COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab
Cross, Anne H. (Department of Neurology. Washington University)
Delgado, Silvia (University of Miami Miller School of Medicine)
Habek, Mario (University Hospital Center Zagreb. University of Zagreb. School of Medicine)
Davydovskaya, Maria (Moscow State Public Healthcare InsCity Clinical Hospital 24)
Ward, Brian J. (Infectious Diseases Division. Research Institute of the McGill University Health Centre)
Cree, Bruce A. C (UCSF Weill Institute for Neurosciences. Department of Neurology. University of California San Francisco)
Totolyan, Natalia (First Saint Petersburg State Medical University)
Pingili, Ratnakar (Novartis Pharmaceuticals Corporation)
Mancione, Linda (Novartis Pharmaceuticals Corporation)
Hu, Xixi (Novartis Pharmaceuticals Corporation)
Sullivan, Roseanne (Novartis Pharmaceuticals Corporation)
Su, Wendy (Novartis Pharmaceuticals Corporation)
Zielman, Ronald (Novartis Pharma B.V.)
Gupta, Ayan Das (Novartis Healthcare Private Limited)
Montalban, Xavier (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Winthrop, Kevin (School of Public Health at Oregon Health and Science University)
Universitat Autònoma de Barcelona. Departament de Medicina

Data:	2022
Resum:	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 < 0. 4 g/l in 23 (9. 4%) patients. No patient had a reinfection. Overall, 559 patients were vaccinated (full, 476; partial, 74; unspecified, 9). Breakthrough infection was reported in 1. 5% (7/476) patients, and 11 reported COVID-19 after partial vaccination. As of 25 September 2021, the Novartis Safety Database (~ 4713 patient-treatment years) recorded 90 confirmed COVID-19 cases receiving ofatumumab. Most cases were non-serious (n = 80), and ten were serious (1 medically significant, 9 hospitalized, 0 deaths). Among 36 of 90 cases with outcomes reported, 30 recovered and 6 did not recover. Conclusion: COVID-19 in RMS patients on ofatumumab was primarily of mild/moderate severity and non-serious in these observational data. Most recovered from COVID-19 without treatment interruption. Two people died with COVID-19. Breakthrough COVID-19 despite being fully/partially vaccinated was uncommon.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	ALITHIOS ; Anti-CD20 THERAPY ; B-cell therapy ; COVID-19 ; Ofatumumab ; Post-marketing ; Relapsing multiple sclerosis ; SARS-CoV-2 ; Vaccination
Publicat a:	Neurology and Therapy, Vol. 11 Núm. 2 (june 2022) , p. 741-758, ISSN 2193-6536
Obra relacionada:	Cross, A.H., Delgado, S., Habek, M. et al. Correction to: COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab. Neurol Ther 11, 759-762 (2022) https://doi.org/10.1007/s40120-022-00346-8

Correcció de l'article: https://ddd.uab.cat/record/274638
DOI: 10.1007/s40120-022-00341-z
PMID: 35284994

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