Real-world pharmacovigilance of ofatumumab in multiple sclerosis: a comprehensive FAERS data analysis

Hui Chen · 2025

Read Real-world pharmacovigilance of ofatumumab in multiple sclerosis: a comprehensive FAERS data analysis by Hui Chen (2025) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-11799251.txt.

Description

Hui Chen mined a United States drug safety database in a study the hosted text dates to 2024, checking real-world harms of a multiple sclerosis drug. The drug targets a marker on immune cells and is approved for relapsing forms of the disease. Chen pulled reports from late 2020 to mid 2024 where the drug was the prime suspect. Four statistical methods hunted for events reported more often than expected.

Known harms, such as injection site reactions and chest infections, showed up as expected. New signals also appeared, including brain fog, muscle spasms, and mood changes. Most events clustered in the first month of treatment, and patterns differed by sex and age. Chen urges close checks early in care and larger studies to confirm the new signals.

Catalog record

CREATORHui Chen
YEAR2025
COLLECTIONPAPERS
FORMATTXT
FILE SIZE41 KB
VERSION1.0
LICENSECC BY 4.0
RIGHTSCC BY
SOURCEEurope PMC

Source: https://europepmc.org/articles/PMC11799251

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