Evidence map›Paper›PMID 19015206›Full record

Trial reportAnnals of the rheumatic diseases2009

Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study.

R Fleischmann, J Vencovsky, R F van Vollenhoven, D Borenstein, J Box, G Coteur, N Goel, H-P Brezinschek, A Innes, V Strand

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00548834 (Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD), which is not on this map. Cited by 126 papers, 23 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
126citing papers in PubMed, 23 pooled it
21.9field-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.

NCT00548834 phase3completednot on this map

Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD

TypeinterventionalSponsorUCB PharmaRan2003 to 2004Enrolled220ConditionsRheumatoid ArthritisArmsCDP870
3 · Its place in the literature

Who cites it

126 citing papers in PubMed, 23 syntheses or guidelines pooled it, 335 citations in OpenAlex.

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  8. Certolizumab pegol (CDP870) for rheumatoid arthritis in adults.The Cochrane database of systematic reviews · 2017
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  9. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017
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  14. Biologic interventions for fatigue in rheumatoid arthritis.The Cochrane database of systematic reviews · 2016
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66 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 9 institutions in 5 countries.

R FleischmannUniversity of Texas Southwestern Medical Center, Dallas, 75235, USA. rfleischmann@arthdocs.com
J Vencovsky
R F van Vollenhoven
D Borenstein
J Box
G Coteur
N Goel
H-P Brezinschek
A Innes
V Strand
Institute of Rheumatology · CZKarolinska Institutet · SEMedical University of Graz · ATStanford University · USThe University of Texas Southwestern Medical Center · USUCB Pharma (Belgium) · BEUCB Pharma (United States) · USUnited States Bone and Joint Initiative · USWashington University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTumour necrosis factor alpha (TNFalpha) is a proinflammatory cytokine involved in the pathogenesis of rheumatoid arthritis (RA). Treatment with TNFalpha inhibitors reduces disease activity and improves outcomes for patients with RA. This study evaluated the efficacy and safety of certolizumab pegol 400 mg, a novel, poly-(ethylene glycol) (PEG)ylated, Fc-free TNFalpha inhibitor, as monotherapy in patients with active RA.

methodsIn this 24-week, multicentre, randomised, double-blind, placebo-controlled study, 220 patients previously failing > or =1 disease-modifying antirheumatic drug (DMARD) were randomised 1:1 to receive subcutaneous certolizumab pegol 400 mg (n = 111) or placebo (n = 109) every 4 weeks. The primary endpoint was 20% improvement according to the American College of Rheumatology criteria (ACR20) at week 24. Secondary endpoints included ACR50/70 response, ACR component scores, 28-joint Disease Activity Score Erythrocyte Sedimentation Rate 3 (DAS28(ESR)3), patient-reported outcomes (including physical function, health-related quality of life (HRQoL), pain and fatigue) and safety.

resultsAt week 24, the ACR20 response rates were 45.5% for certolizumab pegol 400 mg every 4 weeks vs 9.3% for placebo (p<0.001). Differences for certolizumab pegol vs placebo in the ACR20 response were statistically significant as early as week 1 through to week 24 (p<0.001). Significant improvements in ACR50, ACR components, DAS28(ESR)3 and all patient-reported outcomes were also observed early with certolizumab pegol and were sustained throughout the study. Most adverse events were mild or moderate and no deaths or cases of tuberculosis were reported.

conclusionsTreatment with certolizumab pegol 400 mg monotherapy every 4 weeks effectively reduced the signs and symptoms of active RA in patients previously failing > or =1 DMARD compared with placebo, and demonstrated an acceptable safety profile. TRIAL REGISTRATION NUMBER: NCT00548834.

Indexed as

AdultAnalysis of VarianceAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedArthritis, RheumatoidCertolizumab PegolDouble-Blind MethodDrug Administration ScheduleFemaleHumansImmunoglobulin Fab FragmentsImmunosuppressive AgentsInjections, SubcutaneousMaleMiddle AgedPolyethylene GlycolsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCertolizumab PegolImmunoglobulin Fab FragmentsImmunosuppressive AgentsPolyethylene GlycolsTumor Necrosis Factor-alpha

Identifiers

PMID19015206
PMCPMC2674555
OpenAlexW2099199787

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.