ocrelizumab (Ocrevus)
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Indications
- multiple sclerosis in adults*
- primary progressive multiple sclerosis
- relapsing multiple sclerosis[4]
*FDA-approved March 2017
Contraindications
- hepatitis B infection
- delay treatment if active infection
- vaccination with live virus vaccines is not advisable[1]
Pregnancy:
Dosage
Adverse effects
- most common side
- infusion-related reactions
- may increase risk for breast cancer
- progressive multifocal leukoencephalopathy (PML)[2][7]
- reduced humoral vaccine response[5]
Mechanism of action
- depletes B cells via binding by CD20
- changes in gut bacteria occur[6]
- reduces high IgA coating index for butyrate-producing Lachnospiraceae family noted in patients with multiple sclerosis[6]
Notes
- list price: $65,000/year (2017) - Genentech, Inc
* relative to high-dose interferon:
- 47% reduction in relapse rate
- 40% reduction in worsening disability
- >95% reduction in new lesions after 3 months
* 33% worsening disability at 3 months vs 39% with placebo
More general terms
References
- ↑ 1.0 1.1 Young K, Sadoughi S, Saitz R. FDA Approves Ocrelizumab for Severe MS Physician's First Watch, March 30, 2017 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
FDA News Release. March 29, 2017 FDA approves new drug to treat multiple sclerosis. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549325.htm
Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871
U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm - ↑ 2.0 2.1 Fiore K. Genentech Reports PML Case with Ocrelizumab - Occurred in patient transitioning from natalizumab. MedPage Today May 24, 2017 https://www.medpagetoday.com/Neurology/MultipleSclerosis/65537
- ↑ Hauser SL, Bar-Or A, Comi G et al Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. Epub 2016 Dec 21. PMID: https://www.ncbi.nlm.nih.gov/pubmed/28002679 Free Article
Montalban X, Hauser SL, Kappos L et al Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. Epub 2016 Dec 21. PMID: https://www.ncbi.nlm.nih.gov/pubmed/28002688 Free Article - ↑ 4.0 4.1 Boyles S MRI Improvements in MS with Switch from IFN to Ocrelizumab. Rapid and robust reduction in activity. MedPage Today. June 4, 2018 https://www.medpagetoday.com/meetingcoverage/cmsc/73267
Troboulsee A, et al Brain MRI activity and atrophy in ocrelizumab-treated relapsing multiple sclerosis patients in the open-label extension of the pooled OPERA trials. Consortium of Multiple Sclerosis Centers (CMSC) 2018; Abstract #DX45. - ↑ 5.0 5.1 Boyles S Biologic for MS Linked to Reduced Vaccine Response. Ocrelizumab treatment associated with decreased humoral response. MedPage Today. June 4, 2018 https://www.medpagetoday.com/meetingcoverage/cmsc/73225
- ↑ 6.0 6.1 6.2 Melville NA 'Intriguing Changes' in Gut Bacteria After MS Treatment. Medscape. Oct 24, 2019 https://www.medscape.com/viewarticle/920373
- ↑ 7.0 7.1 7.2 George J PML Reported in Ocrelizumab-Treated MS Patient. Case raises questions about treatments for older people with multiple sclerosis. MedPage Today March 16, 2021 https://www.medpagetoday.com/neurology/multiplesclerosis/91647
Patel A, Sul J, Gordon ML et al Progressive Multifocal Leukoencephalopathy in a Patient With Progressive Multiple Sclerosis Treated With Ocrelizumab Monotherapy. JAMA Neurol. Published online March 16, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33724354 https://jamanetwork.com/journals/jamaneurology/fullarticle/2777642 - ↑ 8.0 8.1 George J No Excess Pregnancy, Infant Risks With Ocrelizumab for MS. Major congenital anomalies, other adverse outcomes were rare. MedPage Today October 28, 2022 https://www.medpagetoday.com/meetingcoverage/ectrims/101491