Evidence map›Paper›PMID 36282530›Full record

Trial reportRheumatology (Oxford, England)2023

Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study.

Lars Erik Kristensen, Mauro Keiserman, Kim Papp, Leslie McCasland, Douglas White, Wenjing Lu, Ahmed M Soliman, Ann Eldred, Lisa Barcomb, Frank Behrens

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2023. 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 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
4.9field-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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Monotherapy or combination therapy in PsA: current aspects.Therapeutic advances in musculoskeletal disease · 2024
    Review
  12. Early psoriatic arthritis: when is the right time to start advanced therapy?Therapeutic advances in musculoskeletal disease · 2024
    Review
  13. Review
  14. Review
  15. Article
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

10 authors at 7 institutions in 6 countries.

Lars Erik KristensenThe Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.ORCID 0000-0002-0686-7102
Mauro KeisermanRheumatology Section, Pontifical Catholic University, School of Medicine, Porto Alegre, Brazil.
Kim PappProbity Medical Research-K Papp Clinical Research, Waterloo, ON, Canada.
Leslie McCaslandDepartment of Rheumatology, Loyola University Medical Center, Maywood, IL, USA.
Douglas WhiteRheumatology Department, Waikato Hospital, Hamilton, New Zealand.
Wenjing LuAbbVie Inc., North Chicago, IL, USA.
Ahmed M SolimanAbbVie Inc., North Chicago, IL, USA.
Ann EldredAbbVie Inc., North Chicago, IL, USA.
Lisa BarcombAbbVie Inc., North Chicago, IL, USA.
Frank BehrensRheumatology & Fraunhofer Institute for Translational Medicine and Pharmacology (ITMP), Fraunhofer Cluster of Excellence for Immune-Mediated Disease (CIMD), Goethe University, Frankfurt, Germany.
AbbVie (United States) · USFrederiksberg Hospital · DKGoethe University Frankfurt · DELoyola University Medical Center · USPontifícia Universidade Católica do Rio Grande do Sul · BRProbity Medical Research · CAUniversity of Auckland · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePsA is a chronic disease with heterogeneous clinical manifestations requiring treatment options with long-term efficacy and safety. In this follow-up analysis, the 52-week efficacy and safety of risankizumab 150 mg in patients with active PsA who had previous inadequate response/intolerance to one or more conventional synthetic DMARDs (csDMARD-IR) were evaluated.

methodsKEEPsAKE 1 is an ongoing, global, phase 3 study with a 24-week, double-blind, placebo-controlled period (period 1) and an open-label extension period (period 2). In period 1, eligible patients were randomized 1:1 to receive subcutaneous risankizumab 150 mg or placebo at weeks 0, 4 and 16. At week 24 (period 2), all continuing patients received open-label risankizumab 150 mg every 12 weeks through week 208.

resultsAt week 24, 57.3% of risankizumab-treated patients (n = 483) achieved ≥20% improvement in ACR criteria (ACR20) vs 33.5% of placebo-treated patients (n = 481; P < 0.001). At week 52, 70.0% of patients who were randomized to receive continuous risankizumab therapy and 63.0% of patients who were randomized to receive placebo in period 1 and then receive risankizumab at week 24 achieved ACR20. Similar result trends were observed for other efficacy measures. Risankizumab was well tolerated through 52 weeks of treatment with a consistent safety profile from week 24 through week 52.

conclusionIn patients with active PsA who were csDMARD-IR, continuous risankizumab treatment demonstrated robust long-term efficacy and was well tolerated through 52 weeks of treatment.

trial registrationClinicalTrials.gov, http://clinicaltrials.gov, KEEPsAKE1, NCT03675308.

Indexed as

Antirheumatic AgentsArthritis, PsoriaticAntibodies, MonoclonalDouble-Blind MethodHumansInjections, SubcutaneousSeverity of Illness IndexTreatment OutcomeAntibodies, MonoclonalAntirheumatic Agentsrisankizumabbiologic agentDMARDIL-23PsArisankizumab

Identifiers

PMID36282530
PMCPMC10234205
OpenAlexW4307232993

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.