- 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) 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).
Bristol-Myers Squibb is a global pharmaceutical and related health
care products company whose mission is to extend and enhance human
 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
ots Originaltext: Bristol-Myers Squibb
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