DMT13
Characteristics and Outcome of COVID-19 in Patients with Relapsing Multiple Sclerosis Receiving Ofatumumab

Tuesday, October 26, 2021
Exhibit Hall (Rosen Shingle Creek)
Anne H. Cross, MD , Neurology, Washington University School of Medicine, St Louis, MO
Silvia Delgado, MD , Neurology, University of Miami Miller School of Medicine, Miami, FL
Mario Habek, MD , University Hospital Center Zagreb, University of Zagreb, School of Medicine, Zagreb, Croatia
Maria Davydovskaya, PhD , Pirogov Russian National Research Medical University, Moscow, Russian Federation
Natalia Totolyan, MD , National Medical University, St Petersburg, Russian Federation
Ratnakar Pingili, MBBS , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Linda Mancione, BA , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Roseanne Sullivan, PharmD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Martin Zalesak, MD, PhD , Novartis Pharma AG, Basel, Switzerland
Wendy Su, PhD , Autoimmune, TG Therapeutics, Inc, New York, NY
Krishnan Ramanathan, PhD , Novartis Pharma AG, Basel, Switzerland
Xavier Montalban, MD, PhD , Vall d'Hebron University Hospital, Barcelona, Spain
Kevin Winthrop, MD MPH , School of Public Health at Oregon Health & Science University, Portland, OR



Background:

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.

Objectives:

Report characteristics of COVID-19 infections in pwMS receiving subcutaneous 20 mg ofatumumab, a human anti-CD20 monoclonal antibody, every 4 weeks.

Methods:

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.

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 ofatumumab only in ALITHIOS) and 17.4–44.2 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.

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 ofatumumab. More surveillance data are needed to determine the risks associated with COVID-19 in pwMS treated with ofatumumab.

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