Evidence map›Paper›PMID 24476416›Full record

Trial reportArthritis research & therapy2014

Good correlation between changes in objective and subjective signs of inflammation in patients with short- but not long duration of axial spondyloarthritis treated with tumor necrosis factor-blockers.

Anja Weiß, In-Ho Song, Hildrun Haibel, Joachim Listing, Joachim Sieper

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

Trial report in Arthritis research & therapy, 2014. 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 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 10% 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.

NCT00235105 phase2 / phase3unknown statusnot on this map

Adalimumab in Early Axial Spondyloarthritis (Without Radiological Sacroiliitis): Placebo Controlled Phase Over 3 Months Followed by a 9 Months Open Extension Phase

TypeinterventionalSponsorCharite University, Berlin, GermanyRan2005 to 2007Enrolled46ConditionsAnkylosing SpondylitisArmsAdalimumab 40 mg sc every other week
NCT00844142 phase2unknown statusnot on this map

Randomized Controlled 12 Months Trial With Etanercept (Enbrel ®) vs. Sulfasalazine in Early Axial Spondyloarthritis With Focus on Improvement of Acute Inflammatory Lesions as Detected by MRI. Amendment 4: 1-Year Extension of Study

TypeinterventionalSponsorCharite University, Berlin, GermanyRan2005 to 2013Enrolled80ConditionsModerate to Severe Active Axial SpondyloarthritisArmsEtanercept 25mg, Sulfasalazine
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

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  17. Clinical characteristics of Japanese patients with axial spondyloarthritis, and short-term efficacy of adalimumab.Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association · 2015
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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

5 authors at 2 institutions in 1 country.

Anja Weiß
In-Ho Song
Hildrun Haibel
Joachim Listing
Joachim Sieper
Charité - Universitätsmedizin Berlin · DEGerman Rheumatism Research Centre · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe aim of this study was to investigate the influence of symptom duration on treatment response and on the correlation between improvements in patient reported outcomes (PRO) and objective inflammation in patients with axial spondylarthritis (SpA) treated with etanercept (ETA) or adalimumab (ADA).

methodsData from 112 patients with axial SpA originally enrolled in two randomized controlled clinical trials were pooled and analyzed after one year of treatment with ETA (n = 66) or ADA (n = 46). Patients with <4 years and ≥4 years of disease were compared for improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Disease Activity Score (ASDAS), C-reactive protein (CRP) and magnetic resonance imaging (MRI) score for sacroiliac joints (SIJ).

resultsPatients with <4 years of disease showed a significantly better improvement than longer diseased patients in BASDAI (3.2 (95% confidence interval (CI): 2.7 to 3.7) vs. 1.7 (1.1 to 2.2)), BASFI, BASMI and ASDAS (1.6 (1.4 to 1.8) vs. 0.9 (0.7 to 1.1)). The change in BASDAI showed a significant correlation with the change in SIJ score (Spearman's rank correlation coefficient (rho) = 0.37, P = 0.01) and the change in CRP (rho = 0.45, P = 0.001) in patients with <4 years of disease. For long diseased patients this correlation was poor and did not achieve statistical significance (rho = 0.13, P = 0.46; rho = 0.22, P = 0.13 respectively).

conclusionThe low correlation between change of PROs and change of objective signs of inflammation seen in axial SpA patients with longer symptom duration treated with tumor necrosis factor-blocker seems to indicate that inflammation is not the only cause of the patients' symptoms, while inflammation seems to be the major cause in short diseased patients.

trial registrationClinical Trials.gov NCT00844142 (Trial 1); NCT00235105 (Trial 2).

Indexed as

AdalimumabAdultAge of OnsetAntibodies, Monoclonal, HumanizedAntirheumatic AgentsC-Reactive ProteinEtanerceptFemaleHumansImmunoglobulin GInflammationMaleReceptors, Tumor Necrosis FactorSpondylarthritisTime FactorsTumor Necrosis Factor-alphaAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsC-Reactive ProteinEtanerceptImmunoglobulin GReceptors, Tumor Necrosis FactorTumor Necrosis Factor-alpha

Identifiers

PMID24476416
PMCPMC3978619
OpenAlexW2172273687

What OpenQuestion holds

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LicenceCC BY
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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.