Evidence map›Paper›PMID 30848558›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2019

A Fifty-Two-Week, Randomized, Placebo-Controlled Trial of Certolizumab Pegol in Nonradiographic Axial Spondyloarthritis.

Atul Deodhar, Lianne S Gensler, Jonathan Kay, Walter P Maksymowych, Nigil Haroon, Robert Landewé, Martin Rudwaleit, Stephen Hall, Lars Bauer, Bengt Hoepken and 3 more

Open access · hybridAbstract readRandomized Controlled TrialVideo-Audio Media
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 6 pooled it
13.6field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 6 syntheses or guidelines pooled it, 100 citations in OpenAlex.

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  10. Efficacy and Safety of Intravenous Golimumab in Ankylosing Spondylitis Patients With Early and Late Disease Through One Year of the GO-ALIVE Study.Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases · 2022
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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

13 authors at 12 institutions in 6 countries.

Atul DeodharOregon Health & Science University, Portland.
Lianne S GenslerUniversity of California, San Francisco.
Jonathan KayUMass Memorial Medical Center and University of Massachusetts Medical School, Worcester.ORCID 0000-0002-8970-4260
Walter P MaksymowychUniversity of Alberta, Edmonton, Alberta, Canada.
Nigil HaroonUniversity Health Network and University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0003-3210-4771
Robert LandewéAcademic Medical Center and Zuyderland Medical Center, Heerlen, The Netherlands.
Martin RudwaleitKlinikum Bielefeld, Bielefeld, Germany.
Stephen HallCabrini Medical Centre, Monash University, and Emeritus Research, Melbourne, Victoria, Australia.
Lars BauerUCB Pharma, Monheim am Rhein, Germany.
Bengt HoepkenUCB Pharma, Monheim am Rhein, Germany.
Natasha de PeyrecaveUCB Pharma, Brussels, Belgium.
Brian KilgallenUCB Pharma, Raleigh, North Carolina.
Désirée van der HeijdeLeiden University Medical Center, Leiden, The Netherlands.
UCB Pharma (Germany) · DEAmsterdam UMC Location University of Amsterdam · NLKlinikum Bielefeld · DELeiden University Medical Center · NLMonash Medical Centre · AUOregon Health & Science University · USUCB Pharma (Belgium) · BEUCB Pharma (United States) · USUniversity Health Network · CAUniversity of Alberta · CAUniversity of California, San Francisco · USUniversity of Massachusetts Chan Medical School · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe natural history of nonradiographic axial spondyloarthritis (SpA) is incompletely characterized, and there are concerns that nonsteroidal antiinflammatory drugs provide inadequate disease control in patients with active disease. This study was undertaken to investigate the effects of certolizumab pegol (CZP), an anti-tumor necrosis factor treatment, in patients with nonradiographic axial SpA with objective signs of inflammation.

methodsIn this ongoing parallel-group double-blind study, adults with active disease were recruited from 80 centers in Australia, Europe, North America, and Taiwan, and were randomized 1:1 to receive placebo or CZP (400 mg at weeks 0, 2, and 4, followed by 200 mg every 2 weeks) in addition to nonbiologic background medication (NBBM). Switching to open-label CZP (or other biologic) or making background medication changes was permitted at any point during the trial, although changes before week 12 were discouraged. The primary end point was the proportion of patients achieving major improvement (MI) (i.e., a ≥2.0-point decrease in the score from baseline or achievement of the lowest possible score [0.6]) in the Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 52.

resultsA total of 317 patients were randomized to receive placebo plus NBBM (n = 158) or CZP plus NBBM (n = 159). ASDAS-MI at week 52 was achieved in 47.2% (75 of 159) of CZP plus NBBM patients, which was significantly greater (P < 0.0001) than the 7.0% (11 of 158) of placebo plus NBBM patients in whom ASDAS-MI was achieved. Of the placebo plus NBBM patients, 60.8% (96 of 158) switched to open-label treatment before week 52 compared to 12.6% (20 of 159) of the CZP plus NBBM patients.

conclusionAdding CZP to background medication is superior to adding placebo in patients with active nonradiographic axial SpA. These results indicate that remission in nonradiographic axial SpA treated without biologics occurs infrequently, demonstrating the need for treatment beyond nonbiologic therapy.

Indexed as

AdultCertolizumab PegolC-Reactive ProteinDouble-Blind MethodFemaleHumansMagnetic Resonance ImagingMaleMiddle AgedSacroiliitisSpondylarthropathiesTreatment OutcomeTumor Necrosis Factor InhibitorsCertolizumab PegolC-Reactive ProteinTumor Necrosis Factor Inhibitors

Identifiers

PMID30848558
PMCPMC6619287
OpenAlexW2922280445

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.