Efficacy of divozilimab in the treatment of systemic sclerosis: results of the randomized phase III clinical trial BCD-132-5/LIBERIUS
L. P. Ananyeva,
M. N. Starovoytova,
I. Z. Gaydukova,
G. V. Lukina,
E. V. Zonova,
L. V. Eliseeva,
G. F. Fatkhullina,
D. I. Abdulganieva,
D. G. Krechikova,
T. V. Kropotina,
O. B. Nesmeyanova,
I. B. Vinogradova,
E. S. Zhugrova,
L. V. Ivanova,
N. E. Nikulenkova,
O. R. Ziganshin,
T. V. Plaksina,
M. V. Zlobin,
Yu. Yu. Grabovetskaya,
N. F. Soroka,
O. B. Ershova,
T. V. Povarova,
O. N. Anoshenkova,
A. A. Lutsky,
A. V. Zinkina-Orikhan,
Yu. N. Linkova,
E. A. Fokina,
A. A. Porozova,
A. V. Eremeeva https://doi.org/10.14412/1996-7012-2025-1-44-48
Abstract
The search for new therapeutic options for the treatment of systemic sclerosis (SSc) is an urgent issue in rheumatology. The article presents the results of the double-blind, randomized, placebo-controlled phase III clinical trial BCD-132-5/LIBERIUS on the efficacy and safety of divozilimab (BCD-132) in the treatment of SSc.
Objective: to investigate the efficacy and safety of divozilimab in patients with SSc compared to placebo.
Material and methods. After enrolment in the study, patients received divozilimab or placebo for 48 weeks, after which they were switched to an open-label divozilimab therapy until week 96.
Results and discussion. Divozilimab was superior to placebo regarding the primary endpoint change in mRSS at week 48 compared to baseline, and the therapy had a positive effect on respiratory function parameters. Divozilimab treatment was well tolerated.
Conclusion. Thus, divosilimab may represent a new therapeutic option for patients with SSc.
About the Authors
L. P. Ananyeva
V.A. Nasonova Research Institute of Rheumatology
Russian Federation
Russian Federation
34A, Kashirskoe Shosse, Moscow 115522
M. N. Starovoytova
V.A. Nasonova Research Institute of Rheumatology
Russian Federation
Russian Federation
34A, Kashirskoe Shosse, Moscow 115522
I. Z. Gaydukova
Clinical Rheumatological Hospital No.25
Russian Federation
Russian Federation
30A, Bolshaya Pod’yacheskaya Street, St. Petersburg 190068
G. V. Lukina
A.S. Loginov Moscow Clinical Scientific and Practical Center of the Moscow City Health Department
Russian Federation
Russian Federation
1, Novogireevskaya Street, Moscow 111123
E. V. Zonova
Novosibirsk State Medical University, Ministry of Health of Russia
Russian Federation
Russian Federation
52, Krasny Prospect, Novosibirsk 630091
L. V. Eliseeva
Siberian State Medical University, Ministry of Health of Russia
Russian Federation
Russian Federation
2, Moskovsky Trakt, Tomsk 634050
G. F. Fatkhullina
G.G. Kuvatov Republican Clinical Hospital
Russian Federation
Russian Federation
132, Dostoevskogo Street, Ufa 450005
D. I. Abdulganieva
Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan
Russian Federation
Russian Federation
138, Orenburgsky Trakt, Kazan 420064
D. G. Krechikova
Clinical Hospital “RZhD-Medicine”
Russian Federation
Russian Federation
15, 1st Krasnoflotsky Lane, Smolensk 214025
T. V. Kropotina
Regional Clinical Hospital
Russian Federation
Russian Federation
3, Berezovaya Street, Omsk 644012
O. B. Nesmeyanova
Chelyabinsk Regional Clinical Hospital”
Russian Federation
Russian Federation
70, Vorovskogo Street, Chelyabinsk 454048
I. B. Vinogradova
Ulyanovsk Regional Clinical Hospital
Russian Federation
Russian Federation
7, III Internatzionala Street, Ulyanovsk 432017
E. S. Zhugrova
Medical and Sanitary Unit №157
Russian Federation
Russian Federation
100, Varshavskaya Street, St. Petersburg 196066
L. V. Ivanova
MEDSI-Izhevsk LLC
Russian Federation
Russian Federation
53A, Karl Marks Street, Izhevsk 426011
N. E. Nikulenkova
BioMed LLC
Russian Federation
Russian Federation
7, 1st Kollektivniy Proezd, Vladimir 600005
O. R. Ziganshin
Chelyabinsk Regional Clinical Dermatovenereological Dispensary
Russian Federation
Russian Federation
24, Yablochkina Street, Chelyabinsk 454048
T. V. Plaksina
N.A. Semashko Nizhny Novgorod Regional Clinical Hospital
Russian Federation
Russian Federation
190, Rodionova Street, Nizhny Novgorod 603093
M. V. Zlobin
N.A. Semashko Nizhny Novgorod Regional Clinical Hospital
Russian Federation
Russian Federation
190, Rodionova Street, Nizhny Novgorod 603093
Yu. Yu. Grabovetskaya
Kaliningrad Regional Clinical Hospital
Russian Federation
Russian Federation
74, Klinicheskaya Street, Kaliningrad 236016
N. F. Soroka
Minsk Scientific and Practical Center for Surgery, Transplantology and Hematology
Belarus
Belarus
8, Semashko Street, Minsk 220087
O. B. Ershova
N.V. Solovyov Clinical Hospital of Emergency Medicine
Russian Federation
Russian Federation
11, Zagorodniy Sad Street, Build. 2, Yaroslavl 150003
T. V. Povarova
Saratov Clinical Hospital “RZhD-Medicine”
Russian Federation
Russian Federation
7A, 1st Stantsionniy Proezd, Build. 2, Saratov 410004
O. N. Anoshenkova
Nebbiolo LLC
Russian Federation
Russian Federation
23, Nikolay Ostrovskogo Lane, Tomsk 634009
A. A. Lutsky
JSC BIOCAD
Russian Federation
Russian Federation
34A, Svyazi Street, Strelna, St. Petersburg, 198515
A. V. Zinkina-Orikhan
JSC BIOCAD
Russian Federation
Russian Federation
34A, Svyazi Street, Strelna, St. Petersburg, 198515
Yu. N. Linkova
JSC BIOCAD
Russian Federation
Russian Federation
34A, Svyazi Street, Strelna, St. Petersburg, 198515
E. A. Fokina
JSC BIOCAD
Russian Federation
Russian Federation
34A, Svyazi Street, Strelna, St. Petersburg, 198515
A. A. Porozova
JSC BIOCAD
Russian Federation
Russian Federation
34A, Svyazi Street, Strelna, St. Petersburg, 198515
A. V. Eremeeva
JSC BIOCAD
Russian Federation
Russian Federation
34A, Svyazi Street, Strelna, St. Petersburg, 198515
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Review
For citations:
Ananyeva LP, Starovoytova MN, Gaydukova IZ, Lukina GV, Zonova EV, Eliseeva LV, Fatkhullina GF, Abdulganieva DI, Krechikova DG, Kropotina TV, Nesmeyanova OB, Vinogradova IB, Zhugrova ES, Ivanova LV, Nikulenkova NE, Ziganshin OR, Plaksina TV, Zlobin MV, Grabovetskaya YY, Soroka NF, Ershova OB, Povarova TV, Anoshenkova ON, Lutsky AA, Zinkina-Orikhan AV, Linkova YN, Fokina EA, Porozova AA, Eremeeva AV. Efficacy of divozilimab in the treatment of systemic sclerosis: results of the randomized phase III clinical trial BCD-132-5/LIBERIUS. Sovremennaya Revmatologiya=Modern Rheumatology Journal. 2025;19(1):44-48. https://doi.org/10.14412/1996-7012-2025-1-44-48
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