Abatacept (Orencia) Inhibits Structural Damage Progression in recent onset & more established RA

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ABATACEPT INHIBITS STRUCTURAL DAMAGE PROGRESSION IN RECENT-ONSET AND MORE

ESTABLISHED RHEUMATOID ARTHRITIS: RESULTS FROM THE AIM TRIAL

http://www.jrheum.com/subscribers/06/02/81-100.html

Objective:The effect of abatacept on structural damage progression was

compared with placebo in rheumatoid arthritis (RA) patients with an

inadequate response to methotrexate (MTX). A sub-analysis evaluating the

impact of disease duration was performed.

Methods:AIM (Abatacept in Inadequate responders to Methotrexate) was a

1-year, randomized, double-blind, placebo-controlled, multicenter, Phase III

trial of a fixed dose of abatacept approximating 10 mg/kg vs. placebo with

background MTX in patients with active RA and an inadequate response to MTX.

Radiographs of hands and feet were performed at randomization and at 1 year

or upon early termination (if applicable). Paired radiographs were

independently scored for erosions, joint-space narrowing (JSN) and total

score by two trained radiologists, blinded to treatment group assignment and

chronologic order of the radiographs, using the Genant-modified Sharp score.

For this sub-analysis, radiographic endpoints in patients with baseline

disease durations of ≤2 years, >2 to ≤5 years, >5 to ≤10 years and >10

years

were evaluated.

Results Obtained and Conclusion: A total of 433 and 219 patients were

randomized and treated with abatacept or placebo, respectively, with 385

(88.9%) of the abatacept group and 162 (74.0%) of the placebo group

completing 1 year. Mean disease duration was ~9 years. Baseline clinical and

radiographic characteristics were similar among groups. Overall, abatacept

significantly inhibited the progression of structural damage; the mean

change from baseline in erosion scores were 0.63 vs. 1.14 for abatacept vs.

placebo at 1 year (p=0.029). When the progression of erosions was

sub-analyzed by baseline disease duration (mean change from baseline), a

positive trend was seen with abatacept treatment in all sub-groups for

abatacept vs. placebo: ≤2 years, 0.59 vs. 2.12; >2 to ≤5 years, 1.03 vs.

1.34; >5to ≤10 years, 0.54 vs. 0.76; >10 years, 0.44 vs. 0.79. Similar

results were observed for JSN and total scores.

Brief Conclusion: In AIM, abatacept inhibited the progression of structural

damage in patients with recent-onset as well as more established RA; this

inhibition was most pronounced in patients with ≤2 years of disease.

Garza , Kremer, Aranda, Jean-Claude Becker, Oksana

Mokliatchouk , Harry Genant, Thorne, Teng (Jefe del servicio de

Reumatología del Hospital Universitario, Monterrey NL , México, The Center

for Rheumatology, Albany NY, USA, Bristol-Myers Squibb, Princeton NJ, USA,

University of Alberta Hospital, Edmonton AB, Canada, The Arthritis Program,

Southlake Regional Health Center, Newmarket, Canada)