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Abstract Details

Outcomes of COVID-19 in Ofatumumab-treated Patients with RMS: Data from the ALITHIOS Open-label Extension Study
Multiple Sclerosis
P1 - Poster Session 1 (8:00 AM-9:00 AM)
6-010

 To present updated cumulative coronavirus disease 2019 (COVID-19) outcomes from the ongoing ALITHIOS (NCT03650114) study up to cutoff (25-Sep-2022).
COVID-19 created challenges in managing patients with multiple sclerosis (MS). Data collected on COVID-19 outcomes in patients with relapsing MS (RMS) treated with ofatumumab from the pandemic start to 25-Sep-2021 were previously reported.
ALITHIOS is a phase 3, open-label, single-arm extension of the core ofatumumab clinical trials. COVID-19 incidence, seriousness, severity, and outcomes, including cases after initial/booster vaccinations, were analyzed in ofatumumab-treated patients from ALITHIOS. Risk factors associated with serious COVID-19 were evaluated.

Of 1703 patients who entered ALITHIOS (mean age at baseline, 39.2 years; females, 69.6%; body mass index [BMI], ≥30 kg/m2, 18%), 648 (38.1%) reported COVID-19 (confirmed, 603; suspected, 45). Most cases were nonserious (598; 92.3%). The majority of cases were mild/moderate in severity (94.0%). Most patients recovered (96.1%), were recovering (0.6%), or recovered with sequelae (1.9%). Five patients had fatal outcomes (unvaccinated, 3; fully vaccinated, 2). Postvaccination COVID-19 cases mainly occurred during the SARS-CoV-2 Omicron wave. 167 of 704 patients who received the primary vaccine series and 109 of 329 who received 1 booster dose reported COVID-19. Serious/severe COVID-19 cases decreased in vaccinated patients following booster vaccination (before/after booster: serious, 8.4% [14/167]/2.8% [3/109]; severe, 3.0% [5/167]/1.8% [2/109], respectively). After adjusting for age, race, vaccination status, Expanded Disability Status Scale, number of underlying conditions, and time since first dose of ofatumumab, a statistically significant association with higher risk of serious COVID-19 was found in patients with BMIs ≥30 kg/m2 vs <30 kg/m2 (hazard ratio [HR] 1.99) and males vs females (HR 1.86).

Most COVID-19 cases in patients with RMS receiving ofatumumab in ALITHIOS were nonserious and mild/moderate in severity, and most patients recovered. Except for known risk factors for serious COVID-19 (sex/BMI), no other risk factors were identified.
Authors/Disclosures
Xavier Montalban, MD, PhD, FAAN (Vall Hebron University Hospital-Multiple Sclerosis Centre of Catalonia)
PRESENTER 		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.
Ibolya Boer, MD Ibolya Boer has received personal compensation for serving as an employee of Novartis AG.
Bruce A. Cree, MD, PhD, MAS, FAAN (UCSF, Multiple Sclerosis Center) The institution of Dr. Cree has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. The institution of Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Cree has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neuron23. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Pharma. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Hexal/Sandoz. Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic AG. The institution of Dr. Cree has received research support from Genentech. The institution of Dr. Cree has received research support from Kyverna. Dr. Cree has received publishing royalties from a publication relating to health care.
Heinz Wiendl, MD, FAAN (University of Freiburg) Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Johnson&Johnson / Janssen. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Wiendl has received personal compensation in the range of $0-$499 for serving as a Consultant for Idorsia. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Argenx. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunic. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for LTS. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Samsung. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sangamo. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dianthus. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for INmune Bio_Syneos Health. Dr. Wiendl has received personal compensation in the range of $0-$499 for serving as a Consultant for Muna Therapeutics. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Myrobalan Therapeutics. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PSL Group. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Red Nucleus. Dr. Wiendl has received personal compensation in the range of $0-$499 for serving as a Consultant for Swiss Multiple Sclerosis Society. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teladoc Health. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Toleranzia . Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viatris. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Wiendl 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 Serono. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz-Hexal. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cellerys. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Uniqure. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biocryst. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Galapagos. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Idorsia. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biontech. The institution of Dr. Wiendl has received research support from Biogen. The institution of Dr. Wiendl has received research support from Roche. The institution of Dr. Wiendl has received research support from Deutsche Forschungsgemeinschaft. The institution of Dr. Wiendl has received research support from European Union. The institution of Dr. Wiendl has received research support from Argenx. The institution of Dr. Wiendl has received research support from CSL Behring. The institution of Dr. Wiendl has received research support from Merck. The institution of Dr. Wiendl has received research support from UCB. Dr. Wiendl has received research support from Alexion Syneos Health iVH UK Ltd.. The institution of Dr. Wiendl has received research support from Deutsche Myasthenie-Gesellschaft. The institution of Dr. Wiendl has received research support from Winicker Norimed GmbH. The institution of Dr. Wiendl has received research support from Novartis. Dr. Wiendl has received publishing royalties from a publication relating to health care. Dr. Wiendl has received publishing royalties from a publication relating to health care. Dr. Wiendl has received publishing royalties from a publication relating to health care.
Anne H. Cross, MD, FAAN (Washington University School of Medicine) 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.
Natalia Khachanova (Russian National Research Medical University N.I. Pirgov) Natalia Khachanova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Natalia Khachanova has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Natalia Khachanova has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Natalia Khachanova has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Johnson&Johnson. Natalia Khachanova has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi-Aventis. Natalia Khachanova has received research support from Sanofi-Aventis. Natalia Khachanova has received research support from Roche. Natalia Khachanova has received research support from Merck. Natalia Khachanova has received research support from Novartis. Natalia Khachanova has received research support from Actelion Pharmaceuticals. Natalia Khachanova has received research support from TG Therapeutics.
Brian Ward (Medicago Inc - McGill University) No disclosure on file
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.
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.
Ronald Zielman (Novartis) No disclosure on file
Xixi Hu Xixi Hu has received personal compensation for serving as an employee of Novartis. Xixi Hu has stock in Novartis.
Ayan Das Gupta (Novartis Healthcare) Ayan Das Gupta has received personal compensation for serving as an employee of Novartis Health Care Pvt. Ltd.
Kevin Winthrop Kevin Winthrop has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Johnson & Johnson .