Evidence map›Paper›PMID 36282537›Full record

Trial reportRheumatology (Oxford, England)2023

Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study.

Andrew Östör, Filip Van den Bosch, Kim Papp, Cecilia Asnal, Ricardo Blanco, Jacob Aelion, Wenjing Lu, Zailong Wang, Ahmed M Soliman, Ann Eldred and 2 more

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 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 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
4.3field-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.

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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

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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

12 authors at 6 institutions in 5 countries.

Andrew ÖstörDepartment of Medicine, Monash University; Department of Rheumatology, Cabrini Hospital; and Emeritus Research, Melbourne, Victoria, Australia.ORCID 0000-0002-7929-4827
Filip Van den BoschDepartment of Rheumatology, Ghent University, and Unit for Molecular Immunology and Inflammation, VIB Center for Inflammation Research, Ghent, Belgium.
Kim PappProbity Medical Research-K. Papp Clinical Research, Waterloo, Ontario, Canada.
Cecilia AsnalDOM Centro de Reumatología, Buenos Aires, Argentina.
Ricardo BlancoRheumatology Division, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.
Jacob AelionArthritis Clinic and West Tennessee Research Institute, Jackson, TN, USA.
Wenjing LuAbbVie Inc, North Chicago, IL, USA.
Zailong WangAbbVie Inc, North Chicago, IL, USA.
Ahmed M SolimanAbbVie Inc, North Chicago, IL, USA.
Ann EldredAbbVie Inc, North Chicago, IL, USA.
Byron PadillaAbbVie Inc, North Chicago, IL, USA.
Alan KivitzAltoona Center for Clinical Research, Duncansville, PA, USA.
AbbVie (United States) · USAltoona Center for Clinical Research · USCabrini Hospital · AUGhent 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

objectivePsA is a chronic inflammatory disease in which the skin and joints are affected. 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 two biologic therapies (Bio-IR) or one or more conventional synthetic DMARDs (csDMARD-IR) were evaluated.

methodsIn the ongoing, phase 3, KEEPsAKE 2 trial, patients with active PsA were randomized 1:1 to receive subcutaneous risankizumab 150 mg or placebo at weeks 0, 4 and 16 (period 1). At week 24 (period 2), patients who received placebo were switched to risankizumab, and all patients received risankizumab 150 mg every 12 weeks from weeks 28 to 208.

resultsAt week 24, 51.3% of risankizumab-treated patients (n = 224) achieved ≥20% improvement in ACR criteria (ACR 20) vs 26.5% of placebo-treated patients (n = 220; P < 0.001). At week 52, 58.5% of patients randomized to receive continuous risankizumab achieved ACR20, and 55.7% of patients who switched from placebo to risankizumab at week 24 achieved ACR20. Similar trends were observed for other efficacy measures. Rates of serious treatment-emergent adverse events (TEAEs) and TEAEs leading to discontinuation remained stable through week 52, and no deaths were reported.

conclusionRisankizumab was well tolerated and improved symptoms of PsA in Bio-IR/csDMARD-IR patients, with a consistent long-term safety profile from weeks 24 to 52.

trial registrationUnited States National Library of Medicine clinical trials database www.clinicaltrials.gov; KEEPsAKE 2; NCT03671148.

Indexed as

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

Identifiers

PMID36282537
PMCPMC10234194
OpenAlexW4307230117

What OpenQuestion holds

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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.