Abstract Details

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

Topic Multiple Sclerosis

Presentation(s) MS and CNS Inflammatory Disease Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 197

Objective Report characteristics of COVID-19 infections in people with multiple sclerosis (pwMS) receiving subcutaneous 20mg ofatumumab, 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, 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.

Authors/Disclosures
Anne H. Cross, MD, FAAN (Washington University School of Medicine) PRESENTER	Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech / F. Hoffman la Roche. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb . Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Octave. Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Cross has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as an officer or member of the Board of Directors for Consortium of MS Centers. Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN. The institution of Dr. Cross has received research support from Genentech. Dr. Cross has received intellectual property interests from a discovery or technology relating to health care.
Sylvia R. Delgado, MD, FAAN (University of Miami School of Medicine)	The institution of Dr. Delgado has received research support from Novartis. The institution of Dr. Delgado has received research support from EMD Serono.
Mario Habek, MD (University of Zagreb, School of Medicine)	Dr. Habek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Habek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck . Dr. Habek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Habek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra Zeneca. Dr. Habek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Habek has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Habek has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Habek has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Habek has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck.
Maria Davydovskaya (Medical university)	Maria Davydovskaya has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merk . Maria Davydovskaya has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. Maria Davydovskaya has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Janssen. Maria Davydovskaya has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merc.
Natalia Totolyan, MD (1st St Petersburg Pavlov State Medical University)	Dr. Totolyan has received research support from Alexion. The institution of Dr. Totolyan has received research support from Biocad (Russia). The institution of Dr. Totolyan has received research support from Janssen. The institution of Dr. Totolyan has received research support from MAPI Pharma LTD. The institution of Dr. Totolyan has received research support from Merck. The institution of Dr. Totolyan has received research support from Novartis. Dr. Totolyan has received research support from Roche. The institution of Dr. Totolyan has received research support from Receptos. The institution of Dr. Totolyan has received research support from Sanofi. The institution of Dr. Totolyan has received research support from TG-Therapeutics.
	No disclosure on file
Linda Mancione	Linda Mancione has received personal compensation for serving as an employee of Novartis Pharmaceuticals Corporation.
Roseanne Sullivan (novartis)	Roseanne Sullivan has received personal compensation for serving as an employee of Novartis Pharmaceuticals. Roseanne Sullivan has stock in Novartis Pharmaceuticals.
	No disclosure on file
Wendy Su, PhD	No disclosure on file
Krishnan Ramanathan	Krishnan Ramanathan has received personal compensation for serving as an employee of Novartis.
Xavier Montalban, MD, PhD, FAAN (Vall Hebron University Hospital-Multiple Sclerosis Centre of Catalonia)	The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck/ EMD Serono. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Hoffmann-La Roche. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Actelion/ Janssen Pharmaceuticals. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for BMS/ Celgene. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi/ Genzyme. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BIAL PD. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PeerVoice. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Samsung Biosys. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zenas BioPharma. Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Actelion/ Janssen Pharmaceuticals. Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS/ Celgene. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck/ EMD Serono. Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hoffmann-La Roche. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzyme. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic Therapeutics. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Viatris/ Mylan. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. The institution of Dr. Montalban has received research support from Biogen. The institution of Dr. Montalban has received research support from Hoffmann-La Roche. The institution of Dr. Montalban has received research support from Sanofi/ Genzyme. The institution of Dr. Montalban has received research support from Merck/ EMD Serono. The institution of Dr. Montalban has received research support from Novartis. The institution of Dr. Montalban has received research support from Teva Pharmaceuticals. The institution of Dr. Montalban has received research support from Actelion/ Janssen Pharmaceuticals. The institution of Dr. Montalban has received research support from BMS/ Celgene.
Kevin Winthrop	Kevin Winthrop has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Johnson & Johnson .

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