Bristol-Myers Squibb to Present New Data on ORENCIA(R)? ...

14.05.12 14:04

Bristol-Myers Squibb to Present New Data on ORENCIA(R)? (abatacept)
at the European League Against Rheumatism (EULAR) 2012 Congress

Paris (ots/PRNewswire) -

- Results of head-to-head study comparing two biologic drugs on a background
of methotrexate for the treatment of moderate to severe rheumatoid arthritis to be

Bristol-Myers Squibb Company [ ] today
announced that the company will present 18 abstracts on abatacept at
the European League Against Rheumatism (EULAR) Annual European
Congress of Rheumatology in Berlin, June 6-9.
Among the data being
presented will be results from the AMPLE study, a head-to-head phase
3 clinical trial comparing subcutaneous (SC) ORENCIA(R) (abatacept)
to HUMIRA(R) (adalimumab), both in combination with methotrexate. The
combination of a biologic medication and methotrexate is the most
commonly prescribed treatment approach in moderate to severe RA.

AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naive
RA Subjects With Background Methotrexate) is a randomized, controlled
study powered to compare the efficacy of abatacept SC versus
adalimumab on a background of methotrexate in adult, biologic naive
patients with moderate to severe RA. AMPLE is an ongoing 2 year
study, with primary analyses at 1 year. In addition to assessing the
primary endpoint of non-inferiority between abatacept SC and
adalimumab as defined by the proportion of subjects achieving the
American College of Rheumatology criteria of 20 percent improvement
(ACR 20) after 12 months of treatment, the trial also evaluated the
following secondary endpoints: frequency of injection site reactions,
radiographic non-progression as assessed using the van der Heijde
modified total Sharp score (mTSS) method, safety and retention. The
study also evaluated additional efficacy measures including ACR 50,
ACR 70 and disease activity scores (DAS).

"The data being presented highlight Bristol-Myers Squibb's
continued commitment to expanding our understanding of the efficacy
and safety of abatacept, including important areas of study such as
kinetics of response and radiographic non-progression," said Brian
[ ],
M.D., senior vice president, Global Development and Medical Affairs,
Bristol-Myers Squibb. "AMPLE provides a direct comparison of
abatacept SC and adalimumab, an important step to help address the
lack of comparative studies among biologic medications for RA."

In addition to the one-year results of AMPLE, other key data
being presented at EULAR include:

- The first report of data on early response to abatacept plus methotrexate
in patients not responding to methotrexate using power Doppler ultrasonography.
- Results of a long-term comparison of abatacept SC and its intravenous (IV)
infusion formulation.
- New data on the efficacy and safety of the IV formulation of abatacept in
patients with lupus nephritis.

Key presentations at the EULAR Annual European Congress of
Rheumatology are shown below. The full set of abstracts can be
accessed on the EULAR website
[ ].

Oral/Poster Presentations:

Session Date, Time, Location Presentation Title Lead Author
June 7, 2012, 10:30 AM, Hall 1.1 Abatacept SC Versus M. Schiff
Adalimumab on Denver, CO
Methotrexate in RA:
One Year Results from
the AMPLE Study
June 7, 2012, 12:15 PM, Poster Area Early Response to M.A. D'Agostino
Hall 2.2 Abatacept Plus Boulogne-Billancourt,
MTX in MTV-IR RA Patients France
Using Power Doppler
Ultrasonography: An
Open-Label Study
June 8, 2012, 11:45 SC vs IV Abatacept in M.C. Genovese
AM, Poster Area RA: Post-Hoc Efficacy Palo Alto, CA
Analysis of Long-Term
ACQUIRE (SC) Data with
AIM (IV) Data
June 8, 2012, 11:45 Immunogenicity is Low M. Weinblatt
AM, Poster Area and Transient with Boston, MA
Intravenous Abatacept
June 9, 2012, 10:45 Efficacy and Safety of R. Furie
AM, Poster Area Hall Abatacept in Lupus Lake Success, NY
2.2 Nephritis
June 9, 2012, 10:15 Comparative Analysis D. Wofsy
AM, Poster Area of Alternative Outcome San Francisco, CA
Measures for use in
Lupus Nephritis Trials
June 8, 2012, 11:45 In Patients with P. Emery
AM, Poster Area Established RA, Leeds, United Kingdom
Abatacept Efficacy is
Independent of
Baseline Annual
Progression Rate
June 7, 2012, 11:45 A Multi-Center, T. Matsubara
AM, Poster Area Double-Dummy, Kato, Japan
Double-Blind Study of
Subcutaneous (SC)
Abatacept (ABA)
Compared with
Intraveneous (IV) ABA
in Japanese Rheumatoid
Arthritis Patients
with Inadequate
Response to

About ORENCIA(R) (abatacept)

Abatacept is a selective co-stimulation modulator of T-cell
activation. It is designed to prevent full T-cell activation and
inhibit the release of chemicals leading to joint inflammation and
destruction as observed in RA[i,ii,iii,iv] and pJIA.[1]

Abatacept is the first biologic discovered and developed in
Bristol-Myers Squibb research centres and abatacept IV was first
approved for adult RA in May 2007 by the European Commission.
Abatacept SC is not currently licensed in the European Union.

Abatacept in combination with methotrexate (MTX) is indicated for
the treatment of moderate to severe active RA in adult patients who
responded inadequately to previous therapy with one or more DMARDs
including MTX or a TNF-alpha inhibitor. A reduction in the
progression of joint damage and improvement of physical function have
been demonstrated during combination treatment with abatacept and

Abatacept, in combination with MTX, is also indicated for the
treatment of moderate to severe active polyarticular Juvenile
Idiopathic Arthritis in paediatric patients six years of age and
older who have had an insufficient response to other DMARDS,
including at least one TNF inhibitor. Abatacept has not been studied
in children under six years old.

The most frequently reported adverse reactions (greater than or
equal to 5%) among abatacept-treated patients are headache, nausea,
and upper respiratory tract infections. In younger patients, side
effects are similar to adults. For the full list of all side effects
reported with abatacept, see the Product Information.

Abatacept should not be prescribed to persons who are
hypersensitive to abatacept or any of the other ingredients. It must
not be used in patients with severe and uncontrolled infections, such
as sepsis or opportunistic infections. Patients who receive abatacept
are given a special alert card that explains this restriction and
instructs them to contact their doctor immediately if they develop an
infection during a course of treatment.[2]

For a full description of abatacept, including efficacy and
safety profile, please consult the Summary of Product Characteristics
roduct_Information/human/000701/WC500048935.pdf .

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a systemic, chronic, autoimmune
disease characterized by inflammation in the lining of joints (or
synovium), causing joint damage with chronic pain, stiffness,
swelling and fatigue. RA causes limited range of motion and decreased
joint function. The condition is more common in women than in men,
who account for 75% of patients diagnosed with RA.

Abatacept is one treatment option indicated in adult patients
with moderately to severely active RA. Abatacept may be used as a
monotherapy or concomitantly with DMARDs other than TNF antagonists.
Abatacept is not recommended for use concomitantly with other
biologic RA therapy, such as anakinra.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company
committed to discovering, developing and delivering innovative
medicines that help patients prevail over serious diseases.

ORENCIA is a registered trademark of Bristol-Myers Squibb
Company. All other trademarks are property of their respective

# # #

i. Kremer M, et al. N Engl J Med 2003;349(20):1907-15. ii. Davis
P, et al. Abstract submitted to ACR/ARHP Meeting 2008, San Francisco
Oct 24-29th 2008;08-A-2321-ACR. iii.European Medicines Agency (EMEA).
ORENCIA Scientific Discussion. 2007:1-36. iv. Buch MH, et al. Ann
Rheum Dis 2009;68(7):1220-7.

1. Kremer M, et al. N Engl J Med 2003;349(20):1907-15.

2. Davis P, et al. Abstract submitted to ACR/ARHP Meeting 2008,
San Francisco Oct 24-29th 2008;08-A-2321-ACR.

Intended media targets: trade and professional, including
pharmaceutical, medical, financial.

ots Originaltext: Bristol-Myers Squibb GmbH & Co.KG aA
Im Internet recherchierbar:

Media: Celine Van Doosselaere,,
+33-1-58-83-60-27; Investors: John Elicker, 609-252-4611,

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