Evidence map›Paper›PMID 38498141›Full record

ArticleRheumatology and therapy2024

Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the Phase 3 KEEPsAKE 1 Randomized Clinical Trial.

Lars Erik Kristensen, Mauro Keiserman, Kim Papp, Leslie McCasland, Douglas White, Kyle Carter, Ralph Lippe, Huzefa Photowala, Leonidas Drogaris, Ahmed M Soliman and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03675308 (A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
5.2field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT03675308 phase3active not recruitingnot on this map

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)

TypeinterventionalSponsorAbbVieRan2019 to 2026Enrolled964ConditionsPsoriatic ArthritisArmsPlacebo, Risankizumab
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 6 countries.

Lars Erik KristensenThe Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Nordre Fasanvej 57 Road 8, Entrance 19, 2000, Frederiksberg, Copenhagen, Denmark. lars.erik.kristensen@regionh.dk.
Mauro KeisermanRheumatology Section, Pontifical Catholic University, School of Medicine, Porto Alegre, Brazil.
Kim PappProbity Medical Research and Alliance Clinical Trials, Waterloo, ON, Canada.ORCID http://orcid.org/0000-0001-9557-3642
Leslie McCaslandArthritis and Rheumatism Associates, LLC, Jonesboro, AR, USA.
Douglas WhiteRheumatology Department, Waikato Hospital, Hamilton, New Zealand.ORCID http://orcid.org/0000-0003-0839-8511
Kyle CarterAbbVie Inc, North Chicago, IL, USA.
Ralph LippeAbbVie Inc, North Chicago, IL, USA.
Huzefa PhotowalaAbbVie Inc, North Chicago, IL, USA.
Leonidas DrogarisAbbVie Inc, North Chicago, IL, USA.
Ahmed M SolimanAbbVie Inc, North Chicago, IL, USA.
Michael ChenAbbVie Inc, North Chicago, IL, USA.
Byron PadillaAbbVie Inc, North Chicago, IL, USA.
Frank BehrensRheumatology, Immunology, Inflammation Medicine, University Hospital and Fraunhofer Institute for Translational Medicine & Pharmacology ITMP, Fraunhofer Cluster of Excellence Immune-Mediated Diseases CIMD, Goethe University, Frankfurt Am Main, Germany.ORCID http://orcid.org/0000-0001-8750-7186
AbbVie (United States) · USArthritis and Rheumatism Associates · USFrederiksberg Hospital · DKGoethe University Frankfurt · DEPontifícia Universidade Católica do Rio Grande do Sul · BRUniversity of Auckland · NZUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients 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).

methodsKEEPsAKE 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.

resultsOverall, 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.

conclusionsFor 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 registrationClinicalTrials.gov identifier, NCT03675308.

Indexed as

csDMARD-IRIL-23KEEPsAKE 1Long-term treatmentPsoriatic arthritisRisankizumab

Identifiers

PMID38498141
PMCPMC11111619
OpenAlexW4392911023

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.