DMT36
COVID-19 Outcomes and Vaccination Status in Patients with Relapsing Multiple Sclerosis Receiving Ofatumumab

Thursday, June 2, 2022
Prince George's Exhibit Hall (Gaylord National Resort & Convention Center)
Kevin Winthrop, MD, MPH , Public Health and Preventive Medicine, Division of Infectious Diseases, Oregon Health and Sciences University, Portland, OR
Silvia Delgado, MD , University of Miami Miller School of Medicine, Miami, Florida, USA, FL
Mario Habek, MD , University Hospital Center Zagreb, University of Zagreb, School of Medicine, Zagreb, Croatia, Croatia
Maria Davydovskaya, PhD , Moscow state Public Healthcare InszCity Clinical Hospital 24, Moscow, Russia, Russian Federation
Brian Ward, MD , Infectious Diseases Division, Research Institute of the McGill University Health Centre, Montreal, QC, Canada
Bruce A. C. Cree, MD, PhD , Neurology, UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, California, USA, San Francisco, CA
Natalia Totolyan, MD , First Saint Petersburg State Medical University, St Petersburg, Russian Federation
Linda Mancione, BA , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Roseanne Sullivan, PharmD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Ronald Zielman, MD, PhD , Novartis Pharma B.V., Amsterdam, Netherlands
Xixi Hu, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Ayan Das Gupta, MSc , Novartis Healthcare Pvt. Ltd, Hyderabad, India
Xavier Montalban, MD PhD , Department of Neurology-Neuroimmunology, Centre d’Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d’Hebron, Barcelona, Spain
Anne Cross, MD , Neurology, Washington University School of Medicine, Saint Louis, St. Louis, MO
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Background: With increasing focus on COVID-19 and the introduction of vaccines, further evidence is required to better understand the effect of COVID-19 and vaccination in multiple sclerosis (MS) patients treated with disease-modifying therapies. Data collected since the start of the pandemic to 29-Jan-2021 on the COVID-19 outcomes in ofatumumab-treated relapsing MS (RMS) patients has previously been reported.

Objectives: To report COVID-19 outcomes, vaccination status, and breakthrough infections in patients with RMS on ofatumumab from the ALITHIOS study and post-marketing setting.

Methods: Demographics, baseline characteristics, incidence of COVID-19, severity and outcomes were analyzed from the ongoing, open-label, long-term extension ALITHIOS study and the post-marketing setting (Cut-off date: 25-Sep-2021). Reinfection, vaccination rates and breakthrough infections have also included in this analysis.

Results: In ALITHIOS study, 245/1703 patients (14.3%) (mean±SD age at baseline: 37.9±8.75 years; female, 69.8%) receiving ofatumumab had confirmed (n=210; 85.7%) or suspected (35; 14.3%) COVID-19. Most COVID-19 cases were non-serious (221; 90.2%) and 23 (9.4%) patients were hospitalized. Most reported cases were mild/moderate (Grade 1/2) in severity (90.6%); 19 (7.8%) had severe (Grade 3) and 3 (1.2%) had life-threatening (Grade 4) COVID-19. Most patients had recovered/recovered with sequelae/were recovering (241/245; 98.4%); 2 (0.8%) had not recovered, and 2 (0.8%) had fatal outcomes. COVID-19 led to temporary ofatumumab interruption in 39 patients (15.9%) and discontinuation in 2 patients (0.8%), who were fatal. No patients had COVID-19 reinfection.

Overall, 559/1703 (32.8%) patients were vaccinated (fully vaccinated, 476; partially vaccinated, 74; unspecified, 9). Breakthrough infections occurred in 7 (1.5%) patients and 11 (1.97%) patients had infection after partial vaccination; all patients recovered.

From the post-marketing setting, 90 confirmed COVID-19 cases were reported. Of these, 10 (11.1%) were serious cases. No life-threatening or fatal cases were reported. Among known outcomes (N=36), most recovered/recovered with sequelae/were recovering (n=30). One mild breakthrough COVID-19 case was reported and recovered.

Conclusions: Based on this updated data, there does not appear to be an increased risk of severe COVID-19 or fatal outcomes in RMS patients treated with ofatumumab. A very small number of vaccinated patients had breakthrough infections, and all recovered.

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