Evidence map›Paper›PMID 38724259›Full record

Trial reportRMD open2024

Long-term clinical outcomes of certolizumab pegol treatment in non-radiographic axial spondyloarthritis stratified by baseline MRI and CRP status.

Martin Rudwaleit, Atul Deodhar, Lars Bauer, Lianne Gensler, Bengt Hoepken, Thomas Kumke, Simone Emanuele Auteri, Mindy Kim, Walter Maksymowych

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
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 NCT02552212 (Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT02552212 phase3completednot on this map

Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis (axSpA) Without X-Ray Evidence of Ankylosing Spondylitis (AS) and Objective Signs of Inflammation

TypeinterventionalSponsorUCB BIOSCIENCES GmbHRan2015 to 2020Enrolled317ConditionsAxial Spondyloarthritis, Nonradiographic Axial Spondyloarthritis, Nr-axSpAArmsCertolizumab Pegol, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Year in Review: Axial Spondyloarthritis.Mediterranean journal of rheumatology · 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

9 authors.

Martin RudwaleitKlinikum Bielefeld, University of Bielefeld, Bielefeld, Germany MARTIN.RUDWALEIT@KLINIKUMBIELEFELD.DE.ORCID 0000-0001-5445-548X
Atul DeodharOregon Health & Science University, Portland, Oregon, USA.
Lars BauerUCB Pharma, Monheim am Rhein, Germany.
Lianne GenslerUniversity of California, San Francisco, California, USA.
Bengt HoepkenUCB Pharma, Monheim am Rhein, Germany.
Thomas KumkeUCB Pharma, Monheim am Rhein, Germany.
Simone Emanuele AuteriUCB Pharma, Milan, Italy.
Mindy KimUCB Pharma, Smyrna, Georgia, USA.
Walter MaksymowychDepartment of Medicine, University of Alberta, Edmonton, Alberta, Canada.ORCID 0000-0002-1291-1755

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThere is a paucity of data on long-term clinical responses in patients with non-radiographic axial spondyloarthritis (nr-axSpA) based on their baseline objective signs of inflammation such as MRI or C-reactive protein (CRP) levels. This study reports clinical outcomes up to 3 years of the C-axSpAnd trial, including safety follow-up extension (SFE) from Weeks 52 to 156, stratified by patients' baseline MRI and CRP status.

methodsC-axSpAnd (NCT02552212) was a phase 3, multicentre study that evaluated certolizumab pegol (CZP) in patients with active nr-axSpA who had active sacroiliitis on MRI and/or elevated CRP. In this post hoc analysis, efficacy outcomes are reported to Week 156 of C-axSpAnd for patients stratified according to their MRI and CRP status at Week 0 (MRI+/CRP-, MRI-/CRP+ and MRI+/CRP+).

resultsAcross all outcome measures, including major improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS-MI) and Assessment of SpondyloArthritis international Society criteria ≥40% response (ASAS40), outcomes were generally sustained in SFE patients from Week 52 to Week 156. MRI+/CRP+ patients showed numerically higher or comparable responses relative to MRI-/CRP+ and MRI+/CRP- patients at Weeks 52 and 156; however, all three subgroups demonstrated substantial improvements from Week 0 (in CZP-randomised patients, ASDAS-MI at Week 156 [observed case]: MRI+/CRP+: 73.1%, MRI-/CRP+: 52.2%, MRI+/CRP-: 30.4%; ASAS40: MRI+/CRP+: 76.9%, MRI-/CRP+: 62.5%, MRI+/CRP-: 65.2%).

conclusionsIn patients with nr-axSpA and objective signs of inflammation, long-term clinical outcomes achieved after 1 year were generally sustained at 3 years across MRI+/CRP+, MRI-/CRP+ and MRI+/CRP- subgroups.

Indexed as

Axial SpondyloarthritisCertolizumab PegolC-Reactive ProteinMagnetic Resonance ImagingAdultBiomarkersFemaleHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeBiomarkersCertolizumab PegolC-Reactive ProteinCertolizumab pegolMagnetic Resonance ImagingSpondylitis, Ankylosing

Identifiers

PMID38724259
PMCPMC11086426

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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.