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Abstract Number: 132

Do Ultrasound (PDUS) and DAS28 Measure Different Aspects of Disease Activity? Analyses from the First Prospective International Phase IIIb Study of PDUS Response in Abatacept-Treated Patients with Rheumatoid Arthritis (RA)

Maria-Antonietta d'Agostino1, M Boers2, R Wakefield3, H Berner Hammer4, O Vittecoq5, M Galeazzi6, P Balint7, I Möller8, A Iagnocco9, E Naredo10,11, M Ostergaard12, C Gaillez13, E Barre14, M Le Bars15 and On behalf of the OMERACT-EULAR-Ultrasound Task Force, 1AP-HP Ambroise Paré Hospital, Boulogne-Billancourt, France, 2VU University Medical Center, Amsterdam, Netherlands, 3University of Leeds, Leeds, United Kingdom, 4Diakonhjemmet Hospital, Oslo, Norway, 5University Hospital, Rouen, France, 6University of Siena, Siena, Italy, 7Rheumatology, National Institute of Rheumatology and Physiotherapy, Budapest, Hungary, 8Instituto Poal, Barcelona, Spain, 9Sapienza Università di Roma, Roma, Italy, 10Hospital Universitario Severo Ochoa, Madrid, Spain, 11Hospital GU Gregorio Marañón, Madrid, Spain, 12Copenhagen University Hospital at Glostrup, Copenhagen, Denmark, 13Formerly of Bristol-Myers Squibb, Rueil-Malmaison, France, 14Bristol-Myers Squibb, Braine-L’Alleud, Belgium, 15Bristol-Myers Squibb, Rueil-Malmaison, France

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Abatacept, rheumatoid arthritis (RA) and ultrasonography

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Session Information

Title: Imaging of Rheumatic Diseases: Ultrasound

Session Type: Abstract Submissions (ACR)

Background/Purpose: A composite (power Doppler/grayscale ultrasound [PDUS]) synovitis score, developed by the OMERACT-EULAR-Ultrasound Task Force, was shown to be responsive in RA patients with inadequate response to MTX who were treated with abatacept (ABA); a rapid parallel change in PDUS and DAS28 was demonstrated.1 Data from clinical studies that have utilized PDUS indicate that it could be useful in monitoring RA treatment effects;2 however, discordant correlations have been found between ultrasound scores and clinical outcomes measured at the same time point.3-7 In this secondary analysis of the APPRAISE study, we explored correlations between changes in PDUS and clinical scores.   Methods: Individual joint PDUS scores were combined in the Global OMERACT-EULAR Synovitis Score (GLOESS) of metacarpophalangeal joints 2–5 (primary objective), reduced joint set (9 paired) and all examined joints (22 paired). Correlation between changes in GLOESS and clinical scores were assessed through: effect size, expressed as standardized response means of GLOESS and mean changes in DAS28 from baseline to Weeks 1, 12 and 24; Pearson’s correlation coefficient, for assessing correlation between early and late changes in DAS28, and early and late changes in all GLOESS scores; and Spearman’s correlation coefficient, for assessing correlation between early changes in GLOESS and lower levels of synovitis at Week 24. Furthermore, the relationship between GLOESS and clinical response was explored by analyzing the correlation between changes from baseline in the number of tender and swollen joints and matched joint GLOESS. Results: No significant correlations were found between: changes from baseline in DAS28 and GLOESS, or component scores (synovial hypertrophy, PD, joint effusion) at any time point; or between early (baseline to Weeks 1, 2 or 4) changes in GLOESS, or components, and changes in the sum of swollen joints from baseline to Weeks 12 or 24. Within the assessment method, i.e. between clinical scores, or between GLOESS at different time points, moderate-to-high correlations were found between early (to Week 12) and late (Week 24) improvements in DAS28, and similarly between changes in GLOESS (any joint set): Pearson’s coefficient range 0.37–0.71. Only changes in GLOESS at Week 12 were able to differentiate between early versus late clinical responders: Pearson’s coefficient (95% CI): 22 joint: 0.71 (0.57, 0.80); 9 joint: 0.62 (0.46, 0.74).

Conclusion: PDUS is a responsive measure of joint activity in patients starting abatacept, but the extent of PDUS response does not correlate with extent of clinical response. Early PDUS changes could differentiate early versus late clinical responders, suggesting that PDUS adds independent information on response to treatment which needs to be explored further.

1.   D’Agostino MA, et al. Arthritis Rheum 2012;64(Suppl):S352.

2.   Backhaus TM, et al. Ann Rheum Dis 2013;72:1163–9. 3.   Filippucci E, et al. Ann Rheum Dis 2006;65:1433–7. 4.   Dougados M, et al. Ann Rheum Dis 2013;72:665–71. 5.   Kume K, et al. Arthritis Care Res (Hoboken) 2011;63:1477–81. 6.   Jousse-Joulin S, et al. J Rheumatol 2010;37:938–45. 7.   Marhadour T, et al. J Rheumatol 2010;37:932–7.  


Disclosure:

M. A. d’Agostino,

Bristol-Myers Squibb, AbbVie,

8;

M. Boers,

Bristol-Myers Squibb,

5;

R. Wakefield,
None;

H. Berner Hammer,
None;

O. Vittecoq,
None;

M. Galeazzi,
None;

P. Balint,
None;

I. Möller,

Bio Iberica pharma, AbbVie, GE, ESAOTE,

5;

A. Iagnocco,
None;

E. Naredo,

AbbVie, Roche Pharma, BMS, Pfizer, UCB, General Electric, Esaote,

5,

MSD,

2;

M. Ostergaard,

bbott/Abbvie, Centocor, Merck, Schering-Plough,,

2,

Abbott/Abbvie, BMS, Boehringer-Ingelheim, Eli-Lilly, Centocor, GSK, Janssen, Merck, Mundipharma, Novo, Pfizer, Schering-Plough, Roche UCB, and Wyeth,

5;

C. Gaillez,

Bristol-Myers Squibb, Novartis,

1,

Novartis Pharma AG,

3;

E. Barre,

Bristol-Myers Squibb,

3;

M. Le Bars,

Bristol-Myers Squibb,

3,

Bristol-Myers Squibb,

1.

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