RESEARCH - The impact of Orencia in patients with undifferentiated inflammatory arthritis or very early RA

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Ann Rheum Dis. Published Online First: 23 November 2009.

doi:10.1136/ard.2009.119016

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

Emery1,*, Durez2, Maxime Dougados3, Clarence W Legerton4,

Jean-Claude Becker5, Vratsanos5, Harry K Genant6, G

fy7, Pranab Mitra5, Overfield5, Keqin Qi5, René

Westhovens8

1 University of Leeds, United Kingdom;

2 UCL, St Luc, Belgium;

3 Hopital Cochin, Descartes University, France;

4 Low Country Research Centre, United States;

5 Bristol-Myers Squibb, United States;

6 University of California/Synarc, United States;

7 Synarc, United States;

8 UZ Gasthuisberg, Belgium

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.

http://ard.bmj.com/cgi/content/abstract/ard.2009.119016v1?papetoc

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