Mease Philip J, Lertratanakul Apinya, Papp Kim A, van den Bosch Filip E, Tsuji Shigeyoshi, Dokoupilova Eva, Keiserman Mauro W, Bu Xianwei, Chen Liang, McCaskill Reva M, Zueger Patrick, McDearmon-Blondell Erin L, Pangan Aileen L, Tillett William
Department of Rheumatology, Providence St. Joseph Health and University of Washington, Seattle, WA, USA.
Seattle Rheumatology Associates/Swedish Medical Center, 601 Broadway, Seattle, 98122, WA, USA.
Rheumatol Ther. 2021 Jun;8(2):903-919. doi: 10.1007/s40744-021-00305-z. Epub 2021 Apr 28.
Upadacitinib is a Janus kinase inhibitor under investigation in patients with psoriatic arthritis (PsA). This study assessed the 56-week efficacy and safety of upadacitinib in patients with PsA and an inadequate response or intolerance to biologic therapy.
In the phase 3 SELECT-PsA 2 study, patients were randomized to 56 weeks of blinded treatment with oral upadacitinib 15 or 30 mg once daily, or placebo switched to upadacitinib 15 or 30 mg once daily at week 24. Efficacy endpoints included the proportion of patients achieving 20/50/70% improvement in American College of Rheumatology criteria (ACR20/50/70), 75/90/100% improvement in Psoriasis Area and Severity Index (PASI75/90/100), and minimal disease activity. Safety was assessed throughout the study.
Of 641 patients who received ≥ 1 dose of study drug, 479 (74.7%) completed 56 weeks of treatment. Improvements in the proportion of patients achieving ACR20/50/70, PASI75/90/100, and minimal disease activity were maintained with both doses of upadacitinib through 56 weeks. Week 56 results for patients who switched from placebo to upadacitinib at week 24 were similar to those for patients originally randomized to the upadacitinib groups. The exposure-adjusted event rate for serious infections was 2.6 and 6.1 events/100 patient-years in the upadacitinib 15 and 30 mg groups, respectively. Herpes zoster occurred more frequently with upadacitinib 30 versus 15 mg; most cases were non-serious.
In patients with PsA who had an inadequate response or intolerance to biologic therapy, the efficacy of upadacitinib was maintained over 56 weeks with no new significant safety signals observed.
NCT03104374.
乌帕替尼是一种正在银屑病关节炎（PsA）患者中进行研究的 Janus 激酶抑制剂。本研究评估了乌帕替尼在对生物治疗反应不足或不耐受的 PsA 患者中的 56 周疗效和安全性。
在 3 期 SELECT-PsA 2 研究中，患者被随机分配接受为期 56 周的盲法治疗，每日口服 15 或 30 mg 乌帕替尼，或安慰剂，并在第 24 周改为每日口服 15 或 30 mg 乌帕替尼。疗效终点包括达到美国风湿病学会标准（ACR20/50/70）改善 20/50/70%、银屑病面积和严重程度指数（PASI75/90/100）改善 75/90/100%以及最小疾病活动度的患者比例。在整个研究过程中评估安全性。
在接受≥1 剂研究药物的 641 例患者中，479 例（74.7%）完成了 56 周的治疗。两种剂量的乌帕替尼在 56 周内均维持了达到 ACR20/50/70、PASI75/90/100 和最小疾病活动度的患者比例的改善。第 24 周从安慰剂转为乌帕替尼的患者在第 56 周的结果与最初随机分配到乌帕替尼组的患者相似。乌帕替尼 15 mg 组和 30 mg 组严重感染的暴露调整事件发生率分别为 2.6 次和 6.1 次/100 患者年。与 15 mg 乌帕替尼相比，30 mg 乌帕替尼组带状疱疹的发生频率更高；大多数病例不严重。
在对生物治疗反应不足或不耐受的 PsA 患者中，乌帕替尼的疗效在 56 周内得以维持，未观察到新的重大安全信号。
NCT03104374。
