Bristol-Myers
Squibb Company (NYSE:BMY) announced today that 20 abstracts for Orencia®
(abatacept), and clazakizumab have been accepted for presentation
at the 2014 annual meeting of the European
League Against Rheumatism (EULAR), to be held June 11-14 in Paris,
France. The extensive data being presented underscores the Company’s
commitment to develop innovative treatments for patients suffering from
rheumatoid arthritis (RA) and other immune-mediated diseases, including
its pioneering T-cell co-stimulation modulator, Orencia, and
clazakizumab, an investigational selective IL-6 cytokine inhibitor.
“Leveraging our heritage and expertise in immunoscience, Bristol-Myers
Squibb remains focused on changing the course of immune-mediated
diseases like RA,” said Michael Giordano, senior vice president, Head of
Development, Oncology and Immunoscience, Bristol-Myers Squibb. “The
clinical results and real-world data we will present at the EULAR annual
meeting reflect our commitment to develop innovative therapies to
improve the health of patients suffering from RA.”
The complete list of Bristol-Myers Squibb presentations is below.
Abstracts can be accessed on the EULAR website at https://b-com.mci-group.com/AbstractList/EULAR2014.aspx.
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Title
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Date/Time
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ORENCIA (Abatacept)
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Induction of Clinical Remission Followed by Drug-free Withdrawal
with Abatacept Combination and Monotherapy in Early RA: Results from
the AVERT Study Over 18 Months
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June 12, 2014 at 10:30 a.m. CET
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MRI Results from the AVERT Study: A Randomized, Active-Controlled
Trial to Evaluate Induction of Remission and Maintenance of
Drug-Free Remission Using Abatacept in Combination with Methotrexate
or as Monotherapy in Patients with Early RA
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June 12, 2014 at 11:10 a.m. CET
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Modulation of the ACPA Fine Specificity in Patients with RA Treated
with Either Abatacept or Adalimumab in the AMPLE Study
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June 13, 2014 at
11:45 a.m. CET
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Clinical Responses By Baseline RA Disease Duration in the AMPLE
(Abatacept versus Adalimumab Comparison in Biologic-Naïve RA
Patients with Background Methotrexate) Trial: 2-Year Results
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June 13, 2014 at
11:45 a.m. CET
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Comparison of Abatacept and Other Biologic DMARDS for the Treatment
of Rheumatoid Arthritis Patients: A Systemic Literature Review and
Network Meta-Analysis
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June 14, 2014 at 10:15 a.m. CET
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Correlation of Clinical Response with Patient-Reported Outcomes in
the AMPLE (Abatacept versus Adalimumab Comparison in Biologic-Naïve
RA Patients with Background Methotrexate) Trial: 2-Year Results
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June 14, 2014 at
10:15 a.m. CET
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Association of Radiographic Outcomes with Low Disease Activity and
Remission and Sustainability of Response with Subcutaneous Abatacept
or Adalimumab: 2-Year Results from the AMPLE Trial
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June 13, 2014 at
11:45 a.m. CET
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Two-Year Retention and Effectiveness of Abatacept in Real-Life
Setting: Results from the ACTION Study
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June 13, 2014 at
11:45 a.m. CET
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Two-Year Retention and Effectiveness of IV Abatacept Monotherapy and
Combination in PTS With RA Previously Treated With at Least One
Biologic Agent in a Real-Life Setting: Subgroup Analysis From the
ACTION Study
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June 14, 2014 at
10:15 a.m. CET
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Decreased Use of Glucocorticoids in PTS With RA Who Initiated IV
Abatacept and Previously Failed At Least One Biologic Agent: Results
From the 2-Year Action Study
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June 14, 2014 at
10:15 a.m. CET
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Gene Expression in Whole Blood Predicts the Abatacept-Methotrexate
Combination Responsiveness in Rheumatoid Arthritis: Preliminary
Results From the Power Doppler Ultrasonography Appraise Study
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June 12, 2014 at 11:45 a.m. CET
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CLAZAKIZUMAB
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A Phase IIB Study of the Efficacy and Safety of Subcutaneous
Clazakizumab (Anti-IL-6 Monoclonal Antibody) With or Without
Methotrexate in Adults With Moderate-to-Severe Active Rheumatoid
Arthritis and an Inadequate Response to Methotrexate
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June 14, 2014 at 10:15 a.m. CET
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X-Ray and MRI Results From a Phase IIB Study of Subcutaneous
Anti-Iinterleukin-6 Monoclonal Antibody Clazakizumab With or Without
MTX in Adults with Moderate-to-Severe Active Rheumatoid Arthritis
and an Inadequate Response to Conventional DMARDS Including
Methotrexate
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June 14, 2014 at 10:15 a.m. CET
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Health Economics & Outcomes Research
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Differences (or Variations) in Physical Function in RA By Disease
Activity Levels Defined by DAS, CDAI, and SDAI in Clinical Practice
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June 12, 2014 at 11:45 a.m. CET
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Development and Validation of a Prognostic Clinical Model for Rapid
Radiographic Progression in Patients with RA
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June 14, 2014 at 10:15 a.m. CET
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The Role of C-Reactive Protein or Erythrocyte Sedimentation rate in
Predicting Cardiovascular Outcomes in Rheumatoid Arthritis of Data
From US Managed Care Organization
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June 13, 2014 at 12:00 p.m. CET
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Quality of Life and Economic Benefits of Remission/Low Disease
Activity in Patients with Rheumatoid Arthritis in Clinical Practice
Setting
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June 13, 2014 at 11:45 a.m. CET
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Performance of the Framingham Cardiovascular Risk Prediction Model
With or Without CRP in RA Patients: Analysis of UK Clinical Practice
Research Data
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June 14, 2014 at 10:15 a.m. CET
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Performance of the Framingham Cardiovascular Risk Prediction Model
With and Without C-Reactive Protein or Erythrocyte Sedimentation
Rate in RA: Analysis of US Electronic Medical Records Database
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June 14, 2014 at 10:15 a.m. CET
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DISEASE-STATE PRESENTATION
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Incidence of Malignancy in Adult Patients with Rheumatoid Arthritis:
An Updated Analysis of the Literature
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June 12, 2014 at 12:00 p.m. CET
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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.
About ORENCIA® (abatacept)
ORENCIA SC and IV is 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 practitioner.
Indication/Usage and Important Safety Information for ORENCIA®
(abatacept)
Indication/Usage
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 with ORENCIA:
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:
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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.
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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.
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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.
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Vaccinations. You should not receive ORENCIA®
(abatacept) with certain types of vaccines. ORENCIA may cause some
vaccinations to be less effective.
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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.
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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 Clazakizumab
Clazakizumab is an investigational selective IL-6 cytokine inhibitor,
under investigation for the treatment of RA. 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. Clazakizumab is the second
biologic treatment for RA being developed by Bristol-Myers Squibb,
demonstrating the company’s long-standing commitment to immunoscience.
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, visit www.bms.com,
or follow us on Twitter at http://twitter.com/bmsnews
ORENCIA® (abatacept) is a registered trademark of
Bristol-Myers Squibb Company.
About Bristol-Myers Squibb Immunoscience
The immune system is the body’s natural defense against disease. These
processes come into play in almost every human disease. That is why
Bristol-Myers Squibb is focused on exploring ways to harness the body’s
own immune system to treat immune-related diseases with high unmet
medical needs, including RA – a chronic, systemic, inflammatory
autoimmune disorder that affects the joints.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995
regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based on
current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them, and
could cause actual outcomes and results to differ materially from
current expectations. No forward-looking statement can be guaranteed.
Forward-looking statements in this press release should be evaluated
together with the many uncertainties that affect Bristol-Myers Squibb's
business, particularly those identified in the cautionary factors
discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the
year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and
our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no
obligation to publicly update any forward-looking statement, whether as
a result of new information, future events or otherwise.
Copyright Business Wire 2014