司库奇尤单抗在银屑病关节炎GRAPPA各领域的疗效:3期KEEPsAKE 1和2研究患者的汇总分析

Efficacy of risankizumab across GRAPPA domains in psoriatic arthritis: a pooled analysis of patients from the phase 3 KEEPsAKE 1 and 2 studies.

作者信息

Coates Laura C, Blanco Ricardo, Behrens Frank, Ogdie Alexis, Van den Bosch Filip, Ranza Roberto, Klionsky Yael, Soliman Ahmed M, Chen Michael, Coombs Derek, Shi Linyu, Urbanik Jamie R, Iyile Thomas, Lippe Ralph, Gossec Laure

机构信息

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK

Department of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.

出版信息

RMD Open. 2025 Aug 25;11(3):e005522. doi: 10.1136/rmdopen-2025-005522.

Abstract

OBJECTIVE

To assess the efficacy of long-term treatment with risankizumab across the updated Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) domains and key related conditions of psoriatic arthritis (PsA).

METHODS

This post hoc analysis primarily used data from the phase 3 KEEPsAKE 1 trial of adult patients with PsA, with data from KEEPsAKE 2 pooled for prespecified outcomes. Outcomes measuring risankizumab efficacy across key GRAPPA-recognised domains of PsA (peripheral arthritis, enthesitis, dactylitis, skin and nail psoriasis, axial disease) and PsA-related conditions such as inflammatory bowel disease (IBD) and uveitis were assessed over 100 weeks of treatment (~2 years). Statistical approaches included non-responder imputation (as-observed with imputation) for categorical variables and mixed-effect model for repeated measures for continuous variables including as-observed measurements at all visits. PsA-related conditions were evaluated via adverse events through 100 weeks.

RESULTS

Overall, in KEEPsAKE 1 and KEEPsAKE 2, 412/483 (85.3%) and 181/224 (80.8%) of patients randomised to risankizumab completed treatment to week 100. Risankizumab demonstrated efficacy across all GRAPPA-defined domains through 100 weeks, including swollen and tender joint counts, enthesitis, dactylitis, skin and nail outcomes, and axial disease. In KEEPsAKE 1, 42.4% of patients had achieved a Disease Activity in Psoriatic Arthritis measurement of low disease activity and 62.9% had reached a minimal clinically important difference in pain at week 100. Rates of new onset or flare of IBD and uveitis were low.

CONCLUSIONS

Treatment with risankizumab provides durable improvement in the signs and symptoms of PsA across all GRAPPA disease domains and related conditions.

摘要

目的

评估在银屑病和银屑病关节炎研究与评估小组(GRAPPA)更新的领域以及银屑病关节炎(PsA)的关键相关病症中,长期使用司库奇尤单抗治疗的疗效。

方法

这项事后分析主要使用了PsA成年患者3期KEEPsAKE 1试验的数据,并汇总了KEEPsAKE 2中针对预先指定结局的数据。在长达100周(约2年)的治疗过程中,评估了衡量司库奇尤单抗在PsA关键的GRAPPA认可领域(外周关节炎、附着点炎、指(趾)炎、皮肤和指甲银屑病、中轴疾病)以及PsA相关病症(如炎症性肠病(IBD)和葡萄膜炎)方面疗效的结局指标。统计方法包括对分类变量采用无反应者插补法(观察值插补),对连续变量采用重复测量混合效应模型,包括所有访视时的观察测量值。通过100周内的不良事件评估PsA相关病症。

结果

总体而言,在KEEPsAKE 1和KEEPsAKE 2中,随机分配至司库奇尤单抗组的患者分别有412/483(85.3%)和181/224(80.8%)完成了至第100周的治疗。司库奇尤单抗在长达100周的时间里在所有GRAPPA定义的领域均显示出疗效,包括肿胀和压痛关节计数、附着点炎、指(趾)炎、皮肤和指甲结局以及中轴疾病。在KEEPsAKE 1中,42.4%的患者在第100周时达到了银屑病关节炎疾病活动度低疾病活动度的测量标准,62.9%的患者在疼痛方面达到了最小临床重要差异。IBD和葡萄膜炎的新发或复发率较低。

结论

司库奇尤单抗治疗可使PsA在所有GRAPPA疾病领域及相关病症的体征和症状得到持久改善。

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