Evidence map›Paper›PMID 38296802›Full record

ArticleRMD open2024

Validity and score interpretation of the 12-item Psoriatic Arthritis Impact of Disease: an analysis of pooled data from two phase 3 trials of bimekizumab in patients with psoriatic arthritis.

Laure Gossec, Ana-Maria Orbai, Laura C Coates, Dafna D Gladman, Alexis Ogdie, Christopher G Pelligra, Valérie Ciaravino, Barbara Ink, Vanessa Taieb, Jérémy Lambert and 1 more

2 registry-linked trialsAbstract readValidation Study
In one paragraph

Article in RMD open, 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT03895203 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorUCB Biopharma SRLRan2019 to 2022Enrolled852ConditionsPsoriatic ArthritisArmsBimekizumab, Adalimumab, Placebo
NCT03896581 phase3completednot on this map

A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorUCB Biopharma SRLRan2019 to 2022Enrolled400ConditionsPsoriatic ArthritisArmsBimekizumab, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Observational
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

11 authors.

Laure GossecINSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université, Paris, France laure.gossec@aphp.fr.ORCID http://orcid.org/0000-0002-4528-310X
Ana-Maria OrbaiDivision of Rheumatology, John Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID http://orcid.org/0000-0001-8644-8567
Laura C CoatesNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-4756-663X
Dafna D GladmanSchroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, Ontario, Canada.ORCID http://orcid.org/0000-0002-9074-0592
Alexis OgdiePerelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.ORCID http://orcid.org/0000-0002-4639-0775
Christopher G PelligraEvidera, Medellín, Colombia.ORCID http://orcid.org/0000-0002-5255-2777
Valérie CiaravinoUCB Pharma, Colombes, France.
Barbara InkUCB Pharma, Slough, UK.
Vanessa TaiebUCB Pharma, Colombes, France.
Jérémy LambertUCB Pharma, Colombes, France.
Maarten de WitPatient Research Partner, Stichting Tools, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0002-8428-6354

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo investigate psychometric performance of the 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) total and individual item scores in patients with psoriatic arthritis (PsA) and to estimate score change thresholds and scores corresponding to different levels of symptom/impact severity.

methodsData up to week 16 from 1252 patients with active PsA enrolled in two randomised controlled trials of bimekizumab (BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581)) were used to assess construct validity (correlations with other patient-reported outcomes), known-groups validity (based on Minimal Disease Activity index, Disease Activity Index for Psoriatic Arthritis and Psoriatic Arthritis Disease Activity Score), reliability (Cronbach's alpha and intraclass correlation coefficients (ICCs)) and responsiveness (sensitivity to change). Clinically meaningful within-patient improvement thresholds were estimated by anchor-based and distribution-based analyses, and symptom/impact severity thresholds were estimated by receiver operating characteristic curve analyses.

resultsThe mean (SD) PsAID-12 total score at baseline was 4.19 (1.94). PsAID-12 scores demonstrated good convergent validity and good known-groups validity. Internal consistency reliability (Cronbach's alpha 0.95) and test-retest reliability (ICC ≥ 0.70) were also good. Responsiveness was acceptable (correlations ≥0.30 for most scores). Improvement thresholds were estimated at 1.5-2 points for the PsAID-12 total score and 2 or 3 points for item scores. Thresholds for different levels of symptom/impact severity could be derived for most PsAID-12 items.

conclusionsThe PsAID-12 demonstrated robust psychometric properties in a large sample of patients with active PsA, supporting its use as a fit-for-purpose patient-reported outcome in this population. Furthermore, thresholds for score interpretation were derived.

Indexed as

Arthritis, PsoriaticAntibodies, Monoclonal, HumanizedClinical Trials, Phase III as TopicHumansRandomized Controlled Trials as TopicReproducibility of ResultsSeverity of Illness IndexAntibodies, Monoclonal, HumanizedbimekizumabArthritis, PsoriaticOutcome Assessment, Health CarePatient Reported Outcome Measures

Identifiers

PMID38296802
PMCPMC10831419

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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.