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COVID-19 in ocrelizumab-treated people with multiple sclerosis.
Hughes, Richard; Whitley, Louise; Fitovski, Kocho; Schneble, Hans-Martin; Muros, Erwan; Sauter, Annette; Craveiro, Licinio; Dillon, Paul; Bonati, Ulrike; Jessop, Nikki; Pedotti, Rosetta; Koendgen, Harold.
  • Hughes R; F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Whitley L; TranScrip Partners LLP, Wokingham, UK.
  • Fitovski K; F. Hoffmann-La Roche Ltd, Basel, Switzerland. Electronic address: kocho.fitovski@roche.com.
  • Schneble HM; F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Muros E; F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Sauter A; F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Craveiro L; F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Dillon P; F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Bonati U; F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Jessop N; F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Pedotti R; F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Koendgen H; F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Mult Scler Relat Disord ; 49: 102725, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-1002925
ABSTRACT

BACKGROUND:

There are limited data on the impact of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on people with multiple sclerosis (MS).

OBJECTIVE:

To better understand SARS-CoV-2 infection in ocrelizumab-treated people with MS.

METHODS:

Internal Roche/Genentech data sources Cases of COVID-19 from ongoing Roche/Genentech clinical trials and from post-marketing use of ocrelizumab until July 31, 2020 were identified and assessed using descriptive statistics. External real-world data (RWD) source An MS COVID-19 cohort and an ocrelizumab-treated MS COVID-19 cohort were identified and assessed from the OPTUMⓇ de-identified COVID-19 electronic health record (EHR) database.

RESULTS:

Roche/Genentech clinical trial data There were 51 (1.3%) suspected or confirmed cases of COVID-19 identified from 4,000 patients ongoing in 10 Roche/Genentech clinical trials. Of these, 26 (51%) were confirmed COVID-19 and 25 (49%) were suspected COVID-19. Sixteen (31.4%) patients were hospitalized. COVID-19 severity was mild to moderate in most patients (35, 68.6%). Ten (19.6%) patients had severe disease and there were three (5.9%) fatal cases. Most patients (43, 84.3%) recovered or were recovering. There was no association apparent between duration of exposure to ocrelizumab and COVID-19. Among COVID-19 patients with previous serum immunoglobulin status (27/51, 52.9%), all (27/27, 100%) had IgG levels within the normal range. Roche/Genentech post-marketing safety database data There were 307 post-marketing cases of COVID-19 in the Roche/Genentech global safety database. Of these, 263 (85.7%) were confirmed and 44 (14.3%) were suspected COVID-19. 100 (32.6%) patients were hospitalized. COVID-19 was asymptomatic, mild or moderate in 143 (46.6%) patients, severe in 52 (16.9%) patients, and critical in 15 (4.9%) patients. There were 17 (5.5%) fatal cases. Information on severity was not reported in 80 (26.1%) cases. Most patients (211, 68.7%) recovered or were recovering at the time of the report. External RWD data source As of July 13, 2020, the OPTUMⓇ database included EHRs for almost 1.2 million patients with suspected COVID-19, 130,500 of whom met the criteria for confirmed/clinically diagnosed COVID-19. A total of 357 patients with MS with confirmed COVID-19 were identified. Forty-eight (13.4%) were treated with ocrelizumab, of whom 12 (25.0%) were hospitalized and one died (2.1%). Similar rates of hospitalization, invasive ventilation, and death were observed in the ocrelizumab-treated and non-ocrelizumab-treated MS cohorts. Across the Roche/Genentech and RWD sources assessed, age, male sex, and the presence of comorbidities such as hypertension were associated with a more severe disease course of COVID-19. There was a higher number of comorbidities present in hospitalized versus non-hospitalized patients.

CONCLUSIONS:

This assessment provides evidence that COVID-19 in ocrelizumab-treated people with MS is predominantly mild to moderate in severity with most patients not requiring hospitalization; in line with data reported from the general population and MS datasets. Risk factors known to be associated with severe COVID-19 outcomes in the general population also appear to influence COVID-19 severity in ocrelizumab-treated people with MS. Case fatality rates for ocrelizumab-treated people with MS were within published ranges for the general population and other MS cohorts.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Monoclonal, Humanized / COVID-19 / Multiple Sclerosis Type of study: Cohort study / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Mult Scler Relat Disord Year: 2021 Document Type: Article Affiliation country: J.msard.2020.102725

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Monoclonal, Humanized / COVID-19 / Multiple Sclerosis Type of study: Cohort study / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Mult Scler Relat Disord Year: 2021 Document Type: Article Affiliation country: J.msard.2020.102725