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Boyko A.N.

N.I. Pirogov Russian National Research Medical University (Pirogov University);
Federal Center of Brain and Neurotechnologies

Alifirova V.M.

Siberian State Medical University

Goncharova Z.A.

Rostov State Medical University

Greshnova I.V.

Regional Clinical Hospital

Zaslavsky L.G.

Pavlov First Saint Petersburg State Medical University

Kotov S.V.

Vladimirsky Moscow Regional Clinical Research Institute

Mishin G.N.

Pyatigorsk City Clinical Hospital No. 2

Parshina Ye.V.

Semashko Regional Clinical Hospital

Poverennova I.Ye.

Seredavin Samara Regional Clinical Hospital

Sivertseva S.A.

Medical and Sanitary unit «Neftyanik»

Totolyan N.A.

Academician I.P. Pavlov First Saint Petersburg State Medical University

Trinitatsky Yu.V.

Rostov Regional Clinical Hospital

Trushnikova T.N.

Wagner Perm State Medical University

Sokolova I.A.

City Clinical Hospital No. 33

Shukin I.A.

City of Moscow City Clinical Hospital No. 1

Dudin V.A.

Center for Cardiology and Neurology»

Pokhabov D.V.

Federal Siberian Scientific and Clinical Center

Krasnova M.V.

JSC «BIOCAD»

Porozova A.A.

JSC «BIOCAD»

Eremeeva A.V.

JSC BIOCAD

Linkova Yu.N.

JSC «BIOCAD»

Zinkina-Orikhan A.V.

JSC «BIOCAD»

Results of 4 years of therapy with divozilimab in patients with relapsing multiple sclerosis

Authors:

Boyko A.N., Alifirova V.M., Goncharova Z.A., Greshnova I.V., Zaslavsky L.G., Kotov S.V., Mishin G.N., Parshina Ye.V., Poverennova I.Ye., Sivertseva S.A., Totolyan N.A., Trinitatsky Yu.V., Trushnikova T.N., Sokolova I.A., Shukin I.A., Dudin V.A., Pokhabov D.V., Krasnova M.V., Porozova A.A., Eremeeva A.V., Linkova Yu.N., Zinkina-Orikhan A.V.

More about the authors

Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2025;125(7‑2): 51‑59

DOI: 10.17116/jnevro202512507251

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Table of contents

RESULTS OF 4 YEARS OF THERAPY WITH DIVOZILIMAB IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS
RESULTS OF 4 YEARS OF THERAPY WITH DIVOZILIMAB IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS

To cite this article:

Boyko AN, Alifirova VM, Goncharova ZA, et al. . Results of 4 years of therapy with divozilimab in patients with relapsing multiple sclerosis. S.S. Korsakov Journal of Neurology and Psychiatry. 2025;125(7‑2):51‑59. (In Russ.)
https://doi.org/10.17116/jnevro202512507251

Подписка 2026 Журнал неврологии и психиатрии им. С.С. Корсакова. Спецвыпуски (S.S. Korsakov Journal of Neurology and Psychiatry (special issues))
МСФ на ЯМ
Использование инфографики авторами научных работ
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Abstract:

OBJECTIVE

To assess the efficacy and safety of long-term treatment with divozilimab in patients with relapsing multiple sclerosis (MS).

MATERIAL AND METHODS

Study No. BCD-132-EXT enrolled patients with relapsing MS who had previously received divozilimab at a dose of 500 mg in a phase II and III studies. Taking into account the participation of patients in previous studies, the total treatment duration was 4 years. The efficacy assessment was carried out using parameters associated with relapses (annualized relapse rate (ARR), time to first relapse), parameters of magnetic resonance imaging of the brain, and also included evaluation of neurological deficit. Safety monitoring included evaluation of standard laboratory parameters and reporting of adverse events.

RESULTS

A total of 44 patients were enrolled in the study, of which 93.2% (41/44) patients completed 4 years of follow-up. During the BCD-132-EXT period, the proportion of relapse-free patients was 97.7%. Over the 4 years of observation, the ARR remained consistently low, with the overall ARR over 4 years of divozilimab treatment being 0.052 (95% CI 0.028; 0.097). The 6-month confirmed disability progression (CDP) during the treatment period was observed in 4.5% (n=2) of patients. Adverse reactions, most of which were mild to moderate in severity, were reported in 59.1% (n=26) of patients. The most common adverse reactions were decreased lymphocyte count, decreased white blood cell count, decreased neutrophil count, and infusion reactions.

CONCLUSION

The obtained results indicate the maintenance of efficacy over 4 years of therapy with divozilimab. The safety profile of divozilimab was favorable and consistent with previously obtained data.

Keywords:

multiple sclerosis
relapsing multiple sclerosis
anti-CD20 therapy
DMTs
divozilimab

Authors:

Boyko A.N.

N.I. Pirogov Russian National Research Medical University (Pirogov University);
Federal Center of Brain and Neurotechnologies

Alifirova V.M.

Siberian State Medical University

Goncharova Z.A.

Rostov State Medical University

Greshnova I.V.

Regional Clinical Hospital

Zaslavsky L.G.

Pavlov First Saint Petersburg State Medical University

Kotov S.V.

Vladimirsky Moscow Regional Clinical Research Institute

Mishin G.N.

Pyatigorsk City Clinical Hospital No. 2

Parshina Ye.V.

Semashko Regional Clinical Hospital

Poverennova I.Ye.

Seredavin Samara Regional Clinical Hospital

Sivertseva S.A.

Medical and Sanitary unit «Neftyanik»

Totolyan N.A.

Academician I.P. Pavlov First Saint Petersburg State Medical University

Trinitatsky Yu.V.

Rostov Regional Clinical Hospital

Trushnikova T.N.

Wagner Perm State Medical University

Sokolova I.A.

City Clinical Hospital No. 33

Shukin I.A.

City of Moscow City Clinical Hospital No. 1

Dudin V.A.

Center for Cardiology and Neurology»

Pokhabov D.V.

Federal Siberian Scientific and Clinical Center

Krasnova M.V.

JSC «BIOCAD»

Porozova A.A.

JSC «BIOCAD»

Eremeeva A.V.

JSC BIOCAD

Linkova Yu.N.

JSC «BIOCAD»

Zinkina-Orikhan A.V.

JSC «BIOCAD»

Received:

23.05.2025

Accepted:

11.06.2025

Close metadata

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