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24.06.2006 – 08:19

Bristol-Myers Squibb SA

Abatacept Sustains Clinical Benefit for Three Years in Rheumatoid Arthritis Patients for Whom Methotrexate is Inadequate

Amsterdam (ots/PRNewswire)

Data presented at the 2006 European
League Against Rheumatism (EULAR) Annual Congress in Amsterdam show
that 3 years of treatment with the selective co-stimulation modulator
abatacept, maintains improvements in Rheumatoid Arthritis (RA)
symptoms, physical function, disease activity and patient and
physician global assessments, in patients with active disease for
whom treatment with methotrexate is inadequate[1]. During the
long-term extension, the abatacept 10mg/kg group maintained the ACR
20, 50 and 70 responses achieved during the first year of treatment,
with almost one third of patients experiencing an ACR 70 at Year 3.
The new data come from a 2-year open-label extension study in
patients who completed a one-year double-blind placebo-controlled
trial of abatacept at a dose of 2 or 10 mg/kg monthly. 219 patients
were treated with abatacept ~10 mg/kg monthly, of whom 159 (72.6%)
completed the additional 2 years of treatment. Treatment with
methotrexate was continued throughout the 3-year study period. The
study's endpoints were the proportion of patients who achieved a 20%,
50% or 70% improvement in American College of Rheumatology (ACR)
criteria and the change in individual ACR core components.
At the end of the one year double-blind trial, treatment with
abatacept resulted in a greater proportion of patients experiencing
ACR 20, 50 and 70 scores compared with treatment with placebo (ACR20
76.2% vs. 55.2%; ACR50 52.4% vs. 31.3%; ACR70 28.6% vs. 13.4%). Per
protocol analysis showed that after a further 2 years of treatment,
these improvements were sustained in patients originally randomised
to abatacept 10mg/kg (ACR20 75.4%, ACR50 55.4%, ACR70, 32.8%).
Similar ACR scores were achieved in patients originally randomised
to placebo, who had switched to abatacept at the end of the double
blind period (ACR20 71.4%, ACR50 59.2%, ACR70 32.7%).
Analysis of the core components of the ACR criteria revealed that,
irrespective of the treatment originally assigned, abatacept was
associated with similar improvements in tender joints, swollen joints
and pain after 2 and 3 years of treatment. Improvements in physical
function (assessed by the modified Health Assessment Questionnaire)
and disease activity (assessed by C-reactive protein as a laboratory
inflammation marker) were also sustained. Global assessments by
patients and physicians continued to show improvements with
"These findings show that, even after unsatisfactory response to
methotrexate therapy, patients with active RA can have long-term
symptomatic improvement when treated with abatacept," commented
Professor Rene Westhovens, Rheumatology Department, Katholieke
Universiteit Leuven, Belgium.
Adverse events, such as headache and upper respiratory tract
infections, were similar in the long-term extension trial, to those
seen in the 1 year double-blind trial.
In Europe, a marketing authorisation application for abatacept has
been submitted to the European Medicines Agency (EMEA).
Bristol-Myers Squibb is a global pharmaceutical and related health
care products company whose mission is to extend and enhance human
Note to Editor:
ACR core components are: tender joints, swollen joints, pain,
physical function, Health Assessment Questionnaire, patient global,
physician global, C-reative protein level
[1] Westhovens R, Emery P, Aranda R, Becker J P, Zhou Y, Dougados
M. Abatacept provides sustained clinical benefit through 3 years in
Rheumatoid Arthritis (RA) patients with inadequate responses to
methotrexate (MTX). Poster presentation SAT0203 at: 2006 European
League Against Rheumatism (EULAR) annual congress. Amsterdam,
Netherlands, June 21-26, 2006.


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