Optimization of treatment of patients with multiple sclerosis: benefits of using the subcutaneous form of ocrelizumab Review article
Main Article Content
Abstract
Multiple sclerosis is a chronic autoimmune disease in which B lymphocytes play a significant role in disease pathogenesis. Recognition of their involvement led to the development of anti-CD20 therapies, currently considered among the most effective treatments for multiple sclerosis. Ocrelizumab was the first anti-CD20 monoclonal antibody approved for relapsing-remitting multiple sclerosis (RRMS) and remains the only therapy with proven efficacy in primary progressive multiple sclerosis (PPMS). The efficacy of ocrelizumab was demonstrated in the OPERA I and OPERA II trials, which showed reduced relapse rates, slower disability progression, and marked suppression of MRI disease activity. Long-term observations also indicated a beneficial effect on brain volume loss. To overcome limitations associated with intravenous administration, a subcutaneous formulation of ocrelizumab was developed. The OCARINA I and OCARINA II studies demonstrated comparable clinical and radiological efficacy between subcutaneous and intravenous administration. Subcutaneous treatment was mainly associated with mild local reactions, and most patients preferred this route because of greater convenience and shorter administration time. The introduction of subcutaneous ocrelizumab may improve patient comfort and reduce the organizational burden on healthcare centres.
Article Details
Copyright ? by Medical Education. All rights reserved.
References
2. Mycko M. The mechanism of action of anti-CD20 monoclonal antibodies used in the treatment of multiple sclerosis. Aktualn Neurol. 2023; 23(3): 72-8.
3. Hauser SL, Bar-Or A, Comi G et al.; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017; 376: 221-34.
4. Hauser SL, Kappos L, Arnold DL et al. Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension. Neurology. 2020; 95(13): e1854-67.
5. Newsome SD, Goldstick L, Robertson DS, Bowen JD et al. Subcutaneous ocrelizumab in multiple sclerosis: results of the phase 1b OCARINA I study. Ann Clin Transl Neurol. 2024; 11(12): 3215-26. http://doi.org/10.1002/acn3.52229.
6. Newsome SD, Krzystanek E, Selmaj K et al. Subcutaneous ocrelizumab in patients with multiple sclerosis: results of the phase 3 OCARINA II study. Neurology. 2025; 104(9): e213574. http://doi.org/10.1212/WNL.0000000000213574.
7. Locke KW, Maneval DC, LaBarre MJ. ENHANZE® drug delivery technology: a novel approach to subcutaneous administration using recombinant human hyaluronidase PH20. Drug Deliv. 2019; 26(1): 98-106. http://doi.org/10.1080/10717544.2018.1551442.
8. Krzystanek E, Selmaj K, Rękawek B et al. Comparison of intravenous and subcutaneous administration of ocrelizumab: time and motion study. Aktualn Neurol. 2024; 24(3): 91-6. http://doi.org/10.15557/AN.2024.0014.