ABSTRACT

Introduction

Guselkumab is a subcutaneously administered human monoclonal antibody, selectively blocking IL-23 through binding to its p19 subunit. It was initially approved for the treatment of patients with moderate-to-severe plaque-psoriasis who are candidates for systemic therapy or phototherapy. Pubmed and Embase databases were searched for publications, using the following search terms: psoriasis, psoriatic arthritis, guselkumab, risankizumab, tildrakizumab, p19, interleukin 23, guidelines, treatment recommendations, DISCOVER, ECLIPSE, and VOYAGE.

Areas covered

Accumulating evidence suggests that the IL-23/Th17 pathway is important in the pathogenesis of both psoriasis and psoriatic arthritis. Following a successful development program in psoriasis, guselkumab was evaluated for its efficacy and safety in psoriatic arthritis in a comprehensive clinical trial program, comprising one phase-2 study and two phase-3 studies (DISCOVER-1 and −2). Complementary data on pharmacokinetics and safety exist from pre-clinical experiments and pooled analyses from two long-term studies in psoriasis (VOYAGE-1 and −2). Based on the DISCOVER-1 and −2 data, guselkumab was approved by the FDA for the treatment of active psoriatic arthritis in 2020.

Expert Opinion

Guselkumab is the first selective IL-23 inhibitor approved to treat adults with active psoriatic arthritis, broadening therapeutic options in the field through a novel mode of action.

中文翻译：

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Guselkumab：第一种用于成人活动性银屑病关节炎的选择性 IL-23 抑制剂

摘要

介绍

Guselkumab 是一种皮下给药的人单克隆抗体，通过与其 p19 亚基结合来选择性阻断 IL-23。它最初被批准用于治疗适合全身治疗或光疗的中度至重度斑块状银屑病患者。使用以下搜索词在 Pubmed 和 Embase 数据库中搜索出版物：银屑病、银屑病关节炎、guselkumab、risankizumab、tildrakizumab、p19、白细胞介素 23、指南、治疗建议、DISCOVER、ECLIPSE 和 VOYAGE。

覆盖区域

越来越多的证据表明 IL-23/Th17 通路在银屑病和银屑病关节炎的发病机制中都很重要。在银屑病的成功开发计划之后，在一项综合临床试验计划中评估了古塞库单抗在银屑病关节炎中的疗效和安全性，该计划包括一项 2 期研究和两项 3 期研究（DISCOVER-1 和 -2）。药代动力学和安全性的补充数据来自临床前实验和两项银屑病长期研究（VOYAGE-1 和 -2）的汇总分析。基于 DISCOVER-1 和 -2 数据，guselkumab 于 2020 年被 FDA 批准用于治疗活动性银屑病关节炎。

专家意见

Guselkumab 是第一个被批准用于治疗成人活动性银屑病关节炎的选择性 IL-23 抑制剂，通过一种新的作用模式拓宽了该领域的治疗选择。