COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab.
COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab.
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DOI：
10.1007/s40120-022-00341-z
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发表时间：
2022-06
影响因子：
3.7
通讯作者：
Winthrop K
中科院分区：
文献类型：
--
作者：
Cross AH;Delgado S;Habek M;Davydovskaya M;Ward BJ;Cree BAC;Totolyan N;Pingili R;Mancione L;Hu X;Sullivan R;Su W;Zielman R;Gupta AD;Montalban X;Winthrop K
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. 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. 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. 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. The online version contains supplementary material available at 10.1007/s40120-022-00341-z.
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影响因子：
4
作者：
Novak F;Nilsson AC;Nielsen C;Holm DK;Østergaard K;Bystrup A;Byg KE;Johansen IS;Mittl K;Rowles W;Mcpolin K;Spencer C;Sagan S;Gerungan C;Wilson MR;Zamvil SS;Bove R;Sabatino JJ;Sejbaek T
通讯作者：
Sejbaek T
影响因子：
3.6
作者：
Druyan, Amit;Lidar, Merav;Pavlotsky, Felix
通讯作者：
Pavlotsky, Felix
DOI：
10.1177/13524585211044479
发表时间：
2022-05
期刊：
Multiple sclerosis (Houndmills, Basingstoke, England)
影响因子：
--
作者：
通讯作者：
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影响因子：
158.5
作者：
Hauser, Stephen L.;Bar-Or, Amit;Kappos, Ludwig
通讯作者：
Kappos, Ludwig
影响因子：
3.3
作者：
Adamec I;Rogić D;Penz MG;Braun C;Habek M
通讯作者：
Habek M