prikaz prve stranice dokumenta COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab
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Scientific paper - Original scientific paper
COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab
Neurology and Therapy, 11 (2022), 2; 741-758. https://doi.org/10.1007/s40120-022-00341-z
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 More authors...

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Cross, A. H., Delgado, S., Habek, M., Davydovskaya, M., Ward, B. J., Cree, B. A. C. ... Winthrop, K. (2022). COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab. Neurology and Therapy, 11. (2), 741-758. doi: 10.1007/s40120-022-00341-z

Cross, Anne H., et al. "COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab." Neurology and Therapy, vol. 11, no. 2, 2022, pp. 741-758. https://doi.org/10.1007/s40120-022-00341-z

Cross, Anne H., Silvia Delgado, Mario Habek, Maria Davydovskaya, Brian J. Ward, Bruce A. C. Cree, Natalia Totolyan, et al. "COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab." Neurology and Therapy 11, no. 2 (2022): 741-758. https://doi.org/10.1007/s40120-022-00341-z

Cross, A. H., et al. (2022) 'COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab', Neurology and Therapy, 11(2), pp. 741-758. doi: 10.1007/s40120-022-00341-z

Cross AH, Delgado S, Habek M, Davydovskaya M, Ward BJ, Cree BAC, and sur.. COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab. Neurology and Therapy [Internet]. 2022 June [cited 2024 December 23];11(2):741-758. doi: 10.1007/s40120-022-00341-z

A. H. Cross, et al., "COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab", Neurology and Therapy, vol. 11, no. 2, pp. 741-758, June 2022. [Online]. Available at: https://urn.nsk.hr/urn:nbn:hr:105:176399. [Accessed: 23 December 2024]

Metadata
Title (english)COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab
AuthorAnne H. Cross
AuthorSilvia Delgado
AuthorMario Habek
AuthorMaria Davydovskaya
AuthorBrian J. Ward
AuthorBruce A. C. Cree
AuthorNatalia Totolyan
AuthorRatnakar Pingili
AuthorLinda Mancione
AuthorXixi Hu
AuthorRoseanne Sullivan
AuthorWendy Su
AuthorRonald Zielman
AuthorAyan Das Gupta
AuthorXavier Montalban
AuthorKevin Winthrop
Author's institutionUniversity of Zagreb
School of Medicine
(Department of Neurology)
Scientific / art field,
discipline and subdiscipline		BIOMEDICINE AND HEALTHCARE
Clinical Medical Sciences
Neurology
Abstract (english)
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.
Keywords (english)
Languageenglish
Publication typeScientific paper - Original scientific paper
Publication statusPublished
Peer reviewPeer review
Publication versionPublished version
Journal titleNeurology and Therapy
Numberingvol. 11, no. 2, pp. 741-758
p-ISSN2193-8253
e-ISSN2193-6536
DOIhttps://doi.org/10.1007/s40120-022-00341-z
URN:NBNurn:nbn:hr:105:176399
Publication2022-06
Document URLhttps://link.springer.com/10.1007/s40120-022-00341-z
Type of resourceText
Access conditionsOpen access
Terms of useLicence Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) icon
Created on2022-10-03 07:10:03