AMSTERDAM, June 24 /PRNewswire/ -- New data presented at the 2006 European League Against Rheumatism (EULAR) Annual Congress from the one-year open label extension of the 6-month ATTAIN trial (Abatacept Trial in Treatment of Anti-TNF INadequate responders)[1] in which all patients were treated with abatacept, a selective co-stimulation modulator, show that the benefits of abatacept in patients with active rheumatoid arthritis (RA) are sustained for up to 18 months in inadequate responders to anti-TNF therapy.
Improvements in quality of life scores (the physical and mental components of Short Form-36) and improvements in physical function (measured by the Health Assessment Questionnaire Disability Index) originally achieved at 6 months in the ATTAIN trial, were sustained for a further 12 months of treatment, according to the results of the one-year extension study.
In 317 patients with RA who were taking conventional DMARDs, but who had an inadequate response to anti-TNF therapy, a further year of treatment with abatacept maintained both the reduction in disease activity seen at six months in the original ATTAIN trial, as well as the improvements in quality of life and physical function.
ATTAIN, a 6-month randomised double-blind trial, showed that compared to placebo abatacept significantly reduced disease activity scores and improved patient-reported outcomes in 391 patients with active RA, treated with conventional DMARDs, who had an inadequate response to anti-TNF therapy. All patients who completed the ATTAIN trial were eligible to enter the one-year extension study and receive open-label treatment with abatacept (10 mg/kg every 4 weeks) in addition to DMARD therapy.
In patients originally randomised to 6 months of treatment with abatacept, a further decrease in mean Disease Activity Score 28 (DAS28) was achieved after an additional year's treatment (-1.99 with abatacept vs. -0.93 with placebo at 6 months; -2.81 with abatacept after 18 months).
In patients who were originally randomised to treatment with placebo, the improvement in the DAS28 score at 18 months (-2.72) was comparable with that attained in the group that was originally randomised to abatacept.
"These data show that treatment with abatacept over an eighteen month period can help maintain a reduction in disease activity in rheumatoid arthritis patients, whilst also helping to improve their general quality of life," commented Professor Jean Sibilia, Rheumatology Department and Immunopathology Laboratory, Centre Hospitalier Universitaire Louis Pasteur University, Strasbourg, France, "We now know these benefits are sustained in the longer term for patients whose condition is difficult to treat."
Adverse events, such as headache and upper respiratory tract infections, were similar in the long-term extension trial to those seen in the 6-month double-blind trial.
In Europe, a marketing authorisation application for abatacept has been submitted to the European Medicines Agency (EMEA).
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References
[1] Sibilia J, Schiff M, Genovese M C, Becker J P, Li T, McCann T, Dougados M. Sustained improvements in disease activity score 28 (DAS28) and patient (PT)-reported outcomes (PRO) with abatacept (ABA) in Rheumatoid Arthritis (RA) PTS with an inadequate response to anti-TNF therapy: the long-term extension (LTE) of the ATTAIN trial. Poster presentation SAT0170 at: 2006 European League Against Rheumatism (EULAR) annual congress. Amsterdam, Netherlands, June 21-26, 2006.
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