Monash Medical School, Cabrini Hospital and Emertius Research, Melbourne, Victoria, Australia
Department of Rheumatology, Ghent University, VIB Center for Inflammation Research, Gent, Belgium.
Ann Rheum Dis. 2022 Mar;81(3):351-358. doi: 10.1136/annrheumdis-2021-221048. Epub 2021 Nov 23.
Risankizumab is an interleukin-23 inhibitor under study for the treatment of patients with psoriatic arthritis (PsA). The phase 3 KEEPsAKE 2 trial investigated the efficacy and safety of risankizumab versus placebo in patients with active PsA who had previous inadequate response or intolerance to ≤2 biological therapies (Bio-IR) and/or ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR). Results through week 24 are reported here.
Adults with PsA who were Bio-IR and/or csDMARD-IR were randomised to receive subcutaneously administered risankizumab 150 mg or placebo at weeks 0, 4 and 16 during a 24-week, double-blind treatment period. The primary endpoint was the proportion of patients who achieved ≥20% improvement in American College of Rheumatology score (ACR20) at week 24. Secondary endpoints assessed key domains of PsA and patient-reported outcomes.
A total of 444 patients (median age 53 years, range 23-84 years) were randomised to risankizumab (n=224) or placebo (n=220); 206 patients (46.5%) were Bio-IR. At week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (51.3% vs 26.5%, p<0.001) and all secondary endpoints (p<0.05) compared with placebo. Serious adverse events were reported for 4.0% and 5.5% of risankizumab-treated and placebo-treated patients, respectively; serious infections were reported for 0.9% and 2.3%, respectively.
Treatment with risankizumab resulted in significant improvements versus placebo in key disease outcomes and was well tolerated in patients with PsA who were Bio-IR and/or csDMARD-IR.
NCT03671148.
risankizumab 是一种白细胞介素 23 抑制剂，正在研究用于治疗银屑病关节炎（PsA）患者。3 期 KEEPsAKE 2 试验研究了 risankizumab 与安慰剂在先前对 ≤2 种生物疗法（Bio-IR）和/或 ≥1 种常规合成疾病修饰抗风湿药物（csDMARD-IR）反应不足或不耐受的活动性 PsA 患者中的疗效和安全性。这里报告的结果截至第 24 周。
先前对生物疗法反应不足或不耐受的活动性 PsA 患者，随机接受皮下注射 risankizumab 150mg 或安慰剂，在 24 周的双盲治疗期间，分别在第 0、4 和 16 周给药。主要终点是第 24 周达到美国风湿病学会评分（ACR20）改善≥20%的患者比例。次要终点评估了 PsA 的关键领域和患者报告的结果。
共 444 名患者（中位年龄 53 岁，范围 23-84 岁）被随机分配至 risankizumab（n=224）或安慰剂（n=220）；206 名患者（46.5%）为 Bio-IR。在第 24 周，接受 risankizumab 治疗的患者达到主要终点 ACR20 的比例显著高于安慰剂（51.3%比 26.5%，p<0.001）和所有次要终点（p<0.05）。 risankizumab 治疗组和安慰剂治疗组分别有 4.0%和 5.5%的患者报告了严重不良事件；分别有 0.9%和 2.3%的患者报告了严重感染。
在先前对生物疗法反应不足或不耐受的 PsA 患者中，与安慰剂相比， risankizumab 治疗可显著改善关键疾病结局，且耐受性良好。
NCT03671148。
