[Results of 4 years of therapy with divozilimab in patients with relapsing multiple sclerosis].
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Boyko A N, Alifirova V M, Goncharova Z A, Greshnova I V, Zaslavsky L G, Kotov S V, Mishin G N, Parshina E V, Poverennova I Ye, Sivertseva S A, Totolyan N A, Trinitatsky Yu V, Trushnikova T N, Sokolova I A, Shukin I A, Dudin V A, Pokhabov D V, Krasnova M V, Porozova A A, Eremeeva A V, Linkova Yu N, Zinkina-Orikhan A V
Аннотация
MATERIAL AND METHODS: Study No. BCD-132-EXT enrolled patients with relapsing MS who had previously received divozilimab at a dose of 500 mg in a phase II and III studies. Taking into account the participation of patients in previous studies, the total treatment duration was 4 years. The efficacy assessment was carried out using parameters associated with relapses (annualized relapse rate (ARR), time to first relapse), parameters of magnetic resonance imaging of the brain, and also included evaluation of neurological deficit. Safety monitoring included evaluation of standard laboratory parameters and reporting of adverse events.
RESULTS: A total of 44 patients were enrolled in the study, of which 93.2% (41/44) patients completed 4 years of follow-up. During the BCD-132-EXT period, the proportion of relapse-free patients was 97.7%. Over the 4 years of observation, the ARR remained consistently low, with the overall ARR over 4 years of divozilimab treatment being 0.052 (95% CI 0.028; 0.097). The 6-month confirmed disability progression (CDP) during the treatment period was observed in 4.5% (n=2) of patients. Adverse reactions, most of which were mild to moderate in severity, were reported in 59.1% (n=26) of patients. The most common adverse reactions were decreased lymphocyte count, decreased white blood cell count, decreased neutrophil count, and infusion reactions.
CONCLUSION: The obtained results indicate the maintenance of efficacy over 4 years of therapy with divozilimab. The safety profile of divozilimab was favorable and consistent with previously obtained data.
Оригинал публикации
[Results of 4 years of therapy with divozilimab in patients with relapsing multiple sclerosis].
OBJECTIVE: To assess the efficacy and safety of long-term treatment with divozilimab in patients with relapsing multiple sclerosis (MS).
MATERIAL AND METHODS: Study No. BCD-132-EXT enrolled patients with relapsing MS who had previously received divozilimab at a dose of 500 mg in a phase II and III studies. Taking into account the participation of patients in previous studies, the total treatment duration was 4 years. The efficacy assessment was carried out using parameters associated with relapses (annualized relapse rate (ARR), time to first relapse), parameters of magnetic resonance imaging of the brain, and also included evaluation of neurological deficit. Safety monitoring included evaluation of standard laboratory parameters and reporting of adverse events.
RESULTS: A total of 44 patients were enrolled in the study, of which 93.2% (41/44) patients completed 4 years of follow-up. During the BCD-132-EXT period, the proportion of relapse-free patients was 97.7%. Over the 4 years of observation, the ARR remained consistently low, with the overall ARR over 4 years of divozilimab treatment being 0.052 (95% CI 0.028; 0.097). The 6-month confirmed disability progression (CDP) during the treatment period was observed in 4.5% (n=2) of patients. Adverse reactions, most of which were mild to moderate in severity, were reported in 59.1% (n=26) of patients. The most common adverse reactions were decreased lymphocyte count, decreased white blood cell count, decreased neutrophil count, and infusion reactions.
CONCLUSION: The obtained results indicate the maintenance of efficacy over 4 years of therapy with divozilimab. The safety profile of divozilimab was favorable and consistent with previously obtained data.