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Ocrelizumab – a monoclonal antibody – in the treatment of adult patients with multiple sclerosis: a systematic review

https://doi.org/10.17749/2070-4909.2018.11.3-043-056

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Abstract

Aim: To analyze the efficacy, safety and pharmacoeconomic aspects of using ocrelizumab in adult patients with relapsing/remitting multiple sclerosis (R/R MS).

Materials and Methods. We used the commonly accepted PICo(S) questionnaire with the following specifics: the population – patients with R/R MS; the intervention – ocrelizumab; the comparators – all disease-modifying treatments for MS; the outcomes – the annualized relapse rate, confirmed disability progression, MRI results, quality-adjusted years of survival (QALYs), adverse events, and other clinical outcomes. The search for the relevant information was conducted in 2018 by using the embase, PubMed, Cochrane and eLibrary.ru databases and the «ocrelizumab» AND «multiple sclerosis» keywords. The levels of evidence and conclusiveness of the cited studies were also assessed.

Results. Treatments with ocrelizumab resulted in a lower rate of disease progression as compared with interferon β -1a. As evidenced by a randomized clinical trial, the annualized relapse rate estimated after 96 weeks was lower with ocrelizumab than that with interferon β-1a (0.16 vs. 0.29, 47% decrease, p<0.001). For most secondary end points, patients on ocrelizumab showed better outcomes than those on interferon β-1a. In the ocrelizumab group, the most common adverse events were caused by reactions to the drug infusion, nasopharyngitis, upper respiratory and urinary tract infections, and headaches. No cases of progressive multifocal leukoencephalopathy have been reported so far. ocrelizumab is more clinically effective than the first-line disease-modifying therapies; this conclusion also refers to patients with the aggressive (highly active) form of MS. ocrelizumab showed the efficacy similar to the second-line disease-modifying therapies, but it had a more favorable safety profile. The pharmacoeconomic indices showed that using ocrelizumab had a positive impact on the budget in the long-term perspective.

Conclusions. ocrelizumab can be considered as the main treatment alternative for patients with highly active MS and patients with a high risk of progressive multifocal leukoencephalopathy. However, an additional assessment of the risk caused by rare adverse events is needed. 

About the Authors

D. L. Klabukova
Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare.
Russian Federation
Klabukova Daria Leonidovna – PhD (Biology), Leading Researcher, Department of Drug Provision and Pharmacoeconomic Analysis, Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare. 12-2 Minskaya Str., Moscow 121096.


M. E. Holownia-Voloskova
Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare.
Russian Federation
Holownia-Voloskova Malwina eva – Researcher, Department of Drug Provision and Pharmacoeconomic Analysis, Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare. 12-2 Minskaya Str., Moscow 121096.


M. V. Davydovskaya
Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare; N. I. Pirogov Russian National Research Medical University, Ministry of Health of Russia.
Russian Federation

Davydovskaya Maria Vafaevna – MD, PhD, DSc, Deputy Director for Science, Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare, Russian Federation, Moscow; Professor, Department of Neurology, Neurosurgery and Medical Genetics, Pirogov Russian National Research Medical University, Ministry of Healthcare of the Russian Federation.

12-2 Minskaya Str., Moscow 121096; 1 Ostrovityanova Str., Moscow 117997.



T. N. Ermolaeva
Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare.
Russian Federation
ermolaeva Tatiana Nikolaevna – Head of the Department of Drug Provision and Pharmacoeconomic Analysis, Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare. 12-2 Minskaya Str., Moscow 121096.


K. I. Polyakova
Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare.
Russian Federation
Polyakova Kseniya Igorevna – Junior Researcher, Department of Drug Provision and Pharmacoeconomic Analysis, Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare. 12-2 Minskaya Str., Moscow 121096.


A. G. Fisun
Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare.
Russian Federation

Fisun Anna  Gennadyevna – Junior Researcher, Department of Drug Provision and Pharmacoeconomic Analysis, Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare.

12-2 Minskaya Str., Moscow 121096.



K. A. Kokushkin
Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare.
Russian Federation

Kokushkin Konstantin  Aleksandrovich – Director, Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare.

12-2 Minskaya Str., Moscow 121096.



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For citation:


Klabukova D.L., Holownia-Voloskova M.E., Davydovskaya M.V., Ermolaeva T.N., Polyakova K.I., Fisun A.G., Kokushkin K.A. Ocrelizumab – a monoclonal antibody – in the treatment of adult patients with multiple sclerosis: a systematic review. FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology. 2018;11(3):43-56. (In Russ.) https://doi.org/10.17749/2070-4909.2018.11.3-043-056

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