, one relapse occurred during the study (cohort 1, > 5 months after the last vaccination).
  • No COVID-19 infection was reported, and no adverse events led to permanent discontinuation of study medication until the cut-off date

The interim analysis shows that more than 2 out of 3 patients with SPMS on siponimod develop an immune response to SARS-CoV-2 mRNA vaccines and siponimod treated patients can mount humoral and cellular immune responses, both of which need to be considered for assessing vaccination efficacy

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(New) Interim analysis of AMA-VACC study

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Abbreviations
DMTs, disease-modifying therapies; SPMS, secondary progressive multiple sclerosis; SAEs, serious adverse events
References
1. Ziemssen T, et al. Poster presentation at AAN 2022
* 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.