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COVID-19 Infection in Fingolimod- or Siponimod-Treated Patients: Case Series
Roseanne Sullivan1, Ajay Kilaru2, Bernhard Hemmer2
1From the Novartis Pharmaceuticals Corporation (R.S.), East Hanover, NJ; Novartis Pharma AG (A.K., T.H., V.D.), Basel, Switzerland; Department of Neurology, Technical University of Munich, and Munich Cluster for Systems Neurology (SyNergy) (B.H.), Germany; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco, CA; Department of Neurology (B.M.G.), University of Texas Southwestern, Dallas, TX; Novartis Healthcare Pvt. Ltd. (U.K.), Hyderabad, India; Department of Medicine (B.J.W.), Division of Experimental Medicine, Research Institute of the McGill University Health Centre, Montreal, Canada; and Department of Neurology (J.B.), Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. roseanne.sullivan@novartis.com.
Background And Objectives:
A descriptive analysis of COVID-19 infection in patients with multiple sclerosis (MS) receiving fingolimod or siponimod.
Methods:
We reviewed the cases of COVID-19 from postmarketing or ongoing clinical trials reported to Novartis through December 27, 2020.
Results:
As of December 27, 2020, 283 cases had been reported in fingolimod-treated patients. The mean age was 44 years (from n = 224; range 11-69 years), and 190 were women. Of 161 cases with available information, 138 were asymptomatic (6), mild (100), or moderate (32); 50 cases required hospitalization. At the last follow-up, 140 patients were reported as recovered/recovering, condition was unchanged in 22, and deteriorated in 3 patients; 4 patients had a fatal outcome. Information was not available for 114 patients. Of the 54 cases of COVID-19 reported in siponimod-treated patients, 45 were from the postmarketing setting and 9 from an ongoing open-label clinical trial. The mean age was 54 years (from n = 45; range 31-70), and 30 were women. Of 28 cases with available information, 24 were asymptomatic (2), mild (17), or moderate (5); 9 cases required hospitalization. At the last follow-up, 27 patients were reported as recovered/recovering, condition remained unchanged for 1, and 3 patients had a fatal outcome. Information was not available for 23 patients.
Discussion:
Based on a review of available information, the risk of more severe COVID-19 in patients receiving fingolimod or siponimod seems to be similar to that reported in the general population and the MS population with COVID-19. However, limitations of spontaneous reporting, especially missing data, should be considered in the interpretation of these observations.
Insights
COVID-19 outcomes in patients with multiple sclerosis (MS) on fingolimod or siponimod appear similar to the general population. However, data limitations from spontaneous reporting require careful interpretation of these findings.
Area of Science:
- Neurology
- Immunology
- Infectious Diseases
Background:
- Multiple Sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system.
- Fingolimod and siponimod are sphingosine-1-phosphate receptor modulators used in MS treatment.
- Understanding COVID-19 impact in MS patients on these therapies is crucial.
Purpose of the Study:
- To analyze COVID-19 infection characteristics and outcomes in patients treated with fingolimod or siponimod.
- To compare the severity of COVID-19 in these patients with general and MS populations.
Main Methods:
- Descriptive analysis of COVID-19 cases reported to Novartis through December 27, 2020.
- Inclusion of data from postmarketing surveillance and ongoing clinical trials.
- Review of patient demographics, disease presentation, hospitalization, and outcomes.
Main Results:
- 283 COVID-19 cases in fingolimod users (mean age 44); 54 cases in siponimod users (mean age 54).
- Majority of cases were asymptomatic or mild; hospitalization rates were 31% for fingolimod and 17% for siponimod.
- Fatal outcomes reported in 1.4% of fingolimod cases and 5.6% of siponimod cases.
Conclusions:
- The risk of severe COVID-19 in patients on fingolimod or siponimod seems comparable to the general and MS populations.
- Limitations due to spontaneous reporting and missing data necessitate cautious interpretation.
- Further research may be needed to fully elucidate COVID-19 risks in this patient group.
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