古塞单抗，一种白细胞介素-23p19 亚单位抑制剂，对中重度银屑病关节炎患者附着点炎和指（趾）炎的影响：一项随机、安慰剂对照、II 期研究的结果。
Impact of guselkumab, an interleukin-23 p19 subunit inhibitor, on enthesitis and dactylitis in patients with moderate to severe psoriatic arthritis: results from a randomised, placebo-controlled, phase II study.
机构信息
Swedish Medical Center/Providence St. Joseph Health, Seattle, Washington, USA
University of Washington, Seattle, Washington, USA.
出版信息
RMD Open. 2020 Jul;6(2). doi: 10.1136/rmdopen-2020-001217.
OBJECTIVE
To evaluate the effect of guselkumab on enthesitis and dactylitis in a phase II trial of patients with active psoriatic arthritis (PsA).
METHODS
This was a phase II, randomised, placebo-controlled, double-blind trial of adults with active PsA (≥3 swollen and ≥3 tender joints and C reactive protein ≥0.3 mg/dL) despite conventional synthetic disease-modifying anti-rheumatic drug, non-steroidal anti-inflammatory drug, and/or oral corticosteroid therapy. Patients were randomised to subcutaneous injections of guselkumab 100 mg or placebo at weeks 0, 4 and every 8 weeks, with placebo crossover to guselkumab at week 24. Dactylitis was scored on a scale of 0-3 on each digit; enthesitis was assessed using the Leeds Enthesitis Index (0-6). Other assessments included American College of Rheumatology (ACR) and Psoriasis Area and Severity Index responses.
RESULTS
Of 149 randomised patients, 107 patients had enthesitis (mean score=2.7) and 81 patients had dactylitis (mean dactylitis score=5.7) at baseline. Mean improvements in enthesitis and dactylitis at week 24 were greater in the guselkumab group versus placebo and sustained through week 56. Similar results were observed for the proportions of patients with resolution of enthesitis and dactylitis. At week 56, mean improvements in enthesitis and dactylitis among patients who switched from placebo to guselkumab treatment were similar to those in the guselkumab group. In the guselkumab group, ACR20 responders had greater improvements in enthesitis and dactylitis versus non-responders (week 24).
CONCLUSIONS
At week 24, the guselkumab group had greater mean improvements in enthesitis and dactylitis and greater proportions of patients with resolution of enthesitis and dactylitis versus placebo. ACR20 response was associated with improvements in enthesitis and dactylitis.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov: NCT02319759.URL: https://clinicaltrials.gov/ct2/show/NCT02319759; Registered 18 December 2014.
目的
评估 Guselkumab 在活动性银屑病关节炎（PsA）患者的 II 期试验中对附着点炎和指（趾）炎的疗效。
方法
这是一项 II 期、随机、安慰剂对照、双盲试验，纳入了患有活动性 PsA（≥3 个肿胀关节和≥3 个触痛关节，C 反应蛋白≥0.3mg/dL）的成年患者，这些患者尽管接受了常规合成疾病修饰抗风湿药物、非甾体抗炎药和/或口服皮质类固醇治疗，但病情仍未得到控制。患者按 0:4:8 周的方案接受 Guselkumab 100mg 或安慰剂皮下注射，并且在第 24 周时安慰剂交叉至 Guselkumab 治疗。每个手指的指（趾）炎均按 0-3 分的量表评分；附着点炎采用 Leeds 附着点炎指数（0-6）评估。其他评估包括美国风湿病学会（ACR）和银屑病面积和严重程度指数的反应。
结果
在 149 名随机患者中，107 名患者在基线时存在附着点炎（平均评分=2.7），81 名患者存在指（趾）炎（平均指（趾）炎评分=5.7）。与安慰剂相比，Guselkumab 组在第 24 周时附着点炎和指（趾）炎的平均改善程度更大，并持续至第 56 周。在附着点炎和指（趾）炎缓解的患者比例方面，也观察到了类似的结果。在第 56 周时，从安慰剂转为 Guselkumab 治疗的患者的附着点炎和指（趾）炎的平均改善程度与 Guselkumab 组相似。在 Guselkumab 组中，与非应答者相比，ACR20 应答者的附着点炎和指（趾）炎改善程度更大（第 24 周）。
结论
在第 24 周时，Guselkumab 组的附着点炎和指（趾）炎的平均改善程度更大，且附着点炎和指（趾）炎缓解的患者比例更大。ACR20 应答与附着点炎和指（趾）炎的改善相关。
试验注册号
ClinicalTrials.gov：NCT02319759。网址：https://clinicaltrials.gov/ct2/show/NCT02319759；注册日期：2014 年 12 月 18 日。
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