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

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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.

About the authors

A. V. Samtsov

Military Medical Academy of S. M. Kirov of the Ministry of Defence of the Russian Federation, St. Petersburg

Email: fake@neicon.ru
Akademika Lebedeva str., 6, lit. Ж, 194044 Россия

V. R. Khairutdinov

Military Medical Academy of S. M. Kirov of the Ministry of Defence of the Russian Federation, St. Petersburg

Email: fake@neicon.ru
Akademika Lebedeva str., 6, lit. Ж, 194044 Россия

A. L. Bakulev

Saratov State Medical University named after V. I. Razumovsky of the Ministry of Health of the Russian Federation, Saratov

Email: fake@neicon.ru
Bol’shaya Kazach’ya str., 112, 410012 Россия

A. A. Kubanov

State Scientific Centre of Dermatovenereology and Cosmetology of the Ministry of Health of the Russian Federation, Moscow

Email: fake@neicon.ru
Korolenko str., 3, bldg 6, 107076 Россия

A. E. Karamova

State Scientific Centre of Dermatovenereology and Cosmetology of the Ministry of Health of the Russian Federation, Moscow

Email: fake@neicon.ru
Korolenko str., 3, bldg 6, 107076 Россия

A. V. Artem’eva

Closed Joint-stock Company BIOCAD, St. Petersburg

Author for correspondence.
Email: artemevaav@biocad.ru
Svyazi str., 34, lit. A, Strelna, 198515 Россия

T. V. Korotaeva

Research Institute of Rheumatogy named after V. A. Nasonova, Moscow

Email: fake@neicon.ru
Kashirskoe shosse, 34A, 115522 Россия

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Copyright (c) 2017 Samtsov A.V., Khairutdinov V.R., Bakulev A.L., Kubanov A.A., Karamova A.E., Artem’eva A.V., Korotaeva T.V.

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