Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE 2 Randomized Clinical Trial

IF 2.9 3区医学 Q2 RHEUMATOLOGY

Rheumatology and Therapy Pub Date : 2024-03-18 DOI:10.1007/s40744-024-00657-2

Andrew Östör, Filip Van den Bosch, Kim Papp, Cecilia Asnal, Ricardo Blanco, Jacob Aelion, Kyle Carter, Vassilis Stakias, Ralph Lippe, Leonidas Drogaris, Ahmed M. Soliman, Michael M. Chen, Byron Padilla, Alan Kivitz

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引用次数: 0

Abstract

Introduction

Long-term therapeutic options providing durable response and tolerability are needed for psoriatic arthritis (PsA). The ongoing KEEPsAKE 2 trial is evaluating risankizumab treatment in patients with active PsA who previously had inadequate response/intolerance to ≥ 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR) and/or 1–2 biologic DMARDs (bDMARD-IR). Herein, we report results through 100 weeks of treatment.

Methods

KEEPsAKE 2 is a global phase 3 trial. Patients with active PsA were randomized 1:1 to double-blind subcutaneous risankizumab 150 mg or placebo (weeks 0, 4, and 16). At week 24, all patients received open-label risankizumab every 12 weeks until end of study. Efficacy endpoints included achieving ≥ 20% improvement in PsA symptoms using American College of Rheumatology criteria (ACR20), attaining minimal disease activity (MDA; meeting ≥ 5/7 criteria of low disease activity and extent), and improving in other measures.

Results

At the cutoff date, 345/443 (77.9%) patients were ongoing in the study. ACR20 was achieved in 57.1% and 52.5% of the continuous risankizumab and placebo/risankizumab cohorts, respectively, at week 100 and in 60.0% and 55.8%, respectively, at week 52. In week 52 responders, maintenance of ACR20 at week 100 was achieved in 74.8% (continuous risankizumab) and 78.7% (placebo/risankizumab) of patients. In the continuous risankizumab and placebo/risankizumab cohorts, respectively, MDA was achieved by 33.0% and 33.3% of patients at week 100 and by 27.2% and 33.8% at week 52. Among MDA responders at week 52, maintenance of MDA response was achieved by 83.6% and 73.0% of the continuous risankizumab and placebo/risankizumab cohorts, respectively. Risankizumab was well tolerated through week 100.

Conclusions

Risankizumab demonstrated durable efficacy and tolerability through 100 weeks; most patients who achieved ACR20 and MDA responses at week 52 maintained this achievement through week 100. There were no new safety signals in patients who had csDMARD-IR and bDMARD-IR.

Trial Registration

ClinicalTrials.gov NCT03671148.

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利桑珠单抗治疗活动性银屑病关节炎的有效性和安全性：KEEPsAKE 2 随机临床试验的 100 周结果

导言银屑病关节炎（PsA）需要具有持久反应和耐受性的长期治疗方案。正在进行的KEEPsAKE 2试验正在评估利桑单抗治疗活动性PsA患者的疗效，这些患者曾对≥1种传统合成改善病情抗风湿药（csDMARD-IR）和/或1-2种生物DMARDs（bDMARD-IR）反应不足/不耐受。方法KEEPsAKE 2是一项全球性的3期试验。活动性 PsA 患者按 1:1 随机分配到双盲皮下注射利桑珠单抗 150 毫克或安慰剂（第 0、4 和 16 周）。第24周时，所有患者接受开放标签利桑珠单抗治疗，每12周一次，直至研究结束。疗效终点包括：根据美国风湿病学会标准（ACR20），PsA症状改善≥20%；达到最小疾病活动度（MDA；符合≥5/7的低疾病活动度和程度标准）；以及其他指标改善。在第100周时，利桑珠单抗和安慰剂/利桑珠单抗组分别有57.1%和52.5%的患者达到ACR20，在第52周时，分别有60.0%和55.8%的患者达到ACR20。在第52周有反应的患者中，第100周ACR20维持率达到74.8%（持续利抗珠单抗）和78.7%（安慰剂/利抗珠单抗）的患者。在利桑珠单抗持续治疗组和安慰剂/利桑珠单抗治疗组中，分别有33.0%和33.3%的患者在第100周和第52周达到了MDA，分别有27.2%和33.8%的患者达到了MDA。在第52周的MDA应答者中，持续使用利桑珠单抗和安慰剂/利桑珠单抗组分别有83.6%和73.0%的患者维持了MDA应答。结论利桑珠单抗在100周内表现出持久的疗效和耐受性；大多数在第52周达到ACR20和MDA应答的患者在第100周内保持了这一疗效和耐受性。在使用 csDMARD-IR 和 bDMARD-IR 的患者中没有出现新的安全性信号。

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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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