1. COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab
- Author
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Cross, Anne H., Delgado, Silvia, Habek, Mario, Davydovskaya, Maria, Ward, Brian J., Cree, Bruce A. C, Totolyan, Natalia, Pingili, Ratnakar, Mancione, Linda, Hu, Xixi, Sullivan, Roseanne, Su, Wendy, Zielman, Ronald, Gupta, Ayan Das, Montalban, Xavier, Winthrop, Kevin, Universitat Autònoma de Barcelona. Departament de Medicina, Institut Català de la Salut, [Cross AH] Department of Neurology, Washington University, St. Louis, USA. [Delgado S] University of Miami Miller School of Medicine, Miami, USA. [Habek M] University Hospital Center Zagreb, University of Zagreb, School of Medicine, Zagreb, Croatia. [Davydovskaya M] Moscow State Public Healthcare InsCity Clinical Hospital 24, Moscow, Russia. [Ward BJ] Infectious Diseases Division, Research Institute of the McGill University Health Centre, Montreal, Canada. [Cree BAC] UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, USA. [Montalban X] Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
- Subjects
ALITHIOS ,Vaccine Related ,Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis::Multiple Sclerosis, Relapsing-Remitting [DISEASES] ,B-cell therapy ,Cancer ,Anti-CD20 THERAPY ,Anti-CD20 therapy ,SARS-CoV-2 ,Prevention ,Vaccination ,Otros calificadores::Otros calificadores::/terapia [Otros calificadores] ,COVID-19 ,Ofatumumab ,enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple::esclerosis múltiple recurrente-remitente [ENFERMEDADES] ,Emerging Infectious Diseases ,Infectious Diseases ,Good Health and Well Being ,Neurology ,Other subheadings::Other subheadings::/therapy [Other subheadings] ,Relapsing multiple sclerosis ,Avaluació de resultats (Assistència sanitària) ,Immunization ,Neurology (clinical) ,Infection ,Esclerosi múltiple - Tractament ,Post-marketing ,COVID-19 (Malaltia) - Vacunació - Abstract
COVID-19; Ofatumumab; Vaccination COVID-19; Ofatumumab; Vacunación COVID-19; Ofatumumab; Vacunació Introduction The SARS-CoV-2 pandemic necessitated better understanding of the impact of disease-modifying therapies on COVID-19 outcomes and vaccination. We report characteristics of COVID-19 cases and vaccination status in ofatumumab-treated relapsing multiple sclerosis (RMS) patients. Methods COVID-19 data analyzed were from the ongoing, open-label, long-term extension phase 3b ALITHIOS study from December 2019 (pandemic start) and post-marketing cases from August 2020 (ofatumumab first approval) up to 25 September 2021. COVID-19 cases, severity, seriousness, outcomes, vaccination status, and breakthrough infection were evaluated. Results As of 25 September 2021, 245 of 1703 patients (14.4%) enrolled in ALITHIOS receiving ofatumumab (median exposure: 2.45 years) reported COVID-19 (confirmed: 210; suspected: 35). Most COVID-19 was of mild (44.1%) or moderate (46.5%) severity, but 9% had severe/life-threatening COVID-19. There were 24 serious cases (9.8%) with 23 patients hospitalized; 22 recovered and 2 died. At study cut-off, 241 patients (98.4%) had recovered or were recovering or had recovered with sequelae and 2 (0.8%) had not recovered. Ofatumumab was temporarily interrupted in 39 (15.9%) patients. Before COVID-19 onset, IgG levels were within the normal range in all COVID-19–affected patients, while IgM was
- Published
- 2022