[Efficacy and safety of antiCD20 monoclonal antibody divozilimab during 48-week treatment of multiple sclerosis patients in randomized double-blind placebo-controlled clinical trial BCD-132-4/MIRANTIBUS].

Autor:	Boyko AN; Pirogov Russian National Research Medical University, Moscow, Russia.; Federal Center of Brain and Neurotechnologies of the Federal Medical Biological Agency, Moscow, Russia., Alifirova VM; Siberian State Medical University, Tomsk, Russia., Lukashevich IG; City Clinical Hospital No. 1, Chelyabinsk, Russia., Goncharova ZA; Rostov State Medical University, Rostov-on-Don, Russia., Greshnova IV; Ulyanovsk Regional Clinical Hospital, Ulyanovsk, Russia., Zaslavsky LG; Leningrad Regional Clinical Hospital, St. Petersburg, Russia., Kotov SV; Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia., Malkova NA; State Novosibirsk Regional Clinical Hospital, Novosibirsk, Russia., Mishin GN; Pyatigorsk City Clinical Hospital No. 2, Pyatigorsk, Russia., Parshina EV; Semashko Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod, Russia., Poverennova IY; Seredavin Samara Regional Clinical Hospital, Samara, Russia., Prakhova LN; N. Bechtereva Institute of the Human Brain, St. Petersburg, Russia., Sivertseva SA; Medical and Sanitary unit «Neftyanik», Tyumen, Russia., Smagina IV; Regional Clinical Hospital, Barnaul, Russia., Totolyan NA; Pavlov First Saint Petersburg State Medical University, St. Petersburg, Russia., Trinitatsky YV; Rostov Regional Clinical Hospital, Rostov-on-Don, Russia., Trushnikova TN; Wagner Perm State Medical University, Perm, Russia., Khabirov FA; Republican Clinical Nerological Center, Kazan, Russia., Chefranova JY; Belgorod Regional Clinical Hospital of St. Joasaph, Belgogrod, Russia., Shchur SG; Municipal Filatov Clinical Hospital No. 15, Moscow, Russia., Dudin VA; Center for Cardiology and Neurology», Kirov, Russia., Pokhabov DV; Federal Siberian Scientific and Clinical Center, Krasnoyarsk, Russia., Bolsun DD; JSC BIOCAD, St. Petersburg, Russia., Eremeeva AV; JSC BIOCAD, St. Petersburg, Russia., Linkova YN; JSC BIOCAD, St. Petersburg, Russia., Zinkina-Orikhan AV; JSC BIOCAD, St. Petersburg, Russia.
Jazyk:	ruština
Zdroj:	Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova [Zh Nevrol Psikhiatr Im S S Korsakova] 2023; Vol. 123 (7. Vyp. 2), pp. 43-52.
DOI:	10.17116/jnevro202312307243
Abstrakt:	Objective: To evaluate the efficacy and safety of the anti-CD20 monoclonal antibody divozilimab (DIV) used as an intravenous infusion at a dose of 500 mg for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) in comparison with the teriflunomide (TRF). The study of the efficacy and safety of the use of the drug DIV was carried out for 48 weeks of therapy. Material and Methods: The multicenter, randomized, double-blind and double-masked phase III clinical trial (CT) BCD-132-4/MIRANTIBUS included 338 adult patients with RRMS distributed in a 1:1 ratio into two groups: DIV 500 mg and TRF 14 mg. After screening, subjects were included in the main CT period, which consisted of two cycles of therapy over 48 weeks. The primary end point was «Mean annualized relapse rate 48 weeks after the last patient is randomized in the study». Results: 321 subjects completed 48 weeks of therapy according to the study protocol. The analysis of the of efficacy data for the primary endpoint successively proved the hypothesis of superiority of the test drug DIV at a dose of 500 mg over the reference drug TRF. A rapid suppression of acute disease activity according to the brain MRI and clinical manifestations of the disease was shown after the first infusion of DIV in patients with RRMS. Thus, after 48 weeks of therapy in patients treated with DIV, there were no T1 gadolinium-enhancing lesions, while in the TRF group such lesions were observed in 20.7% (35/169) of subjects. Evaluation of the CUA per scan showed that the mean values for the estimated period were statistically significantly lower in the DIV drug group compared to the TRF group: the ratio of the adjusted per scan rates (DIV/TRF) was 0.125 [95% CI: 0.089; 0.177]. Over the 48 weeks of therapy, the proportion of subjects with relapses was 9.5% ( n =16/169) in the DIV group and 19.5% (33/169) in the TRF group ( p =0.0086). DIV has shown a favorable safety profile. Among the adverse reactions (AR), infusion reactions and deviations of laboratory data, such as a decrease in the number of leukocytes, neutrophils, and lymphocytes, were most often recorded. Identified AR were expected, had mild to moderate severity, and resolved without any negative consequences. Conclusion: The results of the clinical study indicate the high efficacy and safety of DIV in comparison with TRF.
Databáze:	MEDLINE
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