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Sullivan R et al. COVID-19 Infection in Fingolimod- or Siponimod- Treated Patients Case Series. Neurol Neuroimmunol Neuroinflamm. 2021 Nov 30;9(1):e1092. DOI: 10.1212/NXI.0000000000001092

Figure: COVID-19 Severity* and Outcome in Fingolimod-Treated People Living With Multiple Sclerosis at the last follow-up

COVID-19 Severity-1
  • Of the 283 confirmed cases of COVID-19 reported in fingolimod-treated MS patients [mean age: 44 years; women (73%)], case severity was reported in 161 cases (asymptomatic, n = 6; mild, n = 100; and moderate, n = 32; 50 cases required hospitalization)

Figure: COVID-19 Severity* and Outcome in Siponimod-Treated People Living With Multiple Sclerosis at the last follow-up

COVID-19 Severity-2
  • Of the 54 confirmed cases of COVID-19 (45 were from the postmarketing setting and 9 from an ongoing open-label clinical trial) in siponimod-treated MS patients [mean age: 54 years; women (68%)], case severity was reported in 28 cases (asymptomatic, n = 2, mild, n = 17, or moderate, n = 5; 9 cases required hospitalization)


The risk of more severe COVID-19 symptoms in patients receiving fingolimod seems to be similar to that reported in the general population and the MS population with COVID-19. For siponimod, the less number of cases reported coupled with insufficient information precludes meaningful conclusions.

COVID-19, corona virus disease-19; MS, multiple sclerosis
Sullivan R, et al. Neurol Neuroimmunol Neuroinflamm Jan 2022, 9 (1) e1092. DOI: 10.1212/NXI.0000000000001092
* 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.