Long-term efficacy and safety of netakimab in patients with moderate-to-severe psoriasis. Results of phase II open-label extension clinical study BCD-085-2-ext

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Abstract

Netakimabis original monoclonal antibody against IL-17. This article outlines the key results of a phase II open-label extension trial of netakimab 80 mg and 120 mg in patients with moderate-to-severe psoriasis.

The main aim of the trial is to estimate efficacy, safety and immunogenicity of long-term treatment with netakimab 80 mg and 120 mg in patients with moderate-to-severe psoriasis.

Materials and methods. The BCD-085-2-ext study is a comparative, open-label phase 2 clinical study of the effi - cacy and safety of netakimab in patients with moderate-to-severe plaque psoriasis who had finished BCD-085-2 (NCT02762994) trial. Main efficacy endpoints includePASI75, PASI90, PASI100, sPGA = 0–1 on week 38 of the trial, long-term PASI75/90/100 retention, efficacy keeping after switch from once every 2 week regimen to once every 4 week regimen. Safety endpoints include adverse events, serious adverse events number and their profile.

Results. 103 patients were included. PASI75 at week 38 was reached by 98.06 %, PASI90 — by 92.23 %, PASI100 — by 59.22 % of patients. There were no cases of serious adverse event, early with drawal due to adverse events and cases of grade 4 toxicity according to CTCAE 4.03. There were no cases of binding antibodies to netakimab during the 38 weeks of the study.

Conclusion. The first Russian original IL-17 inhibitor netakimabis promising modern medicine for moderate-to-severe plaque psoriasis treatment. Netakimabshowed high efficacy, favorable safety profile and low immunogenicity during one year of the treatment.

About the authors

A. L. Bakulev

Saratov State Medical Universit y named after V. I. Razumovsky, Ministr y of Health of the Russian Federation

Email: fake@neicon.ru
Andrey L. Bakulev — Dr. Sci. (Med.), Prof., Head of the Department of Dermatology and Cosmetology Russian Federation

A. V. Samtsov

S. M. Kirov Militar y Medical Academy, Ministr y of Defence of the Russian Federation

Email: fake@neicon.ru
Alexey V. Samtsov — Dr. Sci. (Med.), Prof., Head of the Department of Skin and Venereal Diseases Russian Federation

A. A. Kubanov

State Research Center of Dermatovenereology and Cosmetology, Ministr y of Health of the Russian Federation

Email: fake@neicon.ru
Alexey A. Kubanov — Dr. Sci. (Med.), Prof., RAS Corresponding Member, Acting Director Russian Federation

V. R. Khairutdinov

S. M. Kirov Militar y Medical Academy, Ministr y of Defence of the Russian Federation

Email: fake@neicon.ru
Vladislav R. Khairutdinov — Dr. Sci. (Med.), Assoc. Prof. of the Department of Skin and Venereal Diseases Russian Federation

M. M. Kokhan

Ural Research Institute for Dermatovenerology and Immunopatology

Email: fake@neicon.ru
Muza M. Kokhan — Dr. Sci. (Med.), Prof., Head of the Scientific Clinical Department of Dermatology Russian Federation

A. V. Artemyeva

BIOCAD

Email: fake@neicon.ru
Antonina V. Artemyeva — Medical Expert Russian Federation

S. I. Derbin

BIOCAD

Author for correspondence.
Email: derbin@biocad.ru

Sergey I. Derbin* — Senior Medical Advisor

tel. +7 (905) 274-65-59

Russian Federation

E. V. Chernyaeva

BIOCAD

Email: fake@neicon.ru
Ekaterina V. Chernyaeva — Director for R&D in the Field of Rheumatology and Dermatology Russian Federation

R. A. Ivanov

BIOCAD

Email: fake@neicon.ru
Roman A. Ivanov — Cand. Sci. (Med.), Deputy General Director for Biomedical R&D Russian Federation

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Copyright (c) 2019 Bakulev A.L., Samtsov A.V., Kubanov A.A., Khairutdinov V.R., Kokhan M.M., Artemyeva A.V., Derbin S.I., Chernyaeva E.V., Ivanov R.A.

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