Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement
The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.
Abatacept Reduces Osteitis and Inhibits Bone Erosion in Anti-CCP2 Positive Patients with Synovitis at High Risk of Developing RA
Peterfy1, C., Durez2, P., DiCarlo1, J., Becker3, J. C., Vratsanos3, G., Overfield3, S., Qi3, K.
SYNARC, Inc, San Francisco, CA,
Cliniques Universitaires Saint-Luc, UCL, Brussels, Belgium,
Bristol-Myers Squibb, Princeton, NJ,
University of California, San Francisco,
University of Leeds, Leeds, United Kingdom
Osteitis on magnetic resonance imaging (MRI) is a strong predictor of radiographic progression in patients with RA1. Here, for the first time, we assess the impact of T-cell co-stimulation modulation with abatacept on MRI osteitis score in very early arthritis in patients with synovitis and anti-CCP antibodies, who are at a high risk of developing RA.
ADJUST (Abatacept study to Determine the effectiveness in preventing the development of RA in patients with Undifferentiated inflammatory arthritis and to evaluate Safety and Tolerability) was a randomized, double-blind, Phase II, placebo-controlled exploratory study of patients with undifferentiated arthritis, symptomatic clinical synovitis of >=2 joints and anti-CCP2 positivity; the primary endpoint was proportion of patients who developed RA by ACR criteria. A total of 56 patients with mean symptom duration of 7.9 months were randomized 1:1 to abatacept (~10 mg/kg) or placebo for up to 6 months, after which treatment was stopped. Patients who developed RA were discontinued. In this substudy, 21 patients had gadolinium-enhanced MRI of one hand/wrist within 2 weeks prior to initiating study drug and repeated at Month 6 and Year 1. MRI images were scored using the OMERACT 6 method2.
At Month 6, osteitis scores had improved from baseline with abatacept, but increased with placebo (Table). For patients who completed Year 1, 6 months after stopping therapy there was little progression in osteitis in the abatacept group but worsening in the placebo group (Table). MRI erosion and synovitis scores showed a similar trend; at Month 6, mean changes from baseline were 0.45 and 0.27, respectively, in the abatacept group and 1.20 and 1.60 in the placebo group. By Year 1, mean change from baseline in erosion and synovitis scores were 0 and 0.22, respectively, in the abatacept group versus 5.00 and 2.33 in the placebo group.
|Baseline (SD)||2.36 (5.28)||3.40 (8.42)|
|Month 6 (SD)||0.73 (1.10)||4.80 (7.84)|
|Change (95% CI)||-1.64 (-4.94, 1.67)||1.40 (-2.19, 4.99)|
|Baseline (SD)||0.56 (1.01)||0.67 (1.63)|
|Year 1 (SD)||0.78 (1.30)||7.33 (11.52)|
|Change (95% CI)||0.22 (-0.92, 1.36)||6.67 (-4.19, 17.53)|
|SD=standard deviation; CI=confidence interval|
To cite this abstract, please use the following information:
Peterfy, C., Durez, P., DiCarlo, J., Becker, J. C., Vratsanos, G., Overfield, S., et al; Abatacept Reduces Osteitis and Inhibits Bone Erosion in Anti-CCP2 Positive Patients with Synovitis at High Risk of Developing RA [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1690