Современная ревматология (Feb 2025)
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
Affiliations
- L. P. Ananyeva
- V.A. Nasonova Research Institute of Rheumatology
- M. N. Starovoytova
- V.A. Nasonova Research Institute of Rheumatology
- I. Z. Gaydukova
- Clinical Rheumatological Hospital No.25
- G. V. Lukina
- A.S. Loginov Moscow Clinical Scientific and Practical Center of the Moscow City Health Department
- E. V. Zonova
- Novosibirsk State Medical University, Ministry of Health of Russia
- L. V. Eliseeva
- Siberian State Medical University, Ministry of Health of Russia
- G. F. Fatkhullina
- G.G. Kuvatov Republican Clinical Hospital
- D. I. Abdulganieva
- Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan
- D. G. Krechikova
- Clinical Hospital “RZhD-Medicine”
- T. V. Kropotina
- Regional Clinical Hospital
- O. B. Nesmeyanova
- Chelyabinsk Regional Clinical Hospital”
- I. B. Vinogradova
- Ulyanovsk Regional Clinical Hospital
- E. S. Zhugrova
- Medical and Sanitary Unit №157
- L. V. Ivanova
- MEDSI-Izhevsk LLC
- N. E. Nikulenkova
- BioMed LLC
- O. R. Ziganshin
- Chelyabinsk Regional Clinical Dermatovenereological Dispensary
- T. V. Plaksina
- N.A. Semashko Nizhny Novgorod Regional Clinical Hospital
- M. V. Zlobin
- N.A. Semashko Nizhny Novgorod Regional Clinical Hospital
- Yu. Yu. Grabovetskaya
- Kaliningrad Regional Clinical Hospital
- N. F. Soroka
- Minsk Scientific and Practical Center for Surgery, Transplantology and Hematology
- O. B. Ershova
- N.V. Solovyov Clinical Hospital of Emergency Medicine
- T. V. Povarova
- Saratov Clinical Hospital “RZhD-Medicine”
- O. N. Anoshenkova
- Nebbiolo LLC
- A. A. Lutsky
- JSC BIOCAD
- A. V. Zinkina-Orikhan
- JSC BIOCAD
- Yu. N. Linkova
- JSC BIOCAD
- E. A. Fokina
- JSC BIOCAD
- A. A. Porozova
- JSC BIOCAD
- A. V. Eremeeva
- JSC BIOCAD
- DOI
- https://doi.org/10.14412/1996-7012-2025-1-44-48
- Journal volume & issue
-
Vol. 19,
no. 1
pp. 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.
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