Evidence map›Paper›PMID 29343510›Full record

Trial reportAnnals of the rheumatic diseases2018

Limited radiographic progression and sustained reductions in MRI inflammation in patients with axial spondyloarthritis: 4-year imaging outcomes from the RAPID-axSpA phase III randomised trial.

Désirée van der Heijde, Xenofon Baraliakos, Kay-Geert A Hermann, Robert B M Landewé, Pedro M Machado, Walter P Maksymowych, Owen R Davies, Natasha de Peyrecave, Bengt Hoepken, Lars Bauer and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01087762 (Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis), which is not on this map. Cited by 65 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 3 pooled it
16.0field-weighted citation impact, top 1% 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.

NCT01087762 phase3completednot on this map

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

TypeinterventionalSponsorUCB BIOSCIENCES GmbHRan2010 to 2015Enrolled325ConditionsSpondyloarthropathiesArmsCZP 200 mg Q2W, CZP 400 mg Q4W, Placebo
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 3 syntheses or guidelines pooled it, 130 citations in OpenAlex.

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5 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 4 countries.

Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-5781-158X
Xenofon BaraliakosRuhr-University Bochum, Herne, Germany.ORCID 0000-0002-9475-9362
Kay-Geert A HermannDepartment of Radiology, Charité Medical School, Berlin, Germany.
Robert B M LandewéAcademic Medical Center, Amsterdam and Atrium Medical Center, Heerlen, The Netherlands.
Pedro M MachadoCentre for Rheumatology and MRC Centre for Neuromuscular Diseases, University College London, London, UK.
Walter P MaksymowychDepartment of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Owen R DaviesUCB Celltech, Slough, UK.
Natasha de PeyrecaveUCB Celltech, Slough, UK.
Bengt HoepkenUCB Pharma, Monheim, Germany.
Lars BauerUCB Pharma, Monheim, Germany.
Tommi NurminenUCB Pharma, Monheim, Germany.
Juergen BraunRheumazentrum Ruhrgebiet, Herne, Germany.
UCB Pharma (Germany) · DEUCB Pharma (United Kingdom) · GBAmsterdam UMC Location University of Amsterdam · NLLeiden University Medical Center · NLMSB Medical School Berlin · DERheumazentrum Ruhrgebiet · DERuhr University Bochum · DEUniversity College London · GBUniversity of Alberta · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo report 4-year imaging outcomes in the RAPID-axSpA (NCT01087762) study of patients with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA), treated with certolizumab pegol (CZP).

methodsThis phase III, randomised trial was placebo-controlled and double-blind to week 24, dose-blind to week 48 and open-label to week 204. Patients fulfilling the Assessment of Spondyloarthritis International Society (ASAS) axSpA criteria with active disease were stratified (AS/nr-axSpA) according to the modified New York (mNY) criteria at randomisation. Spinal radiographs were assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). MRI inflammation used the Spondyloarthritis Research Consortium of Canada (SPARCC) score for sacroiliac joints (SIJ) and the Berlin spinal score (remission defined as SPARCC <2 and Berlin ≤2, respectively).

resultsMRI improvements from baseline (BL) to week 12 were maintained to week 204 (SPARCC BL: AS=8.5, nr-axSpA=7.5; SPARCC week 204: AS=1.3, nr-axSpA=2.4; Berlin BL: AS=7.4, nr-axSpA=4.4; Berlin week 204: AS=2.6, nr-axSpA=1.9). 66.7% of patients with AS and 69.6% of patients with nr-axSpA with BL SPARCC scores ≥2, and 65.4% of patients with AS and 57.3% of patients with nr-axSpA with BL Berlin score >2, achieved remission at week 204. Mean mSASSS change in AS from BL to week 204 was 0.98 (95% CI 0.34, 1.63); 0.67 (95% CI 0.21,1.13) from BL to week 96; and 0.31 (95% CI 0.02,0.60) from week 96 to week 204. Corresponding nr-axSpA changes were 0.06 (95% CI -0.17,0.28), -0.01 (95% CI -0.19,0.17) and 0.07 (95% CI -0.07,0.20). 4.5% of patients with nr-axSpA fulfilled the mNY criteria at week 204, while 4.3% of patients with AS no longer did so.

conclusionsIn patients with CZP-treated axSpA, rapid decreases in spinal and SIJ MRI inflammation were maintained to week 204. Overall, 4-year spinal progression was low, with less progression during years 2-4 than 0-2. Radiographic SIJ grading changes demonstrated limited progression. TRIAL REGISTRATION NUMBER: NCT01087762; Post-results.

Indexed as

Disease ProgressionAdultAntirheumatic AgentsCertolizumab PegolDouble-Blind MethodFemaleHumansInduction ChemotherapyInflammationMagnetic Resonance ImagingMaleMiddle AgedRadiographySacroiliac JointSeverity of Illness IndexSpineAntirheumatic AgentsCertolizumab Pegolankylosing spondylitisanti-tnfinflammationmagnetic resonance imagingspondyloarthritis

Identifiers

PMID29343510
PMCPMC5909752
OpenAlexW2782992211

What OpenQuestion holds

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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.