Evidence map›Paper›PMID 34911706›Full record

Trial reportAnnals of the rheumatic diseases2022

Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial.

Lars Erik Kristensen, Mauro Keiserman, Kim Papp, Leslie McCasland, Douglas White, Wenjing Lu, Zailong Wang, Ahmed M Soliman, Ann Eldred, Lisa Barcomb and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2022. 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 70 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 11 pooled it
18.5field-weighted citation impact, top 1% 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

70 citing papers in PubMed, 11 syntheses or guidelines pooled it, 135 citations in OpenAlex.

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10 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 6 countries.

Lars Erik KristensenThe Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark lars.erik.kristensen@regionh.dk.
Mauro KeisermanRheumatology Section, Pontifical Catholic University, School of Medicine, Porto Alegre, Brazil.
Kim PappProbity Medical Research-K Papp Clinical Research, Waterloo, Ontario, Canada.
Leslie McCaslandDepartment of Rheumatology, Loyola University Medical Center, Maywood, Illinois, USA, and Department of Veterans Affairs, Hines VA Hospital, Hines, Illinois, USA.
Douglas WhiteRheumatology Department, Waikato Hospital, Hamilton, New Zealand, and Waikato Clinical School, University of Auckland, Auckland, New Zealand.
Wenjing LuAbbVie Inc, North Chicago, Illinois, USA.
Zailong WangAbbVie Inc, North Chicago, Illinois, USA.
Ahmed M SolimanAbbVie Inc, North Chicago, Illinois, USA.
Ann EldredAbbVie Inc, North Chicago, Illinois, USA.
Lisa BarcombAbbVie Inc, North Chicago, Illinois, USA.
Frank BehrensCIRI/Rheumatology & Fraunhofer Institute for Translational Medicine and Pharmacology (ITMP), Fraunhofer Cluster of Excellence for Immune-Mediated Disease (CIMD), Goethe University, Frankfurt, Germany.
AbbVie (United States) · USEdward Hines, Jr. VA Hospital · USFraunhofer Institute for Translational Medicine and Pharmacology · DEFrederiksberg Hospital · DKPontifícia 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

objectiveTo evaluate risankizumab, a biological therapy that inhibits interleukin 23, in patients with active psoriatic arthritis (PsA) who have responded inadequately or are intolerant to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD).

methodsIn the randomised, placebo-controlled, double-blind KEEPsAKE 1 trial, 964 patients with active PsA were randomised (1:1) to receive risankizumab 150 mg or placebo at weeks 0, 4 and 16. The primary endpoint was the proportion of patients achieving ≥20% improvement in American College of Rheumatology criteria (ACR20) at week 24. Here, we report the results from the 24-week double-blind period; the open-label period with all patients receiving risankizumab is ongoing.

resultsAt week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (57.3% vs placebo, 33.5%; p<0.001). Significant differences were also observed for risankizumab versus placebo for the first eight ranked secondary endpoints, including skin and nail psoriasis endpoints, minimal disease activity and resolution of enthesitis and dactylitis (p<0.001). Adverse events and serious adverse events were reported at similar rates in the risankizumab and placebo groups. Serious infections were reported for 1.0% and 1.2% of patients receiving risankizumab and placebo, respectively. There was one death in the risankizumab group (urosepsis deemed unrelated to the study drug).

conclusionsRisankizumab treatment results in significantly greater improvement of signs and symptoms of PsA compared with placebo and is well tolerated in patients with active PsA who have responded inadequately or are intolerant to ≥1 csDMARD. TRIAL REGISTRATION NUMBER: NCT03675308.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntirheumatic AgentsArthritis, PsoriaticDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, MonoclonalAntirheumatic Agentsrisankizumabarthritisbiological therapypsoriatic

Identifiers

PMID34911706
PMCPMC8762015
OpenAlexW4200318327

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.