Key analyses focus on treatment outcomes among RA patients with a traditionally poor prognosis
ORENCIA ® (abatacept) continuing research underscores Bristol-Myers Squibb’s commitment to advancing the science of modulating the body’s immune response to treat disease
Bristol-Myers
Squibb Company (NYSE:BMY) today confirmed that 23 abstracts related
to ORENCIA® (abatacept), including new data on the role of
biomarkers and MRI in RA patient identification and treatment, will be
presented at the Annual European Congress of Rheumatology (EULAR 2017),
June 14-17 in Madrid, Spain. The Company also will share first-in-human
data from BMS-986165, an investigational TYK2 inhibitor.
Bristol-Myers Squibb has played a leading role for more than two decades
in discovering and developing medicines designed to help modulate the
body’s immune response to treat disease. The abstracts from
Bristol-Myers Squibb accepted for EULAR 2017 include three
practice-informing analyses pertaining to ORENCIA treatment responses in
patients with highly active, progressive rheumatoid arthritis (RA), who
traditionally have a poor prognosis. 1-3
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A post hoc analysis of the phase 3 AGREE* clinical trial showing that
among patients with early, erosive RA, treatment with ORENCIA + MTX
(vs. MTX alone) resulted in higher seroconversion rates.2
Seroconversion refers to the RA autoantibodies ACPA and RF –
anti-citrullinated protein antibodies and rheumatoid factor – falling
to undetectable levels among patients who entered the trial with
measurable (seropositive) levels.2 ACPA and RF are
biomarkers associated with poor prognosis in RA.2 The full
data analysis will be featured in a poster tour on Friday, June 16,
from 11:45 – 13:30 CET.
-
A post hoc analysis of the phase 3b AVERT** study (MTX versus
Orencia+MTX) evaluating the proportion of patients achieving remission
at 12 months as measured by baseline MRI-detected inflammation status.3
The analysis explored the response of patients with higher
inflammation levels at baseline – as measured by MRI – versus patients
with lower baseline levels.3 The full data analysis will be
featured in an oral presentation on Friday, June 16, at 10:30 CET.
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A post hoc analysis of the phase 3b AMPLE*** study that investigated
the efficacy of ORENCIA+MTX versus the TNF inhibitor adalimumab+MTX in
patients with seropositive, erosive early RA.1 The analysis
looked at differences in treatment effect between the two regimens
among patients with seropositive, erosive early RA. The full data
analysis will be featured in a poster tour on Saturday, June 17, from
10:15 – 12:00 CET.
“The research Bristol-Myers Squibb is presenting at EULAR 2017 shows our
commitment to advancing scientific understanding of how biomarkers and
tools, such as MRI, can be used to guide patient selection and treatment
in highly active, progressive rheumatoid arthritis,” said Brian J.
Gavin, Vice President, ORENCIA Development Lead at Bristol-Myers Squibb.
“Importantly, the research also yields critical insights into the role
of modulating the body’s immune system in rheumatoid arthritis and
potentially other autoimmune conditions where we are committed to making
a meaningful, positive impact on patients’ lives.”
In RA, the body’s immune system mistakenly attacks the joints.4
The costimulation blockade of ORENCIA prevents T-cell activation and the
resulting cascade of events that contribute to joint destruction.
The full listing of abstracts Bristol-Myers Squibb will present at EULAR
2017, including data and analyses in rheumatoid arthritis, polyarticular
juvenile idiopathic arthritis and psoriatic arthritis, 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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Oral Presentations
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OP0284: Evaluation of the Impact of Baseline
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Friday, June 16
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Levels of MRI-Detected Inflammation on Treatment
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10:30 CET
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Response in Early, Seropositive, MTX-Naïve RA:
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Data from the AVERT Trial
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OP0223: Abatacept in the Treatment of Active
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Friday, June 16
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Psoriatic Arthritis: 1-Year Results from a Phase
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11:30 CET
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III Study
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OP0058: Improvement in Patient-Reported Outcomes
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Wednesday, June 14
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in Patients with Polyarticular-Course Juvenile
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17:25 CET
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Idiopathic Arthritis and Inadequate Response to
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Biologic or Non-Biologic Disease-Modifying
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Antirheumatic Drugs Treated with SC Abatacept
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OP0101: Risk of Opportunistic Infections in
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Thursday, June 15
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Patients with Rheumatoid Arthritis Initiating
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10:50 CET
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Abatacept: Analysis of all Available Clinical
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Trial Data
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Poster Tours
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FRI0219: Association Between Seroconversion
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Friday, June 16
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Status and Clinical Outcomes Following Treatment
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11:45 – 13:30 CET
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with Abatacept in Combination with Methotrexate
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Compared with Methotrexate Alone in Patients
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with Early Rheumatoid Arthritis and Poor
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Prognostic Indicators
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SAT0041: Efficacy of Abatacept versus Adalimumab
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Saturday, June 17
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in Patients with Seropositive, Erosive Early RA:
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10:15 – 12:00 CET
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Analysis of a Randomized Controlled Clinical
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Trial (AMPLE)
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SAT0177: Safety Events are Similar with Abatacept
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Saturday, June 17
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Versus Placebo Treatment in RA: Results from
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10:15 – 12:00 CET
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Integrated Data Analysis from Nine Clinical
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Trials
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FRI0129: Comparative Safety of Biologic DMARD
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Friday, June 16
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Initiation in RA: A Population-Based
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11:45 – 13:30 CET
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Observational Study of Malignancy Risk
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SAT0226: A First-in-Human, Study of BMS-986165, a
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Saturday, June 17
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Selective, Potent, Allosteric Small Molecule
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10:15 – 12:00 CET
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Inhibitor of Tyrosine Kinase 2
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Poster Presentations
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FRI0245: Abatacept Retention Rates and Prognostic
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Friday, June 16
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Factors of Retention in Patients with Rheumatoid
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11:45 – 13:30 CET
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Arthritis: 2-Year Results from the Real-world
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ACTION Study
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THU0104: Both MRI and HAQ-DI Can Predict Relapses
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Thursday, June 15
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Following all Treatment Withdrawal in MTX-Naïve
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11:45 – 13:30 CET
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Patients with RA in Remission after 12 Months of
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Abatacept Therapy in the AVERT Trial
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THU0725-HPR: Cost Effectiveness Analysis of
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Thursday, June 15
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Abatacept Compared with TNF Inhibitors in
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11:45 – 13:30 CET
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Patients who are Positive for Anti-Citrullinated
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Protein Antibodies Based on Results from an
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Observational Trial
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FRI0232: Treatment Effects of Abatacept and Anti-
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Friday, June 16
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TNF in Patients with RA with Poor Prognostic
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11:45 – 13:30 CET
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Factors: Data from Community Rheumatology
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Clinics
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SAT0188: First-Line Treatment Patterns of
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Saturday, June 17
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Patients with Rheumatoid Arthritis who are Anti-
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10:15 – 12:00 CET
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Cyclic Citrullinated Peptide Antibody Positive
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Versus Negative
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FRI0223: Anti-CCP is an Independent Predictor of
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Friday, June 16
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12-Month EULAR Response in Patients with RA
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11:45 – 13:30 CET
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treated with Abatacept
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THU0626: Cost-Effectiveness of Early Treatment of
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Thursday, June 15
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ACPA Positive Rheumatoid Arthritis Patients with
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11:45 – 13:30 CET
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Abatacept
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THU0089: M-DAS28, DAS28 (CRP) and RAPID3 Scores
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Thursday, June 15
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at Baseline are Good Predictors of Radiographic
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11:45 – 13:30 CET
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Disease Progress at 1 and 2 Years: Data from the
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AMPLE Trial
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SAT0197: Treatment Outcomes with Anti-TNF and
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Saturday, June 17
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Non-Anti-TNF Disease-Modifying Therapy by
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10:15 – 12:00 CET
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Baseline Body Mass Index
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FRI0230: Retention Rates of TNF Inhibitors and
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Friday, June 16
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Abatacept Used as a First Biologic DMARD in the
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11:45 – 13:30 CET
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Treatment of Rheumatoid Arthritis: 8 Years of
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Experience from the RHUMADATA® Registry
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SAT0468: Presence of Poor Prognostic Factors May
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Saturday, June 17
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Predict Response to Abatacept in Patients with
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10:15 – 12:00 CET
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Active Psoriatic Arthritis: Results from a Post
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Hoc Analysis from a Phase III Study
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FRI0520: Improved Patient-Reported Outcomes in
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Friday, June 16
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Psoriatic Arthritis Patients Treated with
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11:45 – 13:30 CET
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Abatacept: Results from a Phase III Trial
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FRI0499: Real-World Study on the Patterns and
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Friday, June 16
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Cost of Treatment Failure in Patients with
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11:45 – 13:30 CET
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Psoriatic Arthritis Using U.S. Claims Data
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THU0534: Baseline Characteristics and Descriptive
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Thursday, June 15
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Safety Data of Intravenous Abatacept-Treated
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11:45 – 13:30 CET
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Patients with Juvenile Idiopathic Arthritis in a
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U.S. Healthcare Claims Database
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FRI0106: Results of a Systematic Literature
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Friday, June 16
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Review of Prognostic Factors in Rheumatoid
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11:45 – 13:30 CET
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Arthritis as a Basis for a Prospective
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Rheumatologists Survey
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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.4-5
RA causes limited range of motion and decreased joint function.4-5
The condition is more common in women than in men, who account for 75%
of patients diagnosed with RA.4-5
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.
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 aged 2 years of
age 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 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 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,
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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.
*Abatacept study to Gauge Remission and joint
damage progression in MTX-naive patients with Early Erosive
RA
**Assessing Very Early Rheumatoid Arthritis
Treatment
***Abatacept versus AdaliMumab ComParison in BioLogic-NaivE
RA Subjects with Background Methotrexate
References
1. Fleischmann R., Weinblatt M., Ahmad H., et al. Efficacy of
Abatacept Versus Adalimumab in Patients with Serepositive, Erosive Early
RA: Analysis of a Randomized Controlled Clinical Trial (AMPLE). EULAR
2017 Abstract.
2. Jansen D., Emery P., Smolen J, et al. Association Between
Conversation to ACPA/RD Serenegative Status and Clinical Outcomes
Following Treatment with Abatacept in Combination with Methotrexate
Compared with Methtrexate Alone in Patients with Early Rheumatoid
Arthritis and Poor Prognostic Indicator. EULAR 2017 Abstract.
3. Ahmad H., Baker J., Emery P., et al. Evaluation of the Impact
of Baseline Levels of MRI-Detected Inflammation of Treatment Response in
Early, Seropositive, MTX-Naïve RA: Data from AVERT Trial. EULAR 2017
Abstract.
4. American College of Rheumatology. Rheumatoid Arthritis. https://www.rheumatology.org/i-am-a/patient-caregiver/diseases-conditions/rheumatoid-arthritis.
Accessed May 11, 2017.
5. Centers for Disease Control and Prevention. Rheumatoid Arthritis Fact
Sheet. https://www.cdc.gov/arthritis/basics/rheumatoid-arthritis.html.
Accessed May 11, 2017
Bristol-Myers Squibb CompanyMedia:Robert Perry, 407-492-4616 rob.perry@bms.com orInvestors:Tim Power, 609-252-7509 timothy.power@bms.com orBill Szablewski, 609-252-5894 william.szablewski@bms.com