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Real World Evidence 

UCSF Longitudinal study: interim analysis

Sabatino J et al. Longitudinal Analysis of Adaptive Immunity Following Additional SARS-CoV-2 Vaccination in MS Patients on Anti-CD20 Therapies and Sphingosine-1-phosphate Receptor Modulators

Figure: Antibody responses to SARS-CoV-2 vaccination for the different groups at each time point

Updated 1a
Updated 1b
​​​​​​The dotted line in figure A and B indicates the cut-off for seropositivity; Time points (T) at blood sample collection: T0 - Baseline, T1 – Sample collected after receiving full two dose vaccination series, T2 – Sample collected prior to 3rd vaccine (booster) and T3 – Sample collected after 3rd vaccine (booster); S1P-(fingolimod and siponimod)
  • IgG levels to total spike (A) and spike (receptor binding domain) RBD (B) for the different groups at each time point.
  • Seropositivity at T3 (at least 14 days after the third dose of mRNA vaccine):
    • For total spike IgG, which includes activity against any epitope on spike protein that may not correlate to neutralizing antibodies, 62.5% (5/8) ofatumumab, 75.5% (9/12) ocrelizumab,100% (7/7) S1P, and 100% (7/7) healthy volunteers
    • For spike RBD IgG, which is more specific and a better correlate of neutralizing antibodies, 62.5% (5/8) ofatumumab, 50.0% (6/12) ocrelizumab, 71.4% (5/7) S1P, and 100% (7/7) healthy volunteers

Figure T-cell response – Proportion of CD4+ T cells (A) and CD8+ T cells (B) that are spike-reactive are shown for the different treatment groups at each time point

Figure 4c
Figure 4b
Time points (T) at blood sample collection: T0 - Baseline, T1 – Sample collected after receiving full two dose vaccination series, T2 – Sample collected prior to 3rd vaccine (booster) and T3 – Sample collected after 3rd vaccine (booster); S1P- (fingolimod and siponimod)
  • At T3, all participants appeared to have both a CD4 and CD8 T-cell response

In this interim analysis of adult MS patients on S1Ps (fingolimod and siponimod) and anti-CD20s(ocrelizumab and ofatumumab), while immune response was overall attenuated, a majority of patients in all DMT groups (> 70% S1P and > 50% anti-CD20) mounted an antibody response to 3rd vaccination (booster), All adult MS patients on S1Ps and anti-CD20s mounted a T-cell response to 3rd (booster) vaccine in all DMT groups

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Abbreviations
HC: Healthy controls; OFA:ofatumumab; OCR: ocrelizumab; S1P: sphingosine-1-phosphate
References
1. Sabatino J et al. Poster presented at ACTRIMS Forum 2022,, https://www.abstractsonline.com/pp8/#!/10495/presentation/608 .
* 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.