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Extended report
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
  1. Maria-Antonietta D'Agostino1,2,
  2. Richard J Wakefield3,
  3. Hilde Berner-Hammer4,
  4. Olivier Vittecoq5,
  5. Georgios Filippou6,
  6. Peter Balint7,
  7. Ingrid Möller8,
  8. Annamaria Iagnocco9,
  9. Esperanza Naredo10,
  10. Mikkel Østergaard11,
  11. Maarten Boers12,
  12. Corine Gaillez13,
  13. Karina Van Holder14,
  14. Manuela Le Bars13
  15. on behalf of the OMERACT-EULAR-Ultrasound Task Force
  1. 1Service de Rhumatologie, APHP, Hôpital Ambroise Paré, Boulogne-Billancourt, France
  2. 2Laboratoire d'Excellence INFLAMEX, INSERM U1173, Université Paris Ouest-Versailles Saint-Quentin, Saint-Quentin-en-Yvelines, France
  3. 3NIHR Leeds Musculoskeletal Biomedical Research Unit (LMBRU), Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
  4. 4Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
  5. 5Department of Rheumatology and CIC-CRB-1404, Inserm U905, Rouen University Hospital, Rouen University, Rouen, France
  6. 6Department of Medicine, Surgery and Neurosciences, Rheumatology Section, University of Siena, Siena, Italy
  7. 73rd Rheumatology Department, National Institute of Rheumatology and Physiotherapy, Budapest, Hungary
  8. 8Department of Rheumatology, Instituto Poal, Barcelona, Spain
  9. 9Rheumatology Unit, Dipartimento Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Roma, Italy
  10. 10Department of Rheumatology, Hospital GU Gregorio Marañón, Madrid, Spain
  11. 11Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark
  12. 12Department of Epidemiology and Biostatistics, The Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, Netherlands
  13. 13Medical Affairs, Bristol-Myers Squibb, Rueil-Malmaison, France
  14. 14Global Clinical Operations and Strategy, Bristol-Myers Squibb, Braine-L'Alleud, Belgium
  1. Correspondence to Professor Maria-Antonietta D'Agostino, Université Versailles Saint Quentin en Yvelines, AP-HP Ambroise Paré Hospital, 9 Avenue Charles de Gaulle, Boulogne-Billancourt 92100, France; maria-antonietta.dagostino{at}apr.aphp.fr

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.

  • Rheumatoid Arthritis
  • Ultrasonography
  • Disease Activity
  • DMARDs (biologic)

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