ABSTRACT
Objective: Report characteristics of COVID-19 infections in people with multiple sclerosis (pwMS) receiving subcutaneous 20mg of atumumab, a human anti-CD20 monoclonal antibody, every 4 weeks. Background: A global pandemic of COVID-19 has resulted in over 40 million cases as of 19 October 2020. Risks of COVID-19 in pwMS receiving disease-modifying therapies are of increased interest, but still under investigation. Design/Methods: Demographics, COVID-19 seriousness category, of atumumab treatment duration and action taken with of atumumab, interventions and COVID-19 outcomes were recorded for pwMS in the open-label extension study ALITHIOS or in the post-marketing setting. Results: As of 28 September 2020, 12/1623 pwMS (5/12 females;9/12 white) in the ALITHIOS study were reported to have laboratory-confirmed SARS-CoV-2 infection. Mean age was 37.8 years (median 44 years, range 25-51 years), disease duration 3 to 23 years, and EDSS score 0-5.5. Ofatumumab exposure range was 8.5-13.8 months (n=6 who received of atumumab only in ALITHIOS) and 17.4-44.2 months (n=6 who continued of atumumab from prior trials). One of 12 had COVID-19 seriousness grade 3-A 39 year old white male with bilateral pneumonia requiring hospitalization who recovered with normal follow-up chest X-ray. The remaining 11 cases were non-serious grades 1 or 2: Seven reported as completely recovered, one recovering, two as ongoing and one asymptomatic with SARS-CoV-2 IgM and IgG positive. Six patients were treated with anti-infectives (three received both antivirals and antibacterials and three received antibacterials). Ofatumumab treatment was unchanged in seven and interrupted in four (resumed in three;information not available for one) patients;action unknown in one. To date, no post-marketing COVID-19 cases have been reported. Conclusions: We report 12 cases (11 non-serious;one serious hospitalized for bilateral pneumonia) of laboratory-confirmed SARS-CoV-2 infection in pwMS treated with of atumumab. More surveillance data are needed to determine the risks associated with COVID19 in pwMS treated with of atumumab.