Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the Phase 3 KEEPsAKE 1 Randomized Clinical Trial
IF 2.9
3区 医学
Q2 RHEUMATOLOGY
引用次数: 0
Abstract
Introduction
Patients with psoriatic arthritis (PsA) require treatment providing durable long-term efficacy in different disease domains as well as safety. We present 100-week efficacy and safety results of risankizumab in patients with active PsA and previous inadequate response/intolerance to ≥ 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR).
Methods
KEEPsAKE 1 (NCT03675308) is a global phase 3 study, including a 24-week, double-blind, placebo-controlled and ongoing open-label extension periods. Patients were randomized 1:1 to receive risankizumab 150 mg or placebo at baseline and weeks 4 and 16. After week 24, all patients received open-label risankizumab every 12 weeks thereafter. Patients were evaluated through 100 weeks. Endpoints included achieving ≥ 20% reduction in American College of Rheumatology criteria for symptoms of rheumatoid arthritis (ACR20), minimal disease activity (MDA; defined as ≥ 5/7 criteria of low disease activity and extent), and other measures.
Results
Overall, 828/964 (85.9%) patients completed week 100. For patients receiving continuous risankizumab, 57.3%, 70.6%, and 64.3% achieved ACR20 at weeks 24, 52, and 100, respectively. For the placebo/risankizumab cohort, 33.5% achieved ACR20 at week 24 but increased after switching to active treatment at weeks 52 (63.7%) and 100 (62.1%). In ACR20 responders at week 52, 81.2% of both treatment cohorts maintained response at week 100. MDA was achieved by 25.0%, 38.3%, and 38.2% of the continuous risankizumab cohort at weeks 24, 52, and 100. In the placebo/risankizumab cohort, 10.2% achieved MDA at week 24, increasing at weeks 52 (28.0%) and 100 (35.2%). MDA response was maintained at week 100 in week 52 responders in the continuous risankizumab (75.5%) and placebo/risankizumab cohorts (78.2%). Similar trends were observed for other efficacy measures. Risankizumab was generally well tolerated through 100 weeks.
Conclusions
For patients with active PsA who are csDMARD-IR, risankizumab demonstrated durable long-term efficacy and was generally well tolerated, with a consistent long-term safety profile.
Trial Registration
ClinicalTrials.gov identifier, NCT03675308.
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 1 随机临床试验 3 期 100 周结果
导言银屑病关节炎（PsA）患者需要在不同疾病领域具有长期持久疗效和安全性的治疗。方法KEEPsAKE 1（NCT03675308）是一项全球性的三期研究，包括为期24周的双盲安慰剂对照和正在进行的开放标签延长期。患者按 1:1 随机分配，在基线、第 4 周和第 16 周接受利桑珠单抗 150 毫克或安慰剂治疗。第24周后，所有患者每12周接受一次开放标签利桑珠单抗治疗。对患者的评估持续了100周。终点包括美国风湿病学会类风湿性关节炎症状标准（ACR20）降低≥20%、最小疾病活动度（MDA；定义为疾病活动度和程度低的标准≥5/7）和其他指标。结果总体而言，828/964（85.9%）名患者完成了第100周的治疗。在连续接受利桑单抗治疗的患者中，分别有57.3%、70.6%和64.3%的患者在第24周、第52周和第100周达到了ACR20。在安慰剂/利桑珠单抗组中，33.5%的患者在第24周达到ACR20，但在第52周（63.7%）和第100周（62.1%）转为积极治疗后，这一比例有所上升。在第 52 周达到 ACR20 反应的患者中，81.2% 的患者在第 100 周保持了反应。在第 24 周、第 52 周和第 100 周，25.0%、38.3% 和 38.2% 的利桑珠单抗连续治疗组患者达到了 MDA。在安慰剂/利桑珠单抗队列中，10.2%的患者在第24周达到了MDA，在第52周（28.0%）和第100周（35.2%）时有所上升。利桑珠单抗持续治疗组（75.5%）和安慰剂/利桑珠单抗治疗组（78.2%）的第52周应答者在第100周时维持了MDA应答。其他疗效指标也呈类似趋势。结论对于使用csDMARD-IR的活动性PsA患者，利坦珠单抗显示出持久的长期疗效，耐受性一般，长期安全性一致。试验注册ClinicalTrials.gov标识符，NCT03675308。
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来源期刊
Rheumatology and Therapy
RHEUMATOLOGY-
CiteScore
6.00
自引率
5.30%
发文量
91
审稿时长
6 weeks
期刊介绍：
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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.
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