Mease Philip J, Kellner Herbert, Morita Akimichi, Kivitz Alan J, Aslanyan Stella, Padula Steven J, Topp Andrew S, Eldred Ann, Behrens Frank, Papp Kim A
Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA.
Seattle Rheumatology Associates, 601 Broadway, Suite 600, Seattle, WA, 98122, USA.
Rheumatol Ther. 2022 Oct;9(5):1361-1375. doi: 10.1007/s40744-022-00474-5. Epub 2022 Aug 5.
The objective of this work was to assess the efficacy and safety of risankizumab in psoriatic arthritis (PsA) over 76 weeks.
In this double-blind, dose-ranging phase 2 study, adults with active PsA were randomized 2:2:2:1:2 to risankizumab 150 mg at weeks 0, 4, 8, 12, and 16 (arm 1), 150 mg at weeks 0, 4, and 16 (arm 2), 150 mg at weeks 0 and 12 (arm 3), 75 mg at week 0 (arm 4), or placebo (arm 5). Patients completing week 24 could receive risankizumab 150 mg in a 52-week open-label extension study. Efficacy assessments included American College of Rheumatology (ACR) responses, Psoriasis Area Severity Index (PASI) responses, minimal disease activity (MDA), and 28-joint Disease Activity Score based on C-reactive protein (DAS28[CRP]).
Of 185 randomized patients, 173 (93.5%) completed week 16 and 145 (78.4%) entered the open-label extension. Significantly more patients in each risankizumab arm achieved ACR20 at week 16 versus placebo (primary endpoint: pooled arms 1 + 2 [59.5%] versus placebo [35.7%]; treatment difference [90% CI] 24.0 [9.3, 38.7]; P = 0.007). Similarly, significantly more patients in most risankizumab arms achieved ACR20/50/70, PASI75/90/100, MDA, and greater improvements in DAS28(CRP) versus placebo at week 16. These benefits of risankizumab were maintained long term. Treatment-emergent adverse events were comparable across treatment arms. Risankizumab 150 mg was well tolerated over 76 weeks.
Risankizumab improved joint and skin symptoms versus placebo in patients with active PsA over 16 weeks; improvements were sustained long term. Risankizumab was well tolerated over the long term with no new safety findings.
NCT02719171 and NCT02986373.
本研究旨在评估司库奇尤单抗治疗银屑病关节炎（PsA）76周的疗效和安全性。
在这项双盲、剂量范围的2期研究中，活动性PsA成人患者按2:2:2:1:2随机分为5组，分别在第0、4、8、12和16周接受150mg司库奇尤单抗（第1组），在第0、4和16周接受150mg司库奇尤单抗（第2组），在第0和12周接受150mg司库奇尤单抗（第3组），在第0周接受75mg司库奇尤单抗（第4组），或接受安慰剂（第5组）。完成第24周的患者可在一项为期52周的开放标签扩展研究中接受150mg司库奇尤单抗治疗。疗效评估包括美国风湿病学会（ACR）反应、银屑病面积和严重程度指数（PASI）反应、最小疾病活动度（MDA）以及基于C反应蛋白的28关节疾病活动评分（DAS28[CRP]）。
185例随机分组患者中，173例（93.5%）完成了第16周的治疗，145例（78.4%）进入开放标签扩展研究。与安慰剂组相比，各司库奇尤单抗组在第16周达到ACR20的患者显著更多（主要终点：第1组和第2组合并组[59.5%]对比安慰剂组[35.7%]；治疗差异[90%CI]24.0[9.3,38.7]；P = 0.007）。同样，在第16周时，大多数司库奇尤单抗组达到ACR20/50/70、PASI75/90/100、MDA以及DAS28(CRP)改善更明显的患者显著多于安慰剂组。司库奇尤单抗的这些益处长期维持。各治疗组的治疗中出现的不良事件相当。150mg司库奇尤单抗在76周内耐受性良好。
与安慰剂相比，司库奇尤单抗在16周内改善了活动性PsA患者的关节和皮肤症状；改善效果长期维持。司库奇尤单抗长期耐受性良好，未发现新的安全性问题。
NCT02719171和NCT02986373。
