Analyses explore ORENCIA ® (abatacept) treatment and disease burden among patients with poor prognostic factors for rapidly progressive rheumatoid arthritis (RA)
New abatacept data from Phase 3 psoriatic arthritis and juvenile idiopathic arthritis studies
Pipeline Phase 2 and 3 data highlight Bristol-Myers Squibb’s commitment to researching novel immune pathways
Bristol-Myers
Squibb Company (NYSE:BMY) today announced that 23 abstracts related
to ORENCIA® (abatacept) and the company’s immunoscience
pipeline will be presented at the 2016 annual meeting of the American
College of Rheumatology (ACR) and the Association of Rheumatology Health
Professionals (ARHP) to be held November 11-16 in Washington, D.C. These
data highlight Bristol-Myers Squibb’s significant capabilities in
immunoscience research and its commitment to meeting the unmet needs of
patients living with autoimmune diseases.
“As a leader in immunoscience, Bristol-Myers Squibb is advancing our
work in rheumatoid arthritis and fostering therapeutic advancements for
related autoimmune diseases,” said Brian J. Gavin, Vice President,
ORENCIA Development Lead, Bristol-Myers Squibb. “The broad range of data
being shared at ACR/ARHP this year reflects our focus on improving
patient care through immuno-modulation, exploring investigational
treatment pathways and defining the role that biomarkers may play in
informing therapeutic decisions in rheumatologic disease.”
The full listing of abstracts Bristol-Myers Squibb will present at the
2016 ACR/ARHP annual meeting follows. Multiple abstracts focus on the
impact of anti-citrullinated protein antibody positivity, also known as
ACPA positivity, among patients with RA. Bristol-Myers Squibb’s
ACPA-related research is focused on furthering the understanding of ACPA
as a key prognostic factor related to rapidly progressive RA. In
addition, data from recently completed abatacept Phase 3 trials in
psoriatic arthritis (PsA) and polyarticular juvenile idiopathic
arthritis (pJIA) will be presented. Bristol-Myers Squibb will also
present late-breaking data exploring preclinical models of systemic
lupus erythematosus and inflammatory bowel disease on November 13th
at 9:00 a.m. - 11:00 a.m. EST. Complete abstracts can be accessed online
at: http://acrannualmeeting.org/abstracts/.
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Abstract Title
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Presentation Date and Time
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Oral Presentations
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Abstract 948: Subcutaneous Abatacept In Patients With
Polyarticular-Course Juvenile Idiopathic Arthritis And
Inadequate Response To Biologic Or Non-Biologic
Disease-Modifying Antirheumatic Drugs: Pharmacokinetics,
Efficacy And Safety
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Sunday, November 13 2:30 p.m. - 4:00 p.m. EST
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Abstract 1041: Abatacept In The Treatment Of Active Psoriatic
Arthritis: 24-Week Results From A Phase III Study
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Sunday, November 13 4:30 p.m. - 6:00 p.m. EST
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Poster Presentations
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Abstract #11L: BMS-986165 is a Highly Potent and Selective
Allosteric Inhibitor of Tyk2, Blocks IL-12, IL-23 and Type I
Interferon Signaling and Provides for Robust Efficacy in
Preclinical Models of Systemic Lupus Erythematosus and Inflammatory
Bowel Disease
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Sunday, November 13 9:00 a.m. - 11:00 a.m. EST
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Abstract 389: Long-Term Effectiveness And Safety Of Abatacept
In Juvenile Idiopathic Arthritis: Interim Results From The
Abatacept In JIA Registry
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Sunday, November 13 9:00 a.m. - 11:00 a.m. EST
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Abstract 491: Anti-Citrullinated Peptide Antibodies Testing
Rate Over Time In Newly Diagnosed RA Patients – Data From
Three Administrative Claims Databases (2007–2014)
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Sunday, November 13 9:00 a.m. - 11:00 a.m. EST
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Abstract 509: Association of Anti-citrullinated Protein
Antibody Positivity and Titer Levels to Low Hand BMD, and the
Consequence of Low Hand BMD on DAS28 (CRP) Remission in Established
RA: Findings from a US Observational Cohort
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Sunday, November 13 9:00 a.m. - 11:00 a.m. EST
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Abstract 549: Work Status In Patients With Rheumatoid
Arthritis Who Have Poor Prognostic Factors: Findings From A
US Observational Cohort
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Sunday, November 13 9:00 a.m. - 11:00 a.m. EST
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Abstract 644: Seroprevalence And Its Impact On Radiographic
Damage In Korean Rheumatoid Arthritis Patients Starting
Biologics
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Sunday, November 13 9:00 a.m. - 11:00 a.m. EST
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Abstract 759: Gene Signature For Glucocorticoid, From In
Vitro To In Vivo
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Sunday, November 13 9:00 a.m. - 11:00 a.m. EST
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Abstract 1201: Deconvolution Of Immune Cell Proportions From
Whole Blood RNA Using Next-Generation Sequencing
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Monday, November 14 9:00 a.m. - 11:00 a.m. EST
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Abstract 1220: Comparison Of Healthcare Utilization Of
Patients With Rheumatoid Arthritis Who Are Anti-Cyclic
Citrullinated Peptide Antibody Positive Versus Negative
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Monday, November 14 9:00 a.m. - 11:00 a.m. EST
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Abstract 1226: Evaluation Of The Association Between
C-Reactive Protein And Anti- Citrullinated Protein Antibody
In Rheumatoid Arthritis: Analysis Of Two Clinical Practice
Data Sets
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Monday, November 14 9:00 a.m. - 11:00 a.m. EST
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Abstract 1583: Body Mass Index Does Not Affect Response To
Subcutaneous Or Intravenous Abatacept In Patients With
Rheumatoid Arthritis
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Monday, November 14 9:00 a.m. - 11:00 a.m. EST
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Abstract 1589: Body Mass Index Does Not Impact Abatacept
Retention In Biologic-Naïve Patients With Rheumatoid
Arthritis Who Have Poor Prognostic Factors: A 12-Month Interim Analysis
Of An Observational, Prospective Study
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Monday, November 14 9:00 a.m. - 11:00 a.m. EST
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Abstract 2228: Real-World Cost Of Treating Inadequate
Responders To Anti-Tumor Necrosis Factor Therapy
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Tuesday, November 15 9:00 a.m. - 11:00 a.m. EST
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Abstract 2229: Economic Burden Of Rheumatoid Arthritis Is
Higher For ACPA-Positive Patients
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Tuesday, November 15 9:00 a.m. - 11:00 a.m. EST
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Abstract 2478: Impact Of Poor Prognostic Factors On Treatment
Decisions In Clinical Practice In Patients With Rheumatoid
Arthritis: Findings From A US Observational Cohort
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Tuesday, November 15 9:00 a.m. - 11:00 a.m. EST
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Abstract 2494: The Effect Of Body Mass On DAS28 Response In
Patients With Rheumatoid Arthritis Treated With Abatacept
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Tuesday, November 15 9:00 a.m. - 11:00 a.m. EST
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Abstract 2553: Pregnancy Outcomes In Patients With Rheumatoid
Arthritis Treated With Abatacept – Review Of A Safety Database
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Tuesday, November 15 9:00 a.m. - 11:00 a.m. EST
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Abstract 2628: Retention Of Use And Safety Of Subcutaneous
Abatacept In Rheumatoid Arthritis: A Patient Record
Assessment In A Compassionate Use Programme In South Africa, A
Tuberculosis Endemic Country
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Tuesday, November 15 9:00 a.m. - 11:00 a.m. EST
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Abstract 2629: Serious Adverse Events In Patients With RA
Taking Abatacept Compared With Other Dmards. Results From A
US-Wide Safety Registry
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Tuesday, November 15 9:00 a.m. - 11:00 a.m. EST
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Abstract 2863: High Frequency Of Terminally Differentiated
CD8+ T Cells Characterize Systemic Lupus Erythematosus
Patients With Renal Involvement
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Tuesday, November 15 9:00 a.m. - 11:00 a.m. EST
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Abstract 2864: Identifying Dysregulated And Co- Dysregulated
Markers In Systemic Lupus Erythematosus Using Multi-Modal
Biomarker Data From A Large Pre-Clinical Study
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Tuesday, November 15 9:00 a.m. - 11:00 a.m. EST
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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, and swelling in the
joints.1,2 RA causes decreased range of motion and function
in the joints.1,2 The condition is three times more common in
women than in men.1
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 pediatric patients aged
6 years and older with moderately to severely active polyarticular JIA.
ORENCIA may be used as monotherapy or concomitantly with methotrexate
(MTX).
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 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 (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 exacerbation, 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 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 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. Other events
reported in ≥5% of JIA patients were diarrhea, cough, pyrexia, and
abdominal pain. In general, the adverse events in pediatric patients
were similar in frequency and type to those seen in adult patients.
Note Concerning SC ORENCIA: The safety and efficacy of SC ORENCIA
have not been studied in patients under 18 years of age.
Please see Full Prescribing Information at http://packageinserts.bms.com/pi/pi_orencia.pdf.
ORENCIA® (abatacept) is a registered trademark of
Bristol-Myers Squibb Company.
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. As we discover more about the immune system in such
diseases with substantial unmet medical needs, 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, 2015 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.
References
1. Rheumatoid Arthritis. American College of Rheumatology. August 2012.
2. Centers for Disease Control and Prevention. Rheumatoid Arthritis. CDC
Website. http://www.cdc.gov/arthritis/basics/rheumatoid.htm.
Accessed May 19, 2016.
Bristol-Myers Squibb CompanyMedia:Erin McMaster, 609-955-2253 erin.mcmaster@bms.com orInvestors:Bill Szablewski, 609-252-5894 william.szablewski@bms.com