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Randomized Controlled Trial
. 2008 Aug;67(8):1084-9.
doi: 10.1136/ard.2007.085084. Epub 2007 Dec 17.

Abatacept inhibits progression of structural damage in rheumatoid arthritis: results from the long-term extension of the AIM trial

H K Genant  1 , C G Peterfy, R Westhovens, J-C Becker, R Aranda, G Vratsanos, J Teng, J M Kremer
Affiliations
Randomized Controlled Trial

Abatacept inhibits progression of structural damage in rheumatoid arthritis: results from the long-term extension of the AIM trial

H K Genant et al. Ann Rheum Dis. 2008 Aug.

Abstract

Objective: Assess the effect of abatacept on progression of structural damage over 2 years in patients with rheumatoid arthritis who had an inadequate response to methotrexate.

Methods: 539 patients entered an open-label extension of the AIM (Abatacept in Inadequate responders to Methotrexate) trial and received abatacept. Radiographic assessment of the hands and feet was performed at baseline, year 1 and year 2. At year 2, each patient's radiographs were scored for progression blinded to sequence and treatment allocation.

Results: In patients treated with abatacept for 2 years, greater reduction in progression of structural damage was observed in year 2 than in year 1. The mean change in total Genant-modified Sharp scores was reduced from 1.07 units in year 1 to 0.46 units in year 2. Similar reductions were observed in erosion and joint space narrowing scores. Following 2 years of treatment with abatacept, 50% of patients had no progression of structural damage as defined by a change in the total score of < or =0 compared with baseline. 56% of patients treated with abatacept had no progression during the first year compared with 45% of patients treated with placebo. In their second year of treatment with abatacept, more patients had no progression than in the first year (66% vs 56%).

Conclusions: Abatacept has a sustained effect that inhibits progression of structural damage. Furthermore, the mean change in radiographic progression in patients treated with abatacept for 2 years was significantly lower in year 2 versus year 1, suggesting that abatacept may have an increasing disease-modifying effect on structural damage over time.

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Conflict of interest statement

Competing interests: HG has been reimbursed by Bristol-Myers Squibb, Amgen, Wyeth, Novartis, Merck, Sanofi-Aventis, Lilly, GSK, Roche and Genentech for speaking fees and honoraria. HG has also received research funding from these organisations. HG is a founder and share holder of Synarc, Inc., and serves as a member of the board of directors. RW has been reimbursed >$10 000 by Bristol-Myers Squibb and Schering-Plough for speaking fees and honoraria. J-CB is an employee of Bristol-Myers Squibb, and has shares with the company. RA is an employee of Bristol-Myers Squibb, and has shares with the company. GV is an employee of Bristol-Myers Squibb, and has shares with the company. JT is an employee of Bristol-Myers Squibb, and has shares with the company. JK has been reimbursed >$10 000 by Bristol-Myers Squibb for speaking fees and honoraria. CP is an employee and shareholder of Synarc, Inc., and is a provider of central image analysis, molecular marker assays and subject recruitment for global clinical trials for numerous pharmaceutical and biotechnology companies across a broad range of therapeutic areas.

Figures

Figure 1
Figure 1. Genant-modified Sharp scoring system. Coloured areas indicate sites used to evaluate erosion and joint space narrowing (JSN) scores. Each site was evaluated in 0.5-unit increments as indicated. Erosion and JSN scores are normalised to 145 for a maximum total score of 290.
Figure 2
Figure 2. Mean change from baseline in total (A), erosion (B) and joint space narrowing (C) Genant-modified Sharp scores for patients at 12 months and 2 years. *Placebo patients were switched to abatacept after 12 months. All patients received background methotrexate.
Figure 3
Figure 3. Cumulative probability distribution of changes from baseline in Genant-modified total Sharp scores by treatment at year 1 (A) and year 2 (B). The solid line represents patients treated with abatacept (A,B) and the dotted line represents patients treated with placebo (A) or treated with placebo for 12 months then abatacept for 12 months (B). All patients received background methotrexate.
See this image and copyright information in PMC

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