Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 196-Week Results from the KEEPsAKE 1 and KEEPsAKE 2 Randomized Clinical Trials.

IF 2.9 3区医学 Q2 RHEUMATOLOGY

Rheumatology and Therapy Pub Date : 2025-09-30 DOI:10.1007/s40744-025-00793-3

Andrew Östör, Filip Van den Bosch, Kim Papp, Mauro Keiserman, Ricardo Blanco, Angela Crowley, Douglas White, Ana Biljan, Tshepiso Madihlaba, Kyle Carter, Fang Liu, Ahmed M Soliman, Doug Ashley, Michael Chen, Lila Glotfelty, Alan Kivitz

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引用次数: 0

Abstract

Introduction: The ongoing KEEPsAKE 1 and 2 (KS1; KS2) trials evaluate the efficacy and safety of risankizumab in patients with psoriatic arthritis (PsA) who had an inadequate response to ≥ 1 conventional synthetic disease-modifying antirheumatic drug(s) (csDMARD-IR, KS1&2) and/or 1-2 biologic DMARDs (bDMARD-IR, KS2). Herein, we present week 196 efficacy and safety findings from KS1 and KS2.

Methods: Patients were randomized 1:1 in a double-blind fashion to receive subcutaneous risankizumab 150 mg or placebo (weeks 0, 4, 16, and 24). All patients received open-label risankizumab at week 28 and every 12 weeks thereafter (i.e., continuous risankizumab, placebo/risankizumab). Assessments included ≥ 20%/50%/70% improvement in PsA symptoms using American College of Rheumatology criteria (ACR20/50/70) and achievement of minimal disease activity (MDA).

Results: At week 196, 749 patients remained in KS1 and 289 in KS2. In KS1, 57.1% of patients receiving continuous risankizumab and 56.5% receiving placebo/risankizumab achieved ACR20, while 54.5% receiving continuous risankizumab and 50.2% receiving placebo/risankizumab achieved ACR20 in KS2 at week 196. Maintenance of ACR20 achievement in KS1 from week 52 to week 196 was observed for 71.0% of patients receiving continuous risankizumab and 72.7% receiving placebo/risankizumab. The same was observed in KS2 for 68.7% of patients receiving continuous risankizumab and 73.0% receiving placebo/risankizumab. The proportion of patients achieving MDA was 39.6% receiving continuous risankizumab and 35.2% receiving placebo/risankizumab in KS1, while 35.3% of patients receiving continuous risankizumab and 37.4% receiving placebo/risankizumab achieved MDA in KS2 at week 196. In KS1, maintenance of MDA at week 196 from week 52 was achieved by 72.8% of patients receiving continuous risankizumab and 72.2% receiving placebo/risankizumab. In KS2, 77.0% of patients receiving continuous risankizumab and 70.3% receiving placebo/risankizumab achieved the same. No new safety signals were reported.

Conclusions: Risankizumab demonstrated durable efficacy and safety at week 196 in KS1 and KS2.

Trial registration: KS1: ClinicalTrials.gov, NCT03675308; KS2: ClinicalTrials.gov, NCT03671148.

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利桑单抗治疗活动性银屑病关节炎的疗效和安全性：来自KEEPsAKE 1和KEEPsAKE 2随机临床试验196周的结果

正在进行的KEEPsAKE 1和2 （KS1; KS2）试验评估了risankizumab对≥1种常规合成疾病改善抗风湿药物（csDMARD-IR, KS1&2）和/或1-2种生物dmard （bDMARD-IR, KS2）反应不足的银屑病关节炎（PsA）患者的疗效和安全性。在此，我们报告了第196周KS1和KS2的疗效和安全性结果。方法：患者以双盲方式按1:1随机分组，分别接受150mg皮下瑞善珠单抗或安慰剂治疗（第0、4、16和24周）。所有患者在第28周和之后每12周接受开放标签的利桑单抗治疗（即持续的利桑单抗、安慰剂/利桑单抗）。评估包括使用美国风湿病学会标准（ACR20/50/70）的PsA症状改善≥20%/50%/70%和达到最小疾病活动度（MDA）。结果：在第196周，749例患者留在KS1, 289例患者留在KS2。在KS1中，57.1%接受持续瑞桑单抗的患者和56.5%接受安慰剂/瑞桑单抗的患者达到ACR20，而54.5%接受持续瑞桑单抗的患者和50.2%接受安慰剂/瑞桑单抗的患者在KS2第196周达到ACR20。从第52周到第196周，71.0%接受持续利桑单抗治疗的患者和72.7%接受安慰剂/利桑单抗治疗的患者在KS1中维持ACR20水平。在接受持续利桑单抗治疗的患者中，68.7%的KS2患者和73.0%接受安慰剂/利桑单抗治疗的患者也观察到同样的结果。在KS1期，接受持续利桑单抗治疗的患者达到MDA的比例为39.6%，接受安慰剂/利桑单抗治疗的患者为35.2%，而在第196周，接受持续利桑单抗治疗的患者为35.3%，接受安慰剂/利桑单抗治疗的患者为37.4%。在KS1中，从第52周开始的第196周，72.8%接受持续利桑单抗治疗的患者和72.2%接受安慰剂/利桑单抗治疗的患者实现了MDA的维持。在KS2中，77.0%接受持续利桑单抗的患者和70.3%接受安慰剂/利桑单抗的患者达到了相同的效果。没有新的安全信号报道。结论：Risankizumab在KS1和KS2的第196周表现出持久的有效性和安全性。试验注册：KS1: ClinicalTrials.gov, NCT03675308；KS2: ClinicalTrials.gov, NCT03671148。

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来源期刊

Rheumatology and Therapy RHEUMATOLOGY-

CiteScore

6.00

自引率

5.30%

发文量

审稿时长

6 weeks

期刊介绍： Aims and Scope Rheumatology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of rheumatologic therapies. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. Areas of focus include, but are not limited to, rheumatoid arthritis, gout, gouty arthritis, psoriatic arthritis, osteoarthritis, juvenile idiopathic/rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, Pompe’s disease, inflammatory joint conditions, musculoskeletal conditions, systemic sclerosis, and fibromyalgia. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial protocols, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Rheumatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Ethics and Disclosures The journal is a member of the Committee on Publication Ethics (COPE) and subscribes to its principles on how to deal with acts of misconduct thereby committing to investigate allegations of misconduct in order to ensure the integrity of research. Content in this journal is peer-reviewed (Single-blind). 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