Divozilimab in neuromyelitis optica spectrum disorders: Evidence-based consensus of Russian committees of experts and clinical potential
V. S. Krasnov,
Ya. V. Vlasov,
E. Р. Evdoshenko,
D. S. Korobko,
V. М. Lebedev,
I. G. Lukashevich,
A. I. Nilov,
E. S. Novikova,
E. V. Popova,
K. V. Sapozhnikov,
A. А. Sokolova,
N. А. Totolyan,
N. V. Khachanova,
M. V. Shumilina,
T. I. Yakushina,
M. V. Davydovskaya https://doi.org/10.21518/ms2026-249
Abstract
Neuromyelitis optica spectrum disorders (NMOSD) are a group of inflammatory diseases of the central nervous system. B-lymphocytes play leading role in their pathogenesis in most cases. СD20 surface antigen is one of the B-lymphocytes makers. There is extensive world experience with chimeric monoclonal anti-CD20 antibody rituximab off-label using for NMOSD exacerbations prevention. It has been included in published international and Russian algorithms for NMOSD treatment along with other approved medications. Divozilimab is recombinant humanized anti-CD20 monoclonal antibody with a modified glycosylation pattern of Fc-fragment which is approved in Russian Federation for the treatment of multiple sclerosis, systemic scleroderma and also for NMOSD (September 2025). The publication is intended to present the results of the Russian Expert Councils work in September 2025 and February 2026. According to the analysis of publications on anti-CD20 NMOSD therapy, the 6-month results of divozilimab study BCD-132-6/AQUARELLE (NCT05730699) and data of additional subanalysis experts agreed the profiles of NMOSD patients for divozilimab therapy, time to full therapeutic effect and monitoring plan during treatment with divozilimab. Experts supplemented the algorithm for initial prescription and switching of medications for prevention of NMOSD attacks in patients with AQP4-IgG aged 18 years and older, agreed on the algorithm for the administration of medications for prevention of NMOSD attack in patients without AQP4-IgG aged 18 years and older, determined positions of divozilimab in both algorithms. According to experts opinion divozilimab appears as promising treatment option in NMOSD. Analysis of divozilimab effectiveness and safety long-term results in BCD-132-6/AQUARELLE study and real-world practice will be important steps toward clarifying and potentially extending patient profiles.
About the Authors
V. S. Krasnov
Pavlov First Saint Petersburg State Medical University
Russian Federation
Russian Federation
Vladimir S. Krasnov - Cand. Sci. (Med.), Associate Professor, Associate Professor of the Neurology Department.
6–8, Lev Tolstoy St., St Petersburg, 197022
Ya. V. Vlasov
Samara State Medical University
Russian Federation
Russian Federation
Yan V. Vlasov - Dr. Sci. (Med.), Associate Professor, Professor of the Neurology and Neurosurgery Department.
89, Chapaevskaya St., Samara 443099
E. Р. Evdoshenko
City Clinical Hospital No. 31
Russian Federation
Russian Federation
Evgeniy P. Evdoshenko - Cand. Sci. (Med.), Director of the City Center for Multiple Sclerosis.
3, Dinamo Ave., St Petersburg, 197110
D. S. Korobko
Novosibirsk State Regional Clinical Hospital; Novosibirsk State Medical University
Russian Federation
Russian Federation
Denis S. Korobko - Cand. Sci. (Med.), Head of Center, Neurologist of the Regional Center for Multiple Sclerosis and Other Autoimmune Diseases of the Nervous System, Novosibirsk SRCH; Associate of the Neurology Department, Novosibirsk SMU.
130, Nemirovich-Danchenko St., Novosibirsk, 630087; 52, Krasny Аve., Novosibirsk, 630091
V. М. Lebedev
Bechtereva Institute of the Human Brain of the Russian Academy of Sciences
Russian Federation
Russian Federation
Valeriy M. Lebedev - Head of the Department of Neurology, Junior Research Fellow.
9, Akademik Pavlov St., St Petersburg, 197022
I. G. Lukashevich
Chelyabinsk City Clinical Hospital No. 1
Russian Federation
Russian Federation
Irina G. Lukashevich - Head of the Neurological Service.
16, Vorovskiy St., Chelyabinsk, 454092
A. I. Nilov
Samara Regional Clinical Hospital named after V.D. Seredavin
Russian Federation
Russian Federation
Aleksej I. Nilov - Neurologist, Head of the Consultative and Diagnostic Department of Neurology.
159, Tashkentskaya St., Samara, 443095
E. S. Novikova
Moscow Regional Research and Clinical Institute (“MONIKI”)
Russian Federation
Russian Federation
Ekaterina S. Novikova - Neurologist of the Orphan Diseases Department of the Clinical Diagnostic Center, Junior Research Scientist.
61/2, Schepkin St., Moscow, 129110
E. V. Popova
City Clinical Hospital No. 24
Russian Federation
Russian Federation
Ekaterina V. Popova - Dr. Sci. (Med.), Director of the Interdistrict Department of Multiple Sclerosis.
10, Pistcovaya St., Moscow, 127015
K. V. Sapozhnikov
Kirov Military Medical Academy
Russian Federation
Russian Federation
Kirill V. Sapozhnikov - Cand. Sci. (Med.), Lecturer of the Department of Automation of Medical Service Management with Military Medical Statistics.
6, Akademik Lebedev St., St Petersburg, 194044
A. А. Sokolova
Khanty-Mansiysk State Medical Academy; District Clinical Hospital
Russian Federation
Russian Federation
Azaliya А. Sokolova - Cand. Sci. (Med.), Associate Professor Department of the Hospital Therapy, Khanty-Mansiysk State Medical Academy; Neurologist, Head of the District Center for Multiple Sclerosis, District CH.
40, Mira St., Khanty-Mansiysk, 628011; 40, Kalinin St., Khanty-Mansiysk, 628012
N. А. Totolyan
Pavlov First Saint Petersburg State Medical University
Russian Federation
Russian Federation
Natalia A. Totolyan - Dr. Sci. (Med.), Professor, Professor of the Neurology Department.
6–8, Lev Tolstoy St., St Petersburg, 197022
N. V. Khachanova
City Clinical Hospital No. 24; Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Natalia V. Khachanova - Cand. Sci. (Med.), Professor of the Department of Neurology, Neurosurgery and Medical Genetics, Pirogov Russian National Research Medical University; Neurologist of the Interdistrict Department of Multiple Sclerosis, City Clinical Hospital No. 24.
1, Ostrovityanov St., Moscow, 117513; 10, Pistcovaya St., Moscow, 127015
M. V. Shumilina
Pavlov First Saint Petersburg State Medical University; City Clinical Hospital No. 31
Russian Federation
Russian Federation
Maria V. Shumilina - Cand. Sci. (Med.), Head of the Оutpatient Department of the City Center for Multiple Sclerosis, CCH No. 31; Associate Professor of the Neurology Department, Pavlov First Saint Petersburg SMU
3, Dynamo Ave., St Petersburg, 197110; 6–8, Lev Tolstoy St., St Petersburg, 197022
T. I. Yakushina
Moscow Regional Research and Clinical Institute (“MONIKI”)
Russian Federation
Russian Federation
Tatiana I. Yakushina - Dr. Sci. (Med.), Professor of the Department of Neurology, Senior Researcher of the Neurological Department, Neurologist of the Center for Multiple Sclerosis.
61/2, Schepkin St., Moscow, 129110
M. V. Davydovskaya
City Clinical Hospital No. 24
Russian Federation
Russian Federation
Maria V. Davydovskaya - Dr. Sci. (Med.), Neurologist of the Interdistrict Department of Multiple Sclerosis.
10, Pistcovaya St., Moscow 127015
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For citations:
Krasnov VS, Vlasov YV, Evdoshenko EР, Korobko DS, Lebedev VМ, Lukashevich IG, Nilov AI, Novikova ES, Popova EV, Sapozhnikov KV, Sokolova AА, Totolyan NА, Khachanova NV, Shumilina MV, Yakushina TI, Davydovskaya MV. Divozilimab in neuromyelitis optica spectrum disorders: Evidence-based consensus of Russian committees of experts and clinical potential. Meditsinskiy sovet = Medical Council. 2026;(12):124-136. (In Russ.) https://doi.org/10.21518/ms2026-249
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