RT Journal Article
SR Electronic
T1 COVID-19 Infection in Fingolimod- or Siponimod-Treated Patients
JF Neurology - Neuroimmunology Neuroinflammation
JO Neurol Neuroimmunol Neuroinflamm
FD Lippincott Williams & Wilkins
SP e1092
DO 10.1212/NXI.0000000000001092
VO 9
IS 1
A1 Sullivan, Roseanne
A1 Kilaru, Ajay
A1 Hemmer, Bernhard
A1 Campbell Cree, Bruce Anthony
A1 Greenberg, Benjamin M.
A1 Kundu, Uma
A1 Hach, Thomas
A1 DeLasHeras, Virginia
A1 Ward, Brian J.
A1 Berger, Joseph
YR 2022
UL http://nn.neurology.org/content/9/1/e1092.abstract
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