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

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...

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Autores principales:	Luis Puig, Andrey L. Bakulev, Muza M. Kokhan, Alexey V. Samtsov, Vladislav R. Khairutdinov, Maria A. Morozova, Nikita A. Zolkin, Ivan V. Kuryshev, Alexey N. Petrov, Antonina V. Artemeva, Arina V. Zinkina-Orikhan
Formato:	article
Lenguaje:	RU
Publicado:	State Scientific Center of Dermatovenereology and Cosmetology 2021
Materias:	psoriasis monoclonal antibodies interleukin-17 inhibitors Dermatology RL1-803
Acceso en línea:	https://doaj.org/article/e87e2e9dcfab4ce2ac14f940344d122b
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spelling	oai:doaj.org-article:e87e2e9dcfab4ce2ac14f940344d122b2021-12-01T22:16:30ZEfficacy 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 trial0042-46092313-629410.25208/vdv1251https://doaj.org/article/e87e2e9dcfab4ce2ac14f940344d122b2021-10-01T00:00:00Zhttps://vestnikdv.ru/jour/article/viewFile/1251/1234https://doaj.org/toc/0042-4609https://doaj.org/toc/2313-6294Background. 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, Fishers 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.Luis PuigAndrey L. BakulevMuza M. KokhanAlexey V. SamtsovVladislav R. KhairutdinovMaria A. MorozovaNikita A. ZolkinIvan V. KuryshevAlexey N. PetrovAntonina V. ArtemevaArina V. Zinkina-OrikhanState Scientific Center of Dermatovenereology and Cosmetologyarticlepsoriasismonoclonal antibodiesinterleukin-17 inhibitorsDermatologyRL1-803RUVestnik Dermatologii i Venerologii, Vol 97, Iss 4, Pp 80-91 (2021)
institution	DOAJ
collection	DOAJ
language	RU
topic	psoriasis monoclonal antibodies interleukin-17 inhibitors Dermatology RL1-803
spellingShingle	psoriasis monoclonal antibodies interleukin-17 inhibitors Dermatology RL1-803 Luis Puig Andrey L. Bakulev Muza M. Kokhan Alexey V. Samtsov Vladislav R. Khairutdinov Maria A. Morozova Nikita A. Zolkin Ivan V. Kuryshev Alexey N. Petrov Antonina V. Artemeva Arina V. Zinkina-Orikhan 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
description	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, Fishers 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.
format	article
author	Luis Puig Andrey L. Bakulev Muza M. Kokhan Alexey V. Samtsov Vladislav R. Khairutdinov Maria A. Morozova Nikita A. Zolkin Ivan V. Kuryshev Alexey N. Petrov Antonina V. Artemeva Arina V. Zinkina-Orikhan
author_facet	Luis Puig Andrey L. Bakulev Muza M. Kokhan Alexey V. Samtsov Vladislav R. Khairutdinov Maria A. Morozova Nikita A. Zolkin Ivan V. Kuryshev Alexey N. Petrov Antonina V. Artemeva Arina V. Zinkina-Orikhan
author_sort	Luis Puig
title	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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	State Scientific Center of Dermatovenereology and Cosmetology
publishDate	2021
url	https://doaj.org/article/e87e2e9dcfab4ce2ac14f940344d122b
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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

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