Evidence map›Paper›PMID 35137002›Full record

Trial reportRheumatology (Oxford, England)2022

Implementation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Scoring System in a randomized phase IIb study of abatacept in psoriatic arthritis.

Mikkel Østergaard, Paul Bird, Chahin Pachai, Shuyan Du, Chun Wu, Jessica Landis, Thomas Fuerst, Harris A Ahmad, Sean E Connolly, Philip G Conaghan

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Rheumatology (Oxford, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00534313 (A Phase IIB, Multi-Dose, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis), which is 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
1.7field-weighted citation impact, top 16% 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.

NCT00534313 phase2terminatednot on this map

A Phase IIB, Multi-Dose, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis

TypeinterventionalSponsorBristol-Myers SquibbRan2007 to 2011Enrolled191ConditionsPsoriatic ArthritisArmsAbatacept, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Imaging in psoriatic arthritis: established methods and emerging techniques.Therapeutic advances in musculoskeletal disease · 2024
    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

10 authors at 5 institutions in 5 countries.

Mikkel ØstergaardCopenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Rigshospitalet, Glostrup.ORCID 0000-0003-3690-467X
Paul BirdDivision of Medicine, University of New South Wales, Sydney, NSW, Australia.
Chahin PachaiTranslational Medicine.
Shuyan DuTranslational Medicine.
Chun WuTranslational Bioinformatics, Bristol Myers Squibb, Princeton, NJ.
Jessica LandisTranslational Bioinformatics, Bristol Myers Squibb, Princeton, NJ.
Thomas FuerstMedical and Scientific Affairs, Bioclinica Inc., Newark, CA.
Harris A AhmadMedical Affairs, Immunology and Fibrosis.ORCID 0000-0002-0890-2071
Sean E ConnollyGlobal Drug Development, Bristol Myers Squibb, Princeton, NJ, USA.
Philip G ConaghanLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds.
Bristol-Myers Squibb (United States) · USCenter for Translational Molecular Medicine · NLUniversity of Copenhagen · DKUniversity of Leeds · GBUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo investigate if the OMERACT PsA MRI Scoring System (PsAMRIS), including a novel total inflammation score, shows sensitivity to change with an agent (abatacept) known to impact clinical outcomes in PsA.

methodsWe performed a post hoc analysis of a randomized phase IIb study of abatacept in patients with PsA and inadequate DMARD response. Participants received one of three abatacept dosing regimens [ABA3, ABA10 or ABA30/10 mg/kg (30 mg/kg switched to 10 mg/kg after two doses)] or placebo until day 169, then ABA10 through day 365. MRIs at baseline and days 85, 169 and 365 were centrally evaluated by two readers blinded to chronological order and treatment arm. Synovitis, osteitis, tenosynovitis, periarticular inflammation, bone erosions, joint space narrowing and bone proliferation were assessed using the PsAMRIS. A novel total inflammation score was tested.

resultsMRIs for 123 patients were included. On day 169, ABA10 and ABA30/10 significantly reduced MRI synovitis and tenosynovitis, respectively, vs placebo [differences -0.966 (P = 0.039) and -1.652 (P = 0.014), respectively]. Synovitis in the placebo group increased non-significantly from baseline to day 169, total inflammation and tenosynovitis decreased non-significantly and all measures improved significantly after a switch to ABA10 [-1.019, -0.940, -2.275 (P < 0.05), respectively, day 365 vs day 169]. Structural outcomes changed minimally across groups.

conclusionAdults with PsA receiving ABA10 and ABA30/10 demonstrated significant resolution of inflammatory components of disease, confirmed by MRI, with synovitis and tenosynovitis improvements consistent with previously reported clinical responses for these doses. Results indicate that a reduction in OMERACT PsAMRIS inflammation scores may provide proof of tissue-level efficacy in PsA clinical trials. REGISTRATION: ClinicalTrials.gov (https://clinicaltrials.gov), NCT00534313.

Indexed as

Arthritis, PsoriaticSynovitisTenosynovitisAbataceptAdultHumansInflammationMagnetic Resonance ImagingAbataceptDMARDsfoothandinflammationMRIspondylarthropathies (including psoriatic arthritis)

Identifiers

PMID35137002
PMCPMC9629349
OpenAlexW4210513007

What OpenQuestion holds

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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.