IV = Intravenous, SC = Subcutaneous
Safety Topics
The information in this section may include content beyond what is in the FDA-approved label. Because the US Food and Drug Administration (FDA) has not approved such content, no conclusions regarding safety or efficacy may be made. Providing this information should not be construed as recommendation for use of a Genentech product for unapproved uses. For FDA-approved products, please consult the full prescribing information for a complete discussion of risks and benefits of the product(s) for its approved indication(s).
Our Commitment to Safety Communication
Safety updates from ongoing ocrelizumab clinical trials and post-marketing experience
Data is drawn from the experience of patients who have started on ocrelizumab globally (as of March 2024): >350,000 patients (>1,000,000 patient-years), including >9,990 patients from clinical trials and open-label extension1.
- Data on file. Genentech. Accessed on Sep. 18, 2024.
Report an Adverse Event
To report suspected adverse reactions, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
View global safety updates by topic and explore their associated publications, fact sheets, and post-marketing commitments below.
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).
The select publications and congress posters/presentations provided below have been chosen to feature data related to the following topics of interest. These data are not an exhaustive list of published materials on this topic.
General Safety
View updates on safety data from the ocrelizumab clinical trials.
Publications
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.
Congresses
Safety of Ocrelizumab in Multiple Sclerosis: Up to 11 Years of Updated Analysis in Patients With Relapsing and Progressive Multiple Sclerosis
Hauser SL, Kappos L, Montalban X, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Poster #P300
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 the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P304
Safety of Ocrelizumab in Multiple Sclerosis: Long-Term Adverse Event Analyses Based on Initial Exposure Quartiles
Hauser S, Bar-Or A, Weber M, et al. Presented at: 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 26-28, 2022; Amsterdam, the Netherlands. Poster #eP1221.
Congresses
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; June 29-July 2, 2019; Oslo, Norway.
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: European Committee for Treatment and Research in Multiple Sclerosis; October 10–12, 2018; Berlin, Germany.
Pregnancy and Lactation
Roche Global Safety Database Analysis
Family planning is an important consideration for many patients with MS. At the 2023 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting, Genentech presented data related to pregnancy and lactation from the Roche Global Safety Database.
Additional Resources
Explore pregnancy and lactation data in patients treated with ocrelizumab. Check back soon for an updated fact sheet.
Congresses
Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Receiving Ocrelizumab: Analysis of Approximately 4,000 Pregnancies to Date
Dobson R, Vukusic S, Bove R, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Poster #P085
B-Cell Levels and Placental Transfer in Infants Potentially Exposed to Ocrelizumab During Pregnancy: Primary Analysis of the Prospective Multicentre, Open-Label Phase IV MINORE Study
Hellwig K, Bove R, Oreja-Guevera C, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Poster #P087
B-Cell Levels and Breastmilk Transfer in Infants of Lactating Women With Multiple Sclerosis Treated With Ocrelizumab: Primary Results of the Prospective Multicentre, Open-Label Phase IV Study SOPRANINO
Bove R, Oreja-Guevera C, Hellwig K, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Oral presentation #O039
Disease Activity Before, During and After Pregnancy in Women with MS Receiving Ocrelizumab: An Integrated Analysis From 13 Interventional Clinical Trials
Vukusic S, Ross A, Oreja-Guevera C, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Poster #P591
Pregnancy and Infant Outcomes in Women Receiving OCR for the Treatment of Multiple Sclerosis: Analysis of the Largest Available Outcome Database
Hellwig K, Oreja-Guevara C, Vukusic S, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P061
Congresses
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: American Academy of Neurology Annual Meeting; April 21–27, 2018; Los Angeles, CA, USA.
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
Wormser D, Engel P, Hahn K, et al. Presented at: American Academy of Neurology Annual Meeting; April 21–27, 2018; Los Angeles, CA, USA.
Serum Immunoglobulin Levels
Explore data on serum immunoglobulin (Ig) levels and infections in patients treated with ocrelizumab.
Infections
Explore data on infections in patients treated with ocrelizumab.
PML
View reports on cases of progressive multifocal leukoencephalopathy (PML) in patients treated with ocrelizumab.
Congresses
Cases Reported as Progressive Multifocal Leukoencephalopathy in Ocrelizumab-Treated Patients With Multiple Sclerosis
Clifford DB, Gass A, Richert N, et al. Presented at: European Committee for Treatment and Research in Multiple Sclerosis. September 11-13, 2019, Stockholm, Sweden. Poster 970. Data-cut: July 2019.
COVID-19 and Vaccines
Explore data on COVID-19, including infections and vaccination, with ocrelizumab.
Publications
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.
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.
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.
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(14):e1999-e2008. Data-cut: February 2017.
Congresses
COVID-19 in People With Multiple Sclerosis Treated With Ocrelizumab: Clinical Outcomes in Vaccinated Patients
Hauser S, Gold R, Cutter G, et al. Presented at: 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 26-28, 2022; Amsterdam, the Netherlands. Poster #EP1238.
SARS-CoV-2 Vaccination and COVID-19 Infections in People With Multiple Sclerosis Treated With Ocrelizumab in the Prospective, Multicentre, Noninterventional MuSicalE and CONFIDENCE Studies
Trojano M, Meuth S, Buttmann M, et al. Presented at: 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 26-28, 2022; Amsterdam, the Netherlands. Poster #P562.
SARS-CoV-2 Vaccine-Induced Immune Responses and Breakthrough Infections in People With Multiple Sclerosis Treated With Ocrelizumab
Bar-Or A, Bhargava P, Patti F, et al. Presented at: 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 26-28, 2022; Amsterdam, the Netherlands. Poster #P553.
Malignancies
Explore data on malignancies, including breast cancer, in patients treated with ocrelizumab.
Congresses
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: American Academy of Neurology Annual Meeting; May 4–10, 2019; Philadelphia, PA, USA.
Fatalities
Explore data on fatalities among patients treated with ocrelizumab.
Frequently Asked Questions
This section is not a comprehensive source of safety information on ocrelizumab. Due to the nature of post-marketing adverse event reports, information may be duplicated and/or incomplete. Some investigations remain ongoing, and therefore, information is subject to change. Additionally, the existence of an adverse event report does not establish causation. We evaluate these reports through our drug safety department, and attempt to verify the information to the extent possible. The Prescribing Information remains the primary source of information on the known and potential risks of ocrelizumab for RMS and PPMS.
An adverse event is an untoward medical occurrence in a patient or participant in a clinical investigation, but does not necessarily have a causal relationship with an administered treatment. A post-marketing adverse event report is a report received by Genentech regarding an adverse event in a patient taking one of our marketed products.
Robust global systems are in place to continuously monitor the safety of a drug, from the time it is first evaluated in clinical studies through commercialization. All adverse event reports are received by Genentech/Roche and due diligence is performed. The reports are then submitted to the FDA as per regulatory requirements.
Yes; this website includes post-marketing adverse event reports received by Genentech/Roche. As part of our robust global pharmacovigilance process, these adverse event reports are reviewed, assessed, and due diligence is performed.
The FAERS database generally includes post-marketing cases reported by the Market Authorization Holder. However, FAERS may also include reports from clinical trials based on the specific requirements set in FDA regulations along with reports that are submitted voluntarily to the FDA by other resources. As the FDA acknowledges, unverified information, as well as incomplete or duplicate cases, can be reported in the FAERS dashboard.
Looking for more information?
Reach out to a Genentech Medical Science Liaison near you, or connect with the contact center.
Call Us: 1-800-821-8590 Hours: Monday-Friday, 5am-5pm PT
Publications and Congresses
The information in this section may include content beyond what is in the FDA-approved label. Because the FDA has not approved such content, no conclusions regarding safety or efficacy may be made. Providing this information should not be construed as recommendation for use of a Genentech product for unapproved uses. For FDA-approved products please consult the product’s full prescribing information for a complete discussion of risks and benefits of the product(s) for its approved indication(s).
Publications: The list of publications is not an exhaustive list of published materials on the product. The list of references by data topics is selected per evidence-based medicine criteria. To browse a full listing of published scientific literature:
Congresses: The list of congresses is a subset of Roche/Genentech posters and oral presentations for the product with data presented at scientific meetings in the recent 24 months. To browse full Roche/Genentech congress presentations and posters:
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20240919 B-Cell Levels and Breastmilk Transfer in Infants of Lactating Women With Multiple Sclerosis Treated With Ocrelizumab: Primary Results of the Prospective Multicentre, Open-Label Phase IV Study SOPRANINO
Bove R, Oreja-Guevera C, Hellwig K, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Oral presentation #O039SafetyIntravenous -
20240919 Disease Activity Before, During and After Pregnancy in Women with MS Receiving Ocrelizumab: An Integrated Analysis From 13 Interventional Clinical Trials
Vukusic S, Ross A, Oreja-Guevera C, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Poster #P591SafetyIntravenous -
20240919 Two-year Results of Patient-Reported Outcomes in Patients with Multiple Sclerosis Treated with Ocrelizumab in a Large Real-World Setting: MuSicalE Interim Analysis
Trojano M, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Poster #P875Real World Experience (RWE)Intravenous -
20240919 Real-World Persistence, Adherence and Treatment Satisfaction in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Ocrelizumab for 2 Years
Trojano M, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS ePoster #P1716Real World Experience (RWE)Intravenous -
20240919 Ocrelizumab Subcutaneous Injection in Patients With Multiple Sclerosis: Further Characterisation of the Benefit–Risk Profile From the OCARINA Clinical Development Programme
Newsome SD, Krzystanek E, Selmaj K, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Poster #P797Pivotal Trial(s)IntravenousSubcutaneous -
20240919 Two-Year Analysis of Efficacy and Safety Data From Black and Hispanic People WIth Relapsing Multiple Sclerosis Receiving Ocrelizumab Treatment in the CHIMES Trial
Monson NL, Wu G, Cuascut F, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Poster #P804Supportive StudiesIntravenous -
20240919 Circulating B-cell and Serum Neurofilament Light Chain Levels Associated With Progressive Disease Outcomes in Phase 3 Trials of Ocrelizumab in People With Relapsing or Progressive Multiple Sclerosis
Hauser SL, Strauli N, Raievska A, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Poster #P764Exploratory AnalysisIntravenous -
20240918 Long-Term Effect of Ocrelizumab on Brain Volume and Lesion Activity Outcomes in Patients with Relapsing Multiple Sclerosis: Analysis of 10-Year Data from the OPERA Trials
Granziera C, Kolind S, Traboulsee A, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Oral presentation #O094Exploratory AnalysisIntravenous -
20240918 Reduced Cerebrospinal Fluid Biomarkers (Neurofilament Light Chain, B cells, T cells) and Improved Clinical/Imaging Assessments of Relapsing Disease Activity Are Sustained After 5 Years of Ocrelizumab Treatment: Long-Term Extension Results From OBOE
Cross AH, Gelfand J, von Büdingen HC, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Oral presentation #O025Supportive StudiesIntravenous -
20240918 Evaluation of CHIT1 and SERPINA3 as Candidate Cerebrospinal Fluid Biomarkers of Progressive Biology in Multiple Sclerosis
Bar-Or A, Gelfand J, Agbim C, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Oral presentation #O026Supportive StudiesIntravenous -
20240918 Clinical Outcomes Among Persons With Relapsing Multiple Sclerosis Initiating First-Line Treatment With Ocrelizumab: Insights From Real-World Studies MSBase OCR-R Substudy, MuSicalE and CONFIDENCE
Butzkueven H, Hobart J, Bluemich S, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Poster #P837Real World Experience (RWE)Intravenous -
20240918 Early Treatment With Ocrelizumab: a Multicentre, Real-World Observational Study
Alvarez E, Naismith R, Hua L, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS ePoster #P1759Real World Experience (RWE)Intravenous -
20240918 B-Cell Levels and Placental Transfer in Infants Potentially Exposed to Ocrelizumab During Pregnancy: Primary Analysis of the Prospective Multicentre, Open-Label Phase IV MINORE Study
Hellwig K, Bove R, Oreja-Guevera C, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Poster #P087SafetyIntravenous -
20240918 The Patient Impact of 11 Years of Ocrelizumab Treatment in Multiple Sclerosis: Long-Term Data From the Phase III OPERA and ORATORIO Studies
Hauser SL, Giovannoni G, Filippi M, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS ePoster #P1664Supportive StudiesIntravenous -
20240918 Safety of Ocrelizumab in Multiple Sclerosis: Up to 11 Years of Updated Analysis in Patients With Relapsing and Progressive Multiple Sclerosis
Hauser SL, Kappos L, Montalban X, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Poster #P300SafetyIntravenous -
20240918 Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Receiving Ocrelizumab: Analysis of Approximately 4,000 Pregnancies to Date
Dobson R, Vukusic S, Bove R, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Poster #P085SafetyIntravenous -
20240918 Ocrelizumab Treatment and Risk for Composite Disability Progression in Non-Hispanic Black and Hispanic or Latino Individuals by Self-Identity and Genetic Ancestry With Relapsing Multiple Sclerosis: Findings From the OPERA I and II Trials
Amezcua L, Boorgu D, Oxendine J, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Poster #P794Exploratory AnalysisIntravenous -
20240604 One-Year Analysis of Ocrelizumab Treatment in Black/African American and Hispanic/Latino People With Relapsing Multiple Sclerosis From the CHIMES Trial
Amezcua L, Monson NL, Williams MJ, et al. Presented at the Consortium of Multiple Sclerosis Centers Annual Meeting in Nashville, TN, USA; May 29 - June 1, 2024. CMSC Poster #9537.Supportive StudiesIntravenous -
20240530 Ocrelizumab Administered Subcutaneously: Results From the Clinical Development Program
Newsome SD, Krzystanek E, Selmaj K, et al. Presented at the Consortium of Multiple Sclerosis Centers Annual Meeting in Nashville, TN, USA; May 29 - June 1, 2024. CMSC Oral presentation #DMT06Pivotal Trial(s)IntravenousSubcutaneous -
20240530 Pregnancy and Infant Outcomes in Females Receiving Ocrelizumab for the Treatment of Multiple Sclerosis: Analysis of over 3,000 Pregnancies to Date [ENCORE]
Bove R, Pietrasanta C, Oreja-Guevara C, et al. Presented at the Consortium of Multiple Sclerosis Centers Annual Meeting in Nashville, TN, USA; May 29 - June 1, 2024. CMSC Oral presentation.SafetyIntravenous -
20240417 Subcutaneous Ocrelizumab in Patients With Multiple Sclerosis: Results of the Phase III OCARINA II Study
Newsome SD, Krzystanek E, Selmaj K, et al. Presented at the 76th Annual Meeting of the American Academy of Neurology in Denver, Colorado, USA; April 13-18, 2024. AAN Oral presentation #S31.001.Pivotal Trial(s)IntravenousSubcutaneous -
20240417 10 Years of Ocrelizumab Treatment in Multiple Sclerosis: Long-Term Efficacy and Safety Clinical Trial Data
Hauser SL, Kappos L, Filippi M, et al. Presented at the 76th Annual Meeting of the American Academy of Neurology in Denver, Colorado, USA; April 13-18, 2024. AAN Oral presentation #S31.005.Exploratory AnalysisIntravenous -
20240417 OCARINA I, Phase Ib Study: Dose Selection of Subcutaneous Ocrelizumab in Patients With Multiple Sclerosis
Newsome SD, Goldstick L, Townsend B, et al. Presented at the 76th Annual Meeting of the American Academy of Neurology in Denver, Colorado, USA; April 13-18, 2024. AAN Poster #P10.003.Pivotal Trial(s)IntravenousSubcutaneous -
20240416 Ocrelizumab in Patients With Early-Stage RRMS – Results From The Phase IIIb ENSEMBLE Trial and The Matched Real-World NTD MS Registry Cohort
Hartung HP, Holmoy T, Wuerfel J, et al. Presented at the 76th Annual Meeting of the American Academy of Neurology in Denver, Colorado, USA; April 13-18, 2024. AAN Poster #P9.005.Supportive StudiesIntravenous -
20240416 Low Disease Activity Over 4 Years of Ocrelizumab Therapy in Treatment-Naive Patients With High-Activity, Early-Stage Relapsing-Remitting Multiple Sclerosis in the ENSEMBLE Study
Vollmer T, Bermel R, Brochet B, et al. Presented at the 76th Annual Meeting of the American Academy of Neurology in Denver, Colorado, USA; April 13-18, 2024. AAN Poster #P10.007.Supportive StudiesIntravenous -
20240415 One-Year Analysis of Efficacy and Safety Data From Black/African American and Hispanic/Latino People With Relapsing Multiple Sclerosis Receiving Ocrelizumab Treatment in the CHIMES Trial
Amezcua L, Monson NL, Williams MJ, et al. Presented at the 76th Annual Meeting of the American Academy of Neurology in Denver, Colorado, USA; April 13-18, 2024. AAN Oral presentation #PL5.004.Supportive StudiesIntravenous -
20240414 Pregnancy and Infant Outcomes in Females Receiving Ocrelizumab for the Treatment of Multiple Sclerosis: Analysis of over 3,000 Pregnancies to Date
Bove R, Pietrasanta C, Oreja-Guevara C, et al. Presented at the 76th Annual Meeting of the American Academy of Neurology in Denver, Colorado, USA; April 13-18, 2024. AAN Oral presentation #S7.004.SafetyIntravenous -
20240413 Variation in the Use of Disease-Modifying Therapies in Persons with Multiple Sclerosis by Age
Geiger CK, Wang R, Ng C. Presented at the 76th Annual Meeting of the American Academy of Neurology in Denver, Colorado, USA; April 13-18, 2024. AAN Poster #P2.002.Supportive StudiesIntravenous -
20240311 Emerging Cerebrospinal Fluid Biomarkers of Disease Activity and Progression in Multiple Sclerosis
Cross AH, Gelfand JM, Thebault S, et al. [published online ahead of print Mar 11, 2024] JAMA Neurol. doi:10.1001/jamaneurol.2024.0017.Supportive StudiesIntravenous -
20240229 OCARINA Clinical Trial Program, Dose Selection and Non-Inferiority of Ocrelizumab Administered Subcutaneously in Patients With Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis
Newsome SD, Figueiredo C, Wolf C, et al. Presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum in West Palm Beach, Florida; February 29 - March 2, 2024. ACTRIMS Forum Poster #P101Pivotal Trial(s)IntravenousSubcutaneous -
20240229 One-Year Efficacy and Safety Data Analysis of People With Relapsing Multiple Sclerosis From Kenya Receiving Ocrelizumab in the CHIMES Trial
Sokhi DS, Hooker J, Mavuti J, et al. Presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum in West Palm Beach, Florida; February 29 - March 2, 2024. ACTRIMS Forum Poster #P095Supportive StudiesIntravenous -
20240229 Disability Outcomes Among Persons With Multiple Sclerosis Treated With First-Line Ocrelizumab vs. Other Disease-Modifying Therapies
Geiger CK, Moustaid F, Rosettie KL, et al. Presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum in West Palm Beach, Florida; February 29 - March 2, 2024. ACTRIMS Forum Poster #P071Health Economics and Outcomes Research (HEOR)Intravenous -
20231206 Evolution of atrophied T2 lesion volume in primary-progressive multiple sclerosis: results from the phase 3 ORATORIO study
Zivadinov R, Pei J, Clayton D, et al. J Neurol Neurosurg Psychiatry. 2023;jnnp-2023-332573.Exploratory AnalysisIntravenous -
20231013 Disease Activity During Pre-Conception, Pregnancy and Postpartum in Women With MS Receiving Ocrelizumab or Other Disease-Modifying Therapies in a Real-world Cohort
Yeh W, van der Walt A, Skibina O, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P173SafetyIntravenous -
20231012 Analysis of the Adaptive Immune Receptor Repertoire Alongside Treatment With Ocrelizumab Suggests Clinical Relevance of B-cell Repopulation Versus Reconstruction
Schneider-Hohendorf T, Rubelt F, Mirebrahim H, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P787Pharmacokinetics (PK) and Pharmacodynamics (PD)Intravenous -
20231012 Low Disability Accumulation After 4-Year Ocrelizumab Therapy in Treatment-Naive Patients With Early-Stage Relapsing-Remitting Multiple Sclerosis; Data From the Phase IIIb ENSEMBLE Study
Patti F, Bermel R, Brochet B, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P688Supportive StudiesIntravenous -
20231012 Unsupervised Analysis Reveals That Memory IgA B Cells are Spared by Ocrelizumab Treatment
Garcia A, Dugast E, Lebrun-Frenay C, Thouvenot E, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P762Pharmacokinetics (PK) and Pharmacodynamics (PD)Intravenous -
20231012 Persistence to Ocrelizumab Compared With Other Disease-Modifying Therapies for Multiple Sclerosis in the German NeuroTransData Registry
Braune S, Dirks P, Colloud S, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P732Supportive StudiesIntravenous -
20231011 Immune-Signatures Associated With Ocrelizumab Treatment in Early Relapsing-Remitting MS: New Data on T Cell Function and Pro/Anti-Inflammatory Monocytes of the 12-Month Interim Analysis From the MA30143 Phase IIIb (ENSEMBLE) Substudy
Wirth T, Schulte-Mecklenbeck A, Steinberg OV, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P1460Exploratory AnalysisIntravenous -
20231011 One-Year Analysis of Efficacy and Safety Data From Black and Hispanic Patients With Relapsing Multiple Sclerosis Receiving Ocrelizumab Treatment in the CHIMES Trial
Williams M, Vartanian T, Reder A, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P691Supportive StudiesIntravenous -
20231011 The Patient Impact of 10 Years of Ocrelizumab Treatment in Multiple Sclerosis: Long-Term Data From the Phase III OPERA and ORATORIO Studies
Weber MS, Kappos L, Hauser SL, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P302Supportive StudiesIntravenous -
20231011 Cerebrospinal Fluid Neurofilament Heavy Levels Correlate With Spinal Cord Lesions and Disability in Multiple Sclerosis
Shen Y-A, Harp C, von Büdingen H-C, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P241Pharmacokinetics (PK) and Pharmacodynamics (PD)Intravenous -
20231011 Reduction of Intrathecal Immunoglobulin Levels With Ocrelizumab Treatment in Relapsing and Primary Progressive Multiple Sclerosis
Martin S. Weber, Jeffrey M. Gelfand, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P653Pharmacokinetics (PK) and Pharmacodynamics (PD)Intravenous -
20231011 Utility and Implementation of a Federated Research Infrastructure to Assess Lack of Disease Stability as a Real- World Surrogate of PIRA, by Combining MS Clinical Trial and Real-World Cohort Data (The INTONATE MS Consortium)*
Oh J, Smolders j, Buijs F, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P1181Supportive StudiesIntravenous -
20231011 Subcutaneous ocrelizumab in patients with multiple sclerosis: Results of the Phase Ib dose-finding OCARINA I study
Newsome SD, Goldstick L, Townsend B, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster #371Pivotal Trial(s)IntravenousSubcutaneous -
20231011 Subcutaneous ocrelizumab in patients with multiple sclerosis: Results of the Phase III OCARINA II study
Newsome SD, Krzystanek E, Selmaj K, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster #370Pivotal Trial(s)IntravenousSubcutaneous -
20231011 Pregnancy and Infant Outcomes in Women Receiving OCR for the Treatment of Multiple Sclerosis: Analysis of the Largest Available Outcome Database
Hellwig K, Oreja-Guevara C, Vukusic S, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P061SafetyIntravenous -
20231011 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 the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P304SafetyIntravenous -
20231011 Kinetics of T cell reactivity and antibody responses to SARS-CoV-2 after different rounds of vaccination in persons with multiple sclerosis treated with ocrelizumab
Tarkoswki M, Mandelli A, Gabrieli A, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P788SafetyIntravenous -
20230921 Treatment Patterns by Race and Ethnicity in Newly Diagnosed Persons with Multiple Sclerosis
Geiger CK, Sheinson D, To TM, et al. Drugs Real World Outcomes. 2023;10(4):565-575.Real World Experience (RWE)Intravenous -
20230622 Blood neurofilament light levels predict non-relapsing progression following anti-CD20 therapy in relapsing and primary progressive multiple sclerosis: findings from the ocrelizumab randomized, double-blind phase 3 clinical trials
Bar-Or A, Thanei GA, Harp C, et al. EBioMedicine. 2023;93:104662.Exploratory AnalysisIntravenous -
20230609 Demographics and Baseline Disease Characteristics of Black and Hispanic Patients With Multiple Sclerosis in the Open-Label, Single-Arm, Multicenter, Phase IV CHIMES Trial
Williams MJ, Okai AF, Cross AH, et al. Mult Scler Relat Disord. 2023;76:104794.Supportive StudiesIntravenous -
20230528 Recently Diagnosed Treatment-Naive RRMS: 4-Year Safety & Efficacy Data from the Ocrelizumab Phase IIIb ENSEMBLE Study [ENCORE]
Perrin-Ross A, Berger T, Bermel R, et al. Presented at the Consortium of Multiple Sclerosis Centers Annual Meeting in Aurora, Colorado; May 31 - June 3, 2023. CMSC Poster #DMT12.Supportive StudiesIntravenous -
20230528 Patient-Reported Outcomes in Treatment-Naive Patients with Early Relapsing-Remitting MS Treated with Ocrelizumab: 4-Year Data from the ENSEMBLE Study
Hartung H, Nos C, Perrin RA, et al. Presented at the Consortium of Multiple Sclerosis Centers Annual Meeting in Aurora, Colorado; May 31 - June 3, 2023. CMSC Poster #QOL16.Supportive StudiesIntravenous -
20230528 Real-World Clinical and Economic Outcomes Among Persons with Multiple Sclerosis Initiating First Versus Second-Line Treatment with Ocrelizumab [ENCORE]
Geiger C, Sheinson D, To T, et al. Presented at the Consortium of Multiple Sclerosis Centers Annual Meeting in Aurora, Colorado; May 31 - June 3, 2023. CMSC Poster #DMT23.Real World Experience (RWE)Intravenous -
20230528 Safety of Ocrelizumab in Multiple Sclerosis: Updated Analyses up to 9 Years in Patients with Relapsing and Primary Progressive Multiple Sclerosis [ENCORE]
Freedman M, Montalban X, Vollmer T, et al. Presented at the Consortium of Multiple Sclerosis Centers Annual Meeting in Aurora, Colorado; May 31 - June 3, 2023. CMSC Poster #DMT45.SafetyIntravenous -
20230528 Safety of Shorter Ocrelizumab Infusion Confirmed over Multiple Administrations: Results of the ENSEMBLE PLUS Substudy [ENCORE]
Perrin-Ross A, Killestein J, Berger T, et al. Presented at the Consortium of Multiple Sclerosis Centers Annual Meeting in Aurora, Colorado; May 31 - June 3, 2023. CMSC Poster #DMT13.Supportive StudiesIntravenous -
20230528 An Interim Analysis of Efficacy and Safety Data in Black and Hispanic Patients With Multiple Sclerosis Receiving Ocrelizumab Treatment in the CHIMES Trial [ENCORE]
Bernitsas E, Reder A, Chinea A, et al. Presented at the Consortium of Multiple Sclerosis Centers Annual Meeting in Aurora, Colorado; May 31 - June 3, 2023. CMSC Poster #DMT30.Supportive StudiesIntravenous -
20230528 Long-Term Efficacy of Ocrelizumab up to 8 Years in RMS Patients in the OPERA Study and Open-Label Extension Using Repeated Event Analysis [ENCORE]
Bermel R, Hartung H, Naismith R, et al. Presented at the Consortium of Multiple Sclerosis Centers Annual Meeting in Aurora, Colorado; May 31 - June 3, 2023. CMSC Poster #DMT50.Exploratory AnalysisIntravenous -
20230528 Employment and Patient-Reported Outcomes in Ocrelizumab-Treated Patients with Relapsing-Remitting Multiple Sclerosis: 2-Year CASTING and CHORDS Data
Benedict R, Comi G, Cutter G, et al. Presented at the Consortium of Multiple Sclerosis Centers Annual Meeting in Aurora, Colorado; May 31 - June 3, 2023. CMSC Poster #QOL25.Supportive StudiesIntravenous -
20230506 Ocrelizumab-Treated Patients with Relapsing Multiple Sclerosis Show Volume Loss Rates Similar to Healthy Aging
Kolind S, Gaetano L, Assemlal HE, et al. Mult Scler. 2023;29(6):741-747.Exploratory AnalysisIntravenous -
20230427 Delayed Signs of Early Disability Progression After 8.5 Years of Ocrelizumab Treatment in Patients With Relapsing Multiple Sclerosis
Weber M, Kappos L, Hauser S, et al. Presented at the American Academy of Neurology in Boston, MA; April 22-27, 2023. AAN Oral presentation #S46.003.Exploratory AnalysisIntravenous -
20230427 Long-term treatment with first-line ocrelizumab in early RMS patients:9-year follow-up data from the OPERA trial
Cerqueira J, Berthele A, Cree B, et al. Presented at the American Academy of Neurology in Boston, MA; April 22-27, 2023. AAN Oral presentation #S46.002.Exploratory AnalysisIntravenous -
20230427 Low Disease Activity Over 4 Years of Ocrelizumab Therapy in Treatment-Naive Patients With Early-Stage Relapsing-Remitting Multiple Sclerosis; the Phase IIIb ENSEMBLE Study
Bermel R, Hartung H, Brochet B, et al. Presented at the American Academy of Neurology Annual Meeting in Boston, MA; April 22-27, 2023. AAN Oral presentation #S46.004.Supportive StudiesIntravenous -
20230425 An Interim Analysis of Efficacy and Safety Data in Black and Hispanic Patients With Multiple Sclerosis Receiving Ocrelizumab Treatment in the CHIMES Trial [ENCORE]
Bernitsas E, Reder A, Chinea A, et al. Presented at the American Academy of Neurology in Boston, MA; April 22-27, 2023. AAN Poster #PS31.006.Supportive StudiesIntravenous -
20230425 Infusion-Related Reactions With Ocrelizumab: Risk Factors, Symptom Management and Patient Choices in the ENSEMBLE PLUS Study [ENCORE]
Bermel R, Killestein J, Berger T, et al. Presented at the American Academy of Neurology Annual Meeting in Boston, MA; April 22-27, 2023. AAN Poster #P7.003.Supportive StudiesIntravenous -
20230424 Effect of Ocrelizumab on B- and T-Cell Receptor Repertoire Diversity in Patients With Relapsing Multiple Sclerosis From the Randomized Phase III OPERA Trial
Laurent SA, Strauli NB, Eggers EL, et al. Neurol Neuroimmunol Neuroinflamm. 2023;10(4):e200118.Exploratory AnalysisIntravenous -
20230424 Immunological Signatures Associated With Ocrelizumab Treatment in Early RRMS: 12-Month Interim Analysis From the Ocrelizumab Phase IIIb (ENSEMBLE; NCT03085810) Immunological Substudy
Wirth T, Schulte-Mecklenbeck A, Steinberg O, et al. Presented at the American Academy of Neurology Annual Meeting in Boston, MA; April 22-27, 2023. AAN Oral presentation #S16.016.Supportive StudiesIntravenous -
20230424 Fatigue and Other Patient-Reported Outcomes in Patients With RRMS who Switched to Ocrelizumab: 4-Year Data from CASTING LIBERTO
Kister I, Benedict R, Comi G, et al. Presented at the American Academy of Neurology in Boston, MA; April 22-27, 2023. AAN Poster #P6.010.Supportive StudiesIntravenous -
20230223 Greater Baseline Disease Burden and Risk for Disability Progression in Self-Reported Non-Hispanic Black and Hispanic or Latino Individuals With Relapsing Multiple Sclerosis: Findings From OPERA I and II Trials of Ocrelizumab
Williams M, Boorgu D, Cree B, et al. Presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum in San Diego, CA; February 23-25, 2023. ACTRIMS Poster #P078.Exploratory AnalysisIntravenous -
20230223 Mass Spectrometry-Based Cerebrospinal Fluid Proteomics Identifies Novel Biomarkers of Multiple Sclerosis Disease Burden and Non-Relapsing Progressive Biology
Ramesh A, Gelfand J, Cross A, et al. Presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum in San Diego, CA; February 23-25, 2023. ACTRIMS Poster #P029.Supportive StudiesIntravenous -
20230223 Socioeconomically Disadvantaged, Black and Older Patients Have Decreased Utilization of Telehealth for Multiple Sclerosis Care
McGinley M, Harvey T, Ontaneda D, et al. Presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum in San Diego, CA; February 23-25, 2023. ACTRIMS Poster #P118.Supportive StudiesIntravenous -
20230222 Safety and patient experience with at-home infusion of ocrelizumab for multiple sclerosis
Barrera B, Simpson H, Engebretson E, et al. Ann Clin Transl Neurol. 2023;10(4):579-588.Supportive StudiesIntravenous -
20230215 Association of Higher Ocrelizumab Exposure with Reduced Disability Progression in Multiple Sclerosis
Hauser SL, Bar-Or A, Weber MS, et al. Neurol Neuroimmunol Neuroinflamm. 2023;10(2):e200094.Exploratory AnalysisIntravenous -
20220611 Ocrelizumab during pregnancy and lactation: Rationale and design of the MINORE and SOPRANINO studies in women with MS and their infants
Bove R, Hellwig K, Pasquarelli N, et al. Mult Scler Relat Disord. 2022;64:103963.Supportive StudiesIntravenous -
20220607 Ocrelizumab reduces thalamic volume loss in patients with RMS and PPMS
Arnold DL, Sprenger T, Bar-Or A, et al. Mult Scler. 2022;28(12):1927-1936.Exploratory AnalysisIntravenous -
20220218 Deformation-Based Morphometry Identifies Deep Brain Structures Protected By Ocrelizumab
Song Z, Krishnan A, Gaetano L, et al. Neuroimage Clin. 2022;34:102959.Exploratory AnalysisIntravenous -
20211214 Joint MRI T1 Unenhancing and Contrast-enhancing Multiple Sclerosis Lesion Segmentation with Deep Learning in OPERA Trials
Krishnan AP, Song Z, Clayton D, et al. Radiology. 2022;302(3):662-673.Exploratory AnalysisIntravenous -
20211125 Efficacy and Safety of Ocrelizumab in Patients with Relapsing-Remitting Multiple Sclerosis with Suboptimal Response to Prior Disease-Modifying Therapies: Primary Analysis from the Phase 3b CASTING Single-Arm, Open-Label Trial
Vermersch P, Oreja-Guevara C, Siva A, et al. Eur J Neurol. 2022;29(3):790-801.Supportive StudiesIntravenous -
20210902 Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis
Hauser SL, Kappos L, Montalban X, et al. Neurology. 2021;97(16):e1546-e1559.SafetyIntravenous -
20210812 Ocrelizumab Treatment for Relapsing-Remitting Multiple Sclerosis After a Suboptimal Response to Previous Disease-Modifying Therapy: A Nonrandomized Controlled Trial
Weinstock-Guttman B, Bermel R, Cutter G, et al. Mult Scler. 2022;28(5):790-800.Supportive StudiesIntravenous -
20210507 Efficacy and safety of ocrelizumab vs interferon beta-1a in participants of African descent with relapsing multiple sclerosis in the Phase III OPERA I and OPERA II studies
Cree BAC, Pradhan A, Pei J, et al. Mult Scler Relat Disord. 2021;52:103010.Exploratory AnalysisIntravenous -
20210506 Risk of requiring a walking aid after 6.5 years of ocrelizumab treatment in patients with relapsing multiple sclerosis: Data from the OPERA I and OPERA II trials
Giovannoni G, Kappos L, de Seze J, et al. Eur J Neurol. 2022;29(4):1238-1242.Exploratory AnalysisIntravenous -
20210501 Risk of requiring a wheelchair in primary progressive multiple sclerosis: Data from the ORATORIO trial and the MSBase registry
Butzkueven H, Spelman T, Horakova D, et al. Eur J Neurol. 2022;29(4):1082-1090.Exploratory AnalysisIntravenous -
20210223 Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial
Bermel RA, Waubant E, Pardo G, et al. Ann Clin Transl Neurol. 2021;8(3):711-715.Supportive StudiesIntravenous -
20201230 COVID-19 in ocrelizumab-treated people with multiple sclerosis
Hughes R, Whitley L, Fitovski K, et al. Mult Scler Relat Disord. 2021;49:102725.SafetyIntravenous -
20201207 Ocrelizumab in relapsing and primary progressive multiple sclerosis: pharmacokinetic and pharmacodynamic analyses of OPERA I, OPERA II and ORATORIO
Gibiansky E, Petry C, Mercier F, et al. Br J Clin Pharmacol. 2021;87(6):2511-2520.Pharmacokinetics (PK) and Pharmacodynamics (PD)Intravenous -
20201029 Long-term follow-up from the ORATORIO trial of ocrelizumab for primary progressive multiple sclerosis: a post-hoc analysis from the ongoing open-label extension of the randomised, placebo-controlled, phase 3 trial
Wolinsky JS, Arnold DL, Brochet B, et al. Lancet Neurol. 2020;19(12):998-1009.Exploratory AnalysisIntravenous -
20200924 Shorter infusion time of ocrelizumab: Results from the randomized, double-blind ENSEMBLE PLUS substudy in patients with relapsing-remitting multiple sclerosis
Hartung HP, Berger T, Bermel RA, et al. Mult Scler Relat Disord. 2020;46:102492.Supportive StudiesIntravenous -
20200818 Safety Results of Administering Ocrelizumab per a Shorter Infusion Protocol in Patients With Primary Progressive and Relapsing Multiple Sclerosis
Vollmer TL, Cohen JA, Alvarez E, et al. Mult Scler Relat Disord. 2020;46:102454.Supportive StudiesIntravenous -
20200720 Five-years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label Extension
Hauser SL, Kappos L, Arnold DL, et al. Neurology. 2020;95(13):e1854-e1867.Exploratory AnalysisIntravenous -
20200701 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(14):e1999-e2008.Supportive StudiesIntravenous -
20200608 Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials
Kappos L, Wolinsky JS, Giovannoni G, et al. JAMA Neurol. 2020;77(9):1132-1140.Exploratory AnalysisIntravenous -
20200604 Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS
Hartung HP; ENSEMBLE Steering Committee members and study investigators. Neurol Neuroimmunol Neuroinflamm. 2020;7(5):e807.Supportive StudiesIntravenous -
20200516 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.SafetyIntravenous -
20200316 An exploratory analysis of the efficacy of ocrelizumab in patients with multiple sclerosis with increased disability
Wolinsky JS, Engmann NJ, Pei J, et al. Mult Scler J Exp Transl Clin. 2020;6(1):2055217320911939.Exploratory AnalysisIntravenous -
20190828 Chronic White Matter Lesion Activity Predicts Clinical Progression in Primary Progressive Multiple Sclerosis
Elliott C, Belachew S, Wolinsky JS, et al. Brain. 2019;142(9):2787-2799.Exploratory AnalysisIntravenous -
20190228 Ocrelizumab efficacy in subgroups of patients with relapsing multiple sclerosis
Turner B, Cree BAC, Kappos L, et al. J Neurol. 2019;266(5):1182-1193.Exploratory AnalysisIntravenous -
20190128 Ocrelizumab infusion experience in patients with relapsing and primary progressive multiple sclerosis: results from the phase III randomized OPERA I, OPERA II, and ORATORIO studies
Mayer L, Kappos L, Racke MK, et al. Mult Scler Relat Disord. 2019;30:236-243.SafetyIntravenous -
20181219 Slowly expanding/evolving lesions as a magnetic resonance imaging marker of chronic active multiple sclerosis lesions
Elliott C, Wolinsky JS, Hauser SL, et al. Mult Scler. 2019;25(14):1915-1925.Exploratory AnalysisIntravenous -
20181112 Ocrelizumab reduces progression of upper extremity impairment in patients with primary progressive multiple sclerosis: Findings from the phase III randomized ORATORIO trial
Fox EJ, Markowitz C, Applebee A, et al. Mult Scler. 2018;24(14):1862-1870.Exploratory AnalysisIntravenous -
20180829 Evaluation of no evidence of progression or active disease (NEPAD) in patients with primary progressive multiple sclerosis in the ORATORIO trial
Wolinsky JS, Montalban X, Hauser SL, et al. Ann Neurol. 2018;84(4):527-536.Exploratory AnalysisIntravenous -
20180312 No evidence of disease activity (NEDA) analysis by epochs in patients with relapsing multiple sclerosis treated with ocrelizumab vs interferon beta-1a
Havrdová E, Arnold DL, Bar-Or A, et al. Mult Scler J Exp Transl Clin. 2018;4(1):2055217318760642.Exploratory AnalysisIntravenous -
20170804 Incremental net monetary benefit of ocrelizumab relative to subcutaneous interferon β-1a
Frasco MA, Shih T, Incerti D, et al. J Med Econ. 2017;20(10):1074-1082.Health Economics and Outcomes Research (HEOR)Intravenous -
20170731 Cost-Effectiveness Analysis of Ocrelizumab versus Subcutaneous Interferon Beta-1a for the Treatment of Relapsing Multiple Sclerosis
Yang H, Duchesneau E, Foster R, et al. J Med Econ. 2017;20(10):1056-1065.Health Economics and Outcomes Research (HEOR)Intravenous -
20170119 Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis
Montalban X, Hauser SL, Kappos L, et al. N Engl J Med. 2017;376(3):209-220.Pivotal Trial(s)Intravenous -
20170119 Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis
Hauser SL, Bar-Or A, Comi G, et al. N Engl J Med. 2017;376(3):221-234.Pivotal Trial(s)Intravenous
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AAAAI
American Academy of Allergy Asthma & Immunology -
AE
Adverse event -
Ang2
Angiopoietin-2 -
ARR
Annualized Relapse Rate -
ART
Assisted Reproductive Technology -
ASTCT
American Society for Transplantation and Cellular Therapy -
ATG
Anti-thymocyte globulin -
CAR
Chimeric antigen receptor -
CD3
Cluster of differentiation 3 -
CD4
Cluster of differentiation 4 -
CD8
Cluster of differentiation 8 -
CD19
Cluster of differentiation 19 -
CD20
Cluster of differentiation 20 -
CD226
Cluster of differentiation 226 -
CDC
Centers for Disease Control and Prevention -
CI
Confidence Interval -
COVID-19
Coronavirus disease of 2019 -
CPAP
Continuous positive airway pressure -
CR
Complete response -
CRP
C-reactive protein -
CRS
Cytokine release syndrome -
CT
Computed tomography -
CTCAE
Common Terminology Criteria for Adverse Events -
DIC
Disseminated intravascular coagulation -
DLBCL
Diffuse large B-cell lymphoma -
DMT
Disease-modifying therapy -
DMT
Disease-modifying treatment -
DoCR
Duration of complete response -
DoR
Duration of response -
DBPCFC
Double-blind, placebo-controlled food challenge -
ECOG PS
Eastern Cooperative Oncology Group performance status -
ECTRIMS
European Committee for Treatment and Research in Multiple Sclerosis -
EDSS
Expanded Disability Status Scale -
EMA
European Medicines Association -
FAERS
FDA Adverse Event Reporting System -
FDA
Food and Drug Administration -
FDA
US Food and Drug Administration -
FL
Follicular lymphoma -
HCP
Health Care Provider -
HGBCL
High-grade B-cell lymphoma -
HLH
Hemophagocytic lymphohistiocytosis -
ICANS
Immune effector cell-associated neurotoxicity syndrome -
ICU
Intensive care unit -
Ig
Immunoglobulin -
IgE
Immunoglobulin E -
IgG1
Immunoglobulin G1 -
INR
International normalized ratio -
IRC
Independent Review Committee -
IRR
Infusion-related reaction -
ITIM
Immunoreceptor tyrosine-based inhibitory motif -
LLN
Lower limit of normal -
LMP
last menstrual cycle -
LMP
Last menstrual period -
MAS
Macrophage activation syndrome -
MCA
Major congenital anomalies -
MHC
Major histocompatibility complex -
MS
Multiple sclerosis -
MSKCC
Memorial Sloan Kettering Cancer Center -
NK
Natural killer -
NO
Nitric oxide -
NOS
Not otherwise specified -
OB/Gyn
Obstetrics and Gynecology -
OCR
OCREVUS (ocrelizumab) -
OR
Odds ratio -
ORR
Objective response rate -
PD-1
Programmed cell death protein 1 -
PD-L1
Programmed death-ligand 1 -
PET
Positron emission tomography -
PFS
Progression-free survival -
PMBCL
Primary mediastinal B-cell lymphoma -
PML
progressive multifocal leukoencephalopathy -
PPMS
Primary progressive multiple sclerosis -
PTT
Partial thromboplastin time -
PVR
Poliovirus receptor -
RID
Relative infant dose -
RMS
Relapsing multiple sclerosis -
RRMS
Relapsing-remitting multiple sclerosis -
SAE
Serious adverse event -
T
Trimester -
TCR
T-cell receptor -
TIGIT
T cell immunoreceptor with Ig and ITIM domains -
UCSF
University of California San Francisco -
USPI
United States Prescribing Information -
URTI
Upper respiratory tract infection -
UTI
Urinary tract infection -
VWF
von Wilebrand factor -
NIH
National Institutes of Health