Evidence map›Paper›PMID 28498975›Full record

Trial reportRheumatology (Oxford, England)2017

Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA.

Désirée van der Heijde, Maxime Dougados, Robert Landewé, Joachim Sieper, Walter P Maksymowych, Martin Rudwaleit, Filip Van den Bosch, Jürgen Braun, Philip J Mease, Alan J Kivitz and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2017. 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 56 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 2 pooled it
–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.

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

56 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

16 authors.

Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Maxime DougadosDepartment of Rheumatology, Cochin Hospital, Paris, France.
Robert LandewéClinical Immunology and Rheumatology, Academic Medical Center, Amsterdam.
Joachim SieperRheumatology Department, Charité - University Medicine, Berlin, Germany.
Walter P MaksymowychDepartment of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Martin RudwaleitDepartment of Internal Medicine and Rheumatology, Klinikum Bielefeld, Bielefeld, Germany.
Filip Van den BoschDepartment of Internal Medicine, Ghent University Hospital, Ghent, Belgium.
Jürgen BraunRheumazentrum Ruhrgebiet, Herne, Germany.
Philip J MeaseSwedish Medical Center, University of Washington, Seattle, WA.
Alan J KivitzAltoona Center for Clinical Research, Duncansville, PA.
Jessica WalshDivision of Rheumatology, University of Utah School of Medicine, Salt Lake City, UT, USA.
Owen DaviesUCB Pharma, Slough, UK.
Lars BauerUCB Pharma, Monheim, Germany.
Bengt HoepkenUCB Pharma, Raleigh, NC.
Luke PetersonUCB Pharma, Raleigh, NC.
Atul DeodharDivision of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: The aim was to assess the long-term safety and efficacy of certolizumab pegol over 4 years of continuous treatment in patients with axial spondyloarthritis (axSpA), including both AS and non-radiographic (nr-) axSpA. Methods: RAPID-axSpA was a phase 3 randomized trial, double blind and placebo controlled to week 24, dose blind to week 48 and open label to week 204. Patients had a clinical diagnosis of axSpA, meeting Assessment of SpondyloArthritis international Society (ASAS) criteria, and had active disease. The assessed outcomes included ASAS20, ASAS40, AS DAS (ASDAS), BASDAI, BASFI and BASMI scores, along with selected measures of remission. Further patient-reported outcomes, peripheral arthritis, enthesitis, uveitis and quality-of-life measures are also reported. Results: Two hundred and eighteen of 325 patients randomized (AS: 121; nr-axSpA: 97) received certolizumab pegol from week 0. Of these, 65% remained in the study at week 204 (AS: 67%; nr-axSpA: 63%). Across all outcomes, for AS and nr-axSpA, sustained improvements were observed to week 204 [week 204 overall axSpA: ASAS20: 54.1% (non-responder imputation); 83.7% (observed case, OC); ASAS40: 44.0% (non-responder imputation); 68.1% (OC); ASDAS inactive disease: 32.1% (last observation carried forward); 31.4% (OC)]. In the safety set (n = 315), there were 292.8 adverse events and 10.4 serious adverse events per 100 patient-years. No deaths were reported. Conclusion: In the first study to evaluate the efficacy of an anti-TNF across both axSpA subpopulations, improvements in clinical and patient-reported outcomes at 24 and 96 weeks were sustained through 4 years of treatment, with no new safety signals. Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT01087762.

Indexed as

AdultAntirheumatic AgentsArthritisCertolizumab PegolDouble-Blind MethodFemaleHumansImmunosuppressive AgentsMaleMiddle AgedPatient Reported Outcome MeasuresQuality of LifeRemission InductionSeverity of Illness IndexSpondylarthritisSpondylitis, AnkylosingAntirheumatic AgentsCertolizumab PegolImmunosuppressive AgentsTumor Necrosis Factor-alphaankylosing spondylitisaxial spondyloarthritiscertolizumab pegolnon-radiographic axial spondyloarthritis

Identifiers

PMID28498975
PMCPMC5850296

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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.