Evidence map›Paper›PMID 35801915›Full record

Trial reportRheumatology (Oxford, England)2023

Risankizumab improved health-related quality of life, fatigue, pain and work productivity in psoriatic arthritis: results of KEEPsAKE 1.

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

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 28% 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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Review
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

8 authors at 5 institutions in 5 countries.

Lars Erik KristensenThe Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark.ORCID 0000-0002-0686-7102
Ahmed M SolimanAbbVie Inc., North Chicago, IL, USA.
Kim PappK Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada.
Douglas WhiteRheumatology Department, Waikato Hospital, Hamilton.
Lisa BarcombAbbVie Inc., North Chicago, IL, USA.
Wenjing LuAbbVie Inc., North Chicago, IL, USA.
Ann EldredAbbVie Inc., North Chicago, IL, USA.
Frank BehrensRheumatology, Fraunhofer Institute Translational Medicine and Pharmacology ITMP & Cluster of Excellence CIMD, Goethe University, Frankfurt, Germany.
AbbVie (United States) · USFrederiksberg Hospital · DKGoethe University Frankfurt · DEProbity Medical Research · CAUniversity of Auckland · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesPsA is a heterogeneous disease that impacts many aspects of social and mental life, including quality of life. Risankizumab, an antagonist specific for IL-23, is currently under investigation for the treatment of adults with active PsA. This study evaluated the impact of risankizumab vs placebo on health-related quality of life (HRQoL) and other patient-reported outcomes (PROs) among patients with active PsA and inadequate response or intolerance to conventional synthetic DMARD (csDMARD-IR) in the KEEPsAKE 1 trial.

methodsAdult patients with active PsA (n = 964) were randomized (1:1) to receive risankizumab 150 mg or placebo. PROs assessed included the 36-Item Short-Form Health Survey (SF-36, v2), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), EuroQoL-5 Dimension-5 Level (EQ-5D-5L), Patient's Assessment of Pain, Patient's Global Assessment (PtGA) of Disease Activity, and Work Productivity and Activity Impairment-PsA (WPAI-PsA) questionnaire. Least squares (LS) mean change from baseline at week 24 was compared between risankizumab and placebo.

resultsAt week 24, differences between groups were observed using LS mean changes from baseline in SF-36 physical component summary and mental component summary; FACIT-Fatigue; EQ-5D-5L; Patient's Assessment of Pain; PtGA; all eight SF-36 domains (all nominal P < 0.001); and the WPAI-PsA domains of impairment while working (presenteeism), overall work impairment and activity impairment (all nominal P < 0.01).

conclusionRisankizumab treatment resulted in greater improvements in HRQoL, fatigue, pain and work productivity in patients with active PsA who have csDMARD-IR, when compared with placebo.

trial registrationClinicalTrials.gov, https://clinicaltrials.gov, NCT03675308.

Indexed as

Antirheumatic AgentsArthritis, PsoriaticAdultAntibodies, MonoclonalDouble-Blind MethodFatigueHumansPainPatient Reported Outcome MeasuresQuality of LifeTreatment OutcomeAntibodies, MonoclonalAntirheumatic Agentsrisankizumabbiological therapiesDMARDsoutcome measurespatient attitude to healthquality of lifespondyloarthropathies (including psoriatic arthritis)

Identifiers

PMID35801915
PMCPMC9891435
OpenAlexW4284961667

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.