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Introduction <p>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&amp;2) and/or 1–2 biologic DMARDs (bDMARD-IR, KS2). Herein, we present week 196 efficacy and safety findings from KS1 and KS2.</p> Methods <p>Patients were randomized 1:1 in a double-blind fashion to receive subcutaneous risankizumab 150&#xa0;mg or placebo (weeks 0, 4, 16, and 24). All patients received open-label risankizumab at week 28 and every 12&#xa0;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).</p> Results <p>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.</p> Conclusions <p>Risankizumab demonstrated durable efficacy and safety at week 196 in KS1 and KS2.</p> Trial Registration <p>KS1: ClinicalTrials.gov, NCT03675308; KS2: ClinicalTrials.gov, NCT03671148.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月30日

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  • 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

摘要

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.