Efficacy and safety of izokibep in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study.

Methods

This phase 2, multicentre, placebo-controlledstudy randomised adult patients with active PsA 1:1:1 to izokibep 40 mg, izokibep 80 mg, or placebo every 2 weeks for 16 weeks; subsequently, placebo-treated patients switched to izokibep 80 mg.

这项2期、多中心、安慰剂对照研究将活跃的PsA成年患者按1:1:1的比例随机分配至每两周接受40毫克izokibep、80毫克izokibep或安慰剂治疗，持续16周；随后，接受安慰剂治疗的患者转换为80毫克izokibep治疗。

The primary end point was American College of Rheumatology criteria 50 (ACR50) at week 16 for izokibep 80 mg vs placebo.

主要终点是第16周时izokibep 80 mg与安慰剂组的美国风湿病学会标准50（ACR50）。

Additional efficacy end points and treatment-emergent adverse events were evaluated through week 16 (placebo-controlled) and week 46.

通过第16周（与安慰剂对照）和第46周评估了其他疗效终点和治疗后出现的不良事件。

Results

Of 172 patients screened, 135 were randomised to izokibep 40 mg (n = 44), izokibep 80 mg (n = 47), or placebo (n = 44).

在172名筛查的患者中，有135名被随机分配到izokibep 40 mg组（n = 44），izokibep 80 mg组（n = 47）或安慰剂组（n = 44）。

ACR50 response rates were significantly higher for izokibep 80 mg vs placebo at week 16 (52% vs 13%; 2-sided P = .0006) and week 12 (50% vs 6%; P < .0001); lower rates were observed for izokibep 40 mg (48% and 43% for weeks 16 and 12, respectively).

在第16周，izokibep 80 mg组与安慰剂组相比，ACR50反应率显著更高（52%对比13%；双侧P = .0006），在第12周也是如此（50%对比6%；P < .0001）；而izokibep 40 mg组的反应率较低（分别为第16周的48%和第12周的43%）。

Additional analyses of arthritis, psoriasis, enthesitis, dactylitis, and quality of life outcomes supported the efficacy of izokibep at both doses.

对关节炎、银屑病、附着点炎、指趾炎和生活质量结果的额外分析支持了izokibep两种剂量的疗效。

Response rates generally continued to increase through week 46 with izokibep 80 mg.

在第46周时，使用80毫克izokibep的反应率通常继续增加。

Treatment-emergent adverse eventrates were generally similar across treatment groups except for injection site reactions.

治疗相关不良事件的发生率在各治疗组之间大致相似，除了注射部位反应。

Conclusions

Izokibep resulted in significant and clinically meaningful improvements over placebo across multiple disease domains, and the originally randomised 80-mg dose showed continued improvements to week 46.

Izokibep与安慰剂相比，在多个疾病领域实现了显著且具有临床意义的改善，最初随机分配的80毫克剂量持续改善至第46周。

There were no unexpected safety risks identified.

未发现意外的安全风险。

Izokibep's small size and high potency have the potential for further improved disease control, justifying additional investigation of higher doses.

Izokibep的体积小且效力高，有望进一步改善疾病控制，这证明了对更高剂量进行进一步研究的合理性。