3/22/2026

Janusmed sex and gender

Janusmed sex and gender – Ocrelizumab

Janusmed Sex and Gender is a knowledge database providing information on sex and gender aspects of drug treatment. The knowledge database is primarily intended to be used by physicians and healthcare professionals. The texts are general and should not be considered as treatment guidelines. The individual patient’s physician is responsible for the patient’s drug treatment.

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Ocrelizumab

Ocrelizumab

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  1. Ocrevus (ocrelizumab). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2025-02-13, cited 2026-02-11].

  2. Bove R, Chitnis T. The role of gender and sex hormones in determining the onset and outcome of multiple sclerosis. Mult Scler. 2014;20:520-6.

  3. Voskuhl RR, Gold SM. Sex-related factors in multiple sclerosis susceptibility and progression. Nat Rev Neurol. 2012;8:255-63.

  4. Johnson KM, Zhou H, Lin F, Ko JJ, Herrera V. Real-World Adherence and Persistence to Oral Disease-Modifying Therapies in Multiple Sclerosis Patients Over 1 Year. J Manag Care Spec Pharm. 2017;23:844-852.

  5. Miller DH, Leary SM. Primary-progressive multiple sclerosis. Lancet Neurol. 2007;6(10):903-12.

  6. Ocrevus (ocrelizumab). EPAR Risk management plan. European Medicines Agency (EMA) [www]. [updated 2025-12-17, cited 2026-02-13].

  7. Al-Temaimi R, AbuBaker J, Al-Khairi I, Alroughani R. Remyelination modulators in multiple sclerosis patients. Exp Mol Pathol. 2017;103(3):237-241.

  8. Gibiansky E, Petry C, Mercier F, Günther A, Herman A, Kappos L et al. Ocrelizumab in relapsing and primary progressive multiple sclerosis: Pharmacokinetic and pharmacodynamic analyses of OPERA I, OPERA II and ORATORIO. Br J Clin Pharmacol. 2021;87(6):2511-2520.

  9. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - Ocrevus (ocrelizumab). Drugs@FDA [www]. [updated 2016-09-16, cited 2026-02-13].

  10. Food and Drug Administration (FDA). Prescribing information - Ocrevus (ocrelizumab). Drugs@FDA [www]. [updated 2025-08-01, cited 2026-02-12].

  11. Turner B, Cree BAC, Kappos L, Montalban X, Papeix C, Wolinsky JS et al. Ocrelizumab efficacy in subgroups of patients with relapsing multiple sclerosis. J Neurol. 2019;266(5):1182-1193.

  12. Food and Drug Administration (FDA). Medical review - Ocrevus (okrelizumab). Drugs@FDA [www]. [updated 2016-09-12, cited 2026-02-12].

  13. Wolinsky JS, Montalban X, Hauser SL, Giovannoni G, Vermersch P, Bernasconi C et al. Evaluation of no evidence of progression or active disease (NEPAD) in patients with primary progressive multiple sclerosis in the ORATORIO trial. Ann Neurol. 2018;84(4):527-536.

  14. Zaccone T, Moiola L, Guerrieri S, Nozzolillo A, Zanetta C, Gattuso I et al. Long-term effectiveness and safety of ocrelizumab: a single-centre real-world study. J Neurol. 2025;272(7):481.

  15. Hay M, Rollot F, Casey R, Kerbrat A, Edan G, Mathey G et al. Anti-CD20 Therapies in Drug-Naive Patients With Primary Progressive Multiple Sclerosis: A Multicenter Real-Life Study. Neurology. 2024;103(8):e209886.

  16. Davies L, Shehadeh R, Watkins WJ, Jolles S, Robertson NP, Tallantyre EC. Real-world observational study of infections in people treated with ocrelizumab for multiple sclerosis. J Neurol. 2025;272(6):415.

  17. Karaman B, Dinçer G, Tunçel R, Ekmekci O, Yüceyar N. Secondary hypogammaglobulinemia and lymphocytopenia in patients with inflammatory neurological diseases on anti-CD20 therapy: risk of infection and infection-related mortality. Neurol Sci. 2025;46(9):4569-4574.

  18. Peters J, Longbrake EE. Infection risk in a real-world cohort of patients treated with long-term B-cell depletion for autoimmune neurologic disease. Mult Scler Relat Disord. 2022;68:104400.

  19. Vollmer BL, Wallach AI, Corboy JR, Dubovskaya K, Alvarez E, Kister I. Serious safety events in rituximab-treated multiple sclerosis and related disorders. Ann Clin Transl Neurol. 2020;7(9):1477-1487.

  20. Conte WL, Arndt N, Cipriani VP, Dellaria A, Javed A. Reduction in ocrelizumab-induced infusion reactions by a modified premedication protocol. Mult Scler Relat Disord. 2019;27:397-399.

  21. Hammer H, Kamber N, Pistor M, Diem L, Friedli C, Chan A et al. Ocrelizumab-related neutropenia: Effects of age, sex and bodyweight using the FDA Adverse Event Reporting System (FAERS). Mult Scler Relat Disord. 2022;65:104015.

  1. Ocrevus (ocrelizumab). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2025-02-13, cited 2026-02-11].
  2. Bove R, Chitnis T. The role of gender and sex hormones in determining the onset and outcome of multiple sclerosis. Mult Scler. 2014;20:520-6.
  3. Voskuhl RR, Gold SM. Sex-related factors in multiple sclerosis susceptibility and progression. Nat Rev Neurol. 2012;8:255-63.
  4. Johnson KM, Zhou H, Lin F, Ko JJ, Herrera V. Real-World Adherence and Persistence to Oral Disease-Modifying Therapies in Multiple Sclerosis Patients Over 1 Year. J Manag Care Spec Pharm. 2017;23:844-852.
  5. Miller DH, Leary SM. Primary-progressive multiple sclerosis. Lancet Neurol. 2007;6(10):903-12.
  6. Ocrevus (ocrelizumab). EPAR Risk management plan. European Medicines Agency (EMA) [www]. [updated 2025-12-17, cited 2026-02-13].
  7. Al-Temaimi R, AbuBaker J, Al-Khairi I, Alroughani R. Remyelination modulators in multiple sclerosis patients. Exp Mol Pathol. 2017;103(3):237-241.
  8. Gibiansky E, Petry C, Mercier F, Günther A, Herman A, Kappos L et al. Ocrelizumab in relapsing and primary progressive multiple sclerosis: Pharmacokinetic and pharmacodynamic analyses of OPERA I, OPERA II and ORATORIO. Br J Clin Pharmacol. 2021;87(6):2511-2520.
  9. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - Ocrevus (ocrelizumab). Drugs@FDA [www]. [updated 2016-09-16, cited 2026-02-13].
  10. Food and Drug Administration (FDA). Prescribing information - Ocrevus (ocrelizumab). Drugs@FDA [www]. [updated 2025-08-01, cited 2026-02-12].
  11. Turner B, Cree BAC, Kappos L, Montalban X, Papeix C, Wolinsky JS et al. Ocrelizumab efficacy in subgroups of patients with relapsing multiple sclerosis. J Neurol. 2019;266(5):1182-1193.
  12. Food and Drug Administration (FDA). Medical review - Ocrevus (okrelizumab). Drugs@FDA [www]. [updated 2016-09-12, cited 2026-02-12].
  13. Wolinsky JS, Montalban X, Hauser SL, Giovannoni G, Vermersch P, Bernasconi C et al. Evaluation of no evidence of progression or active disease (NEPAD) in patients with primary progressive multiple sclerosis in the ORATORIO trial. Ann Neurol. 2018;84(4):527-536.
  14. Zaccone T, Moiola L, Guerrieri S, Nozzolillo A, Zanetta C, Gattuso I et al. Long-term effectiveness and safety of ocrelizumab: a single-centre real-world study. J Neurol. 2025;272(7):481.
  15. Hay M, Rollot F, Casey R, Kerbrat A, Edan G, Mathey G et al. Anti-CD20 Therapies in Drug-Naive Patients With Primary Progressive Multiple Sclerosis: A Multicenter Real-Life Study. Neurology. 2024;103(8):e209886.
  16. Davies L, Shehadeh R, Watkins WJ, Jolles S, Robertson NP, Tallantyre EC. Real-world observational study of infections in people treated with ocrelizumab for multiple sclerosis. J Neurol. 2025;272(6):415.
  17. Karaman B, Dinçer G, Tunçel R, Ekmekci O, Yüceyar N. Secondary hypogammaglobulinemia and lymphocytopenia in patients with inflammatory neurological diseases on anti-CD20 therapy: risk of infection and infection-related mortality. Neurol Sci. 2025;46(9):4569-4574.
  18. Peters J, Longbrake EE. Infection risk in a real-world cohort of patients treated with long-term B-cell depletion for autoimmune neurologic disease. Mult Scler Relat Disord. 2022;68:104400.
  19. Vollmer BL, Wallach AI, Corboy JR, Dubovskaya K, Alvarez E, Kister I. Serious safety events in rituximab-treated multiple sclerosis and related disorders. Ann Clin Transl Neurol. 2020;7(9):1477-1487.
  20. Conte WL, Arndt N, Cipriani VP, Dellaria A, Javed A. Reduction in ocrelizumab-induced infusion reactions by a modified premedication protocol. Mult Scler Relat Disord. 2019;27:397-399.
  21. Hammer H, Kamber N, Pistor M, Diem L, Friedli C, Chan A et al. Ocrelizumab-related neutropenia: Effects of age, sex and bodyweight using the FDA Adverse Event Reporting System (FAERS). Mult Scler Relat Disord. 2022;65:104015.