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ocrelizumab (Ocrevus)

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: - no increased risk of adverse pregnancy or infant outcomes [8] Dosage: - 300 mg IV once, then repeat 2 weeks later - maintenance: 600 mg IV every 6 months - FDA-approvee for subcutaneous treatment of multiple sclerosis [9] Adverse effects: - most common side - respiratory tract infections - skin infections - infusion-related reactions - laryngeal edema or pharyngeal edema - hypotension, tachycardia - urticaria, fever - may increase risk for breast cancer - progressive multifocal leukoencephalopathy (PML) [2,7] - case report of PML in 78 year old man on ocrelizumab monotherapy for MS [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

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

General

neurologic agent pharmaceutical monoclonal antibody

References

  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. 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
  3. 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: 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: 28002688 Free Article
  4. 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. 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. Melville NA 'Intriguing Changes' in Gut Bacteria After MS Treatment. Medscape. Oct 24, 2019 https://www.medscape.com/viewarticle/920373
  7. 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: 33724354 https://jamanetwork.com/journals/jamaneurology/fullarticle/2777642
  8. 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
  9. Brooks M FDA Okays Subcutaneous Ocrelizumab for MS Medscape. September 13, 2024 https://www.medscape.com/viewarticle/fda-okays-subcutaneous-ocrelizumab-ms-2024a1000gp3