Divozilimab reduces the risk of exacerbations in patients with neuromyelitis optica spectrum disorders
A. N. Boiko,
M. N. Zakharova,
T. O. Simaniv,
V. M. Alifirova,
E. G. Arefieva,
M. A. Barabanova,
Z. A. Goncharova,
I. V. Greshnova,
N. V. Dorogov,
V. A. Dudin,
D. S. Korobko,
S. V. Kotov,
G. N. Mishin,
E. V. Parshin,
I. E. Poverennova,
D. V. Pokhabov,
V. M. Lebedev,
I. V. Smagina,
N. N. Spirin,
S. A. Sivertseva,
N. A. Totolyan,
D. F. Khairutdinova,
T. N. Trushnikova,
L. G. Zaslavsky,
K. Z. Bakhtiyarova,
E. V. Prazdnichkova,
F. A. Khabirov,
A. G. Bunyak,
R. E. Yakubtsevich,
D. G. Tolkacheva,
K. V. Sapozhnikov,
O. N. Mironenko,
A. A. Lazarev,
V. D. Batorova,
M. V. Krasnova,
A. A. Porozova,
A. V. Eremeeva,
Yu. N. Linkova,
A. V. Zinkina-Orikhan https://doi.org/10.14412/2074-2711-2025-4-16-25
Abstract
Objective: the aim of the AQUARELLE trial was to evaluate the efficacy of divozilimab compared with a historical control (placebo) and to characterise its safety in patients with neuromyelitis optica spectrum disorder (NMOSD).
Material and methods. The AQUARELLE clinical trial population included patients aged 18 years and older with a diagnosis of NMOSD established in accordance with the international consensus diagnostic criteria for NMOSD (2015). The primary efficacy endpoint was the mean annual rate of confirmed exacerbations (MAR) over 6 months of treatment with divozilimab compared with a historical control, which was the placebo from the N-MOmentum study.
Results. A total of 105 patients received treatment with the investigational drug divozilimab. At the time of analysis, the proportion of patients without confirmed exacerbations was 94.3% (99/105); the ARR was 0.124 (95% CI 0.056–0.276). The ARR ratio for divozilimab /historical placebo was 0.172 (90% CI 0,083–0,359), indicating the superiority of divozilimab compared to historical placebo over 6 months of therapy. During divozilimab therapy, a therapy-related decrease in lymphocyte count was reported in 16 (15.2%) patients, and infusion reactions were reported in 6 (5.7%) patients. The overall incidence of therapy-related infectious events was 6 cases (5.7%).
Conclusion. Within patients with NMOSD, the use of divozilimab reduces the risk of exacerbations. The good tolerability of the drug allows divozilimab to be recommended as a new therapeutic option for patients with NMOSD.
Supporting agencies: The article is sponsored by Biocad
About the Authors
A. N. Boiko
N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia; Federal Center for Brain and Neurotechnologies, FMBA of Russia
Russian Federation
Competing Interests:
Russian Federation
Alexey Nikolaevich Boyko
1, Ostrovityanova St., Moscow 117997; 1, Ostrovityanova St., Build. 10, Moscow 117997
Competing Interests:
The conflict of interests did not affect the results of the study
M. N. Zakharova
Russian Center of Neurology and Neurosciences
Russian Federation
Competing Interests:
Russian Federation
80, Volokolamskoe Sh., Moscow 125367
Competing Interests:
The conflict of interests did not affect the results of the study
T. O. Simaniv
Russian Center of Neurology and Neurosciences
Russian Federation
Competing Interests:
Russian Federation
80, Volokolamskoe Sh., Moscow 125367
Competing Interests:
The conflict of interests did not affect the results of the study
V. M. Alifirova
Siberian State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
2, Moskovskiy High Road, Tomsk 634050
Competing Interests:
The conflict of interests did not affect the results of the study
E. G. Arefieva
Kuzbass Regional Clinical Hospital named after S.V. Belyaev
Russian Federation
Competing Interests:
Russian Federation
22, Oktyabrskiy Prosp., Kemerovo 650066
Competing Interests:
The conflict of interests did not affect the results of the study
M. A. Barabanova
Research Institute – S.V. Ochapovsky Regional Clinical Hospital No. 1
Russian Federation
Competing Interests:
Russian Federation
167, 1 Maya St., Krasnodar 350086
Competing Interests:
The conflict of interests did not affect the results of the study
Z. A. Goncharova
Rostov State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
729, Nakhichevanskiy Lane, Rostov-on-Don 344022
Competing Interests:
The conflict of interests did not affect the results of the study
I. V. Greshnova
Ulyanovsk Regional Clinical Hospital
Russian Federation
Competing Interests:
Russian Federation
7, Tret’ego Internationala St., Ulyanovsk 432017
Competing Interests:
The conflict of interests did not affect the results of the study
N. V. Dorogov
Republican Clinical Hospital No. 4
Russian Federation
Competing Interests:
Russian Federation
32, Ulyanova St., Saransk 430032
Competing Interests:
The conflict of interests did not affect the results of the study
V. A. Dudin
Kirov Center of Cardiology and Neurology
Russian Federation
Competing Interests:
Russian Federation
1041, Ivana Popova St., Kirov 610014
Competing Interests:
The conflict of interests did not affect the results of the study
D. S. Korobko
Novosibirsk Regional Clinical Hospital
Russian Federation
Competing Interests:
Russian Federation
130, Nemirovicha-Danchenko St., Novosibirsk 630087
Competing Interests:
The conflict of interests did not affect the results of the study
S. V. Kotov
M.F. Vladimirsky Moscow Regional Research and Clinical Institute
Russian Federation
Competing Interests:
Russian Federation
61/2, Shchepkina St., Moscow 129110
Competing Interests:
The conflict of interests did not affect the results of the study
G. N. Mishin
Pyatigorsk Regional Clinical Hospital No. 2
Russian Federation
Competing Interests:
Russian Federation
6, Admiralskogo St., Pyatigorsk 357500
Competing Interests:
The conflict of interests did not affect the results of the study
E. V. Parshin
Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko
Russian Federation
Competing Interests:
Russian Federation
190, Rodionova St., Nizhny Novgorod 603093
Competing Interests:
The conflict of interests did not affect the results of the study
I. E. Poverennova
Samara Regional Clinical Hospital named after V.D. Seredavin
Russian Federation
Competing Interests:
Russian Federation
159, Tashkentskaya St., Samara 443095
Competing Interests:
The conflict of interests did not affect the results of the study
D. V. Pokhabov
Federal Siberian Scientific and Clinical Centre of the FMBA of Russia
Russian Federation
Competing Interests:
Russian Federation
26, Kolomenskaya St., Krasnoyarsk 660037
Competing Interests:
The conflict of interests did not affect the results of the study
V. M. Lebedev
N.P. Bekhtereva Institute of the Human Brain, Russian Academy of Sciences
Russian Federation
Competing Interests:
Russian Federation
12A, Akademika Pavlova St., St. Petersburg 197022
Competing Interests:
The conflict of interests did not affect the results of the study
I. V. Smagina
PROFIMED LLC
Russian Federation
Competing Interests:
Russian Federation
88, Nikitina St., Barnaul 656043
Competing Interests:
The conflict of interests did not affect the results of the study
N. N. Spirin
Clinical Hospital No. 2
Russian Federation
Competing Interests:
Russian Federation
24, Popova St., Yaroslavl 150010
Competing Interests:
The conflict of interests did not affect the results of the study
S. A. Sivertseva
JSC Medical Sanitary Unit “Neftyanik”
Russian Federation
Competing Interests:
Russian Federation
8/1, Yuriya Semovskih St., Tyumen 625000
Competing Interests:
The conflict of interests did not affect the results of the study
N. A. Totolyan
Acad. I.P. Pavlov First Saint Petersburg State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
6–8, L’va Tolstogo St., St. Petersburg 197022
Competing Interests:
The conflict of interests did not affect the results of the study
D. F. Khairutdinova
Chelyabinsk Order of the Red Banner of Labour City Clinical Hospital No. 1
Russian Federation
Competing Interests:
Russian Federation
16, Vorovskogo St., Chelyabinsk 454092
Competing Interests:
The conflict of interests did not affect the results of the study
T. N. Trushnikova
Order of the Badge of Honour Perm Regional Clinical Hospital
Russian Federation
Competing Interests:
Russian Federation
85, Pushkina St., Perm 614990
Competing Interests:
The conflict of interests did not affect the results of the study
L. G. Zaslavsky
Leningrad Regional Clinical Hospital
Russian Federation
Competing Interests:
Russian Federation
45, Lunacharskogo Prosp., Build. 2, St. Petersburg 194291
Competing Interests:
The conflict of interests did not affect the results of the study
K. Z. Bakhtiyarova
Republican Clinical Hospital named after G.G. Kuvatov
Russian Federation
Competing Interests:
Russian Federation
132, Dostoevskogo St., Ufa 450005
Competing Interests:
The conflict of interests did not affect the results of the study
E. V. Prazdnichkova
Sverdlovsk State Regional Clinical Hospital No. 1
Russian Federation
Competing Interests:
Russian Federation
185, Volgogradskaya St., Yekaterinburg 620102
Competing Interests:
The conflict of interests did not affect the results of the study
F. A. Khabirov
Republican Clinical Neurological Centre
Russian Federation
Competing Interests:
Russian Federation
13, Vatutina St., Kazan 420021
Competing Interests:
The conflict of interests did not affect the results of the study
A. G. Bunyak
Republican Scientific and Practical Centre for Neurology and Neurosurgery
Belarus
Competing Interests:
Belarus
24, F. Skoriny St., Minsk 220114
Competing Interests:
The conflict of interests did not affect the results of the study
R. E. Yakubtsevich
Grodno University Clinic
Belarus
Competing Interests:
Belarus
52, Leninskogo Komsomola Boulev., Grodno 230030
Competing Interests:
The conflict of interests did not affect the results of the study
D. G. Tolkacheva
Russian Presidential Academy of National Economy and Public Administration
Russian Federation
Competing Interests:
Russian Federation
57/43, Sredny Prosp. Vasil’evskogo Ostrova, St. Petersburg 199178
Competing Interests:
The conflict of interests did not affect the results of the study
K. V. Sapozhnikov
S.M. Kirov Military Medical Academy, Ministry of Defence of Russia
Russian Federation
Competing Interests:
Russian Federation
6Zh, Akademika Lebedeva St., St. Petersburg 194044
Competing Interests:
The conflict of interests did not affect the results of the study
O. N. Mironenko
Bonch-Bruevich Saint Petersburg State University of Telecommunications
Russian Federation
Competing Interests:
Russian Federation
22, Bolshevikov Prosp., Build. 1, Letter A, St. Petersburg 193232
Competing Interests:
The conflict of interests did not affect the results of the study
A. A. Lazarev
Bonch-Bruevich Saint Petersburg State University of Telecommunications
Russian Federation
Competing Interests:
Russian Federation
22, Bolshevikov Prosp., Build. 1, Letter A, St. Petersburg 193232
Competing Interests:
The conflict of interests did not affect the results of the study
V. D. Batorova
Russian Presidential Academy of National Economy and Public Administration
Russian Federation
Competing Interests:
Russian Federation
57/43, Sredny Prosp. Vasil’evskogo Ostrova, St. Petersburg 199178
Competing Interests:
The conflict of interests did not affect the results of the study
M. V. Krasnova
Bonch-Bruevich Saint Petersburg State University of Telecommunications
Russian Federation
Competing Interests:
Russian Federation
17, Italianskaya St., Letter A, St. Petersburg 191186
Competing Interests:
The conflict of interests did not affect the results of the study
A. A. Porozova
Bonch-Bruevich Saint Petersburg State University of Telecommunications
Russian Federation
Competing Interests:
Russian Federation
17, Italianskaya St., Letter A, St. Petersburg 191186
Competing Interests:
The conflict of interests did not affect the results of the study
A. V. Eremeeva
Bonch-Bruevich Saint Petersburg State University of Telecommunications
Russian Federation
Competing Interests:
Russian Federation
17, Italianskaya St., Letter A, St. Petersburg 191186
Competing Interests:
The conflict of interests did not affect the results of the study
Yu. N. Linkova
Bonch-Bruevich Saint Petersburg State University of Telecommunications
Russian Federation
Competing Interests:
Russian Federation
17, Italianskaya St., Letter A, St. Petersburg 191186
Competing Interests:
The conflict of interests did not affect the results of the study
A. V. Zinkina-Orikhan
Bonch-Bruevich Saint Petersburg State University of Telecommunications
Russian Federation
Competing Interests:
Russian Federation
17, Italianskaya St., Letter A, St. Petersburg 191186
Competing Interests:
The conflict of interests did not affect the results of the study
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Review
For citations:
Boiko AN, Zakharova MN, Simaniv TO, Alifirova VM, Arefieva EG, Barabanova MA, Goncharova ZA, Greshnova IV, Dorogov NV, Dudin VA, Korobko DS, Kotov SV, Mishin GN, Parshin EV, Poverennova IE, Pokhabov DV, Lebedev VM, Smagina IV, Spirin NN, Sivertseva SA, Totolyan NA, Khairutdinova DF, Trushnikova TN, Zaslavsky LG, Bakhtiyarova KZ, Prazdnichkova EV, Khabirov FA, Bunyak AG, Yakubtsevich RE, Tolkacheva DG, Sapozhnikov KV, Mironenko ON, Lazarev AA, Batorova VD, Krasnova MV, Porozova AA, Eremeeva AV, Linkova YN, Zinkina-Orikhan AV. Divozilimab reduces the risk of exacerbations in patients with neuromyelitis optica spectrum disorders. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2025;17(4):16-25. (In Russ.) https://doi.org/10.14412/2074-2711-2025-4-16-25
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