ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 810

Assessment of Omeract Global Power Doppler Ultrasonography 44-Joint Scoring System and Reduced Joint Scoring Systems in Rheumatoid Arthritis Patients Treated with Abatacept Plus Background Methotrexate

MA D'Agostino1, R. Wakefield2, H. Berner Hammer3, O. Vittecoq4, M. Galeazzi5, P. Balint6, E. Filippucci7, I. Moller8, A. Iagnocco9, E. Naredo10, Mikkel Ostergaard11, C. Gaillez12, K. Van Holder13, M. Le Bars12 and OMERACT-US Task Force14, 1AP-HP Ambroise Pare Hospital, Boulogne-Billancourt, France, 2University of Leeds, Leeds, United Kingdom, 3Diakonhjemmet Hospital, Oslo, Norway, 4University Hospital, Rouen, France, 5University of Siena, Siena, Italy, 6National Institute, Budapest, Hungary, 7University Politecnica delle Marche, Ancona, Italy, 8Instituto Poal, Barcelona, Spain, 9Sapienza Università di Roma, Roma, Italy, 10Hospital Severo Ochoa, Madrid, Spain, 11Copenhagen Center for Arthritis Research, Copenhagen University Hospital at Glostrup, Glostrup, Denmark, 12Bristol-Myers Squibb, Rueil Malmaison, France, 13Bristol-Myers Squibb, Braine-L’Alleud, Belgium, 14Paris

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Title: Imaging of Rheumatic Diseases I: Ultrasound and X-ray

Session Type: Abstract Submissions (ACR)

Background/Purpose: The first international trial using the standardized global OMERACT Power Doppler Ultrasonography (PDUS) synovitis scoring system1 showed early and significant signs of improvement in synovitis in abatacept-treated pts with RA, demonstrating the sensitivity of this score.2 This trial evaluated paired MCPs 2–5 for its primary endpoint. However, there is no consensus on the minimum joint count needed to evaluate response with the OMERACT PDUS synovitis score. Additional analyses evaluated the effect of abatacept on the OMERACT global PDUS synovitis score, using a paired 22-joint count and a reduced set of joints defined here as Global Synovitis Score (GLOSS). We compare the responsiveness of GLOSS with two published reduced joint counts.3,4 Methods: This 6-month, single-arm, open-label study enrolled RA pts with inadequate response to MTX, and DAS28 (CRP) >3.2 or ≥6 tender and swollen joints and CRP >ULN. Global PDUS paired 22-joint score was assessed at baseline (BL); Days 7, 15, 29, 43, and 57; and then monthly by a PDUS examiner blinded from clinical assessments. A reduced subset of joints (GLOSS) that best represented the global PDUS score for paired 22 joints of all pts over three time points was identified at BL, Days 85 and 169, based on principal component analysis. The number of joints was selected based on Eigen values using a statistical method described by Jolliffe.5 The three best subsets of paired joints, one for each time point, were identified using two methods, based on values of efficiency measure (EM) of the reduced subset: EM ≥0.6 at all three time points and the subset with the highest minimum EM over the three time points. The sensitivity to change was assessed for GLOSS and the existing 12-joint3 and 7-joint4 sets using standardized response mean (SRM) in a post hoc analysis.

Results: BL demographics and mean change from BL in global PDUS score (MCPs 2–5) over 6 months have been reported.2 Mean change (95% CIs) from BL in global paired PDUS 22-joint score was –1.7 (–3.4, –0.1; n=87) at Day 7 and improved up to Day 169 [–15.7 (–19.0, –12.5; n=95)]. The GLOSS that best represented the global paired PDUS 22-joint score of all pts over the three time points included 9 paired joints: shoulder, elbow, wrist, MCP1, MCP4, PIP2, knee, MTP3, and MTP5. When comparing the GLOSS with the published reduced joint sets (bilaterally taken), mean changes from BL improved up to Day 169 for all, with a similar SRM (Table).

Conclusion: Abatacept + MTX resulted in early (Day 7, by global PDUS 22-joint score) and continuous reductions in synovitis to Day 169 (with global PDUS 22-joint score and 9-joint GLOSS). The GLOSS 9-joint subset and the 12- and 7-joint sets all demonstrated a similar sensitivity to change.    1. Naredo E, et al. J Rheumatol 2011;38:2063–7 2. D’Agostino MA, et al. Ann Rheum Dis 2012;71(Suppl 3):186 3. Naredo E, et al. Arthritis Rheum 2008;59:515–22 4. Backhaus M, et al. Arthritis Rheum 2009;61:1194–201 5. Jolliffe IT. Appl Statist 1973;22:21–31  

Joint count

n

Mean change in joint count (95% CI)

SRM

GLOSS

84

–6.4
(–7.9, –4.9)

–0.949

12-joint set

85

–5.3
(–6.5, –4.2)

–0.994

7-joint set

85

–6.6
(–8.0, –5.3)

–1.053

n=number of pts with BL and post-BL measurements

 

Disclosure:

M. D’Agostino,

PHRC,

2,

Bristol-Myers Squibb,

5,

Wakefield and D’Agostino: ‘Essential Applications of Musculoskeletal Ultrasound in Rheumatology’ Elsevier,

7,

Roche, BMS, Pfizer, Abbott, UCB,

8;

R. Wakefield,
None;

H. Berner Hammer,
None;

O. Vittecoq,
None;

M. Galeazzi,
None;

P. Balint,
None;

E. Filippucci,

I received consulting fees from Bristol-Myers Squibb (less than $10,000 each).,

5;

I. Moller,

Bristol-Myers Squibb,

5;

A. Iagnocco,
None;

E. Naredo,
None;

M. Ostergaard,

Abbott, Pfizer/wyeth, Centocor/Janssen,

2,

Abbott, MSD/Schering-Plough, Pfizer/wyeth, Centocor/Janssen, Roche, UCB,

5,

Abbott, MSD/Schering-Plough, Pfizer/wyeth, Centocor/Janssen,

8;

C. Gaillez,

Full time BMS Employee,

3;

K. Van Holder,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3;

M. Le Bars,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3;

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