Presentation of the first U.S. observational study exploring
the impact of biomarkers on treatment response for Orencia
and TNF-inhibitors in moderate to severe rheumatoid
arthritis
In this study, patients who tested positive via a common
blood test for certain biomarkers of poor prognosis (anti-CCP or
RF) were more likely to have a greater response with Orencia
treatment than patients testing negative for the biomarkers
Other data being presented: More than 20 abstracts, including
new pediatric study findings demonstrating equivalent efficacy and
safety of subcutaneous Orencia to intravenous Orencia in
pediatric juvenile idiopathic arthritis patients and the first data
disclosure of Phase 1 data showing investigational BTK inhibitor,
BMS-986142, for the treatment of rheumatoid arthritis and other
inflammatory disease was well tolerated
Bristol-Myers Squibb Company (NYSE:BMY) today announced that it
will present new data – offering insights into the field of
rheumatoid arthritis (RA) – at the Annual European Congress of
Rheumatology (EULAR 2016), to be held June 8-11, in London, UK.
Among the studies that Bristol-Myers Squibb will present are
findings from the first U.S. observational study exploring
patients’ response to treatment based on their baseline status for
two biomarkers of poor prognosis, anti-cyclic citrullinated peptide
(anti-CCP, also known as ACPA) and rheumatoid factor
(RF). Both anti-CCP and RF are biomarkers of poor prognosis
which may be associated with more severe disease progression and
joint damage. This new study and its results will be featured in an
Annual European Congress of Rheumatology (EULAR 2016) press release
and in an oral presentation on Thursday, June 9, 10:50 CET.
The study analyzed data from the Corrona, LLC RA registry, the
largest RA cohort prospectively followed in North America. The
analysis included patients with RA who had been tested for both
anti-CCP and RF, and received Orencia, a T cell co-stimulation
blocker (n=566), or another class of RA biologic medicines,
TNF-inhibitors (n=1715), between June 2002 and January 2015. The
primary outcome measured in the analysis was mean change from
baseline in Clinical Disease Activity Index (CDAI) at six months
and secondary outcomes were achievement of low disease activity
(LDA) at six months (LDA; CDAI ≤10 among those with moderate or
high disease activity at baseline) and achievement of remission at
six months (CDAI ≤2.8 among those with low, moderate or high
disease activity at baseline). Response rates for Orencia and
TNF-inhibitors were evaluated based on serologic status: double
positive (anti-CCP+/RF+); single positive (anti-CCP+/RF– or
anti-CCP–/RF+); and double negative (anti-CCP–/RF–).
Topline results from the real-world data analysis showed that in
patients who initiated Orencia, double positive status was
associated with a significantly greater response compared with
double negative status on all outcomes (CDAI –8.9 vs. –4.5,
p=0.002; LDA 43% vs. 26%, p=0.002; remission 15% vs. 5%, p=0.001).
In addition, single positive status was associated with a greater
likelihood of remission as compared with double negative status for
those administered Orencia (12% vs. 5%, p=0.018). The study did not
show significant differences in responses between anti-CCP/RF
status in those administered TNF-inhibitors (double positive vs.
double negative: CDAI –7.5 vs. –6.8, p=0.46; LDA 39% vs. 35%,
p=0.20; remission 16% vs. 14%, p=0.38).
“The Corrona RA registry offers an unrivaled source of
real-world observational data collected from U.S. patients with
RA,” said Leslie Harrold, M.D., M.P.H., the study’s Principal
Investigator and an Associate Professor of Medicine and Orthopedics
and Physical Rehabilitation at the University of Massachusetts
Medical School as well as Senior Medical Director of
Pharmacoepidemiology and Outcomes research at Corrona. “We believe
our findings provide new insights on RA for the rheumatology
community.”
The Corrona RA registry is a real-world observational study that
has collected data from 662 participating rheumatologists in 168
rheumatology practices across 40 states in the U.S. It currently
includes data from more than 40,000 patients with RA.
“As a leader in the field of immunoscience, Bristol-Myers Squibb
is dedicated to the research of disease biomarkers and finding
transformative ways that may help reduce the impact of autoimmune
diseases like RA,” said Douglas Manion, M.D., Head of Specialty
Development, Bristol-Myers Squibb. “The real-world data from the
Corrona RA registry study showed patients who are seropositive for
anti-CCP or RF, and particularly those who are double seropositive,
were more likely to have incremental improvements in response to
Orencia than if they were negative for these biomarkers as compared
to those who initiated TNF-inhibitors. In addition, there was
differential response to Orencia but not with TNF-inhibitors in
patients who were CCP+ vs. CCP-. These findings and scientific
insights underscore our decade-long commitment to ongoing Orencia
research.”
Other key data Bristol-Myers Squibb is presenting at the
Annual European Congress of Rheumatology (EULAR 2016)
includes:
- Phase 3 data from the AVERT
(Assessing Very Early Rheumatoid
Arthritis Treatment) study, which evaluated the
efficacy and safety of re-treating patients with early, active RA
(tested positive for anti-CCP) with Orencia plus methotrexate after
a period of treatment withdrawal. The full analysis of the data
will be featured in a poster presentation on Saturday, June 11,
10:20 CET.
- A Phase 3 juvenile idiopathic arthritis
(pJIA) study demonstrating subcutaneous (SC) Orencia has equivalent
efficacy and comparable safety to intravenous (IV) Orencia for pJIA
patients. SC Orencia showed efficacy after four months with greater
than 80% of patients achieving an ACR30 response with few
clinically relevant adverse events. The data will be featured in an
oral presentation on Friday, June 10, 10:20 CET.
- The first data disclosure for
Bristol-Myers Squibb’s investigational Bruton’s Tyrosine Kinase
(BTK) inhibitor, BMS-986142, targeted for RA and other inflammatory
diseases. Researchers will report on Phase 1 data which showed that
BMS-986142 was well tolerated, warranting further development of
the agent. The data will be featured in a poster presentation on
Thursday, June 9, 11:45 CET.
The full listing of abstracts Bristol-Myers Squibb will present
at the Annual European Congress of Rheumatology (EULAR 2016)
follows. Complete abstracts can be accessed online via the Annual
European Congress of Rheumatology (EULAR 2016) program planner at
https://b-com.mci-group.com/AbstractList/EULAR2016.aspx.
Abstract Title
Presentation Date and Time Oral Presentations
Abstract #OP0178/Corrona: Impact of Anti-Cyclic
Thursday, June 9th
Citrullinated Peptide and Rheumatoid Factor Status on 10:50 CET
Response to Abatacept Therapy: Findings
from a U.S.
Observational Cohort Abstract #OP0215:
Subcutaneous Abatacept In Patients
Friday, June 10th
With Polyarticular Juvenile Idiopathic Arthritis and 10:20 CET
Inadequate Response To Biologic or Non-Biologic Disease-Modifying
Antirheumatic Drugs: Pharmacokinetics, Efficacy and Safety
Poster Presentations
Poster Session Abstract
#THU0066/ACTION: Do Predictors of IV Abatacept
Thursday, June 9th
Retention Depend On the Line of Rheumatoid Arthritis 11:45 CET
Treatment: 12-Month Interim Analysis of the Observational,
Prospective Action Study Abstract #THU0632:
Retrospective Analysis of the
Thursday, June 9th
Association Between Anti-Cyclic Citrullinated Peptide 11:45 CET
Positivity and Healthcare Costs Among Patients With
Rheumatoid Arthritis Initiating Conventional Disease- Modifying
Antirheumatic Drugs Abstract #THU0090/BRASS:
Association of the Rheumatoid
Thursday, June 9th
Arthritis Prognostic Factors Anti-Citrullinated 11:45 CET Peptide
Antibodies Rheumatoid Factor and Erosions With Disease Activity and
Work Productivity Abstract #THU0615: Cost Per
Response For Abatacept
Thursday, June 9th
Compared With Adalimumab In the Treatment of Patients 11:45 CET
With Rheumatoid Arthritis Based On Anti-Citrullinated Protein
Antibody Titres In Italy, Spain and Canada
Abstract #FRI0227/ACQUIRE: Five-year Safety and
Friday, June 10th
Efficacy of Subcutaneous Abatacept In Patients With 11:45 CET
Moderate to Severely Active RA and An Inadequate Response to MTX:
Long-Term Extension of the Phase III, Double-Blind, Randomized
ACQUIRE Study Abstract # FRI0229: Risk of
Hospitalized Infections in Friday, June 10th
Patients with Rheumatoid Arthritis
Initiating
11:45 CET Abatacept and Other Biologics: Analysis of A United
States Claims Database Abstract #FRI0217:
Anaphylactic-Type Reactions
Friday, June 10th
Associated With Abatacept and Other Biologic Agents: 11:45 CET
Review of Safety Reports From Faers
Poster
Tour Abstract #FRI0205/Corrona:
Relationship Between Anti-
Friday, June 10th
Citrullinated Protein Antibody Status and Response To 11:50 CET
Abatacept or Anti-Tumor Necrosis Factor Therapy In Patients With
Rheumatoid Arthritis: A US National Observational Study
Abstract # SAT0153/AVERT: Abatacept Plus Methotrexate
Saturday, June 11th
Can Effectively and Safely Regain the Target of 10:20 CET Remission
Following Re-Treatment For Flares After Drug-Free Withdrawal In
Patients With Early Rhuematoid Arthritis
Abstract #FRI0513/AVERT: Validating MRI-Detected
Friday, June 10th
Inflammation Thresholds Predictive of Structural 11:50 CET Damage
Progression In Patients With Rheumatoid Arthritis In A Randomized
Placebo-Controlled Trial Abstract
#FRI0551/BRASS: Evaluation of Change In Anti-
Friday, June 10th
Citrullinated Peptide Autoantibody Levels In Clinical 11:50 CET
Practice and Association With Resource Use
Abstract #SAT0150: Comparative Risk of Malignancy With
Saturday, June 11th
Initiation of Abatacept and Other Biologics In 10:20 CET Patients
With Rheumatoid Arthritis: A Cohort Analysis of A United States
Claims Database
BTK Inhibitor
Abstract #THU0194: A Novel Reversible Bruton’s
Tyrosine
Thursday, June 9th
Kinase (BTK) Inhibitor (BMS-986142) Provides 11:45 CET Favourable
Safety, Pharmacokinetic and Pharmacodynamic Profiles in Healthy
Subjects
Program Book
Abstract #AB0213/Corrona: Is Disease Duration An N/A
Independent Predictor of Low Disease Activity/Remission Among
Biologic-Naïve Patients With Rheumatoid Arthritis Treated with
Abatacept? Abstract #AB0346: Testing For
Anti-Citrullinated N/A Peptide Antibodies In US Clinical Practice
Settings In Patients Newly Diagnosed with RA - Data From Three
Databases Between 2007-2014 Abstract #AB1006:
Anti-Citullinated Peptide Antibodies N/A and Rheumatoid Factor
Testing Patterns Among Patients With Rheumatoid Arthritis In the US
Abstract #AB1018/AGREE/AIM/ATTAIN: Does
Fatigue Improve N/A In A Similar Manner To Pain In Patients With
Rheumatoid Arthritis (RA) Treated With A Biologic? A Reanalysis of
Randomized Controlled Trials of Abatacept In 1536 Patients With
Active RA Abstract #AB0371/ACTION: Is
Switching From IV to SC N/A Abatacept therapy Sustainable In the
Real World? 1- Year Analysis of the Prospective, International
Action Study Abstract #AB0356: How does
First-line Abatacept Compare N/A to other Biologics? Data from a
Rheumatic Disease
Registry
About Rheumatoid
Arthritis
Rheumatoid arthritis (RA) is a systemic, chronic, autoimmune
disease characterized by inflammation in the lining of joints (or
synovium), causing joint damage with chronic pain, stiffness, and
swelling. RA causes limited range of motion and decreased joint
function. The condition is more common in women than in men, who
account for 75% of patients diagnosed with RA.
About the Corrona RA
Registry
The Corrona RA registry is the largest RA cohort prospectively
followed in North America and consists of data collected from both
physicians and patients at the time of a clinical encounter. The
Corrona RA registry offers insights from more than 40,000 RA
patients and 130,000+ patient-years of longitudinal follow-up
between June 2002 and January 2015.
About Orencia
Orencia SC and IV is indicated for reducing signs and symptoms,
inducing major clinical response, inhibiting the progression of
structural damage, and improving physical function in adult
patients with moderately to severely active rheumatoid arthritis.
Orencia may be used as monotherapy or concomitantly with
disease-modifying antirheumatic drugs (DMARDs) other than tumor
necrosis factor (TNF) antagonists.
Orencia IV is indicated for reducing signs and symptoms in
pediatric patients 6 years of age and older with moderately to
severely active polyarticular juvenile idiopathic arthritis.
Orencia IV may be used as monotherapy or concomitantly with
methotrexate (MTX). Orencia SC has not been studied in pediatric
patients.
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 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 may lead to long-term remission
in patients suffering from immune-mediated disease. As we learn
more about the immune system in diseases with substantial unmet
needs, the potential for new therapies that modulate 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160608005765/en/
Bristol-Myers SquibbMedia:Robert Perry,
407-492-4616rob.perry@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comBill Szablewski,
609-252-5894william.szablewski@bms.com
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