Evidence map›Paper›PMID 21873264›Full record

Trial reportRheumatology (Oxford, England)2011

Tissue and serum markers of inflammation during the follow-up of patients with giant-cell arteritis--a prospective longitudinal study.

Sudha Visvanathan, Mahboob U Rahman, Gary S Hoffman, Stephen Xu, Ana García-Martínez, Marta Segarra, Ester Lozano, Georgina Espígol-Frigolé, José Hernández-Rodríguez, Maria C Cid

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 43 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 3 pooled it
5.5field-weighted citation impact, top 4% 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.

NCT00076726 phase2terminatednot on this map

A Randomized, Double-Masked, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Infliximab in Subjects With Giant Cell Arteritis

TypeinterventionalSponsorCentocor, Inc.Ran2003 to 2005Enrolled44ConditionsGiant Cell ArteritisArmsInfliximab
NCT02844023 naterminatednot on this mapstarted 2015, after this paper: background citation

Biomarkers in Giant Cells Arteritis

TypeinterventionalSponsorUniversity Hospital, GrenobleRan2015 to 2019Enrolled100ConditionsGiant Cells ArteritisArmsClinical evaluation, Paraclinical evaluation, Imaging, Ophthalmologic examination, Dosage of biomarkers
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 3 syntheses or guidelines pooled it, 102 citations in OpenAlex.

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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

10 authors at 2 institutions in 1 country.

Sudha VisvanathanCentocor Research and Development, Malvern, PA, USA.
Mahboob U Rahman
Gary S Hoffman
Stephen Xu
Ana García-Martínez
Marta Segarra
Ester Lozano
Georgina Espígol-Frigolé
José Hernández-Rodríguez
Maria C Cid
Cleveland Clinic Lerner College of Medicine · USMedical Care Development International · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the association between inflammatory markers and relapse in GCA patients longitudinally assessed in a clinical trial of infliximab and glucocorticosteroids.

methodsForty-four newly diagnosed GCA patients in glucocorticosteroid-induced remission were randomized to receive infliximab 5 mg/kg or placebo plus daily glucocorticosteroids, tapered using a standardized schedule. Sera were analysed for inflammatory markers at multiple, pre-defined time points. Temporal artery biopsies were performed in four patients before and after treatment to analyse changes in inflammatory and vascular remodelling marker expression.

resultsThirteen of 44 patients relapsed. Similar proportions of relapsed patients were present in both treatment arms. ESR, CRP, intercellular adhesion molecule (ICAM)-1, TNF-α, and IL-12p40 were significantly elevated near relapse. In post-treatment biopsies, mRNA expression of pro-inflammatory cytokines decreased, while vascular remodelling factors increased relative to baseline biopsies. Tissue IL-12p40 and IFN-γ mRNA remained elevated in relapsing vs remitting patients.

conclusionDespite prior findings of high concentrations of TNF-α in temporal artery biopsies of GCA patients, infliximab plus glucocorticosteroids did not result in improved clinical outcomes. Increased measures of this biomarker did not provide useful insight into the relative importance of TNF-α in the pathogenesis of GCA. Gene expression analysis in paired temporal artery biopsies pre- and post-treatment revealed decreased inflammatory activity and active vascular remodelling following treatment. In relapsing patients, increased expression of IFN-γ and IL-12p40 in post-treatment biopsies suggests a role in sustaining disease and setting the stage for relapse during treatment withdrawal.

trial registrationClinicalTrials.gov; http://www.clinicaltrials.gov; NCT00076726.

Indexed as

Antibodies, MonoclonalBiomarkersDrug Therapy, CombinationGene ExpressionGiant Cell ArteritisGlucocorticoidsHumansInfliximabInterferon-gammaInterleukin-12 Subunit p40Prospective StudiesRecurrenceRemission InductionRNA, MessengerAntibodies, MonoclonalBiomarkersGlucocorticoidsInfliximabInterferon-gammaInterleukin-12 Subunit p40RNA, Messenger

Identifiers

PMID21873264
PMCPMC3198905
OpenAlexW2116148601

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.