Evidence map›Paper›PMID 39231546›Full record

Trial reportRMD open2024

Comparison of established and preliminarily proposed ASAS MRI working group cut-offs for inflammatory MRI lesions in the sacroiliac joints in radiographic and non-radiographic axial spondyloarthritis.

Xenofon Baraliakos, Pedro M Machado, Lars Bauer, Bengt Hoepken, Mindy Kim, Thomas Kumke, Rachel Tham, Martin Rudwaleit

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report 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 trial NCT02505542 (A Multicenter, Open-label), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT02505542 phase3completednot on this map

A Multicenter, Open-label (Part A) Followed by a Randomized, Double-blind, Parallel-group, Placebo Controlled Study (Part B) to Evaluate Maintenance of Remission in Subjects With Active Axial Spondyloarthritis (axSpA) Receiving Either Certolizumab Pegol 200 mg Q2W or 200 mg Q4W as Compared to Placebo

TypeinterventionalSponsorUCB BIOSCIENCES GmbHRan2015 to 2019Enrolled736ConditionsAxial Spondyloarthrithis, Ankylosing SpondylitisArmsCertolizumab Pegol, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. The 60Rheumatology and immunology research · 2026
    Article
  2. Observational
  3. Spondyloarthritis in Latin America: a difficult-to-diagnose challenge.Therapeutic advances in musculoskeletal disease · 2026
    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

8 authors.

Xenofon BaraliakosRheumazentrum Ruhrgebiet, Ruhr University Bochum, Herne, Germany baraliakos@me.com.ORCID 0000-0002-9475-9362
Pedro M MachadoDepartment of Rheumatology, University College London Hospitals NHS Foundation Trust, London, UK.ORCID 0000-0002-8411-7972
Lars BauerUCB Pharma, Monheim am Rhein, Germany.
Bengt HoepkenUCB Pharma, Monheim am Rhein, Germany.
Mindy KimUCB Pharma, Smyrna, Georgia, USA.
Thomas KumkeUCB Pharma, Monheim am Rhein, Germany.
Rachel ThamUCB Pharma, Slough, UK.
Martin RudwaleitKlinikum Bielefled, University of Bielefeld, Bielefeld, Germany.ORCID 0000-0001-5445-548X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA consensus definition for active sacroiliitis by MRI, mentioned in the Assessment of SpondyloArthritis International Society (ASAS) classification criteria for axial spondyloarthritis (axSpA), was published in 2009 and included a qualitative and quantitative MRI cut-off component. In 2021, updates to the quantitative component were preliminarily proposed. This post hoc analysis of part A of the phase 3 open-label C-OPTIMISE study (NCT02505542) explores the differences by applying the 2009 and preliminary 2021 inflammatory cut-offs on clinical outcomes of axSpA patients treated with certolizumab pegol.

methodsBaseline MRI scans were used to classify 657 patients as MRI+ or MRI- according to the quantitative components of the 2009 and preliminary 2021 MRI cut-offs for inflammatory lesions. Clinical outcomes, including ASAS ≥40% improvement (ASAS40), Ankylosing Spondylitis Disease Activity Score and Bath Ankylosing Spondylitis Disease Activity Index, were reported to week 48.

resultsAcross all analysed outcomes, 2009 MRI+ and preliminary 2021 MRI+ subgroups showed similar results. Notably, clinical outcomes for the discordant group (2009 MRI+but preliminary 2021 MRI- group; 53/657 [8.1%]) were close to those seen in MRI- patients according to either 2009 or preliminary 2021 inflammatory cut-offs, and notably different from the totality of MRI+ subgroups.

conclusionThis analysis suggests that the preliminary 2021 cut-offs for MRI inflammatory lesions may slightly increase the specificity of the quantitative part of the 2009 MRI inflammatory lesion definition. The effects of the updated MRI cut-offs need to be assessed on the basis of efficacy outcomes and with the inclusion of aspects of structural changes. TRIAL REGISTRATION NUMBER: NCT02505542.

Indexed as

Axial SpondyloarthritisMagnetic Resonance ImagingSacroiliac JointAdultCertolizumab PegolFemaleHumansMaleMiddle AgedSacroiliitisSeverity of Illness IndexTreatment OutcomeCertolizumab PegolCertolizumab pegolMagnetic Resonance ImagingSpondylitis, Ankylosing

Identifiers

PMID39231546
PMCPMC11409351

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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.