A global pandemic of COVID-19 has resulted in over 78 million cases as of 23 December 2020. Risks of COVID-19 in people with multiple sclerosis (pwMS) receiving disease-modifying therapies are of increased interest, but still under investigation.
Report characteristics of COVID-19 infections in pwMS receiving subcutaneous 20 mg ofatumumab, a human anti-CD20 monoclonal antibody, every 4 weeks.
Demographics, COVID-19 seriousness category, ofatumumab treatment duration and action taken with ofatumumab, interventions and COVID-19 outcomes were recorded for pwMS in the open-label extension study ALITHIOS or in the post-marketing setting.
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 2551 years), disease duration 3 to 23 years, and EDSS score 05.5. Ofatumumab exposure range was 8.513.8 months (n=6 who received ofatumumab only in ALITHIOS) and 17.444.2 months (n=6 who continued ofatumumab 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.
We report 12 cases (11 non-serious; one serious hospitalized for bilateral pneumonia) of laboratory-confirmed SARS-CoV-2 infection in pwMS treated with ofatumumab. More surveillance data are needed to determine the risks associated with COVID-19 in pwMS treated with ofatumumab.