Bristol-Myers Squibb to Showcase Company’s Progress in Researching Personalized Medicine for the Potential Treatment of Autoimmune Diseases at 2017 American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting

Nov 02, 2017

ORENCIA® (abatacept) rheumatoid arthritis data examine potential therapeutic benefit and cost effectiveness in the treatment of patients with highly active, progressive disease

Juvenile idiopathic arthritis study evaluates ORENCIA efficacy at two years in patients 2-17 years old

New pipeline data reflect Company’s long-term commitment to addressing unmet needs in autoimmune diseases

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE:BMY) today confirmed that 34 abstracts related to ORENCIA® (abatacept) and the Company’s immunoscience pipeline will be presented at the 2017 American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting, November 3-8, 2017, in San Diego. Building on its heritage of discovering and developing medicines designed to help modulate the body’s immune response to treat autoimmune disease and cancer, the Company will share clinical and real-world ORENCIA data across rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) and active psoriatic arthritis, as well as pre-clinical and first-in-human data from BMS-986195, an investigational Bruton’s Tyrosine Kinase (BTK) inhibitor.1,2

The Bristol-Myers Squibb data being presented will include new insights about how ORENCIA impacts outcomes and treatment costs in patients who exhibit key biomarkers of highly active, progressive RA, such as anti-citrullinated protein antibodies (ACPA), as well as analyses evaluating the link between these biomarkers and certain advanced disease hallmarks such as structural damage progression.3-8 Treatment retention and safety data in the real-world setting to be presented adds to the growing body of evidence on ORENCIA,9,10 a selective T-cell co-stimulation modulator.

“Bristol-Myers Squibb’s research continues to advance the understanding of the relationship between biomarkers such as ACPA and disease prognosis. These biomarkers play an important role in both identification of patients facing highly active, progressive disease, who traditionally have had poor prognoses, and their treatment plans,” said Brian Gavin, Vice President, ORENCIA Development Lead at Bristol-Myers Squibb. “The ORENCIA data we are presenting at the ACR/ARHP Annual Meeting are reflective of our commitment to advancing the science and addressing unmet needs in autoimmune diseases with the ultimate goal of enabling personalized ‘right treatment for the right patient’ approaches.”

Beyond RA in adults, Bristol-Myers Squibb data evaluating the efficacy and safety of ORENCIA in patients aged 2-17 with JIA followed for up to two years will be presented,11 as will pre-clinical and first-in-human data from BMS-986195, an investigational BTK inhibitor.1,2 Bruton's tyrosine kinase (BTK) is an enzyme found inside certain immune cells that plays a fundamental role in the immune response to antigens, which are proteins recognized as foreign materials in the body.12,13

The full listing of abstracts sponsored by Bristol-Myers Squibb at the 2017 ACR/ARHP Annual Meeting follows. Complete abstracts can be accessed online here.

     
Abstract Title     Presentation Date and Time
Patient Benefit Analyses

Abstract 2755: Comparative Risk of Biologic Therapies in
Patients with Rheumatoid Arthritis Undergoing Elective
Arthroplasty

    Plenary Session III

Tuesday, November 7, 2017

11:00 a.m. – 12:30 p.m. PST

Abstract 2868: Pharmacodynamic Analysis of Whole Blood
Gene Expression Over 2 Years in a Phase IIIb
Head-to-Head Trial of Abatacept and Adalimumab in
Patients With RA

    Oral

Tuesday, November 7, 2017

4:30 p.m. – 6:00 p.m. PST

Abstract 1818: Development of Abatacept- and
Adalimumab-Specific Predictive Models of Response to
Therapy in RA Using Data From a Head-to-Head Study

    Oral

Monday, November 6, 2017

2:30 p.m. – 4:00 p.m. PST

Abstract 2964: Structural Damage in Patients with Very Early
RA is Predicted with Clinical Measures of Baseline Disease
Activity: DAS28 (CRP), SDAI, M-DAS28 and RAPID3 but not
CDAI

    Oral

Wednesday, November 8, 2017

11:00 a.m. – 4:00 p.m. PST

Abstract 2855: SC Aba in Pts Aged 2–17 Yrs With pJIA and
Inadequate Response to Biologic or Non-biologic
Disease-Modifying Antirheumatic Drugs: Pharmacokinetics,
Effectiveness, Safety and Immunogenicity Over 2 Yrs

    Oral

Tuesday, November 7, 2017

4:30 p.m. – 6:00 p.m. PST

Abstract 2891: Do Certain DMARDs Increase Risk of
New-Onset Type 2 Diabetes in RA Patients? A Disease Risk
Score Analysis Using Administrative Databases

    Oral

Wednesday, November 8, 2017

9:00 a.m. – 10:30 a.m. PST

Abstract 1817: Abatacept Shows Better Sustainability Than
TNF Inhibitors When Used Following Initial Biologic DMARD
Failure in the Treatment of RA: 8 Years of Real-World
Observations From the Rhumadata® Clinical Database and
Registry

    Oral

Monday, November 6, 2017

2:30 p.m. – 4:00 p.m. PST

Abstract 2786: Timing of Abatacept Infusions before Elective
Arthroplasty and the Risk of Post-Operative Infection

    Oral

Tuesday, November 7, 2017

2:30 p.m. – 4:00 p.m. PST

Abstract 1034: Presence of Anti-cyclic Citrullinated Peptide
Antibodies is Associated With Better Treatment Response
to Abatacept but not to TNF Inhibitors in Patients With RA: A
Meta-analysis

    Poster

Monday, November 6, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 1468: Abatacept Retention Rates, Overall and by
Participating Country, and Prognostic Factors of Retention in
Patients With RA: 2-Year Results From a Real-World
Observational Study

    Poster

Monday, November 6, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 1424: Impact of Glucocorticoid Therapy on the
Efficacy of SC Abatacept or Adalimumab in RA Patients With
Inadequate Response to MTX: A Post Hoc Analysis of Data
From a Head-to-Head Trial

    Poster

Monday, November 6, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 2450: Comparative Effectiveness of Abatacept
Versus TNFi in Patients With RA who are CCP+ in the
United States Corrona Registry

    Poster

Tuesday, November 7, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 416: The Impact of Therapy on Anti-carbamylated
Protein Antibody Isotypes and Serostatus In Patients With
Early RA Treated With Abatacept and MTX

    Poster

Sunday, November 5, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 1341: The Impact of Anti-cyclic Citrullinated Peptide
Seropositivity on Erosion Prevalence Among Patients With
RA of Varying Disease Duration

    Poster

Monday, November 6, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 410: Association Between Anti-citrullinated Protein
Antibody Status and the Incidence of Erosive Disease in
Patients With RA

    Poster

Sunday, November 5, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 122: Poor Prognostic Factors at the Start of
Methotrexate Therapy are not Associated with Worse
Treatment Response: Results From the Rheumatoid
Arthritis Medication Study

    Poster

Sunday, November 5, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 1454: Association of Poor Prognostic Factors with
Medication Persistence among Adult Rheumatoid Arthritis
Patients within a Community of Rheumatology Clinics

    Poster

Monday, November 6, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 2272: Long-Term Effectiveness and Safety of
Abatacept in Juvenile Idiopathic Arthritis: Ongoing Results
From the Abatacept in JIA Registry

    Poster

Tuesday, November 7, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 609: Body Mass Index Does Not Influence the
Efficacy of Subcutaneous Abatacept in Patients With PsA:
Results From a Phase III Trial

    Poster

Sunday, November 5, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 608: Presence of Poor Prognostic Factors May
Predict Response to Abatacept in Patients With Active
Psoriatic Arthritis: Results From a Post Hoc Analysis From a
Phase III Study

    Poster

Sunday, November 5, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 595: Improved Patient-Reported Outcomes in
Psoriatic Arthritis Patients Treated With Abatacept: Results
From a Phase III Trial

    Poster

Sunday, November 5, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 610: Baseline Structural Damage Predicts
Response to Abatacept in Patients With Psoriatic Arthritis: A
Post Hoc Analysis of a Phase III Study

    Poster

Sunday, November 5, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 2491: Real-World Effectiveness and Safety of
Subcutaneous Abatacept in Biologic-Naive vs.
Biologic-Experienced RA Patients: The Abatacept Best Care
Study

    Poster

Tuesday, November 7, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 1429: Incidence Rates of Adverse Events With
Death as an Outcome During Abatacept Treatment in RA:
Results From an Integrated Data Analysis From 16 Clinical
Trials

    Poster

Monday, November 6, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 1474: A Higher DAS28P, the Subjective Proportion
of the DAS28, Predicts a Favorable Response to Abatacept
in Rheumatoid Arthritis

    Poster

Monday, November 6, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 1035: Risk of Hospitalization Among RA Patients
With Multiple Autoimmune Co-morbidities Differs by DMARD
Treatment

    Poster

Monday, November 6, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 1031: Developing a Multi-Phase Claims-Based
Algorithm to Facilitate the Study of Drug Exposure During
Pregnancy

    Poster

Monday, November 6, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 1469: Treatment Paradigms in Real-World Practice:
Biologic Agent Use Prior to and After Discontinuation of
Abatacept

    Poster

Monday, November 6, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 2452: In Real-World Clinical Practice, Patients
Switching From IV to SC Abatacept Maintain Clinical Efficacy
After Switch

    Poster

Tuesday, November 7, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 1361: How Often Do Rheumatologists Use Valid
Prognostic Factors of Rheumatoid Arthritis? The ProgresAR
Project

    Poster

Monday, November 6, 2017

9:00 a.m. – 11:00 a.m. PST

Cost Analyses

Abstract 1465: Cost per Response for Abatacept Versus
Adalimumab in Patients With Seropositive, Erosive, Early
Rheumatoid Arthritis in the US, Germany, Spain and Canada

    Poster

Monday, November 6, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 413: Economic Burden Associated With Anti-cyclic
Citrullinated Peptide Antibody Positivity in Pts Newly
Diagnosed with RA

    Poster

Sunday, November 5, 2017

9:00 a.m. – 11:00 a.m. PST

Immunoscience Pipeline

Abstract 514: BMS-986195, a Novel, Rapidly Acting, Covalent
Inhibitor of Bruton’s Tyrosine Kinase: Safety,
Pharmacokinetic and Pharmacodynamic Profiles in Healthy
Participants

    Poster

Sunday, November 5, 2017

9:00 a.m. – 11:00 a.m. PST

Abstract 503: BMS-986195 Is a Highly Selective and Rapidly
Acting Covalent Inhibitor of Bruton’s Tyrosine Kinase with
Robust Efficacy at Low Doses in Preclinical Models of RA
and Lupus Nephritis

    Poster

Sunday, November 5, 2017

9:00 a.m. – 11:00 a.m. PST

 

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.14,15 RA causes limited range of motion and decreased joint function.14,15 The condition is more common in women than in men, who account for 75% of patients diagnosed with RA.14

About Orencia

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 rheumatoid arthritis. Orencia may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.

Orencia is indicated for reducing signs and symptoms in patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. Orencia may be used as monotherapy or concomitantly with methotrexate (MTX).

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.

U.S. Indications/Usage and Important Safety Information for ORENCIA® (abatacept)

Indication and Usage

Adult Rheumatoid Arthritis (RA): ORENCIA® (abatacept) 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.

Juvenile Idiopathic Arthritis (JIA): ORENCIA® (abatacept) is indicated for reducing signs and symptoms in patients 2 years of age and older with moderately to severely active polyarticular JIA. ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX).

Adult Psoriatic Arthritis (PsA): ORENCIA® (abatacept) is indicated for the treatment of adult patients with active PsA.

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 for ORENCIA® (abatacept)

Concomitant Use with TNF Antagonists: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult RA 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. There were 2 cases (<0.1%; n=2688) of anaphylaxis or anaphylactoid reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in <0.9% of patients. There was one case of a hypersensitivity reaction with ORENCIA in JIA clinical trials (0.5%; n=190). 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. The efficacy of vaccination in patients receiving ORENCIA is not known. ORENCIA may blunt the effectiveness of some immunizations. It is recommended that JIA patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating therapy with ORENCIA.

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, including COPD exacerbations, cough, rhonchi, and dyspnea. In adult RA studies, 97% of COPD patients treated with ORENCIA developed adverse reactions versus 88% treated with placebo and respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbation, cough, rhonchi, and dyspnea. A greater percentage of adult RA 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 pyrroloquinoline quinone (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.

Pregnancy: There are no adequate and well-controlled studies of ORENCIA use in pregnant women and the data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. A pregnancy registry has been established to monitor pregnancy outcomes in women exposed to ORENCIA during pregnancy. Healthcare professionals are encouraged to register patients by calling 1-877-311-8972.

Lactation: There is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with abatacept.

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 RA patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in RA 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. Other events reported in ≥5% of JIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in JIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients.

Note concerning ORENCIA administration options: Intravenous dosing has not been studied in patients younger than 6 years of age. The safety and efficacy of ORENCIA ClickJect™ Autoinjector for subcutaneous injection has not been studied in patients under 18 years of age.

Please click here to see the Full Prescribing Information.

About Bristol-Myers Squibb Immunoscience

With a robust pipeline of immunomodulatory therapies, Bristol-Myers Squibb is committed to the discovery and development of transformational medicines that could lead to long-term remission in patients with autoimmune diseases. We continue to pioneer novel approaches to optimize the body’s immune response with the hope of delivering life changing medicine for patients with auto-immune diseases like lupus, rheumatoid arthritis and inflammatory bowel disease, where substantial unmet medical need exists. As we discover more about the immune system in such diseases the potential for developing novel therapies that target specific pathways in the immune system continues to drive our research efforts.

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 us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.

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, 2016 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.

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