Netakimab — new IL-17а inhibitor: 12-week results of phase III clinical study BCD-085-7/PLANETA in patients with moderate-tosevere plaque psoriasis

Cover Page
  • Authors: Kubanov A.A.1, Bakulev A.L.2, Samtsov A.V.3, Khairutdinov V.R.3, Sokolovskiy E.V.4, Kokhan M.M.5, Artemyeva A.V.6, Chernyaeva EV.6, Ivanov R.A.6
  • Affiliations:
    1. State Research Center of Dermatovenereology and Cosmetology, Ministry of Health of the Russian Federation
    2. Saratov State Medical University named after V. I. Razumovsky, Ministry of Health of the Russian Federation
    3. S. M. Kirov Military Medical Academy, Ministry of Defence of the Russian Federation
    4. Pavlov First Saint Petersburg State Medical University, Ministry of Health of the Russian Federation
    5. Ural Research Institute for Dermatovenerology and Immunopatology
    6. BIOCAD company
  • Issue: Vol 95, No 2 (2019)
  • Pages: 15-28
  • Section: SCIENTTIFIC RESEARCHES
  • URL: https://vestnikdv.ru/jour/article/view/480
  • DOI: https://doi.org/10.25208/0042-4609-2019-95-2-15-28

Abstract


Netakimab, the original monoclonal antibody against IL-17A, is an innovative drug for the treatment of moderate-to-severe plaque psoriasis in patients who have indications for systemic therapy or phototherapy. Netakimab was approved in Russian Federation, registration certificate number ЛП-005439 from 04.04.2019. This article outlines the first 12-week results of a phase III clinical trial in patients with psoriasis.

Materials and methods. The BCD-085-7 study (PLANETA) is a comparative, randomized, double-blind, placebo-controlled phase 3 clinical study of the efficacy and safety of netakimab in patients with moderate-to-severe plaque psoriasis. This review presents the results of the first 12 weeks. The study is ongoing at the moment, the total duration of treatment for each patient is 3 years (154 weeks). Patients were randomized in a ratio of 2:2:1 into one of three arms: group 1 received netakimab subcutaneously at a dose of 120 mg once a week for the first three weeks (induction) and then once every 2 weeks up to week 10, group 2 received netakimab subcutaneously at a dose of 120 mg once a week for the first three weeks (induction) and then once every 4 weeks up to week 10, group 3 received a placebo subcutaneously on day 1 at weeks 0, 1, 2, 4, 6, 8 10. In order to maintain a double-blind design, placebo was administered to patients in group 2 at weeks 4 and 8.

Results. Both netakimab groups showed a significant superiority over placebo (p < 0.001) and the absence of statistically significant differences between the two regimens of therapy (p > 0.05) across all endpoints. PASI 75 at week 12 was reached by 77.65 % of patients using netakimab once every 2 weeks and 83.33 % of patients using netakimab once every 4 weeks (ITT population). The rate of clear and almost clear skin (sPGA 0–1) was reached by 81.18 and 79.76 % of patients using netakimab once every 2 weeks and once every 4 weeks, respectively. The safety assessment showed no statistically significant differences between the groups, the incidence rate of adverse events in netakimab arms was not higher than in the placebo arm. There were no cases of early withdrawal due to adverse events and cases of grade 4 toxicity according to CTCAE 4.03. During the 12 weeks of the study, one serious adverse event was registered in group 2 (pneumonia grade 3), which was recovered without any consequences. The immunogenicity assessment showed binding antibodies formation at week 12 in one patient who received BCD-085 every 2 weeks. Neutralizing antibodies were not detected. Conclusion. Netakimab showed high efficacy in the treatment of psoriasis, more than 80 % of patients achieved PASI 75 and sPGA 0–1 (clear and almost clear skin) by the week 12 of treatment. The drug showed a favorable safety profile and low immunogenicity. Based on the study results the regimen once a week during the first 3 weeks (induction), then once every 4 weeks was chosen for medical use in patients with psoriasis.


About the authors

A. A. Kubanov

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

Email: fake@neicon.ru

Russian Federation Alexey A. Kubanov — Dr. Sci. (Med.), Prof., RAS Corresponding Member, Leading Researcher of the Dermatology Department

A. L. Bakulev

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

Email: fake@neicon.ru

Russian Federation Andrey L. Bakulev — Dr. Sci. (Med.), Prof., Head of the Department of Dermatology and Cosmetology

A. V. Samtsov

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

Email: fake@neicon.ru

Russian Federation Alexey V. Samtsov — Dr. Sci. (Med.), Prof., Head of the Department of Skin and Venereal Diseases

V. R. Khairutdinov

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

Email: fake@neicon.ru

Russian Federation Vladislav R. Khairutdinov — Dr. Sci. (Med.), Assoc. Prof. of the Department of Skin and Venereal Diseases

E. V. Sokolovskiy

Pavlov First Saint Petersburg State Medical University, Ministry of Health of the Russian Federation

Email: fake@neicon.ru

Russian Federation Evgeny V. Sokolovskiy — Dr. Sci. (Med.), Prof., Head of the Department of Dermatology and Venereology with a Hospital

M. M. Kokhan

Ural Research Institute for Dermatovenerology and Immunopatology

Email: fake@neicon.ru

Russian Federation Muza M. Kokhan — Dr. Sci. (Med.), Prof., Head of the Scientific Clinical Department of Dermatology

A. V. Artemyeva

BIOCAD company

Author for correspondence.
Email: artemevaav@biocad.ru

Russian Federation Antonina V. Artemyeva — Medical Expert; tel.: +7 (911) 110-39-34

E V. Chernyaeva

BIOCAD company

Email: fake@neicon.ru

Russian Federation Ekaterina V. Chernyaeva — Director for R&D in the Field of Rheumatology and Dermatology

R. A. Ivanov

BIOCAD company

Email: fake@neicon.ru

Russian Federation Roman A. Ivanov — Cand. Sci. (Med.), Deputy General Director for Biomedical R&D

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