Objectives PsA is a heterogeneous disease that impacts many aspects of social and mental life, including quality of life. Risankizumab, an antagonist specific for IL-23, is currently under investigation for the treatment of adults with active PsA. This study evaluated the impact of risankizumab vs placebo on health-related quality of life (HRQoL) and other patient-reported outcomes (PROs) among patients with active PsA and inadequate response or intolerance to conventional synthetic DMARD (csDMARD-IR) in the KEEPsAKE 1 trial. Methods Adult patients with active PsA (n = 964) were randomized (1:1) to receive risankizumab 150 mg or placebo. PROs assessed included the 36-Item Short-Form Health Survey (SF-36, v2), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-Fatigue), EuroQoL-5 Dimension-5 Level (EQ-5D-5L), Patient’s Assessment of Pain, Patient’s Global Assessment (PtGA) of Disease Activity, and Work Productivity and Activity Impairment–PsA (WPAI-PsA) questionnaire. Least squares (LS) mean change from baseline at week 24 was compared between risankizumab and placebo. Results At week 24, differences between groups were observed using LS mean changes from baseline in SF-36 physical component summary and mental component summary; FACIT-Fatigue; EQ-5D-5L; Patient’s Assessment of Pain; PtGA; all eight SF-36 domains (all nominal P < 0.001); and the WPAI-PsA domains of impairment while working (presenteeism), overall work impairment and activity impairment (all nominal P < 0.01). Conclusion Risankizumab treatment resulted in greater improvements in HRQoL, fatigue, pain and work productivity in patients with active PsA who have csDMARD-IR, when compared with placebo. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT03675308

中文翻译：

---

Risankizumab 改善了银屑病关节炎的健康相关生活质量、疲劳、疼痛和工作效率：KEEPsAKE 1 的结果

目标 PsA 是一种异质性疾病，会影响社会和心理生活的许多方面，包括生活质量。Risankizumab 是一种 IL-23 特异性拮抗剂，目前正在研究用于治疗患有活动性 PsA 的成人。本研究在 KEEPsAKE 中评估了 risankizumab 与安慰剂对活动性 PsA 和对常规合成 DMARD (csDMARD-IR) 反应不足或不耐受的患者的健康相关生活质量 (HRQoL) 和其他患者报告的结果 (PROs) 的影响1 次试用。方法 患有活动性 PsA 的成年患者 (n = 964) 随机 (1:1) 接受 risankizumab 150 mg 或安慰剂。评估的 PRO 包括 36 项简短健康调查 (SF-36, v2)、慢性疾病治疗功能评估 - 疲劳 (FACIT-Fatigue)、EuroQoL-5 维度 5 级 (EQ-5D-5L)、患者疼痛评估、患者疾病活动总体评估 (PtGA) 以及工作效率和活动障碍-PsA (WPAI-PsA) 问卷。比较 risankizumab 和安慰剂在第 24 周时从基线的最小二乘 (LS) 平均变化。结果 在第 24 周，使用 SF-36 物理成分总结和心理成分总结中基线的 LS 平均变化观察组间差异；FACIT-疲劳；EQ-5D-5L；患者对疼痛的评估；铂GA；所有八个 SF-36 域（所有标称 P < 0.001）；以及工作时损伤（出勤）、总体工作损伤和活动损伤的 WPAI-PsA 域（所有名义 P < 0.01）。结论 Risankizumab 治疗可显着改善患有 csDMARD-IR 的活动性 PsA 患者的 HRQoL、疲劳、疼痛和工作效率，与安慰剂相比。试验注册 ClinicalTrials.gov，https://clinicaltrials.gov，NCT03675308