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核心技术专利:CN118964589B侵权必究
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Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in Japanese patients with moderate to severe plaque, erythrodermic, or generalized pustular psoriasis: Efficacy and safety results from an open-label, phase 3 trial.

作者信息

Imafuku Shinichi, Okubo Yukari, Tada Yayoi, Ohtsuki Mamitaro, Colston Elizabeth, Napoli Andrew, Shao Yanqiu, Banerjee Subhashis, Morita Akimichi

机构信息

Department of Dermatology, Fukuoka University Faculty of Medicine, Fukuoka, Japan.

Department of Dermatology, Tokyo Medical University, Tokyo, Japan.

出版信息

J Dermatol. 2024 Mar;51(3):365-379. doi: 10.1111/1346-8138.17074. Epub 2024 Jan 24.


DOI:10.1111/1346-8138.17074
PMID:38268101
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11483964/
Abstract

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in Japan for adult patients with plaque (PP), generalized pustular (GPP), and erythrodermic (EP) psoriasis who have had an inadequate response to conventional systemic therapies. This approval is based on results from the global phase 3 POETYK PSO-1 and PSO-2 trials in which deucravacitinib was associated with significantly improved efficacy outcomes compared with placebo in adults with moderate to severe plaque psoriasis, and results described here from POETYK PSO-4, an open-label, single-arm, phase 3 trial (NCT03924427), which evaluated the efficacy and safety of deucravacitinib 6 mg once daily in adult Japanese patients with PP, GPP, or EP. The coprimary endpoints were the proportion of patients achieving a ≥75% reduction from baseline in the Psoriasis Area and Severity Index (PASI 75) and a static Physician's Global Assessment score of 0 (clear) or 1 (almost clear) (sPGA 0/1) with at least a two-point improvement from baseline at week 16. Nonresponder imputation was used for missing data. Efficacy responses, adverse events (AEs), and serious AEs (SAEs) were recorded for up to 52 weeks. Seventy-four patients were treated (PP, n = 63; GPP, n = 3; EP, n = 8). At week 16, 76.2%, 66.7%, and 37.5% of patients with PP, GPP, and EP, respectively, had achieved PASI 75, and 82.5%, 0.0%, and 50.0% had achieved sPGA 0/1. Responses were overall maintained through week 52. AEs occurred in 74.6% of patients with PP, 100% of patients with GPP, and 87.5% of patients with EP. The most common AEs were nasopharyngitis and acne. Rates of SAEs and discontinuations were low. There were no deaths. Deucravacitinib was effective and well tolerated in Japanese patients with moderate to severe PP and in a limited number of patients with GPP or EP.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f806/11483964/1d43a84a8945/JDE-51--g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f806/11483964/2fd3c9ba781c/JDE-51--g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f806/11483964/d6b8c5a712ff/JDE-51--g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f806/11483964/a1876209ec7a/JDE-51--g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f806/11483964/cb80e51a28a7/JDE-51--g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f806/11483964/c8bd63dc0904/JDE-51--g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f806/11483964/a49b581402fa/JDE-51--g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f806/11483964/1d43a84a8945/JDE-51--g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f806/11483964/2fd3c9ba781c/JDE-51--g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f806/11483964/d6b8c5a712ff/JDE-51--g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f806/11483964/a1876209ec7a/JDE-51--g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f806/11483964/cb80e51a28a7/JDE-51--g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f806/11483964/c8bd63dc0904/JDE-51--g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f806/11483964/a49b581402fa/JDE-51--g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f806/11483964/1d43a84a8945/JDE-51--g001.jpg

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[8]
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本文引用的文献

[1]
Efficacy and safety of the selective TYK2 inhibitor, deucravacitinib, in Japanese patients with moderate to severe plaque psoriasis: Subgroup analysis of a randomized, double-blind, placebo-controlled, global phase 3 trial.

J Dermatol. 2023-5

[2]
English version of Japanese guidance for use of biologics for psoriasis (the 2022 version).

J Dermatol. 2023-2

[3]
Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program fOr Evaluation of TYK2 inhibitor psoriasis second trial.

J Am Acad Dermatol. 2023-1

[4]
Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial.

J Am Acad Dermatol. 2023-1

[5]
Impact of Body Mass Index on the Efficacy of Biological Therapies in Patients with Psoriasis: A Real-World Study.

Clin Drug Investig. 2021-10

[6]
Establishment of the Western Japan Psoriasis Registry and first cross-sectional analysis of registered patients.

J Dermatol. 2021-11

[7]
Generalized pustular psoriasis: current management status and unmet medical needs in Japan.

Expert Rev Clin Immunol. 2021-9

[8]
Epidemiological survey of the psoriasis patients in the Japanese Society for Psoriasis Research from 2013 to 2018.

J Dermatol. 2021-6

[9]
Incidence of venous and arterial thromboembolic events reported in the tofacitinib rheumatoid arthritis, psoriasis and psoriatic arthritis development programmes and from real-world data.

Ann Rheum Dis. 2020-11

[10]
The influence of body weight of patients with chronic plaque psoriasis on biological treatment response.

Postepy Dermatol Alergol. 2020-4

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