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COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab.
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.
  • Cross AH; Department of Neurology, Washington University, St. Louis, MO, USA. crossa@wustl.edu.
  • Delgado S; University of Miami Miller School of Medicine, Miami, FL, 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, QC, Canada.
  • Cree BAC; UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA.
  • Totolyan N; First Saint Petersburg State Medical University, St. Petersburg, Russia.
  • Pingili R; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
  • Mancione L; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
  • Hu X; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
  • Sullivan R; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
  • Su W; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
  • Zielman R; Novartis Pharma B.V., Amsterdam, The Netherlands.
  • Gupta AD; Novartis Healthcare Private Limited, Hyderabad, India.
  • Montalban X; Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona, Spain.
  • Winthrop K; School of Public Health at Oregon Health and Science University, Portland, OR, USA.
Neurol Ther ; 11(2): 741-758, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1739456
ABSTRACT

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

Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study / Prognostic study Topics: Long Covid / Vaccines Language: English Journal: Neurol Ther Year: 2022 Document Type: Article Affiliation country: S40120-022-00341-z

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study / Prognostic study Topics: Long Covid / Vaccines Language: English Journal: Neurol Ther Year: 2022 Document Type: Article Affiliation country: S40120-022-00341-z