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

on behalf of the OMERACT-EULAR-Ultrasound Task Force

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Abstract

Objectives To 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). Methods In 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. Results Eighty-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. Conclusions In 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.

Original languageEnglish
JournalAnnals of the Rheumatic Diseases
DOIs
Publication statusAccepted/In press - Nov 20 2015

Fingerprint

Ultrasonography
Synovitis
Methotrexate
Rheumatoid Arthritis
Joints
Ultrasonics
Doppler Ultrasonography
Metacarpophalangeal Joint
Composite materials
Biological Products
C-Reactive Protein
Rheumatology
Advisory Committees
Abatacept
Labels
Hyperplasia
Outcome Assessment (Health Care)
Prospective Studies
Therapeutics

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)
  • Immunology and Allergy

Cite this

@article{c4745696fc0447a39ac694ba9345098f,
title = "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",
abstract = "Objectives To study the responsiveness of a combined power Doppler and greyscale ultrasound (PDUS) score for assessing synovitis in biologic-na{\"i}ve patients with rheumatoid arthritis (RA) starting abatacept plus methotrexate (MTX). Methods In 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. Results Eighty-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. Conclusions In 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.",
author = "{on behalf of the OMERACT-EULAR-Ultrasound Task Force} and D'Agostino, {Maria Antonietta} and Wakefield, {Richard J.} and Hilde Berner-Hammer and Olivier Vittecoq and Georgios Filippou and P. B{\'a}lint and Ingrid M{\"o}ller and Annamaria Iagnocco and Esperanza Naredo and Mikkel {\O}stergaard and Maarten Boers and Corine Gaillez and Holder, {Karina Van} and Bars, {Manuela Le} and Silvano Adami and Vivi Bakkenheim and Stefano Bombardieri and Paul Emery and Liana Euller-Ziegler and Gianfranco Ferraccioli and Maurizio Galeazzi and Philippe Gaudin and Walter Grassi and Herbert Kellner and Thierry Lequerr{\'e} and Fredeswinda Romero and Istvan Szombati and Lene Terslev and Jacqueline Uson and Esther Vicente",
year = "2015",
month = "11",
day = "20",
doi = "10.1136/annrheumdis-2015-207709",
language = "English",
journal = "Annals of the Rheumatic Diseases",
issn = "0003-4967",
publisher = "BMJ Publishing Group",

}

TY - JOUR

T1 - Value of ultrasonography as a marker of early response to abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate

T2 - Results from the APPRAISE study

AU - on behalf of the OMERACT-EULAR-Ultrasound Task Force

AU - D'Agostino, Maria Antonietta

AU - Wakefield, Richard J.

AU - Berner-Hammer, Hilde

AU - Vittecoq, Olivier

AU - Filippou, Georgios

AU - Bálint, P.

AU - Möller, Ingrid

AU - Iagnocco, Annamaria

AU - Naredo, Esperanza

AU - Østergaard, Mikkel

AU - Boers, Maarten

AU - Gaillez, Corine

AU - Holder, Karina Van

AU - Bars, Manuela Le

AU - Adami, Silvano

AU - Bakkenheim, Vivi

AU - Bombardieri, Stefano

AU - Emery, Paul

AU - Euller-Ziegler, Liana

AU - Ferraccioli, Gianfranco

AU - Galeazzi, Maurizio

AU - Gaudin, Philippe

AU - Grassi, Walter

AU - Kellner, Herbert

AU - Lequerré, Thierry

AU - Romero, Fredeswinda

AU - Szombati, Istvan

AU - Terslev, Lene

AU - Uson, Jacqueline

AU - Vicente, Esther

PY - 2015/11/20

Y1 - 2015/11/20

N2 - Objectives To 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). Methods In 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. Results Eighty-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. Conclusions In 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.

AB - Objectives To 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). Methods In 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. Results Eighty-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. Conclusions In 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.

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UR - http://www.scopus.com/inward/citedby.url?scp=84958806667&partnerID=8YFLogxK

U2 - 10.1136/annrheumdis-2015-207709

DO - 10.1136/annrheumdis-2015-207709

M3 - Article

C2 - 26590174

AN - SCOPUS:84958806667

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

SN - 0003-4967

ER -