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.
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Abstract Title
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Presentation Date and Time
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Patient Benefit Analyses
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Abstract 2755: Comparative Risk of Biologic Therapies in Patients
with Rheumatoid Arthritis Undergoing Elective Arthroplasty
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Plenary Session III
Tuesday, November 7, 2017
11:00 a.m. – 12:30 p.m. PST
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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
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Oral
Tuesday, November 7, 2017
4:30 p.m. – 6:00 p.m. PST
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Abstract 1818: Development of Abatacept- and Adalimumab-Specific
Predictive Models of Response to Therapy in RA Using Data
From a Head-to-Head Study
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Oral
Monday, November 6, 2017
2:30 p.m. – 4:00 p.m. PST
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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
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Oral
Wednesday, November 8, 2017
11:00 a.m. – 4:00 p.m. PST
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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
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Oral
Tuesday, November 7, 2017
4:30 p.m. – 6:00 p.m. PST
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Abstract 2891: Do Certain DMARDs Increase Risk of New-Onset
Type 2 Diabetes in RA Patients? A Disease Risk Score Analysis
Using Administrative Databases
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Oral
Wednesday, November 8, 2017
9:00 a.m. – 10:30 a.m. PST
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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
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Oral
Monday, November 6, 2017
2:30 p.m. – 4:00 p.m. PST
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Abstract 2786: Timing of Abatacept Infusions before Elective Arthroplasty
and the Risk of Post-Operative Infection
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Oral
Tuesday, November 7, 2017
2:30 p.m. – 4:00 p.m. PST
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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
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Poster
Monday, November 6, 2017
9:00 a.m. – 11:00 a.m. PST
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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
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Poster
Monday, November 6, 2017
9:00 a.m. – 11:00 a.m. PST
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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
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Poster
Monday, November 6, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 2450: Comparative Effectiveness of Abatacept Versus
TNFi in Patients With RA who are CCP+ in the United States
Corrona Registry
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Poster
Tuesday, November 7, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 416: The Impact of Therapy on Anti-carbamylated Protein
Antibody Isotypes and Serostatus In Patients With Early RA
Treated With Abatacept and MTX
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Poster
Sunday, November 5, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 1341: The Impact of Anti-cyclic Citrullinated Peptide Seropositivity
on Erosion Prevalence Among Patients With RA of Varying
Disease Duration
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Poster
Monday, November 6, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 410: Association Between Anti-citrullinated Protein Antibody
Status and the Incidence of Erosive Disease in Patients With
RA
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Poster
Sunday, November 5, 2017
9:00 a.m. – 11:00 a.m. PST
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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
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Poster
Sunday, November 5, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 1454: Association of Poor Prognostic Factors with Medication
Persistence among Adult Rheumatoid Arthritis Patients within
a Community of Rheumatology Clinics
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Poster
Monday, November 6, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 2272: Long-Term Effectiveness and Safety of Abatacept
in Juvenile Idiopathic Arthritis: Ongoing Results From the
Abatacept in JIA Registry
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Poster
Tuesday, November 7, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 609: Body Mass Index Does Not Influence the Efficacy
of Subcutaneous Abatacept in Patients With PsA: Results From
a Phase III Trial
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Poster
Sunday, November 5, 2017
9:00 a.m. – 11:00 a.m. PST
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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
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Poster
Sunday, November 5, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 595: Improved Patient-Reported Outcomes in Psoriatic
Arthritis Patients Treated With Abatacept: Results From a
Phase III Trial
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Poster
Sunday, November 5, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 610: Baseline Structural Damage Predicts Response to
Abatacept in Patients With Psoriatic Arthritis: A Post Hoc
Analysis of a Phase III Study
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Poster
Sunday, November 5, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 2491: Real-World Effectiveness and Safety of Subcutaneous
Abatacept in Biologic-Naive vs. Biologic-Experienced RA
Patients: The Abatacept Best Care Study
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Poster
Tuesday, November 7, 2017
9:00 a.m. – 11:00 a.m. PST
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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
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Poster
Monday, November 6, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 1474: A Higher DAS28P, the Subjective Proportion of
the DAS28, Predicts a Favorable Response to Abatacept in
Rheumatoid Arthritis
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Poster
Monday, November 6, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 1035: Risk of Hospitalization Among RA Patients With
Multiple Autoimmune Co-morbidities Differs by DMARD Treatment
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Poster
Monday, November 6, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 1031: Developing a Multi-Phase Claims-Based Algorithm
to Facilitate the Study of Drug Exposure During Pregnancy
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Poster
Monday, November 6, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 1469: Treatment Paradigms in Real-World Practice: Biologic
Agent Use Prior to and After Discontinuation of Abatacept
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Poster
Monday, November 6, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 2452: In Real-World Clinical Practice, Patients Switching
From IV to SC Abatacept Maintain Clinical Efficacy After
Switch
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Poster
Tuesday, November 7, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 1361: How Often Do Rheumatologists Use Valid Prognostic
Factors of Rheumatoid Arthritis? The ProgresAR Project
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Poster
Monday, November 6, 2017
9:00 a.m. – 11:00 a.m. PST
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Cost Analyses
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Abstract 1465: Cost per Response for Abatacept Versus Adalimumab
in Patients With Seropositive, Erosive, Early Rheumatoid
Arthritis in the US, Germany, Spain and Canada
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Poster
Monday, November 6, 2017
9:00 a.m. – 11:00 a.m. PST
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Abstract 413: Economic Burden Associated With Anti-cyclic Citrullinated
Peptide Antibody Positivity in Pts Newly Diagnosed with RA
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Poster
Sunday, November 5, 2017
9:00 a.m. – 11:00 a.m. PST
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Immunoscience Pipeline
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Abstract 514: BMS-986195, a Novel, Rapidly Acting, Covalent Inhibitor
of Bruton’s Tyrosine Kinase: Safety, Pharmacokinetic and
Pharmacodynamic Profiles in Healthy Participants
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Poster
Sunday, November 5, 2017
9:00 a.m. – 11:00 a.m. PST
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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
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Poster
Sunday, November 5, 2017
9:00 a.m. – 11:00 a.m. PST
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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.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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Rheumatoid Arthritis in the US, Germany, Spain and Canada [abstract]. Arthritis
Rheumatol. 2017; 69 (suppl 10). http://acrabstracts.org/abstract/cost-per-response-for-abatacept-versus-adalimumab-in-patients-with-seropositive-erosive-early-rheumatoid-arthritis-in-the-us-germany-spain-and-canada/.
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Alemao E, Guo Z, Burns L. Do Certain Dmards Increase Risk of New-Onset
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View source version on businesswire.com: http://www.businesswire.com/news/home/20171102005346/en/
Source: Bristol-Myers Squibb Company