Evidence map›Paper›PMID 31639034›Full record

Trial reportArthritis research & therapy2019

Very early MRI responses to therapy as a predictor of later radiographic progression in early rheumatoid arthritis.

Philip G Conaghan, Mikkel Østergaard, Orrin Troum, Michael A Bowes, Gwenael Guillard, Bethanie Wilkinson, Zhiyong Xie, John Andrews, Amy Stein, Douglass Chapman and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01164579 (An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.2field-weighted citation impact, top 12% 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.

NCT01164579 phase2completednot on this map

An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2010 to 2013Enrolled109ConditionsRheumatoid ArthritisArmsTasocitinib plus Methotrexate, Tofacitinib plus placebo methotrexate, Placebo tofacitinib plus Methotrexate
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 25 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

11 authors at 5 institutions in 3 countries.

Philip G ConaghanLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and UK National Institute for Health Research Leeds Biomedical Research Centre, Leeds, UK. P.Conaghan@leeds.ac.uk.ORCID 0000-0002-3478-5665
Mikkel ØstergaardCopenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Orrin TroumDivision of Rheumatology, University of Southern California Keck School of Medicine, Santa Monica, CA, USA.
Michael A BowesImorphics Ltd, Worthington House, Towers Business Park, Manchester, UK.
Gwenael GuillardImorphics Ltd, Worthington House, Towers Business Park, Manchester, UK.
Bethanie WilkinsonPfizer Inc, Groton, CT, USA.
Zhiyong XiePfizer Inc, Groton, CT, USA.
John AndrewsPfizer Inc, New York, NY, USA.
Amy SteinBiostatistics Department, IQVIA Inc, Morrisville, NC, USA.
Douglass ChapmanPfizer Inc, New York, NY, USA.
Andrew KoenigPfizer Inc, Collegeville, PA, USA.
Pfizer (United States) · USIQVIA (United States) · USUniversity of Copenhagen · DKUniversity of Leeds · GBUniversity of Southern California · US

Funding

Pfizer Inc N/A
6 · The paper itself

Abstract

backgroundThe objective of this study was to evaluate early changes in magnetic resonance imaging (MRI) and clinical disease activity measures as predictors of later structural progression in early rheumatoid arthritis (RA).

methodsThis was a post hoc analysis of data pooled across treatments from a three-arm (tofacitinib monotherapy, tofacitinib with methotrexate [MTX], or MTX monotherapy) trial of MTX-naïve patients with early, active RA. Synovitis, osteitis and erosions were assessed with the Outcome Measures in Rheumatology (OMERACT) RA MRI scoring system (RAMRIS) and RAMRIQ (automated quantitative RA MRI assessment system; automated RAMRIS) at months 0, 1, 3, 6 and 12. Radiographs were assessed at months 0, 6 and 12, and clinical endpoints were assessed at all timepoints. Univariate and multivariate analyses explored the predictive value of early changes in RAMRIS/RAMRIQ parameters and disease activity measures, with respect to subsequent radiographic progression.

resultsData from 109 patients with a mean RA duration of 0.7 years were included. In univariate analyses, changes in RAMRIS erosions at months 1 and 3 significantly predicted radiographic progression at month 12 (both p <  0.01); changes in RAMRIQ synovitis and osteitis at months 1 and 3 were significant predictors of RAMRIS erosions and radiographic progression at month 12 (all p <  0.01). In subsequent multivariate analyses, RAMRIS erosion change at month 1 (p <  0.05) and RAMRIQ osteitis changes at months 1 and 3 (both p <  0.01) were significant independent predictors of radiographic progression at month 12. Univariate analyses demonstrated that changes in Clinical Disease Activity Index (CDAI) and Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4[ESR]) at months 1 and 3 were not predictive of month 12 radiographic progression.

conclusionsMRI changes seen as early as 1 month after RA treatment initiation have the potential to better predict long-term radiographic progression than changes in disease activity measures.

trial registrationClinicalTrials.gov, NCT01164579 .

Indexed as

Disease ProgressionAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMagnetic Resonance ImagingMaleMethotrexatePiperidinesPredictive Value of TestsProtein Kinase InhibitorsPyrimidinesPyrrolesTreatment OutcomeAntirheumatic AgentsMethotrexatePiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolestofacitinibBone erosionDisease activityJoint space narrowingOsteitisPredictive abilityRadiographic progressionRAMRIQRAMRISRheumatoid arthritisSynovitis

Identifiers

PMID31639034
PMCPMC6805378
OpenAlexW2981648030

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.