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在中度至重度银屑病韩国患者中，古塞库单抗与安慰剂和阿达木单抗相比的疗效和安全性：来自 III 期、双盲、安慰剂和阳性对照对照 VOYAGE 1/2 试验的分析。

Efficacy and safety of guselkumab compared with placebo and adalimumab in Korean patients with moderate-to-severe psoriasis: analysis from the phase III, double-blind, placebo- and active-comparator-controlled VOYAGE 1/2 trials.

机构信息

Department of Dermatology, Seoul National University Bundang Hospital and Seoul National University College of Medicine, Seongnam, Korea.

Medical Affairs, Janssen Korea Ltd., Seoul, Korea.

出版信息

J Dermatolog Treat. 2022 Feb;33(1):535-541. doi: 10.1080/09546634.2020.1770174. Epub 2020 May 27.

DOI:10.1080/09546634.2020.1770174
PMID:32419536
Abstract

BACKGROUND: The phase 3 studies, VOYAGE 1 and 2, were conducted to assess guselkumab in the treatment of patients with moderate-to-severe psoriasis. OBJECTIVES: To investigate the efficacy and safety of guselkumab in Korean patients. METHODS: The Korean sub-population of VOYAGE 1 and 2 study patients were included in this analysis. Efficacy and safety were evaluated through Weeks 24 and 28, respectively. RESULTS: Of 126 randomized Korean patients, 30, 63, and 33 received placebo, guselkumab, and adalimumab, respectively. At Week 16, guselkumab was superior to placebo in achieving an Investigator's Global Assessment (IGA) score of 0 or 1 (cleared or minimal; 90.5 vs. 20.0%, <.001) and a Psoriasis Area and Severity Index (PASI) 90 response (71.4 vs. 3.3%, <.001). At week 24, a significantly higher proportion of guselkumab-treated patients achieved PASI 75 and IGA 0 (clear skin) responses compared to adalimumab-treated patients (PASI 75: 93.7 vs. 66.7%, <.001; IGA 0: 52.4 vs. 21.2%, =.004). Through Week 28, guselkumab and adalimumab showed comparable safety profiles. CONCLUSION: The efficacy and safety of guselkumab in Korean psoriasis patients through 28 weeks were consistent with findings for the overall VOYAGE 1 and 2 study population.

摘要

背景：两项 3 期 VOYAGE1 和 2 研究评估了古塞库单抗在中重度银屑病患者中的治疗作用。

目的：评估古塞库单抗在韩国患者中的疗效和安全性。

方法：本分析纳入了 VOYAGE1 和 2 研究韩国亚人群患者。分别在第 24 周和第 28 周评估疗效和安全性。

结果：126 例随机分组的韩国患者中，分别有 30、63 和 33 例患者接受安慰剂、古塞库单抗和阿达木单抗治疗。在第 16 周，古塞库单抗在实现研究者整体评估（IGA）评分 0 或 1（清除或最小；90.5% vs. 20.0%，<.001）和银屑病面积和严重程度指数（PASI）90 应答（71.4% vs. 3.3%，<.001）方面优于安慰剂。在第 24 周，与阿达木单抗治疗组相比，古塞库单抗治疗组达到 PASI75 和 IGA0（无皮损）应答的患者比例显著更高（PASI75：93.7% vs. 66.7%，<.001；IGA0：52.4% vs. 21.2%，=.004）。在第 28 周，古塞库单抗和阿达木单抗的安全性特征相似。

结论：古塞库单抗在韩国银屑病患者中的疗效和安全性在 28 周时与总体 VOYAGE1 和 2 研究人群的结果一致。

相似文献

[1]
Efficacy and safety of guselkumab compared with placebo and adalimumab in Korean patients with moderate-to-severe psoriasis: analysis from the phase III, double-blind, placebo- and active-comparator-controlled VOYAGE 1/2 trials.

J Dermatolog Treat. 2022-2

[2]
Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial.

J Am Acad Dermatol. 2017-1-2

[3]
Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial.

J Am Acad Dermatol. 2017-1-2

[4]
Improvement in Patient-Reported Outcomes (Dermatology Life Quality Index and the Psoriasis Symptoms and Signs Diary) with Guselkumab in Moderate-to-Severe Plaque Psoriasis: Results from the Phase III VOYAGE 1 and VOYAGE 2 Studies.

Am J Clin Dermatol. 2019-2

[5]
Maintenance of clinical response and consistent safety profile with up to 3 years of continuous treatment with guselkumab: Results from the VOYAGE 1 and VOYAGE 2 trials.

J Am Acad Dermatol. 2019-12-4

[6]
Consistent response to guselkumab treatment between Hispanic and non-Hispanic patients with psoriasis: an analysis from VOYAGE 1 and VOYAGE 2.

J Dermatolog Treat. 2021-8

[7]
Efficacy of Guselkumab Compared With Adalimumab and Placebo for Psoriasis in Specific Body Regions: A Secondary Analysis of 2 Randomized Clinical Trials.

JAMA Dermatol. 2018-6-1

[8]
Long-Term Efficacy of Guselkumab for the Treatment of Moderate-to-Severe Psoriasis: Results from the Phase 3 VOYAGE 1 Trial Through Two Years.

J Drugs Dermatol. 2018-8-1

[9]
Efficacy of guselkumab in difficult-to-treat psoriasis regions: Data from VOYAGE 1 and VOYAGE 2 Asian subpopulations.

J Dermatol. 2023-9

[10]
Five-year maintenance of clinical response and health-related quality of life improvements in patients with moderate-to-severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2.

Br J Dermatol. 2021-12

引用本文的文献

[1]
Psoriasis in People With Skin of Color: An Evidence-Based Update.

Int J Dermatol. 2025-4

[2]
Safety of IL-23 p19 Inhibitors for the Treatment of Patients With Moderate-to-Severe Plaque Psoriasis: A Narrative Review.

Adv Ther. 2023-8

[3]
Basic Therapeutic Approach for Patients with Plaque Psoriasis: Korean Expert Consensus Using the Modified Delphi Method.

Ann Dermatol. 2023-6

[4]
Which Areas Are Still Left in Biologics Responsive Korean Patients with Moderate to Severe Plaque Psoriasis.

Ann Dermatol. 2023-2

[5]
Anti-IL23 biologic therapies in the treatment of psoriasis: real-world experience versus clinical trials data.

Immunol Res. 2023-6

[6]
Comparison of the Efficacy and Safety of Biologics (Secukinumab, Ustekinumab, and Guselkumab) for the Treatment of Moderate-to-Severe Psoriasis: Real-World Data from a Single Korean Center.

Biomedicines. 2022-5-3

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