Ocrelizumab Safety Resources
Select Publications and Congress Posters and Presentations
2021
General Safety
Safety Of Ocrelizumab in Multiple Sclerosis: Updated Analysis in Patients With Relapsing and Primary Progressive Multiple Sclerosis.
Hauser SL, Kappos L, Montalban X, et al. Presented at: ECTRIMS 2021. October 13-15, 2021. Virtual. Poster 724.
Data-cut: November 2020.
COVID-19
COVID-19 in People With Multiple Sclerosis Treated With Ocrelizumab.
Hauser SL, Gold R, Cutter G, et al. Presented at: ECTRIMS 2021. October 13-15, 2021. Virtual. Poster 933.
Data-cut: May 2021.
COVID-19
Understanding the Impacts Of COVID-19 Pandemic in People With Multiple Sclerosis Treated With Ocrelizumab.
Pedotti R, Muros-Le Rouzic E, Raposo C, Schippling S, Jessop N. Mult Scler Relat Disord. 2021;55:103203.
Publication data: October 2021.
Pregnancy
Pregnancy and infant outcomes in women receiving ocrelizumab for the treatment of multiple sclerosis.
Dobson R, Bove R, Boriello F, et al. Presented at: ECTRIMS 2021. October 13-15, 2021. Virtual. Poster 641.
Data-cut: March 2021.
General Safety
Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis.
Hauser SL, Kappos L, Montalban X, et al. Neurology. 2021;97:e1546-e1559.
Data-cut: January 2020.
2020
COVID-19
COVID-19 in Ocrelizumab-Treated People With Multiple Sclerosis.
Hughes R, Whitley L, Fitovski K, et al. Mult Scler Relat Disord. 2021;49:102725.
Data-cut: July 2020.
Vaccines
Effect of Ocrelizumab on Vaccine Responses in Patients With Multiple Sclerosis: The VELOCE Study.
Bar-Or A, Calkwood JC, Chognot C, et al. Neurology. 2020;95:e1999-e2008.
Data-cut: February 2017.
COVID-19
COVID-19 in Persons With Multiple Sclerosis Treated With Ocrelizumab - A Pharmacovigilance Case Series.
Hughes R, Pedotti R, Koendgen H. Mult Scler Relat Disord. 2020;42:102192.
Data-cut: April 2020.
2019
PML
Cases Reported as Progressive Multifocal Leukoencephalopathy in Ocrelizumab-Treated Patients With Multiple Sclerosis.
Clifford DB, Gass A, Richert N, et al. Presented at: ECTRIMS 2019. September 11-13, 2019. Stockholm, Sweden. Poster 970.
Data-cut: July 2019.
Additional Information on Topics of Interest*
Progressive Multifocal Leukoencephalopathy (PML)
Update on ocrelizumab and PML.
Malignancies
Update on ocrelizumab and malignancies.
Serum Ig Levels
Update on ocrelizumab and serum Ig levels.
Pregnancy and Lactation
Update on ocrelizumab and pregnancy.
Fatalities
Update on ocrelizumab and fatalities.
Infections
Update on ocrelizumab and infections.
COVID-19 Cases
Update on ocrelizumab and COVID-19 pharmacovigilance data.
Post-marketing Requirements and Commitments
Post-marketing requirements and commitments for ocrelizumab can be accessed directly on the U.S. Food and Drug Administration website. The following information has also been presented, but may be subject to change based on any further discussions with regulatory authorities:
MANUSCRIPT: Long-Term Surveillance of Ocrelizumab-Treated Patients with Multiple Sclerosis.
Wormser D, Butzkueven H, Hillert J, et al. Presented at the European Academy of Neurology in Oslo, Norway; June 29 –July 2, 2019.
VERISMO: A Post-Marketing Safety Study to Determine the Incidence of All Malignancies and Breast Cancer in Patients With Multiple Sclerosis Treated With Ocrelizumab.
Wormser D, Evershed J, Ferreira G, et al. Presented at the American Academy of Neurology Annual Meeting in Philadelphia, Pennsylvania; May 4–10, 2019.
Design of a Multi-Source Post-Marketing Study to Evaluate Pregnancy and Infant Outcomes in Women With Multiple Sclerosis Who Were Exposed to Ocrelizumab During, or Within 6 Months Before, Pregnancy.
Margulis AV, Andrews EB, Hernandez-Diaz S, et al. Presented at the American Academy of Neurology Annual Meeting in Los Angeles, California; April 21–27, 2018.
Integration of Ocrelizumab Safety Data From the German Study CONFIDENCE Into the Global Post-Marketing Safety Studies MANUSCRIPT and VERISMO.
Ziemssen T, Berthold H, Dirks P, et al. Presented at the European Committee for Treatment and Research in Multiple Sclerosis in Berlin, Germany; October 10–12, 2018.
Design of the Ocrelizumab Pregnancy Registry to Assess Maternal, Fetal and Infant Outcomes in Women With Multiple Sclerosis Who Were Exposed to Ocrelizumab During, or Within 6 Months Before, Pregnancy.
Wormser D, Engel P, Hahn K, et al. Presented at the American Academy of Neurology Annual Meeting in Los Angeles, California; April 21–27, 2018.
Prescribing Information
The Prescribing Information is the primary source of information on the known and potential risks of ocrelizumab for relapsing forms of multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS).
*Due to the nature of post-marketing adverse event reports, some of the investigations remain ongoing and therefore may be subject to change. For more information, please see the FAQ.
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Giovannoni G, et al. Pract Neurol. 2016;16:389–393.
Giovannoni G, et al. Pract Neurol. 2016;16:389–393.
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Rothman KJ, et al, eds. Modern Epidemiology. 3rd ed. Lippincott Williams and Wilkins; 2008.
Rothman KJ, et al, eds. Modern Epidemiology. 3rd ed. Lippincott Williams and Wilkins; 2008.
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New Jersey Department of Health and Senior Services. Fact Sheet: Explanation of Standardized Incidence Ratios. March 2010. Available at: https://www.state.nj.us/health/ceohs/documents/eohap/haz_sites/passaic/pompton_lakes/pompton_lakes_fs_sir.pdf.
New Jersey Department of Health and Senior Services. Fact Sheet: Explanation of Standardized Incidence Ratios. March 2010. Available at: https://www.state.nj.us/health/ceohs/documents/eohap/haz_sites/passaic/pompton_lakes/pompton_lakes_fs_sir.pdf.
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Varallo FR, et al. Clin Ther. 2017;39:686–696.
Varallo FR, et al. Clin Ther. 2017;39:686–696.
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Porta M, ed. A Dictionary of Epidemiology 6th ed. Oxford University Press; 2014. Accessed October 2021. http://irea.ir/files/site1/pages/dictionary.pdf
Porta M, ed. A Dictionary of Epidemiology 6th ed. Oxford University Press; 2014. Accessed October 2021. http://irea.ir/files/site1/pages/dictionary.pdf
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European Medicines Agency. Human regulatory. Post-authorisation. Accessed October 2021. https://www.ema.europa.eu/en/human-regulatory/post-authorisation
European Medicines Agency. Human regulatory. Post-authorisation. Accessed October 2021. https://www.ema.europa.eu/en/human-regulatory/post-authorisation
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US Food and Drug Administration. Postmarketing Requirements and Commitments: reports. Updated November 25, 2020. Accessed October 2021. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm
US Food and Drug Administration. Postmarketing Requirements and Commitments: reports. Updated November 25, 2020. Accessed October 2021. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm
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