PT  - JOURNAL ARTICLE
AU  - Sullivan, Roseanne
AU  - Kilaru, Ajay
AU  - Hemmer, Bernhard
AU  - Campbell Cree, Bruce Anthony
AU  - Greenberg, Benjamin M.
AU  - Kundu, Uma
AU  - Hach, Thomas
AU  - DeLasHeras, Virginia
AU  - Ward, Brian J.
AU  - Berger, Joseph
TI  - COVID-19 Infection in Fingolimod- or Siponimod-Treated Patients
AID  - 10.1212/NXI.0000000000001092
DP  - 2022 Jan 01
TA  - Neurology - Neuroimmunology Neuroinflammation
PG  - e1092
VI  - 9
IP  - 1
4099  - http://nn.neurology.org/content/9/1/e1092.short
4100  - http://nn.neurology.org/content/9/1/e1092.full
SO  - Neurol Neuroimmunol Neuroinflamm2022 Jan 01; 9
AB  - 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.ARDS=acute respiratory distress syndrome; DMT=disease-modifying therapies; EDSS=Expanded Disability Status Scale; FDA=Food and Drug Administration; HCP=health care professional; ICH=International Council on Harmonization; ICU=intensive care unit; MS=multiple sclerosis; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2; WHO=World Health Organization