Targeted therapy of multiple sclerosis: real-world experience with divozilimab

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Abstract

Introduction. Anti-B-cell therapy that prevents clonal expansion of B cells expressing CD20 is a significant achievement in the pharmacotherapy of multiple sclerosis (MS). Randomized studies have shown high efficacy of monoclonal antibodies (mAb), confirmed by a reduction in the annualized relapse rate (ARR), MRI activity, and the risk of disability progression. Divozilimab (DIV) is a humanized afucosylated anti-CD20 mAb with a modified Fc fragment that provides high effector activity.

The aim is to evaluate the efficacy and safety of DIV in patients with various MS phenotypes in real-world clinical practice.

Materials and methods. The prospective study included 43 patients: 24 with rapidly progressive MS, 9 with highly active MS, and 10 with secondary progressive MS with relapses. All received DIV therapy for 6–12 months. We assessed ARR, MRI activity (lesions with contrast enhancement (T1-Gd+), new/enlarged T2 lesions), changes in the Expanded Disability Status Scale (EDSS), CD19+ B-cell levels, and the safety profile. Data were analyzed before therapy, at 6 months, and at 12 months of treatment.

Results. Over 12 months of therapy, ARR decreased from 1.3 to 0.03; the proportion of patients without T1-Gd+ lesions increased from 27.9% to 100%, and new T2 lesions were detected in 6.1%. The median EDSS decreased from 3.0 [2.0; 3.5] to 2.5 [2.0; 3.0]. Profound depletion of CD19+ B cells was noted (0% [0.0; 0.2]); NEDA-3 (No Evidence of Disease Activity-3) status was achieved in 84.9%. Adverse events were limited to mild/moderate infusion reactions (30.2% at the first infusion), and no serious adverse events were recorded.

Conclusion. DIV provides rapid and sustained suppression of clinical and MRI activity in MS with pronounced B-cell depletion and a favorable safety profile, justifying its early use in patients with high disease activity.

About the authors

Daria D. Eliseeva

Russian Center of Neurology and Neurosciences

Author for correspondence.
Email: eliseeva@neurology.ru
ORCID iD: 0000-0003-2173-927X
SPIN-code: 3171-0030
https://orcid.org/0000-0003-2173-927X

Cand. Sci. (Med.), senior researcher, 6th Neurological department, Institute of Clinical and Preventive Neurology

Russian Federation, Moscow

Ekaterina V. Baydina

Russian Center of Neurology and Neurosciences

Email: eliseeva@neurology.ru
ORCID iD: 0000-0001-5911-5855

Cand. Sci. (Med.), Chief Physician

Russian Federation, Moscow

Taras O. Simaniv

Russian Center of Neurology and Neurosciences

Email: eliseeva@neurology.ru
ORCID iD: 0000-0001-7256-2668

Cand. Sci. (Med.), senior researcher, 6th Neurological department, Institute of Clinical and Preventive Neurology

Russian Federation, Moscow

Lola Sh. Askarova

Russian Center of Neurology and Neurosciences

Email: eliseeva@neurology.ru
ORCID iD: 0000-0003-1606-7245

Cand. Sci. (Med.), senior researcher, 6th Neurological department, Institute of Clinical and Preventive Neurology

Russian Federation, Moscow

Julia E. Korzhova

Russian Center of Neurology and Neurosciences

Email: eliseeva@neurology.ru
ORCID iD: 0000-0003-1315-7587

Cand. Sci. (Med.), researcher, 6th Neurological department, Institute of Clinical and Preventive Neurology

Russian Federation, Moscow

Inessa V. Zakroyshchikova

Russian Center of Neurology and Neurosciences

Email: eliseeva@neurology.ru
ORCID iD: 0000-0002-2325-2302

Cand. Sci. (Med.), researcher, 6th Neurological department, Institute of Clinical and Preventive Neurology

Russian Federation, Moscow

Ivan A. Kochergin

Russian Center of Neurology and Neurosciences

Email: eliseeva@neurology.ru
ORCID iD: 0000-0002-1785-4075

neurologist, Consultative and diagnostic department

Russian Federation, Moscow

Oksana E. Panova

Russian Center of Neurology and Neurosciences

Email: eliseeva@neurology.ru
ORCID iD: 0009-0001-5088-5455

Cand. Sci. (Med.), neurologist, Head, Laboratory of clinical research

Russian Federation, Moscow

Ekaterina O. Chekanova

Russian Center of Neurology and Neurosciences

Email: eliseeva@neurology.ru
ORCID iD: 0000-0001-5442-0877

Cand. Sci. (Med.), researcher, 6th Neurological department, Institute of Clinical and Preventive Neurology

Russian Federation, Moscow

Denis V. Shevchuk

Russian Center of Neurology and Neurosciences

Email: eliseeva@neurology.ru
ORCID iD: 0009-0002-1334-9730

neurologist, 6th Neurological department, Institute of Clinical and Preventive Neurology

Russian Federation, Moscow

Aleksandra O. Kozlova

Russian Center of Neurology and Neurosciences

Email: eliseeva@neurology.ru
ORCID iD: 0000-0002-2992-0199

neurologist, 6th Neurological department, Institute of Clinical and Preventive Neurology

Russian Federation, Moscow

Dmitry A. Ganin

Russian Center of Neurology and Neurosciences

Email: eliseeva@neurology.ru
ORCID iD: 0009-0000-6332-1061

neurologist, 6th Neurological department, Institute of Clinical and Preventive Neurology

Russian Federation, Moscow

Kirill V. Sapozhnikov

S.M. Kirov Military Medical Academy

Email: eliseeva@neurology.ru
ORCID iD: 0000-0002-2476-7666

Cand. Sci. (Med.), lecturer, Department of medical service automation with military medical statistics

Russian Federation, St. Petersburg

Mariya N. Zakharova

Russian Center of Neurology and Neurosciences

Email: eliseeva@neurology.ru
ORCID iD: 0000-0002-1072-9968

Dr. Sci. (Med.), Professor, chief researcher, Head, 6th Neurology department, Institute of Clinical and Preventive Neurology

Russian Federation, Moscow

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Copyright (c) 2025 Eliseeva D.D., Baydina E.V., Simaniv T.O., Askarova L.S., Korzhova J.E., Zakroyshchikova I.V., Kochergin I.A., Panova O.E., Chekanova E.O., Shevchuk D.V., Kozlova A.O., Ganin D.A., Sapozhnikov K.V., Zakharova M.N.

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