Evidence map›Paper›PMID 34815219›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 2 trial.

Andrew Östör, Filip Van den Bosch, Kim Papp, Cecilia Asnal, Ricardo Blanco, Jacob Aelion, Gabriela Alperovich, Wenjing Lu, Zailong Wang, Ahmed M Soliman and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
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 NCT03671148 (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), which is not on this map. Cited by 58 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 10 pooled it
13.6field-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.

NCT03671148 phase3completednot on this map

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)

TypeinterventionalSponsorAbbVieRan2019 to 2026Enrolled444ConditionsPsoriatic Arthritis (PsA)ArmsPlacebo, Risankizumab
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 10 syntheses or guidelines pooled it, 102 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 4 countries.

Andrew ÖstörMonash Medical School, Cabrini Hospital and Emertius Research, Melbourne, Victoria, Australia andrewostor@gmail.com.
Filip Van den BoschDepartment of Rheumatology, Ghent University, VIB Center for Inflammation Research, Gent, Belgium.ORCID 0000-0002-3561-5932
Kim PappProbity Medical Research-K Papp Clinical Research, Waterloo, Ontario, Canada.
Cecilia AsnalDOM Centro de Reumatología, Buenos Aires, Argentina.
Ricardo BlancoHospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.ORCID 0000-0003-2344-2285
Jacob AelionArthritis Clinic and West Tennessee Research Institute, Jackson, Tennessee, USA.
Gabriela AlperovichAbbVie Inc, Madrid, Spain.
Wenjing LuAbbVie Inc, Madrid, Spain.
Zailong WangAbbVie Inc, Madrid, Spain.
Ahmed M SolimanAbbVie Inc, Madrid, Spain.
Ann EldredAbbVie Inc, Madrid, Spain.
Lisa BarcombAbbVie Inc, Madrid, Spain.
Alan KivitzAbbVie Inc, North Chicago, Illinois, USA.
AbbVie (Spain) · ESAbbVie (United States) · USGhent University · BEInstituto de Investigación Marqués de Valdecilla · ESProbity Medical Research · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesRisankizumab is an interleukin-23 inhibitor under study for the treatment of patients with psoriatic arthritis (PsA). The phase 3 KEEPsAKE 2 trial investigated the efficacy and safety of risankizumab versus placebo in patients with active PsA who had previous inadequate response or intolerance to ≤2 biological therapies (Bio-IR) and/or ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR). Results through week 24 are reported here.

methodsAdults with PsA who were Bio-IR and/or csDMARD-IR were randomised to receive subcutaneously administered risankizumab 150 mg or placebo at weeks 0, 4 and 16 during a 24-week, double-blind treatment period. The primary endpoint was the proportion of patients who achieved ≥20% improvement in American College of Rheumatology score (ACR20) at week 24. Secondary endpoints assessed key domains of PsA and patient-reported outcomes.

resultsA total of 444 patients (median age 53 years, range 23-84 years) were randomised to risankizumab (n=224) or placebo (n=220); 206 patients (46.5%) were Bio-IR. At week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (51.3% vs 26.5%, p<0.001) and all secondary endpoints (p<0.05) compared with placebo. Serious adverse events were reported for 4.0% and 5.5% of risankizumab-treated and placebo-treated patients, respectively; serious infections were reported for 0.9% and 2.3%, respectively.

conclusionTreatment with risankizumab resulted in significant improvements versus placebo in key disease outcomes and was well tolerated in patients with PsA who were Bio-IR and/or csDMARD-IR. TRIAL REGISTRATION NUMBER: NCT03671148.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntirheumatic AgentsArthritis, PsoriaticDouble-Blind MethodFemaleHumansMaleMiddle AgedPatient Reported Outcome MeasuresTreatment OutcomeYoung AdultAntibodies, MonoclonalAntirheumatic Agentsrisankizumabarthritisbiological therapypsoriatic

Identifiers

PMID34815219
PMCPMC8862056
OpenAlexW3217287927

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.