ArticleRheumatology and therapy2025
Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 196-Week Results from the KEEPsAKE 1 and KEEPsAKE 2 Randomized Clinical Trials.
Article in Rheumatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE 2)
A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1)
Who cites it
1 citing paper in PubMed.
- Exploring clinical subtypes of Chinese patients with psoriatic arthritis based on cluster analysis: a national registry study (CREPAR V).Clinical rheumatology · 2026Article
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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe 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.
methodsPatients 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).
resultsAt 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.
conclusionsRisankizumab demonstrated durable efficacy and safety at week 196 in KS1 and KS2.
trial registrationKS1: ClinicalTrials.gov, NCT03675308; KS2: ClinicalTrials.gov, NCT03671148.
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