Shenzhen Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine, Shenzhen, China.
The Department of Rheumatology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China.
Trials. 2024 Sep 5;25(1):590. doi: 10.1186/s13063-024-08429-7.
Patients with psoriatic arthritis (PsA) often suffer from anxiety disorders. While upadacitinib has shown effectiveness in reducing various disease activity indicators in active PsA, its impact on anxiety disorders in PsA patients needs further investigation.
In this 12-week randomized, open-label, controlled trial, PsA patients with coexisting anxiety were randomly assigned to either the upadacitinib group or the adalimumab group in a 1:1 ratio. The upadacitinib group received a daily dose of 15 mg, while the adalimumab group received 40 mg every 2 weeks. The primary outcome measured the change in Hospital Anxiety Self-Assessment Scale (HADS-A) total scores after the 12-week intervention. Secondary outcomes included changes in the Health Assessment Questionnaire-Disability Index (HAQ-DI), the percentage of participants meeting the ACR20 criteria compared to baseline after 12 weeks, and the percentage of participants achieving a grade 0 or 1 in the psoriasis static Investigator's overall assessment (sPGA) at week 12 with an improvement of at least 2 points from baseline (sPGA 0/1). One-way analysis of variance (ANOVA) was used to compare the means of normally distributed variables between the upadacitinib and adalimumab groups.
The impact of upadacitinib on anxiety in PsA patients remains uncertain. This 12-week open randomized controlled trial aims to provide insights into disease progression and underscore the importance of addressing PsA-related anxiety during treatment.
ChiCTR2400079755. Registered on January 11, 2024, with ChiCTR. https://www.chictr.org.cn/showproj.html?proj=216538.
患有银屑病关节炎（PsA）的患者常伴有焦虑障碍。尽管乌帕替尼已被证实可有效降低活动期 PsA 的多项疾病活动指标，但它对 PsA 患者焦虑障碍的影响仍需进一步研究。
这是一项为期 12 周的随机、开放标签、对照临床试验，入组了伴发焦虑的 PsA 患者，按照 1:1 的比例随机分配至乌帕替尼组或阿达木单抗组。乌帕替尼组每日给予 15mg，阿达木单抗组每 2 周给予 40mg。主要结局是评估 12 周干预后医院焦虑自评量表（HADS-A）总分的变化。次要结局包括健康评估问卷残疾指数（HAQ-DI）的变化、12 周后与基线相比达到 ACR20 标准的患者比例，以及 12 周时银屑病静态评估者整体评估（sPGA）达到 0/1 级且较基线改善至少 2 分（sPGA 0/1）的患者比例。采用单因素方差分析（ANOVA）比较乌帕替尼组和阿达木单抗组间正态分布变量的均值。
乌帕替尼对 PsA 患者焦虑的影响尚不确定。这项为期 12 周的开放随机对照试验旨在深入了解疾病进展，并强调在治疗过程中关注与 PsA 相关的焦虑问题。
ChiCTR2400079755. 于 2024 年 1 月 11 日注册，登记于 ChiCTR，https://www.chictr.org.cn/showproj.html?proj=216538。
