Updated safety analysis

2023

General Safety
Safety of ocrelizumab in multiple sclerosis: Updated analysis in patients with relapsing and progressive multiple sclerosis
Data-cut: November 2022

Pregnancy
Pregnancy and infant outcomes in women receiving ocrelizumab for the treatment of multiple sclerosis: Analysis of the largest available outcomes database
Data-cut: July 2023

2022

General Safety
Safety of ocrelizumab in multiple sclerosis: Updated analysis in patients with relapsing and primary progressive multiple sclerosis
Data-cut: November 2021

COVID-19
COVID-19 in people with multiple sclerosis treated with ocrelizumab: Clinical outcomes in vaccinated patients
Data-cut: May 2021

IRRs
Infusion-Related Reactions With Ocrelizumab in Relapsing Multiple Sclerosis: Over 9 Years of Data From OPERA OLE
Data-cut: November 2021

Pregnancy
Pregnancy and infant outcomes in women with multiple sclerosis treated with ocrelizumab
Data-cut: March 2022

Pregnancy
Ocrelizumab during pregnancy and lactation: Rationale and design of the MINORE and SOPRANINO studies in women with MS and their infants
Publication date: August 2022

Infections
Risk factors for serious infections in patients with MS receiving long-term ocrelizumab treatment: Multivariate analyses
Data-cut: January 2020

2021

COVID-19
Understanding the impacts of the COVID-19 pandemic in people with multiple sclerosis treated with ocrelizumab
Publication date: October 2021
General Safety
Safety of ocrelizumab in patients with relapsing and primary progressive multiple sclerosis
Data-cut: January 2020

2020

COVID-19
COVID-19 in ocrelizumab-treated people with multiple sclerosis
Data-cut: July 2020
                      
Vaccines
Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis: the VELOCE study
Data-cut: February 2017
                      
                      
COVID-19
COVID-19 in persons with multiple sclerosis treated with ocrelizumab - a pharmacovigilance case series
Data-cut: April 2020

2019

PML
Cases reported as progressive multifocal leukoencephalopathy in ocrelizumab-treated patients with multiple sclerosis
Data-cut: July 2019

Abbreviations
COVID-19, coronavirus disease 2019; EAN, European Academy of Neurology; ECTRIMS, European Committee for Treatment and Research in MS; IRRs, infusion-related reactions; OLE, open-label extension; PML, progressive multifocal leukoencephalopathy.

M-XX-00015950 (Date of preparation: January 2024)

Prescribing information

Indications vary in different countries. The local prescribing information from your country is the primary source of information on the known and potential risks associated with ocrelizumab.
Archived data reports for fatalities were last updated February 2021. Please note that there will be no further updates of these archived materials