Bristol-Myers Squibb to Present Data on Rheumatoid Arthritis Assets at American College of Rheumatology (ACR) 2013 Annual

  Bristol-Myers Squibb to Present Data on Rheumatoid Arthritis Assets at
  American College of Rheumatology (ACR) 2013 Annual Meeting

  *New data on investigational anti-IL-6 antibody clazakizumab in adult
    patients with moderate-to-severe rheumatoid arthritis and an inadequate
    response to methotrexate to be highlighted in podium presentation, Monday,
                                    October 28
  *Efficacy, safety and patient-reported outcomes data from the two-year
    AMPLE trial of ORENCIA^® SC (abatacept) in comparison to Humira^®
         (adalimumab) in biologic-naïve RA patients also to be presented
  *Breadth of presentations underscores Bristol-Myers Squibb’s commitment to
    Immunoscience and advancing treatment for immune-mediated diseases

Business Wire

PRINCETON, N.J. -- October 22, 2013

Bristol-Myers Squibb Company (NYSE: BMY) announced today that 20 abstracts
have been accepted for presentation at the 2013 annual meeting of the American
College of Rheumatology (ACR) taking place from October 25-30 in San Diego,
CA. The breadth of data underscores the Company’s continued commitment to
develop medicines that address the unmet medical needs of patients suffering
from rheumatic and other immune-mediated diseases.

Key presentations include:

  *The first presentation of efficacy and safety results from a Phase IIb
    study of subcutaneous (SC) clazakizumab, an investigational anti-IL-6
    monoclonal antibody, in adults with moderate-to-severe rheumatoid
    arthritis (RA) and an inadequate response to methotrexate. Bristol-Myers
    Squibb has exclusive worldwide rights to develop and commercialize
    clazakizumab for all indications outside of cancer under a collaboration
    agreement with its discoverer, Alder Biopharmaceuticals.
  *Results from the two-year AMPLE trial of Orencia^® SC (abatacept) and
    Humira^® (adalimumab) in biologic-naive RA patients, including efficacy,
    safety and patient-reported outcomes data.
  *More than 10 health economics and outcomes research presentations that add
    to the collective understanding of real-world use of RA medications and
    the costs associated with treatment.

“Bristol-Myers Squibb will continue its long standing commitment to
immunoscience research and to a strong culture of innovation to help further
advancements in the treatment of immune-mediated diseases like RA,” said
Michael Giordano, senior vice president, Head of Development, Oncology and
Immunology, Bristol-Myers Squibb. “The data and findings we are presenting at
the ACR annual meeting demonstrate our commitment to pre-clinical, clinical,
and real world and health outcome research to help patients.”

The complete list of Bristol-Myers Squibb presentations is below. Abstracts
can be accessed on the ACR website at

Title                                                       Date/Time
A Phase IIb Study Of The Efficacy and Safety Of              Oral Presentation
Subcutaneous Clazakizumab (anti-IL-6 monoclonal antibody)
With Or Without Methotrexate In Adults With                  October 28
Moderate-To-Severe Active Rheumatoid Arthritis and An
Inadequate Response To Methotrexate                          2:30 - 4 pm
Anti-IL-6 Antibody Clazakizumab Is More Potent Than
Tocilizumab In Blocking In Vitro and Ex Vivo IL-6-Induced    October 29
ORENCIA (Abatacept)                                          
Head-To-Head Comparison of Subcutaneous Abatacept Versus
Adalimumab on Background Methotrexate in RA: Two Year        October 29
Results from the AMPLE Study
2-Year Results from the AMPLE (Abatacept versus Adalimumab
Comparison in Biologic-Naïve RA Patients with Background
Methotrexate) Trial: Changes in Patient-Reported Outcomes    October 27
in Response to Subcutaneous Abatacept or Adalimumab in
Rheumatoid Arthritis
Effects of SC Abatacept or Adalimumab on Remission and
Associated Changes in Physical Function and Radiographic     October 27
Outcomes: Two Year Results from the AMPLE Trial
Abatacept or anti-TNF monoclonal antibodies: Efficacy and    October 29
safety comparisons
Antibody response to pneumococcal and influenza
vaccination in patients with RA receiving subcutaneous       October 27
Adherence to the Recommended Dosing Regimen of Abatacept
in the Real-world Setting in the ACTION Study: Is There a    October 28
Dose-creep in Overweight Patients?
Gene expression in whole blood predicts the
abatacept-methotrexate combination responsiveness in         October 29
rheumatoid arthritis: preliminary results
Abatacept is highly effective at inhibiting T cell priming
and induces a unique transcriptional profile in CD4+ T       October 27
Pilot Study of Abatacept in Patients with Refractory         October 29
Autoimmune Chronic Urticaria
DISEASE-STATE PRESENTATIONS                                  
Musculoskeletal Hospital Admissions Among Patients Treated
For Rheumatoid Arthritis Between 1999 and 2010 Compared      October 27
With The General Population In The Netherlands
Evaluation Of Hospitalizations and Costs In Patients With    October 28
Rheumatoid Arthritis In United States Medicare Population
Analysis Of Non-Steroidal Anti-Inflammatory Drug Burden
Among Rheumatoid Arthritis Patients Using The Dougados       October 27
Biologic Switching Rates among Patients with Rheumatoid      October 29
Arthritis in Medicare
Rates of Switching and Healthcare Costs Associated with
Switching Biologic Disease-modifying Antirheumatic Drugs     October 28
in a Commercial Population: Evidence from Real-world
Observational Studies
Outcomes of patients with rheumatoid arthritis and           October 27
comorbid hyperlipidaemia
Prevalence of Systemic Lupus Erythematosus and Lupus
Nephritis in the United States: Analysis of Commercial and   October 28
Public Insurance Billing Data
Coronary endothelial dysfunction directly measured by N13
Positron Emission Tomography (PET) is detected in            October 27
established Rheumatoid Arthritis (RA), but not early RA
Assessing Validity Of Low Field Magnetic Resonance Imaging
(MRI) for Joint Inflammation and Damage In Wrist/Hand        October 29
Rheumatoid Arthritis (RA) - A Systematic Literature Review

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

About Orencia ^® (abatacept)

Orencia subcutaneous (SC) injection and intravenous (IV) infusion are
indicated for reducing signs and symptoms, inducing major clinical response,
inhibiting the progression of structural damage, and improving physical
function in adult patients with moderately to severely active rheumatoid
arthritis. Orencia may be used as monotherapy or concomitantly with
disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis
factor (TNF) antagonists.

Orencia IV is indicated for reducing signs and symptoms in pediatric patients
6 years of age and older with moderately to severely active polyarticular
juvenile idiopathic arthritis. Orencia IV may be used as monotherapy or
concomitantly with methotrexate (MTX). Orencia SC has not been studied in
pediatric patients.

Orencia should not be administered concomitantly with TNF antagonists.

Orencia is not recommended for use concomitantly with other biologic
rheumatoid arthritis (RA) therapy, such as anakinra.

Orencia is intended for use under the guidance of a physician or healthcare

Indication/Usage and Important Safety Information for ORENCIA^® (abatacept)


Adult Rheumatoid Arthritis (RA): ORENCIA^® (abatacept) is a prescription
medicine that reduces signs and symptoms in adults with moderate to severe
rheumatoid arthritis (RA), including those who have not been helped enough by
other medicines for RA. ORENCIA may prevent further damage to your bones and
joints and may help your ability to perform daily activities. In adults,
ORENCIA may be used alone or with other RA treatments other than tumor
necrosis factor (TNF) antagonists.

Juvenile Idiopathic Arthritis (JIA): ORENCIA also reduces signs and symptoms
in children and adolescents 6 years of age and older with moderate to severe
polyarticular juvenile idiopathic arthritis (JIA). ORENCIA may be used alone
or with methotrexate (MTX).

Important Safety Information About ORENCIA^® (abatacept)

Inform your healthcare provider of the following, before you receive treatment

Infections: If you have any kind of infection, even if it is small (such as an
open cut or sore), an infection that is in your whole body (such as the flu),
an infection that will not go away, or a history of infections that keep
coming back. ORENCIA may make your immune system less able to fight
infections, so you may be more likely to get infections or any infection you
have may get worse.

Tuberculosis: If you have had tuberculosis (TB), a positive skin test for TB,
or if you recently have been in close contact with someone who has had TB. If
you get any of the symptoms of TB (a dry cough that does not go away, weight
loss, fever, night sweats), call your healthcare provider right away. Before
you start ORENCIA, your healthcare provider may examine you for TB or perform
a skin test.

If you have or have had Viral Hepatitis. Before you use ORENCIA, your
healthcare provider may examine you for hepatitis.

If you have a history of Chronic Obstructive Pulmonary (lung) Disease (COPD).

If you are scheduled to have Surgery.

Allergies to the Ingredients of ORENCIA^® (abatacept): The ingredients of
intravenous (IV) ORENCIA are: abatacept, maltose, monobasic sodium phosphate,
and sodium chloride for administration. The ingredients of subcutaneous (SC)
ORENCIA are: abatacept, sucrose, poloxamer 188, monobasic sodium phosphate
monohydrate, dibasic sodium phosphate anhydrous, and water for injection.

Vaccinations: If you have recently received a vaccination or are scheduled for
any vaccination. If you are receiving ORENCIA, and for 3 months after you stop
receiving ORENCIA, you should not take live vaccines.

Diabetes: If you have diabetes and use a blood glucose monitor to check your
sugar levels. The infusion of ORENCIA contains maltose, a sugar that can give
falsely high blood glucose readings with some monitors on the day you receive
your infusion. Your healthcare provider may tell you to use a different way to
monitor your blood sugar levels. ORENCIA for SC injection does not contain
maltose; therefore, you do not need to change the way you monitor your blood
sugar if you are taking ORENCIA subcutaneously.

Pregnancy: If you are pregnant, planning to become pregnant, or are thinking
about becoming pregnant. It is not known if ORENCIA can harm your unborn baby.

Breastfeeding: You will need to decide to either breast-feed or receive
treatment with ORENCIA, but not both.

If you Take Any Other Kinds of Medicine, including prescription and
nonprescription medicines, vitamins, and herbal supplements.

If you are Taking Other Biologic Medicines to Treat RA such as: Enbrel^®
(etanercept), Humira^® (adalimumab), Remicade^® (infliximab), Kineret^®
(anakinra), Rituxan^® (rituximab), Simponi^® (golimumab), Cimzia^®
(certolizumab pegol), Actemra^® (tocilizumab). You may have a higher chance of
getting a serious infection if you take ORENCIA with other biologic medicines.

Possible Side Effects of ORENCIA^® (abatacept)

ORENCIA can cause serious side effects including:

  *Serious infections. ORENCIA can make you more likely to get infections or
    make the infection that you have get worse. Some patients have died from
    these infections. Call your healthcare provider immediately if you feel
    sick or get any of the following signs of infection: fever; feel very
    tired; cough; feel flu-like; or warm, red or painful skin.
  *Allergic reactions. Allergic reactions can happen on the day of treatment
    or the day after receiving ORENCIA. Tell your healthcare provider or get
    emergency medical help right away if you have hives; swollen face,
    eyelids, lips, or tongue; or trouble breathing.
  *Hepatitis B infection. If you are a carrier of the hepatitis B virus (a
    virus that affects the liver), the virus can become active while you use
    ORENCIA. Your healthcare provider may do a blood test before you start or
    while using ORENCIA.
  *Vaccinations. You should not receive ORENCIA^® (abatacept) with certain
    types of vaccines. ORENCIA may cause some vaccinations to be less
  *Respiratory problems in patients with COPD. You may get certain
    respiratory problems more often if you receive ORENCIA and have COPD,
    including: worsened COPD, pneumonia, cough, or trouble breathing.
  *Cancer (malignancies). Certain kinds of cancer have been reported in
    patients receiving ORENCIA. It is not known if ORENCIA increases your
    chance of getting certain kinds of cancer.

Common side effects with ORENCIA are headache, upper respiratory tract
infection, sore throat, and nausea. Other side effects in children and
adolescents may include diarrhea, cough, fever, and abdominal pain.

Note concerning use in children under 18 years of age: ORENCIA for SC
injection has not been studied in children under 18 years of age, therefore it
is not known if ORENCIA for SC injection is safe and effective in children
under 18 years of age.

Please read the Patient Information in the Full US Prescribing Information.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to
discover, develop and deliver innovative medicines that help patients prevail
over serious diseases.

For more information about Bristol-Myers Squibb,, or follow
us on Twitter at

Orencia ^®  (abatacept) is a registered trademark of Bristol-Myers Squibb


Bristol-Myers Squibb Company
Chris Clark, 609-252-6269,
Ranya Dajani, 609-252-5330,
Ryan Asay, 609-252-5020,
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