Bristol-Myers Squibb GmbH & Co. KGaA

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 Daniels [], 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 MTX.

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 (SmPC): 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 owners.

# # #

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.

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