Evidence map›Paper›PMID 24812287›Full record

Trial reportAnnals of the rheumatic diseases2015

Pretreatment multi-biomarker disease activity score and radiographic progression in early RA: results from the SWEFOT trial.

Karen Hambardzumyan, Rebecca Bolce, Saedis Saevarsdottir, Scott E Cruickshank, Eric H Sasso, David Chernoff, Kristina Forslind, Ingemar F Petersson, Pierre Geborek, Ronald F van Vollenhoven

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00764725 (A Prospective Randomized, Open, Multi-Center Trial Comparing TNF-Blockade + MTX to MTX+SSZ+HCQ in Patients With Early RA With an Inadequate Response to MTX), which is not on this map. Cited by 48 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing 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.

NCT00764725 phase4completednot on this map

A Prospective Randomized, Open, Multi-Center Trial Comparing TNF-Blockade + MTX to MTX+SSZ+HCQ in Patients With Early RA With an Inadequate Response to MTX

TypeinterventionalSponsorKarolinska InstitutetRan2002 to 2008Enrolled487ConditionsRheumatoid ArthritisArmsconventional DMARD combination, MTX plus anti-TNF
3 · Its place in the literature

Who cites it

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

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  19. Adding value to real-world data: the role of biomarkers.Rheumatology (Oxford, England) · 2020
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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.

Karen HambardzumyanUnit of Clinical Therapy Research, Inflammatory Diseases (ClinTRID), Karolinska Institute, Stockholm, Sweden.
Rebecca BolceCrescendo Bioscience Inc., South San Francisco, California, USA.
Saedis SaevarsdottirUnit of Clinical Therapy Research, Inflammatory Diseases (ClinTRID), Karolinska Institute, Stockholm, Sweden Rheumatology Unit, Department of Medicine, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden.
Scott E CruickshankScott Cruickshank and Associates Inc., Santa Barbara, California, USA.
Eric H SassoCrescendo Bioscience Inc., South San Francisco, California, USA.
David ChernoffCrescendo Bioscience Inc., South San Francisco, California, USA.
Kristina ForslindSection of Rheumatology, Institution of Clinical Sciences, University Hospital, Lund, Sweden Section of Rheumatology, Department of Medicine, Helsingborg Hospital, Helsingborg, Sweden.
Ingemar F PeterssonSection of Rheumatology, Institution of Clinical Sciences, University Hospital, Lund, Sweden Department of Orthopaedics, Institution of Clinical Sciences, Lund University, Lund, Sweden.
Pierre GeborekSection of Rheumatology, Institution of Clinical Sciences, University Hospital, Lund, Sweden.
Ronald F van VollenhovenUnit of Clinical Therapy Research, Inflammatory Diseases (ClinTRID), Karolinska Institute, Stockholm, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesPrediction of radiographic progression (RP) in early rheumatoid arthritis (eRA) would be very useful for optimal choice among available therapies. We evaluated a multi-biomarker disease activity (MBDA) score, based on 12 serum biomarkers as a baseline predictor for 1-year RP in eRA.

methodsBaseline disease activity score based on erythrocyte sedimentation rate (DAS28-ESR), disease activity score based on C-reactive protein (DAS28-CRP), CRP, MBDA scores and DAS28-ESR at 3 months were analysed for 235 patients with eRA from the Swedish Farmacotherapy (SWEFOT) clinical trial. RP was defined as an increase in the Van der Heijde-modified Sharp score by more than five points over 1 year. Associations between baseline disease activity measures, the MBDA score, and 1-year RP were evaluated using univariate and multivariate logistic regression, adjusted for potential confounders.

resultsAmong 235 patients with eRA, 5 had low and 29 moderate MBDA scores at baseline. None of the former and only one of the latter group (3.4%) had RP during 1 year, while the proportion of patients with RP among those with high MBDA score was 20.9% (p=0.021). Among patients with low/moderate CRP, moderate DAS28-CRP or moderate DAS28-ESR at baseline, progression occurred in 14%, 15%, 14% and 15%, respectively. MBDA score was an independent predictor of RP as a continuous (OR=1.05, 95% CI 1.02 to 1.08) and dichotomised variable (high versus low/moderate, OR=3.86, 95% CI 1.04 to 14.26).

conclusionsIn patients with eRA, the MBDA score at baseline was a strong independent predictor of 1-year RP. These results suggest that when choosing initial treatment in eRA the MBDA test may be clinically useful to identify a subgroup of patients at low risk of RP. TRIAL REGISTRATION NUMBER: WHO database at the Karolinska Institute: CT20080004; and clinicaltrials.gov: NCT00764725.

Indexed as

AdipokinesAntibodies, MonoclonalAntirheumatic AgentsArthritis, RheumatoidBiomarkersChitinase-3-Like Protein 1C-Reactive ProteinDisease ProgressionDrug Therapy, CombinationEpidermal Growth FactorFemaleFoot JointsHand JointsHumansHydroxychloroquineInfliximabAdipokinesAntibodies, MonoclonalAntirheumatic AgentsBiomarkersCHI3L1 protein, humanChitinase-3-Like Protein 1C-Reactive ProteinEpidermal Growth FactorHydroxychloroquineIL6 protein, humanInfliximabInterleukin-6LectinsLeptinMatrix Metalloproteinase 1Matrix Metalloproteinase 3MethotrexateMMP1 protein, humanMMP3 protein, humanReceptors, Tumor Necrosis Factor, Type IResistinSerum Amyloid A ProteinSulfasalazineVascular Cell Adhesion Molecule-1Vascular Endothelial Growth Factor AAnti-TNFCytokinesDisease ActivityPatient perspectiveRheumatoid Arthritis

Identifiers

PMID24812287
PMCPMC4431327

What OpenQuestion holds

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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.