Evidence map›Paper›PMID 26590174›Full record

Trial reportAnnals of the rheumatic diseases2016

Value of ultrasonography as a marker of early response to abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results from the APPRAISE study.

Maria-Antonietta D'Agostino, Richard J Wakefield, Hilde Berner-Hammer, Olivier Vittecoq, Georgios Filippou, Peter Balint, Ingrid Möller, Annamaria Iagnocco, Esperanza Naredo, Mikkel Østergaard and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00767325 (Multi-Center, Open Label Study to Assess Early Response to Abatacept With Background Methotrexate Using Power Doppler Ultrasonography in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate), which is not on this map. Cited by 39 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 1 pooled it
12.9field-weighted citation impact, top 1% 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.

NCT00767325 phase3completednot on this map

Multi-Center, Open Label Study to Assess Early Response to Abatacept With Background Methotrexate Using Power Doppler Ultrasonography in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

TypeinterventionalSponsorBristol-Myers SquibbRan2008 to 2011Enrolled104ConditionsRheumatoid ArthritisArmsAbatacept, Methotrexate
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 1 synthesis or guideline pooled it, 99 citations in OpenAlex.

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  16. Ultrasound in the evaluation of rheumatoid arthritis.European journal of rheumatology · 2022
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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

15 authors at 12 institutions in 9 countries.

Maria-Antonietta D'AgostinoService de Rhumatologie, APHP, Hôpital Ambroise Paré, Boulogne-Billancourt, France Laboratoire d'Excellence INFLAMEX, INSERM U1173, Université Paris Ouest-Versailles Saint-Quentin, Saint-Quentin-en-Yvelines, France.
Richard J WakefieldNIHR Leeds Musculoskeletal Biomedical Research Unit (LMBRU), Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Hilde Berner-HammerDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Olivier VittecoqDepartment of Rheumatology and CIC-CRB-1404, Inserm U905, Rouen University Hospital, Rouen University, Rouen, France.
Georgios FilippouDepartment of Medicine, Surgery and Neurosciences, Rheumatology Section, University of Siena, Siena, Italy.
Peter Balint3rd Rheumatology Department, National Institute of Rheumatology and Physiotherapy, Budapest, Hungary.
Ingrid MöllerDepartment of Rheumatology, Instituto Poal, Barcelona, Spain.
Annamaria IagnoccoRheumatology Unit, Dipartimento Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Roma, Italy.
Esperanza NaredoDepartment of Rheumatology, Hospital GU Gregorio Marañón, Madrid, Spain.
Mikkel ØstergaardCopenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark.
Maarten BoersDepartment of Epidemiology and Biostatistics, The Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, Netherlands.
Corine GaillezMedical Affairs, Bristol-Myers Squibb, Rueil-Malmaison, France.
Karina Van HolderGlobal Clinical Operations and Strategy, Bristol-Myers Squibb, Braine-L'Alleud, Belgium.
Manuela Le BarsMedical Affairs, Bristol-Myers Squibb, Rueil-Malmaison, France.
OMERACT-EULAR-Ultrasound Task Force
Bristol-Myers Squibb (France) · FRAmsterdam UMC Location VUmc · NLBristol-Myers Squibb (Belgium) · BEDiakonhjemmet Hospital · NOHôpital Ambroise-Paré · FRHospital General Universitario Gregorio Marañón · ESNational Institute of Oncology · HUNIHR Leeds Musculoskeletal Biomedical Research Unit · GBPhysiopathologie et Epidémiologie des Maladies Respiratoires · FRSapienza University of Rome · ITUniversity of Copenhagen · DKUniversity of Siena · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo study the responsiveness of a combined power Doppler and greyscale ultrasound (PDUS) score for assessing synovitis in biologic-naïve patients with rheumatoid arthritis (RA) starting abatacept plus methotrexate (MTX).

methodsIn this open-label, multicentre, single-arm study, patients with RA (MTX inadequate responders) received intravenous abatacept (∼10 mg/kg) plus MTX for 24 weeks. A composite PDUS synovitis score, developed by the Outcome Measures in Rheumatology-European League Against Rheumatism (OMERACT-EULAR)-Ultrasound Task Force, was used to evaluate individual joints. The maximal score of each joint was added into a Global OMERACT-EULAR Synovitis Score (GLOESS) for bilateral metacarpophalangeal joints (MCPs) 2-5 (primary objective). The value of GLOESS containing other joint sets was explored, along with clinical efficacy.

resultsEighty-nine patients completed the 24-week treatment period. The earliest PDUS sign of improvement in synovitis was at week 1 (mean change in GLOESS (MCPs 2-5): -0.7 (95% CIs -1.2 to -0.1)), with continuous improvement to week 24. Early improvement was observed in the component scores (power Doppler signal at week 1, synovial hyperplasia at week 2, joint effusion at week 4). Comparable changes were observed for 22 paired joints and minimal joint subsets. Mean Disease Activity Score 28 (C reactive protein) was significantly reduced from weeks 1 to 24, reaching clinical meaningful improvement (change ≥1.2) at week 8.

conclusionsIn this first international prospective study, the composite PDUS score is responsive to abatacept. GLOESS demonstrated the rapid onset of action of abatacept, regardless of the number of joints examined. Ultrasound is an objective tool to monitor patients with RA under treatment. TRIAL REGISTRATION NUMBER: NCT00767325.

Indexed as

AbataceptAdultAgedAntirheumatic AgentsArthritis, RheumatoidBiomarkersDrug Therapy, CombinationEuropeFemaleHumansJointsMaleMethotrexateMiddle AgedPredictive Value of TestsProspective StudiesAbataceptAntirheumatic AgentsBiomarkersMethotrexateDisease ActivityDMARDs (biologic)Rheumatoid ArthritisUltrasonography

Identifiers

PMID26590174
PMCPMC5036216
OpenAlexW2208044338

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.