Efficacy and safety of netakimab, a novel anti-IL-17 monoclonal antibody, in patients with moderate to severe plaque psoriasis. Results of a 54-week randomized double-blind placebo-controlled PLANETA clinical trial
- 作者: Puig L.1, Bakulev A.L.2, Kokhan M.M.3, Samtsov A.V.4, Khairutdinov V.R.4, Morozova M.A.5, Zolkin N.A.5, Kuryshev I.V.5, Petrov A.N.5, Artemeva A.V.5, Zinkina-Orikhan A.V.5
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隶属关系:
- Hospital de Sant Pau
- Saratov State Medical University
- Ural Research Institute of Dermatovenereology and Immunopathology
- S.M. Kirov Military Medical Academy
- JSC BIOCAD
- 期: 卷 97, 编号 4 (2021)
- 页面: 80-91
- 栏目: ORIGINAL STUDIES
- URL: https://bakhtiniada.ru/0042-4609/article/view/117597
- DOI: https://doi.org/10.25208/vdv1251
- ID: 117597
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Background. Netakimab (NTK), an original humanized anti-interleukin-17 monoclonal antibody, showed therapeutic efficacy in moderate to severe plaque psoriasis in a phase 2 clinical study. Herein we report the results of 54 weeks of a phase 3 trial.
Aim. To evaluate the efficacy and safety of two NTK regimens vs. placebo in moderate to severe plaque psoriasis.
Methods. PLANETA is the ongoing randomized double-blind placebo-controlled clinical trial. 213 patients with moderate to severe plaque psoriasis were randomly assigned to receive NTK 120 mg once every 2 weeks (NTK Q2W), NTK 120 mg once every 4 weeks (NTK Q4W) or placebo. During the first 3 weeks, patients received subcutaneous injections of NTK or placebo (according to the allocation) once a week. Patients in the NTK Q2W group then received NTK at weeks 4, 6, 8, and 10. Subjects in the NTK Q4W group received NTK at weeks 6 and 10 and placebo at weeks 4 and 8. Patients in the placebo group received placebo injections at weeks 4, 6, 8, and 10. Treatment was unblinded at week 12. During the open-label phase, patients in both NTK groups continued to receive NTK Q4W. The primary efficacy endpoint was the proportion of patients in each group who achieved a 75% or greater reduction from baseline in psoriasis area and severity index (PASI 75) at week 12.
Results. A total of 77.7%, 83.3%, and 0% of patients had a PASI 75 response at week 12 in the NTK Q2W, NTK Q4W, and placebo groups, respectively (P < 0.0001, Fisher’s exact test, ITT). The effect was maintained throughout the 1-year treatment. NTK showed a good safety profile and low immunogenicity.
Conclusion. Treatment with NTK results in high rates of sustained clinical response in patients with moderate to severe plaque psoriasis. The study is ongoing; thus, long-term use efficacy and safety data are forthcoming.
作者简介
Luis Puig
Hospital de Sant Pau
Email: LPuig@santpau.cat
ORCID iD: 0000-0001-6083-0952
MD (Hon), PhD
西班牙, Sant Quinti, 89, BarcelonaAndrey Bakulev
Saratov State Medical University
编辑信件的主要联系方式.
Email: al_ba05@mail.ru
ORCID iD: 0000-0002-1450-4942
MD, Dr. Sci. (Med.), Professor
俄罗斯联邦, Bolshaya Kazachia str., 112, Saratov
Muza Kokhan
Ural Research Institute of Dermatovenereology and Immunopathology
Email: mkokhan@yandex.ru
ORCID iD: 0000-0001-6353-6644
MD, Dr. Sci. (Med.), Professor
俄罗斯联邦, Shcherbakova str., 8, YekaterinburgAlexey Samtsov
S.M. Kirov Military Medical Academy
Email: avsamtsov@mail.ru
ORCID iD: 0000-0002-9458-0872
MD, Dr. Sci. (Med.), Professor
俄罗斯联邦, Akаdemika Lebedeva str. 6, Saint PetersburgVladislav Khairutdinov
S.M. Kirov Military Medical Academy
Email: haric03@list.ru
ORCID iD: 0000-0002-0387-5481
Dr. Sci. (Med.), assistant professor
俄罗斯联邦, Akаdemika Lebedeva str. 6, Saint PetersburgMaria Morozova
JSC BIOCAD
Email: morozovama@biocad.ru
ORCID iD: 0000-0001-7755-7526
SPIN 代码: 5651-1479
MD, Cand. Sci. (Med.)
俄罗斯联邦, Svyazi st., 34-A, Saint Petersburg, StrelnaNikita Zolkin
JSC BIOCAD
Email: zolkin@biocad.ru
ORCID iD: 0000-0002-7938-710X
俄罗斯联邦, Svyazi st., 34-A, Saint Petersburg, Strelna
Ivan Kuryshev
JSC BIOCAD
Email: kuryshev@biocad.ru
ORCID iD: 0000-0001-8095-8734
俄罗斯联邦, Svyazi st., 34-A, Saint Petersburg, Strelna
Alexey Petrov
JSC BIOCAD
Email: petrovan@biocad.ru
俄罗斯联邦, Svyazi st., 34-A, Saint Petersburg, Strelna
Antonina Artemeva
JSC BIOCAD
Email: artemevaav@biocad.ru
ORCID iD: 0000-0002-5306-3377
俄罗斯联邦, Svyazi st., 34-A, Saint Petersburg, Strelna
Arina Zinkina-Orikhan
JSC BIOCAD
Email: zinkina@biocad.ru
ORCID iD: 0000-0002-8499-2232
俄罗斯联邦, Svyazi st., 34-A, Saint Petersburg, Strelna
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