AMSTERDAM, June 24 /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 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.
Tessa Lush Phone: +44-(0)1895-523-532, Mobile: +44(0)794-910-8568, tessa.lush@bms.com. Vicky Amos Phone: +44-(0)207-632-1817 Mobile: +44-(0)7740-105-966 v.amos@cca-uk.com. Eve Cohen Phone: +44(0)20-7632-1964, Mobile: +44(0)7966-192-095 e.cohen@cca-uk.com
