BMY Bristol Myers Squibb Co

First U.S. presentation of clinical and imaging results from Phase IIIb trial evaluating treatment with Orencia plus Methotrexate (MTX) combination therapy in patients positive for anti-citrullinated protein (anti-CCP) antibodies with early moderate to severe rheumatoid arthritis (RA)

Real-world data highlighting meaningful patient-reported outcomes and reinforcing the established safety data of Orencia

Data identifying potential prognostic factors and predictive biomarkers for Orencia response

Bristol-Myers Squibb Company (NYSE:BMY) announced today that 16 abstracts for Orencia were accepted for presentation at the 2014 annual meeting of the American College of Rheumatology (ACR) taking place from November 14-19, 2014 in Boston, MA. This year’s data reinforce the Company’s commitment to evaluating the use of Orencia in early moderate to severe RA and the potential impact on the course of the disease.

Key presentations include:

• Efficacy results from AVERT (Assessing Very Early Rheumatoid arthritis Treatment), a Phase IIIb trial comparing Orencia in combination with methotrexate (MTX) to MTX alone in patients positive for anti-CCP antibodies with early moderate to severe RA, including MRI imaging outcomes.
• Patient-reported outcomes from AVERT through 12 months of therapy with Orencia in combination with MTX, Orencia alone or MTX alone, and up to 6 months after treatment withdrawal in patients with early moderate to severe RA.
• Studies highlighting real-world Orencia data reinforcing its established safety results.
• An oral presentation highlighting exploratory results from a sub-study of the APPRAISE (Assess the OMERACT-EULAR PDUS score for early signs of improvement of synovitis in RA patients treated with abatacept) trial that was designed to help identify potential biomarkers to predict patient response to the combination of Orencia + MTX in patients with moderate to severe RA.
• Data from the ACTION (Abatacept In routine clinical practice) trial, a real-world prospective study, identifying prognostic factors for long-term retention with Orencia including CCP- and Rheumatoid Factor (RF)- positivity.

“Our exciting data this year underscore our continued commitment to understanding the earlier stages of moderate to severe RA and the potential impact on the course of disease,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “The efficacy, safety and real world data we will present help provide valuable insight into treatment response and outcomes in patients with earlier RA.”

The complete list of Bristol-Myers Squibb presentations is below. Abstracts can be accessed on the ACR website at: http://www.acrabstracts.org

       

Title

     

Date/Time

Early Moderate to Severe RA Efficacy Data: AVERT

Stringent Criteria for Low Disease Activity and Remission after 12 Poster Presentation Months of Treatment, and after Treatment Withdrawal, with Abatacept November 18 Monotherapy, Abatacept with Methotrexate or Methotrexate Alone in 8:30 a.m. – 4 p.m. Early Rheumatoid Arthritis         Sustained Improvements in Magnetic Resonance Imaging Outcomes with Poster Presentation Abatacept Following the Withdrawal of All Treatment in Patients with November 17 Early Rheumatoid Arthritis       8:30 a.m. – 4 p.m. Patient-Reported Outcomes Following 12 Months of Therapy with Poster Presentation Abatacept (Plus Methotrexate or as Monotherapy) or Methotrexate and November 18 Up to 6 Months after Treatment Withdrawal in Patients with Early 8:30 a.m. – 4 p.m. Rheumatoid Arthritis         Predictors of Drug-free Remission Following Treatment with Abatacept Poster Presentation (in Combination with Methotrexate or as Monotherapy) in Early November 18 Rheumatoid Arthritis       8:30 a.m. – 4 p.m. The Impact on Anti-Citrullinated Protein Antibody Isotypes and Epitope Poster Presentation Fine Specificity in Patients with Early RA Treated with Abatacept and November 17 Methotrexate       8:30 a.m. – 4 p.m.

Safety and Real-World Data

Pregnancy Outcomes Following Exposure to Abatacept During Pregnancy Oral Presentation November 17         2:30 p.m. – 4 p.m. Identification of Tuberculosis in Rheumatoid Arthritis Patients Poster Presentation Initiating Therapy with Biologic or Non-Biologic Disease-Modifying November 16 Anti-Rheumatic Drugs Using Health Insurance Claims Data       8:30 a.m. – 4 p.m. Healthcare Costs Associated with Serious Infections among Biologic- Poster Presentation Naïve Rheumatoid Arthritis Patients Initiating First-Line Biologic November 17 Treatment       8:30 a.m. – 4 p.m. Comparison of Patient Characteristics, Healthcare Costs, and Biologic   Poster Presentation   Persistence Between Patients with Rheumatoid Arthritis Initiating November 16 First- or Second-Line Subcutaneous Abatacept, Adalimumab, or 8:30 a.m. – 4 p.m. Etanercept     Are Patients With Rheumatoid Arthritis Initiating a TNF Biologic Poster Presentation Comparable to Patients Initiating a Non TNF? November 18     8:30 a.m. – 4 p.m.

Potential Prognostic Factors and Predictive Biomarkers

Protein Quantification Using Mass Spectrometry Methods to Predict Oral Presentation Response to Abatacept and Methotrexate Combination Therapy in November 18 Rheumatoid Arthritis.   4:30 p.m. – 6 p.m. Prognostic Factors for IV Abatacept Retention in Patients Who Have Poster Presentation Received at Least One Prior Biologic Agent: 2-Year Results from a November 18 Prospective, International, Real-World Study   8:30 a.m. – 4 p.m. Does Body Mass Index Impact Long-Term Retention with Abatacept in Poster Presentation Patients With RA Who Have Received at Least One Prior Biologic Agent? November 18 2-Year Results from a Real-World, International, Prospective Study   8:30 a.m. – 4 p.m. Do Ultrasound (PDUS) and DAS28 Measure Different Aspects of Disease Poster Presentation Activity? Analyses from the First Prospective International Phase November 16 IIIb Study of PDUS Response in Abatacept-Treated Patients with 8:30 a.m. – 4 p.m. Rheumatoid Arthritis (RA)     Analysis of Gene Expression Fluctuation with Abatacept Highlights the Poster Presentation Involvement of the Proteasome Pathway As a Mechanism of Action of November 17 Abatacept in Rheumatoid Arthritis   8:30 a.m. – 4 p.m. Gene Expression Analyses of Abatacept- and Adalimumab-Treated Patients Poster Presentation from the AMPLE Trial November 17     8:30 a.m. – 4 p.m.  

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, and swelling. 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

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). The safety and efficacy of Orencia SC has not been studied in patients under 18 years of age.

Orencia should not be administered concomitantly with TNF antagonists.

Orencia is not recommended for use concomitantly with other biologic 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 ORENCIAIndication and Usage

Adult Rheumatoid Arthritis (RA): ORENCIA 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 RA. ORENCIA may be used as monotherapy or concomitantly with disease-modifying, anti-rheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.

Important Limitations of Use: ORENCIA should not be administered concomitantly with TNF antagonists, and is not recommended for use concomitantly with other biologic RA therapy, such as anakinra.

Important Safety Information

Concomitant Use with TNF Antagonists: Concurrent therapy with ORENCIA and a biologic DMARD is not recommended. In controlled clinical trials, adult patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63%) and serious infections (4.4%) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively), without an important enhancement of efficacy.

Hypersensitivity: Anaphylaxis or anaphylactoid reactions can occur during or after an infusion and can be life-threatening. In controlled, double-blind and open-label clinical trials, anaphylaxis and anaphylactoid reactions were reported in <0.1% of adult patients dosed with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, that occurred within 24 hours of ORENCIA infusion, were uncommon (<1% each). In postmarketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA was reported. Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, have been reported in patients receiving ORENCIA. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.

Immunizations: Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation as it may blunt the effectiveness of some immunizations.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): Adult COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo (97% vs 88%, respectively). Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbations, cough, rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27% vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of ORENCIA in patients with RA and COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase or glucose hexokinase test methods. ORENCIA for subcutaneous (SC) administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.

Pregnant and Nursing Mothers: ORENCIA should be used during pregnancy only if clearly needed. The risk for development of autoimmune diseases in humans exposed in utero to abatacept has not been determined. Nursing mothers should be informed of the risk/benefit of continued breast-feeding or discontinuation of the drug. A pregnancy registry has been established to monitor fetal outcomes. Healthcare professionals are encouraged to register pregnant patients exposed to ORENCIA by calling 1-877-311-8972.

Most Serious Adverse Reactions: Serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo).

Malignancies: The overall frequency of malignancies was similar between adult patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies.

Note concerning SC ORENCIA: The safety and efficacy of SC ORENCIA has not been studied in patients 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 http://www.bms.com , or follow us on Twitter at http://twitter.com/bmsnews

Orencia 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.

Bristol-Myers SquibbMedia:Chris Clark, 609-252-6269chris.clark@bms.comorInvestors:Ranya Dajani, 609-252-5330ranya.dajani@bms.com