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

Tue Oct 22, 2013 4:19pm EDT

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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

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 https://ww2.rheumatology.org/apps/MyAnnualMeeting/.

Title   Date/Time
CLAZAKIZUMAB  
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 Oral Presentation

October 28

2:30 - 4 pm

Anti-IL-6 Antibody Clazakizumab Is More Potent Than Tocilizumab In Blocking In Vitro and Ex Vivo IL-6-Induced Functions October 29
ORENCIA (Abatacept)  
Head-To-Head Comparison of Subcutaneous Abatacept Versus Adalimumab on Background Methotrexate in RA: Two Year Results from the AMPLE Study October 29
2-Year Results from the AMPLE (Abatacept versus Adalimumab Comparison in Biologic-Naïve RA Patients with Background Methotrexate) Trial: Changes in Patient-Reported Outcomes in Response to Subcutaneous Abatacept or Adalimumab in Rheumatoid Arthritis October 27
Effects of SC Abatacept or Adalimumab on Remission and Associated Changes in Physical Function and Radiographic Outcomes: Two Year Results from the AMPLE Trial October 27
Abatacept or anti-TNF monoclonal antibodies: Efficacy and safety comparisons October 29
Antibody response to pneumococcal and influenza vaccination in patients with RA receiving subcutaneous abatacept October 27
Adherence to the Recommended Dosing Regimen of Abatacept in the Real-world Setting in the ACTION Study: Is There a Dose-creep in Overweight Patients? October 28
Gene expression in whole blood predicts the abatacept-methotrexate combination responsiveness in rheumatoid arthritis: preliminary results October 29
Abatacept is highly effective at inhibiting T cell priming and induces a unique transcriptional profile in CD4+ T cells October 27
Pilot Study of Abatacept in Patients with Refractory Autoimmune Chronic Urticaria October 29
DISEASE-STATE PRESENTATIONS  
Musculoskeletal Hospital Admissions Among Patients Treated For Rheumatoid Arthritis Between 1999 and 2010 Compared With The General Population In The Netherlands October 27
Evaluation Of Hospitalizations and Costs In Patients With Rheumatoid Arthritis In United States Medicare Population October 28
Analysis Of Non-Steroidal Anti-Inflammatory Drug Burden Among Rheumatoid Arthritis Patients Using The Dougados Algorithm October 27
Biologic Switching Rates among Patients with Rheumatoid Arthritis in Medicare October 29
Rates of Switching and Healthcare Costs Associated with Switching Biologic Disease-modifying Antirheumatic Drugs in a Commercial Population: Evidence from Real-world Observational Studies October 28
Outcomes of patients with rheumatoid arthritis and comorbid hyperlipidaemia October 27
Prevalence of Systemic Lupus Erythematosus and Lupus Nephritis in the United States: Analysis of Commercial and Public Insurance Billing Data October 28
Coronary endothelial dysfunction directly measured by N13 Positron Emission Tomography (PET) is detected in established Rheumatoid Arthritis (RA), but not early RA October 27
Assessing Validity Of Low Field Magnetic Resonance Imaging (MRI) for Joint Inflammation and Damage In Wrist/Hand Rheumatoid Arthritis (RA) - A Systematic Literature Review (SLR) October 29

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 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 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:

  • 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 effective.
  • 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, 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.

Bristol-Myers Squibb Company
Media:
Chris Clark, 609-252-6269, chris.clark@bms.com
or
Investors:
Ranya Dajani, 609-252-5330, ranya.dajani@bms.com
Ryan Asay, 609-252-5020, ryan.asay@bms.com

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