Title: The impact of T-cell co-stimulation modulation in patients with undifferentiated inflammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abatacept
Authors: Emery, Paul ×
Durez, Patrick
Dougados, Maxime
Legerton, Clarence W
Becker, Jean-Claude
Vratsanos, George
Genant, Harry K
Peterfy, Charles G
Mitra, Pranab
Overfield, Sandra
Qi, Keqin
Westhovens, Rene #
Issue Date: Mar-2010
Publisher: H.K. Lewis
Series Title: Annals of the Rheumatic Diseases vol:69 issue:3 pages:510-516
Abstract: BACKGROUND: Several agents provide treatment for established RA, but a crucial therapeutic goal is to delay/prevent progression of undifferentiated arthritis (UA) or very early RA. METHODS: In this double-blind, Phase II, placebo-controlled 2-year study, anti-CCP2-positive patients with UA (not fulfilling the ACR criteria for RA) and clinical synovitis of >/=2 joints were randomized to abatacept (~10 mg/kg) or placebo for 6 months, then study drug was terminated. The primary endpoint was development of RA (by ACR criteria) at Year 1. Patients were monitored by radiography, MRI, CCP2, RF, DAS28 and 28-joint count over 2 years. RESULTS: At Year 1, 12/26 (46%) abatacept-treated versus 16/24 (67%) placebo-treated patients developed RA (difference [95% CI] -20.5% [-47.4, 7.8]). Adjusted mean changes from baseline to Year 1 in Genant-modified Sharp radiographic scores for abatacept- versus placebo-treated patients, respectively, were: 0 versus 1.1 for TS, and 0 versus 0.9 for ES. Mean changes from baseline to Year 1 in MRI erosion, osteitis and synovitis scores were 0, 0.2 and 0.2, respectively, versus 5.0, 6.7 and 2.3 in the abatacept versus placebo groups. Safety was comparable between groups; serious AEs occurred in one patient (3.6%) in each group. CONCLUSION: Abatacept delayed progression of UA/very early RA in some patients. An impact on radiographic and MRI inhibition was observed, which was maintained for 6 months after therapy cessation. This suggests that it is possible to alter the progression of RA by modulating T-cell responses at a very early stage of disease.
ISSN: 0003-4967
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Rheumatology Section (-)
× corresponding author
# (joint) last author

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