Outcomes of COVID-19 in Ofatumumab-treated Patients with RMS: Data from the ALITHIOS Open-label Extension Study
Ibolya Boer1, Bruce Cree2, Heinz Wiendl3, Anne Cross4, Sylvia Delgado5, Mario Habek6, Natalia Khachanova7, Brian Ward8, Natalia Totolyan9, Linda Mancione10, Roseanne Sullivan10, Ronald Zielman11, Xixi Hu10, Ayan Das Gupta12, Xavier Montalban13, Kevin Winthrop14
1Novartis Pharma AG, 2UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, 3Department of Neurology with Institute of Translational Neurology, University of Münster, 4Washington University School of Medicine, 5University of Miami Miller School of Medicine, 6University Hospital Center Zagreb, University of Zagreb, School of Medicine, 7Pirogov Russian National Research Medical University, 8Infectious Diseases Division, Research Institute of the McGill University Health Centre, 9First Saint Petersburg State Medical University, 10Novartis Pharmaceuticals Corporation, 11Novartis Pharma B.V, 12Novartis Healthcare Private Limited, 13Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, 14School of Public Health at Oregon Health & Science University
Objective:
To present updated cumulative coronavirus disease 2019 (COVID-19) outcomes from the ongoing ALITHIOS (NCT03650114) study up to cutoff (25-Sep-2022).
Background:
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.
Design/Methods:
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.
Results:
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).
Conclusions:
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.