ORENCIA® (abatacept) Shows Comparable Efficacy to Humira® (adalimumab) in First Long Term Head-to-Head Study in Patients with

  ORENCIA® (abatacept) Shows Comparable Efficacy to Humira® (adalimumab) in
    First Long Term Head-to-Head Study in Patients with Moderate to Severe
                           Rheumatoid Arthritis[1]

  PR Newswire

  UXBRIDGE, England, June 11, 2013

UXBRIDGE, England, June 11, 2013 /PRNewswire/ --

   The first and only two-year head-to-head study in adults with rheumatoid
arthritis comparing two biologic drugs each on a background of  methotrexate
      (MTX)  and including assessment of radiographic progression ^[1]

Bristol-Myers Squibb Company (NYSE: BMY) today announced the results of year
two data from AMPLE ( A batacept Versus Adali m umab Com p arison in Bio l
ogic-Naïv e rheumatoid arthritis (RA) Subjects With Background Methotrexate),
a first-of-its-kind trial of 646 patients comparing the safety and efficacy of
the subcutaneous (SC) formulation of abatacept vs. adalimumab, each on a
background of MTX, in biologic naïve patients with moderate to severe RA. ^[
^1 ^] The AMPLE year two data was presented at the European League Against
Rheumatism (EULAR) Annual European Congress of Rheumatology and highlighted
during a congress press conference.

Results from the second year of the AMPLE study reiterate the year one data
confirming comparable efficacy of abatacept plus MTX compared with adalimumab
plus MTX (60%) based on ACR20 (American College of Rheumatology 20 percent
improvement). ACR50, 70, and 90, considered to be more stringent measures of
efficacy, as well as DAS-28-CRP, also were assessed over 24 months and found
to be similar between the two arms. ^[ ^1 ^] Onset of response was similar
between the two groups, as was radiographic progression, with 85% of patients
on abatacept plus MTX and 84% of patients on adalimumab plus MTX achieving
radiographic non-progression at two years. ^[ ^1 ^]

The one year AMPLE data met its primary endpoint as measured by
non-inferiority of ACR20. abatacept plus MTX achieved comparable rates of
efficacy vs. adalimumab plus MTX at year one (64.8% vs. 63.4%, respectively).
^[2]

Dr Andrew Östör, Consultant Rheumatologist at University of Cambridge, said:
"Rheumatoid arthritis is a debilitating disease which seriously impacts
patient quality of life. Following the recent launch of SC abatacept patients
have access to a choice of treatment options, and it is encouraging to have
robust longer-term head-to-head data evaluating efficacy and safety of two of
these biologic treatments."

At 24 months, overall safety data was similar for abatacept plus MTX and
adalimumab plus MTX, including incidence of adverse events (92.8% vs 91.5%),
serious adverse events (13.8% vs 16.5%), and malignancies (2.2% vs 2.1%).
Discontinuations due to adverse events were 3.8% for abatacept plus MTX
compared to 9.5% for adalimumab plus MTX, while discontinuations due to
serious adverse events were 1.6% for abatacept plus MTX compared to 4.9% for
adalimumab plus MTX. ^[ ^1 ^] Injection site reactions were reported in 4.1%
of patients taking abatacept plus MTX and 10.4% of patients taking adalimumab
plus MTX. ^[ ^1 ^] Autoimmune events were reported in 3.8% of patients in the
abatacept plus MTX group and 1.8% of patients in the adalimumab plus MTX
group. All of these autoimmune events were mild or moderate in severity. ^[1]

About the Study

AMPLE is a phase IIIb randomized, investigator-blinded multinational study of
24 months duration with a 12 month efficacy primary endpoint (non-inferiority
for ACR20). ^[ ^1 ^] ^,[2] The study included 646 adult biologic-naïve
patients with active moderate to severe RA and inadequate response to MTX; 318
in the abatacept SC plus MTX group and 328 in the adalimumab plus MTX group.
^[ ^1 ^] Patients were stratified by disease activity and randomised to either
125 mg abatacept SC weekly or 40 mg adalimumab every other week, both on
background MTX. ^[ ^1 ^] The primary endpoint was to determine non-inferiority
of abatacept SC plus MTX to adalimumab plus MTX based on ACR20 response at 12
months. ^[ ^2 ^] Secondary endpoints included injection site reactions ^[ ^2
^] , radiographic non-progression as assessed using the van der Heijde
modified total Sharp score (mTSS) method, safety and retention. ^[2] The
complete year one study results were published in the January 2013 volume of
Arthritis  & Rheumatism , the official monthlyjournalof the American
College of Rheumatology. ^[ ^2 ^]

About  abatacept

Abatacept is the first RA biologic agent to be available in both an
intravenous (IV) and a self-injectable, subcutaneous (SC) formulation ^[3] ^,
^[4] . The approval of the new subcutaneous formulation in 2012 offers more
treatment options, giving patients the opportunity to treat themselves at
home.

Abatacept, in either injectable formulation (IV or SC), is a treatment
designed to reduce the signs and symptoms, reduce the progression of joint
damage and improve physical function in adults with rheumatoid arthritis (RA).
In Europe, it is indicated for use in combination with methotrexate (MTX) to
treat moderate to severe active RA in adults who have had an inadequate
response to a disease-modifying anti-rheumatic drug (DMARD), including MTX or
a tumour necrosis factor (TNF) antagonist (also known as an anti-TNF). ^[ ^3
^] ^, ^[ ^4 ^]

In addition, abatacept IV is approved for use in children six years of age and
older with polyarticular juvenile idiopathic arthritis (JIA) who have
responded inadequately to other treatments including at least one anti-TNF
agent. ^[3] For a full description of abatacept, including efficacy and safety
profile, please consult the Summary of Product Characteristics (SmPC):

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000701/WC500048935.pdf
.

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a systemic, chronic, autoimmune disease
characterised 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.

In Europe, more than 2.9 million people are affected by RA, ^[5] a condition
which can severely impact patients' quality of life and can lead to increased
mortality and morbidity. ^[6] The condition is more common in women, who
account for 75% of patients diagnosed with RA. ^[7]

With appropriate treatment, patients can achieve better clinical outcomes,
resulting in more active days and improved well-being. ^[8]

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.

For more information about Bristol-Myers Squibb, visit http://www.bms.com ,
or follow us on Twitter at http://twitter.com/bmsnews .

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

References

1. Bristol-Myers Squibb Data on File. EULAR13-2689 Abstract: "Head-to-Head
Comparison of Subcutaneous Abatacept Versus Adalimumab on Background
Methotrexate in RA: Two Year Results from the AMPLE Study." To be presented at
the EULAR Annual Congress, June 12-15, 2013.

2. Weinblatt, et al. Arthritis Rheum. January, 2013; 65(1): 28-38.

3. Orencia IV SPC. Available from:
http://www.medicines.org.uk/emc/medicine/19714/SPC/ORENCIA+250+mg+powder+for+concentrate+for+solution+for+infusion/
[
http://www.medicines.org.uk/emc/medicine/19714/SPC/ORENCIA+250+mg+powder+for+concentrate+for+solution+for+infusion
] Last accessed: June 2013

4. Orencia SC SPC. Available from:
http://www.medicines.org.uk/emc/medicine/27216/SPC/ORENCIA+125+mg+solution+for+injection+
(pre-filled+syringe)/ [
http://www.medicines.org.uk/emc/medicine/27216/SPC/ORENCIA+125+mg+solution+for+injection+
(pre-filled+syringe) ] Last accessed: June 2013

5. National Rheumatoid Arthritis Foundation Available at: 
http://www.nras.org.uk/about_rheumatoid_arthritis/living_with_rheumatoid_arthritis/employment_benefits/european_fit_for_work_report.aspx
Last accessed June 2013.

6. March L and Lapsley H. "What are the costs to society and the potential
benefits from the effective management of early rheumatoid arthritis?" Best
Practice & Research Clinical Rheumatology 2001;15(1):171-185.

7. National Institute of Arthritis and Musculoskeletal and Skin Diseases.
National Institutes of Health. U.S.Department of Health and Human Services.
Rheumatoid Arthritis. May 2004.

8. American College of Rheumatology. Available at:
http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp
. Last accessed June 2013.

Contact: Bristol-Myers Squibb - Mark Reale, Office: +44(0)1895-52-3627,
Mobile: +44(0)7581-068092, Email: mark.reale@bms.com
 
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