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Abatacept(Orencia): 3 year study shows benefits in sleep quality, fatigue & reduction of pain

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Three-year studies on a novel therapy for rheumatoid arthritis provides

significant benefits in patients' quality of life

http://www.newswire.ca/en/releases/archive/February2006/22/c0371.html

Patients experience rapid and sustained improvement in sleep and reduction

in pain

and fatigue

MONTREAL, Feb. 22 /CNW Telbec/ - Clinical data released today at the

61st

annual Canadian Rheumatology Association meeting, demonstrates that treating

rheumatoid arthritis (RA) with abatacept (Orencia®) provides significant

benefits in sleep quality, fatigue and the reduction of pain - debilitating

health conditions associated with the disease. The positive effects of

abatacept treatment were seen as early as the first dose and were maintained

over a period of three years.

" These results prove that abatacept is effective in reducing pain and

fatigue, and improving sleep for patients who have not responded to other

therapies. Treating the disease is not enough. We must also focus on

improving how patients feel as they go about their daily lives, " said Dr.

, Clinical Professor at the Heritage Medical Research Centre,

Edmonton.

" It is encouraging that improvements were seen early and sustained over a

period of three years. "

Over 2,600 rheumatoid arthritis patients, who had not responded to

conventional treatments, participated in clinical trial programs with

abatacept, an investigational therapy and first in a new class of biological

treatments. Results show that this drug not only slowed progression of the

disease but improved patient quality of life which is severely impaired for

those suffering from rheumatoid arthritis.

Abatacept was approved by the U.S. Food and Drug Administration in

December 2005. It is indicated for reducing the signs and symptoms of

rheumatoid arthritis and to slow disease progression in patients who have

had an inadequate response to one or more DMARD (disease- modifying anti-

rheumatoid drug) such as methotrexate or TNF antagonists.

" There is a real need for new options to treat our rheumatoid arthritis

patients, " commented Dr. Boulos Haraoui, Clinical Associate Professor of

Medicine at the Centre Hospitalier de l'Université de Montréal. " One thing

that is quite promising and as recently published in the New England Journal

of Medicine is that abatacept works very well even in those patients who

have failed on other biologic agents, such as etanercept and infliximab. In

addition, abatacept has beneficial effects when used for patients who have

failed on mexthotrexate therapy. "

Clinical Data

The clinical data released at the Canadian Rheumatology Association

meeting was a sub-set analysis of the Phase III clinical efficacy program,

that included two major double-blind randomized placebo-controlled studies.

The AIM trial, which compared patients who were not responding adequately to

Methotrexate therapy and the ATTAIN trial, which compared abatacept in

combination with non-biologic DMARDs to non-biologic DMARDs alone in

patients with an inadequate efficacy response to the TNF antagonists

etanercept and

infliximab.

In addition, a third large Phase III study called ASSURE evaluated the

safety of abatacept in the treatment of rheumatoid arthritis.

Orencia® (abatacept) is not approved for marketing in Canada.

For further information: please contact: Marc Osborne, Director, Public

Relations, Bristol-Myers Squibb Canada, (514) 333-2463,

marc.osborne@...

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