Two-Year Data for Abatacept Demonstrate Continued Efficacy in Adults With Rheumatoid Arthritis

Paris, November 9 (ots/PRNewswire) -

- Data to be Presented at Upcoming American College of
Rheumatology Annual Meeting

Bristol-Myers Squibb Company (NYSE: BMY) today announced that
two-year data from three Phase III pivotal trials demonstrate the
long-term efficacy of abatacept in adult patients with moderate to
severe rheumatoid arthritis (RA) who have had an inadequate response
to one or more disease-modifying anti-rheumatic drugs (DMARDs) such
as methotrexate and TNF antagonists. The data also demonstrate that
abatacept provided clinically meaningful improvements in multiple
aspects of health-related quality of life and physical function,
sustained improvements in pain and had a consistent safety and
tolerability profile through two years of treatment.[1],[2] These
data will be presented at the upcoming 2006 American College of
Rheumatology (ACR) Annual Scientific Meeting.

The findings are from analyses of the ongoing open-label,
long-term extension component of Phase III pivotal trials
investigating abatacept, including the AIM (Abatacept in Inadequate
responders to Methotrexate), ATTAIN (Abatacept Trial in Treatment of
Anti-TNF Inadequate Responders) and ASSURE (Abatacept Study of Safety
in Use with other Rheumatoid Arthritis Therapies) trials.

"These data are encouraging and add to the body of evidence
demonstrating that abatacept is an effective option providing durable
response for patients who have not benefited from previous treatment
with disease-modifying anti-rheumatic drugs," said Mark Genovese,
M.D., associate professor of medicine at Stanford University School
of Medicine, Palo Alto, CA, who is presenting data from ATTAIN at the
ACR congress. "Given that rheumatoid arthritis is a chronic disease,
long-term data such as these are important and offer physicians
additional insight to help them make the most appropriate treatment
decisions for their patients."

Details of Data to be Presented

Two separate poster presentations evaluating two-year, open-label,
long-term extension data from the AIM (Abatacept in Inadequate
responders to Methotrexate) and ATTAIN (Abatacept Trial in Treatment
of Anti-TNF Inadequate Responders) trials will be presented at the
ACR Annual Scientific Meeting in Washington, DC. These include
Dougados et al, to be presented on Sunday, November 12, Poster No.
502, and Luggen et al, to be presented on Monday, November 13, Poster
No. 980.

Results from the study presented by Dougados showed a sustained
improvement in pain for both the AIM and ATTAIN populations receiving
abatacept through two years, for the intent-to-treat (ITT)
population. The mean change in baseline at one year was -35.5 for the
abatacept arm of the AIM group (n=376) and -24.1 for the placebo
group (n=160). At two years, the mean change in baseline for
abatacept patients was -37.7. The mean change in baseline at six
months was -30.8 for the abatacept arm of the ATTAIN group (n=217)
and -10.2 for the placebo group (n=99). At two years, the mean change
in baseline for abatacept patients was -37.2.

The study presented by Luggen, showed sustained improvements in
physical function for both the AIM and ATTAIN populations through two
years as assessed using the Health Assessment Questionnaire
Disability Index (HAQ-DI). HAQ-DI was assessed for the
intent-to-treat population (ITT), using a last observation carried
forward (LOCF) analysis. Responders were defined as those achieving a
change of greater than or equal to 0.3 HAQ-DI units from baseline. In
the AIM group, 71.8 percent were HAQ responders at year one and 66.8
percent were HAQ responders at year two. In the ATTAIN group, 54.4
percent were HAQ responders at six months and 47.9 percent were HAQ
responders at two years.

A separate analysis of the two-year ATTAIN trial (Genovese, et al)
will be presented on Sunday, November 12, 2006, Poster No. 498. Of
the 258 patients originally treated with ORENCIA during the
double-blind phase, 218 entered an open-label, long-term extension
(LTE), with 156 of these completing 2 years of the study.[3] Data,
analyzed using an LOCF analysis (all patients who entered the LTE,
with discontinued patients considered as non-responders),
demonstrated sustained efficacy over time in the ATTAIN population.
At six months, ACR 20, 50 and 70 scores were achieved in 59.4
percent, 23.5 percent and 11.5 percent, respectively, in those
treated with ORENCIA. At two years, ACR 20, 50 and 70 scores were
achieved in 56.2 percent, 33.2 percent and 16.1 percent,
respectively, of those completing two years of treatment with
ORENCIA(R) (abatacept).

Two-year data from ASSURE (Abatacept Study of Safety in Use with
other Rheumatoid Arthritis Therapies; Weinblatt, et al) will be
presented on Sunday, November 12, 2006, Poster No. 509. According to
the results, abatacept plus background non-biologic therapies
demonstrated a consistent safety profile through two years.[4] At
year one, the incidence rate for serious adverse events (SAEs) per
100 patient years (n=957 patient years) was 18.8 and 491.4 for
adverse events (AEs). At year two, the incidence rate for SAEs per
100 patient years (n=1292 patient years) was 18.6 and 362.8 for AEs.
During the open-label period, most discontinuations were due to AEs
(3.3 percent), withdrawal of consent (2.5 percent) and lack of
efficacy (2.4 percent).

Adverse events, such as headache and upper respiratory tract
infections, were similar in the two-year long-term extension trials
to those seen in the double-blind trials.

In Europe, a marketing authorisation application for abatacept has
been submitted to the European Medicines Agency (EMEA).

[1] Luggen M, Emery P, Li T, McCann T, Teng J, Schiff M. Abatacept
provided clinically meaningful improvements in multiple aspects of
health related quality of life (HRQoL) and physical function through
2 years of treatment in patients with active rheumatoid arthritis
(RA): results from the AIM and ATTAIN trials. Poster presentation
Monday, November 13, 2006, Poster no 980 at: American College of
Rheumatology annual scientific meeting. Washington DC, November
10-15, 2006.

[2] Dougados M, Russell A, Li T, Sherrer Y, Teng J, McCann T,
Westhovens R. Abatacept provides sustained improvements in pain,
fatigue and sleep quality through 2 years in the treatment of
rheumatoid arthritis patients in the AIM and ATTAIN trials. Poster
presentation Sunday, November 12, 2006, poster no 502 at: American
College of Rheumatology annual scientific meeting. Washington DC,
November 10-15, 2006.

[3] Genovese M, Schiff M,Luggen M, Becker J-C, Aranda R, McCann
T,Schmidely N, Le Bars M, Dougados M, Sustained Efficacy and Safety
Through 2 Years in Patients with Rheumatoid Arthritis in the
Long-term Extension of the ATTAIN Trial. Poster presentation Sunday,
November 12, 2006, Poster no 498 at: American College of Rheumatology
annual scientific meeting. Washington DC, November 10-15, 2006.

[4] Weinblatt, B Combe, C Birbara, A Covucci, T Li, J-C Becker, R
Aranda, E Keystone. Safety and Patient-reported Outcomes Through 2
Years of Treatment with Abatacept in Rheumatoid Arthritis Patients
Receiving Background Disease-modifying Antirheumatic Drugs (DMARDs):
The ASSURE Trial. Poster presentation Sunday, November 12, 2006,
poster no 509 at: American College of Rheumatology annual scientific
meeting. Washington DC, November 10-15, 2006.

ots Originaltext: Bristol-Myers Squibb
Im Internet recherchierbar: http://www.presseportal.de

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