Abstract
Recent studies on psoriasis confirmed that interleukin-17 (IL-17) plays a crucial role in the progression of the disease. Inhibition of this cytokine leads to significant improvement in the course of the disease. Russian biotechnology company BIOCAD have developed an innovative drug, a monoclonal antibody against IL-17, BCD-085. The main objective of the phase II study was to determine the optimal therapeutic dose of BCD-085 in patients with moderate-tosevere plaque psoriasis. The efficacy, safety, and pharmacokinetics of the drug have also been investigated.Materials and methods The study was an international multicenter, comparative, randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of multiple subcutaneous administration of various doses of BCD-085 to patients with moderate to severe plaque psoriasis. Patients were randomized into 4 groups in 1:1:1:1 ratio: group 1 received BCD-085 at a dose of 40 mg, group 2 – 80 mg, group 3 – 120 mg, and group 4 received placebo. Administration of BCD-085/placebo was performed subcutaneously on day 1 at weeks 0, 1, 2, and then on day 1 at weeks 4, 6, 8, 10.Results All studied doses of BCD-085 demonstrated significant superiority over placebo and high efficacy in the treatment of plaque psoriasis. PASI 75 at week 12 was reached by 92.68% of patients in group 3 (120 mg of BCD-085), 83.33% in group 2 (80 mg of BCD-085), 80.0% in group 1 (40 mg of BCD-085), and 23.08% in group 4 (placebo) (p 0.0001). In the course of the study, the dose-dependent effect of the drug was demonstrated. The drug showed favorable safety profile (no cases of serious adverse events or early withdrawal due to adverse events, no cases of adverse events with 4 grade of severity according to CTCAE 4.03). According to the results of pharmacokinetics study, the drug is characterized by a linear increase in serum BCD-085 concentration, reaching its maximum by the end of the first week of observation, and by slow elimination.Conclusion BCD-085 showed high efficiency, more than 90% of patients reached PASI 75 by the 12th week of treatment, and a favorable safety profile. Based on the results of the phase II study, the optimal therapeutic dose was 120 mg.
Highlights
Материалы и методы Проведено международное многоцентровое сравнительное рандомизированное двойное слепое плацебоконтролируемое клиническое исследование эффективности и безопасности многократного подкожного введения различных доз препарата BCD-085 больным среднетяжелым и тяжелым вульгарным псориазом
Recent studies on psoriasis confirmed that interleukin-17 (IL-17) plays a crucial role in the progression of the disease
Patients were randomized into 4 groups in 1:1:1:1 ratio: group 1 received BCD-085 at a dose of 40 mg, group 2 – 80 mg, group 3 – 120 mg, and group 4 received placebo
Summary
Оригинального моноклонального антитела против интерлейкина-17 у пациентов со среднетяжелым и тяжелым вульгарным псориазом. Российской биотехнологической компанией «БИОКАД» был разработан инновационный препарат BCD-085 – моноклональное антитело против ИЛ-17. Результаты Все исследуемые дозы препарата BCD-085 продемонстрировали достоверное превосходство над плацебо и высокую эффективность препарата в терапии вульгарного псориаза. Заключение Препарат BCD-085 имеет высокую эффективность (более 90% пациентов достигли PASI 75 к 12-й неделе лечения), а также благоприятный профиль безопасности. Ключевые слова: псориаз, моноклональное антитело против интерлейкина-17, биологическая терапия, PASI 75, BCD-085. В. Эффективность и безопасность препарата BCD-085 – оригинального моноклонального антитела против интерлейкина-17 у пациентов со среднетяжелым и тяжелым вульгарным псориазом. Результаты II фазы международного многоцентрового сравнительного рандомизированного двойного слепого плацебо-контролируемого клинического исследования.
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