Evidence map›Paper›PMID 38739215›Full record

ArticleDermatology and therapy2024

Enthesitis and Dactylitis Resolution with Risankizumab for Active Psoriatic Arthritis: Integrated Analysis of the Randomized KEEPsAKE 1 and 2 Trials.

Shawn G Kwatra, Saakshi Khattri, Ahmad Z Amin, Roberto Ranza, Blair Kaplan, Linyu Shi, Byron Padilla, Ahmed M Soliman, Dennis McGonagle

2 registry-linked trialsAbstract read
In one paragraph

Article in Dermatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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
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

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. 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

9 authors.

Shawn G KwatraDepartment of Dermatology, John Hopkins University School of Medicine, 601 N Caroline St, 8th Floor, Baltimore, MD, 21287, USA. kwatra.shawn@gmail.com.ORCID http://orcid.org/0000-0003-3736-1515
Saakshi KhattriDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Ahmad Z AminDepartment of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Roberto RanzaRheumatology Unit, Hospital das Clínicas, Federal University of Uberlândia, Uberlândia, Brazil.
Blair KaplanAbbVie Inc, North Chicago, IL, USA.
Linyu ShiAbbVie Inc, North Chicago, IL, USA.
Byron PadillaAbbVie Inc, North Chicago, IL, USA.
Ahmed M SolimanAbbVie Inc, North Chicago, IL, USA.
Dennis McGonagleDivision of Rheumatology, University of Washington, Seattle, WA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe presence (vs absence) of enthesitis/dactylitis is associated with greater psoriatic arthritis (PsA) activity and reduced health-related quality of life. Risankizumab, an interleukin 23 antagonist, demonstrated superior treatment efficacy over placebo in patients with PsA, including enthesitis/dactylitis. Herein, we report the efficacy of risankizumab on complete resolution of enthesitis and/or dactylitis and improvements in patient-reported outcomes in patients with PsA.

methodsThis integrated post hoc analysis of data from KEEPsAKE 1 and KEEPsAKE 2 included patients with baseline enthesitis (Leeds Enthesitis Index > 0) and/or dactylitis (Leeds Dactylitis Index > 0). Efficacy outcomes at weeks 24 and 52 included proportion of patients achieving enthesitis and/or dactylitis resolution and minimal clinically important differences (MCID) in pain, Health Assessment Questionnaire-Disability Index, and Functional Assessment of Chronic Illness Therapy-Fatigue.

resultsOf 1407 patients, approximately 63%, 28%, and 20% had baseline enthesitis, dactylitis, and both enthesitis/dactylitis, respectively. At week 24, higher response rates were observed for risankizumab vs placebo for resolution of enthesitis, dactylitis, and both enthesitis/dactylitis (differences of 13.9%, 16.9%, and 13.3%, respectively; p < 0.05). By week 52, risankizumab treatment resulted in complete resolution of enthesitis, dactylitis, and both enthesitis and dactylitis in 55.0%, 76.1%, and 52.3% of patients; similar resolution rates occurred among patients who switched from placebo to risankizumab. Among risankizumab-treated patients who achieved resolution of enthesitis and/or dactylitis, MCIDs were also attained in patient-reported pain, disability, and fatigue at week 24 (all p < 0.05; except fatigue in patients with resolution of both enthesitis/dactylitis); responses were sustained through week 52.

conclusionsHigher proportions of risankizumab-treated (vs placebo-treated) patients achieved enthesitis and/or dactylitis resolution and meaningful improvements in patient-reported outcomes at week 24 and generally sustained responses at week 52. Thus, risankizumab may result in sustained alleviation of PsA-related pathognomonic musculoskeletal lesions of enthesitis/dactylitis. CLINICALTRIALS: GOV IDENTIFIERS: NCT03675308, and NCT03671148.

Indexed as

BiologicDactylitisEnthesitisInterleukin 23PsoriasisPsoriatic arthritisRisankizumab

Identifiers

PMID38739215
PMCPMC11169338

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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.