Evidence map›Paper›PMID 32859608›Full record

Trial reportAnnals of the rheumatic diseases2020

Cardiovascular effects of biological versus conventional synthetic disease-modifying antirheumatic drug therapy in treatment-naïve, early rheumatoid arthritis.

Sven Plein, Bara Erhayiem, Graham Fent, Sarah Horton, Raluca Bianca Dumitru, Jacqueline Andrews, John P Greenwood, Paul Emery, Elizabeth Ma Hensor, Paul Baxter and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IVRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01295151 (Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor), which is not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 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.

NCT01295151 phase4completednot on this map

Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug

TypeinterventionalSponsorJulia BrownRan2011 to 2015Enrolled122ConditionsRheumatoid ArthritisArmsEtanercept, Abatacept, Rituximab, Adalimumab, Certolizumab Pegol
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Sven PleinLeeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
Bara ErhayiemLeeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
Graham FentLeeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
Sarah HortonCentral Lancashire Moving Well Service, Lancashire and South Cumbria NHS Foundation Trust, Lancashire, UK.
Raluca Bianca DumitruLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.ORCID 0000-0002-0833-4852
Jacqueline AndrewsLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
John P GreenwoodLeeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
Paul EmeryLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.ORCID 0000-0002-7429-8482
Elizabeth Ma HensorLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Paul BaxterLeeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
Sue PavittDental Translational and Clinical Research Unit, University of Leeds, Leeds, UK.
Maya H BuchLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK maya.buch@manchester.ac.uk.ORCID 0000-0002-8962-5642

Funding

Department of Health 11/117/27
6 · The paper itself

Abstract

objectivesTo determine whether patients with early rheumatoid arthritis (ERA) have cardiovascular disease (CVD) that is modifiable with disease-modifying antirheumatic drug (DMARD) therapy, comparing first-line etanercept (ETN) + methotrexate (MTX) with MTX strategy.

methodsPatients from a phase IV ERA trial randomised to ETN+MTX or MTX strategy±month 6 escalation to ETN+MTX, and with no CVD and maximum one traditional risk factor underwent cardiovascular magnetic resonance (CMR) at baseline, years 1 and 2. Thirty matched controls underwent CMR. Primary outcome measure was aortic distensibility (AD) between controls and ERA, and baseline to year 1 AD change in ERA. Secondary analyses between and within ERA groups performed. Additional outcome measures included left ventricular (LV) mass and myocardial extracellular volume (ECV).

resultsEighty-one patients recruited. In ERA versus controls, respectively, baseline (geometric mean, 95% CI) AD was significantly lower (3.0×10

conclusionWe report the first evidence of vascular and myocardial abnormalities in an ERA randomised controlled trial cohort and show improvement with DMARD therapy. The type of DMARD (first-line tumour necrosis factor-inhibitors or MTX) and clinical response to therapy did not affect CVD markers. TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN89222125; ClinicalTrials.gov: NCT01295151.

Indexed as

AdultAgedAntirheumatic AgentsArthritis, RheumatoidCardiovascular DiseasesEtanerceptFemaleHumansMagnetic Resonance ImagingMaleMethotrexateMiddle AgedRisk FactorsTreatment OutcomeVascular StiffnessAntirheumatic AgentsEtanerceptMethotrexatearthritisatherosclerosiscardiovascular diseasesmagnetic resonance imagingrheumatoidtumor necrosis factors

Identifiers

PMID32859608
PMCPMC7569379

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.