Abatacept Sustains Clinical Benefit for 3 Years in RA Patients for Whom MTX is Inadequate

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Abatacept Sustains Clinical Benefit for Three Years in Rheumatoid

Arthritis Patients for Whom Methotrexate is Inadequate

http://www.finanznachrichten.de/nachrichten-2006-06/artikel-6613506.asp

Amsterdam - 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 abatacept.

" 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 life.

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

References

[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.

ots Originaltext: Bristol-Myers Squibb Im Internet recherchierbar:

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