ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 811

The Relationship Between Power Doppler Ultrasonography Outcomes and Clinical Efficacy in Abatacept-Treated Patients with Rheumatoid Arthritis and in Inadequate Response to 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 Ultrasound 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

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

Session Type: Abstract Submissions (ACR)

Background/Purpose: An exploratory study using the standardized global OMERACT Power Doppler Ultrasonography (PDUS) scoring system1 in patients (pts) with established RA and inadequate response to MTX treated with abatacept (ABA) + background MTX demonstrated early signs of improvement in synovitis of paired MCPs 2–5 at Day 7 with further improvement up to Day 169 (Mth 6).2 This analysis investigates the relationship between DAS28 disease status at Day 169 and PDUS improvement at Day 85 (Mth 3) using three joint counts (paired MCPs 2–5, paired 22-joints, and a reduced set of paired 9-joints [Global Synovitis Score; ‘GLOSS’]); and if changes in PDUS at Day 85 in any of the joint counts can differentiate between early (<3 mths) and late (>3 mths) responders. Methods: This was a post hoc analysis of pts who completed 6 mths of treatment with ABA + MTX in the open-label, exploratory Phase IIIb study.2 Global PDUS scores for paired MCPs 2–5 (range: 0–24 units), 22 joints (range: 0–132 units), and a reduced subset of 9 joints (GLOSS: shoulder, elbow, wrist, MCP1, MCP4, PIP2, knee, MTP3, and MTP5; range: 0–54 units) were assessed at baseline (BL) and Mths 3 and 6 by a blinded PDUS examiner. Changes in global and component (synovial hypertrophy, power Doppler [PD], and joint effusion) PDUS paired MCPs 2–5 scores at Mth 3 were analyzed according to remission status (DAS28 <2.6) at Mth 6. In pts reaching LDAS (DAS28 ≤3.2) at Mth 6, changes in global PDUS paired MCPs 2–5, 22 joints, and GLOSS from BL to Mth 3 were summarized according to whether pts achieved clinically meaningful improvement (CMI) in DAS28 (≥1.2) or not at Mth 3 (early vs late responders).

Results: Similar mean change from BL to Mth 3 in global PDUS and synovial hypertrophy was observed irrespective of remission status at Mth 6. A numerically greater improvement in PD signal was seen in pts who reached remission at Mth 6 vs those who did not (Table 1). In pts achieving LDAS at Mth 6, the global PDUS paired 22-joint score and GLOSS, but not MCPs 2–5, could discriminate numerically between early vs late responders (Table 2).

Conclusion: This first international study using the standardized global OMERACT PDUS score showed that abatacept-treated pts demonstrated improvements in PDUS paired MCP 2–5 scores regardless of remission status at Mth 6. However, pts in remission at Mth 6 had numerically greater improvements in PD MCPs 2–5 at Mth 3 than those who were not. In pts reaching LDAS at Mth 6, improvements in all PDUS scores were seen regardless of responder status. Early responders could be identified by numerically greater improvement of either global PDUS paired 22-joint score or GLOSS.

  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  

Table 1. Mean change (95% CIs) from BL to Mth 3 in global PDUS paired MCPs (2–5) scores and components, according to remission status at Mth 6

N=104

 

Global PDUS (MCPs 2–5) score

Synovial hypertrophy

Power Doppler

Joint effusion

Remission (n=37)

 

Mean change
(95% CI)

-4.2

(-5.9, -2.6)

-3.8

(-5.3, -2.3)

-4.9

(-6.2, -3.7)

-1.9

(-3.2, -0.7)

No remission (n=43)

 

Mean change
(95% CI)

-4.0

(-5.2, -2.8)

-3.9

(-5.0, -2.7)

-2.6

(-3.8, -1.4)

-1.4

(-2.4, -0.5)

 

Table 2. Mean change (95% CIs) in global PDUS scores from BL to Mth 3 in pts who achieved LDAS at Mth 6, according to early or late response

 

Patients in LDAS at Mth 6

Global PDUS (MCPs 2–5) score

Global PDUS 22-joint score

GLOSS

 

Early responders

(at least CMI at Mth 3)

(n=37)

-4.2

(-5.8, -2.5)

-12.6

(-17.2, -8.0)

-6.1*

(-8.0, -4.1)

 

Late responders

(no CMI at Mth 3)

(n=10)

-4.3

(-6.2, -2.4)

-10.6

(-16.7, -4.5)

-4.3

(-6.2, -2.4)

 

*n=36

n is the 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, BMS, MSD, Pfizer, UCB, Roche,

2,

Abbott, BMS, MSD, Pfizer, UCB, Roche,

5,

Abbott, BMS, MSD, Pfizer, UCB, Roche,

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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