Efficacy and Safety of BCD-085, a Novel Interleukin-17 Inhibitor. Results of Phase II Clinical Trial in Patients with Moderate-to-Severe Plaque Psoriasis
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 an...
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| Format: | Article |
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State Scientific Center of Dermatovenereology and Cosmetology
2018-01-01
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| Series: | Vestnik Dermatologii i Venerologii |
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| Online Access: | https://www.vestnikdv.ru/jour/article/view/344 |
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| author | A. V. Samtsov V. R. Khairutdinov A. L. Bakulev A. A. Kubanov A. E. Karamova A. V. Artem’eva T. V. Korotaeva |
| author_facet | A. V. Samtsov V. R. Khairutdinov A. L. Bakulev A. A. Kubanov A. E. Karamova A. V. Artem’eva T. V. Korotaeva |
| author_sort | A. V. Samtsov |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T06:02:01Z |
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| institution | Directory Open Access Journal |
| issn | 0042-4609 2313-6294 |
| language | English |
| last_indexed | 2024-03-12T06:02:01Z |
| publishDate | 2018-01-01 |
| publisher | State Scientific Center of Dermatovenereology and Cosmetology |
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| spelling | doaj.art-ad95b195b540473996348322541ef6572023-09-03T04:01:59ZengState Scientific Center of Dermatovenereology and CosmetologyVestnik Dermatologii i Venerologii0042-46092313-62942018-01-0105526310.25208/0042-4609-2017-93-5-52-63339Efficacy and Safety of BCD-085, a Novel Interleukin-17 Inhibitor. Results of Phase II Clinical Trial in Patients with Moderate-to-Severe Plaque PsoriasisA. V. Samtsov0V. R. Khairutdinov1A. L. Bakulev2A. A. Kubanov3A. E. Karamova4A. V. Artem’eva5T. V. Korotaeva6Military Medical Academy of S. M. Kirov of the Ministry of Defence of the Russian Federation, St. PetersburgMilitary Medical Academy of S. M. Kirov of the Ministry of Defence of the Russian Federation, St. PetersburgSaratov State Medical University named after V. I. Razumovsky of the Ministry of Health of the Russian Federation, SaratovState Scientific Centre of Dermatovenereology and Cosmetology of the Ministry of Health of the Russian Federation, MoscowState Scientific Centre of Dermatovenereology and Cosmetology of the Ministry of Health of the Russian Federation, MoscowClosed Joint-stock Company BIOCAD, St. PetersburgResearch Institute of Rheumatogy named after V. A. Nasonova, MoscowRecent 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.https://www.vestnikdv.ru/jour/article/view/344psoriasismonoclonal antibody against interleukin-17biological therapypasi 75bcd-085 |
| spellingShingle | A. V. Samtsov V. R. Khairutdinov A. L. Bakulev A. A. Kubanov A. E. Karamova A. V. Artem’eva T. V. Korotaeva Efficacy and Safety of BCD-085, a Novel Interleukin-17 Inhibitor. Results of Phase II Clinical Trial in Patients with Moderate-to-Severe Plaque Psoriasis Vestnik Dermatologii i Venerologii psoriasis monoclonal antibody against interleukin-17 biological therapy pasi 75 bcd-085 |
| title | Efficacy and Safety of BCD-085, a Novel Interleukin-17 Inhibitor. Results of Phase II Clinical Trial in Patients with Moderate-to-Severe Plaque Psoriasis |
| title_full | Efficacy and Safety of BCD-085, a Novel Interleukin-17 Inhibitor. Results of Phase II Clinical Trial in Patients with Moderate-to-Severe Plaque Psoriasis |
| title_fullStr | Efficacy and Safety of BCD-085, a Novel Interleukin-17 Inhibitor. Results of Phase II Clinical Trial in Patients with Moderate-to-Severe Plaque Psoriasis |
| title_full_unstemmed | Efficacy and Safety of BCD-085, a Novel Interleukin-17 Inhibitor. Results of Phase II Clinical Trial in Patients with Moderate-to-Severe Plaque Psoriasis |
| title_short | Efficacy and Safety of BCD-085, a Novel Interleukin-17 Inhibitor. Results of Phase II Clinical Trial in Patients with Moderate-to-Severe Plaque Psoriasis |
| title_sort | efficacy and safety of bcd 085 a novel interleukin 17 inhibitor results of phase ii clinical trial in patients with moderate to severe plaque psoriasis |
| topic | psoriasis monoclonal antibody against interleukin-17 biological therapy pasi 75 bcd-085 |
| url | https://www.vestnikdv.ru/jour/article/view/344 |
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