Presentation of real-world data
demonstrating that biomarkers of poor prognosis may help identify
rheumatoid arthritis (RA) patient populations at risk for rapidly
progressing disease
New ORENCIA®
(abatacept) data in RA and related autoimmune diseases featured
in multiple presentations
Bristol-Myers Squibb Company (NYSE:BMY) today unveiled
rheumatoid arthritis (RA) and autoimmune disease data being
presented at the 2016 Annual Meeting of the American College of
Rheumatology (ACR) and the Association of Rheumatology Health
Professionals (ARHP) in Washington, D.C. The Company will present
23 abstracts that exemplify Bristol-Myers Squibb’s leadership in
autoimmune disease. This includes real-world data analyses
examining the role of poor prognostic factors, with a focus on
anti-cyclic citrullinated protein antibodies (anti-CCP, also known
as ACPA), in patients with moderate to severe RA. Bristol-Myers
Squibb’s ACPA-related research has helped further the understanding
of ACPA as a key prognostic factor related to rapidly progressive
RA.
Among the data being presented are two real-world data analyses
from the ongoing Corrona® RA registry – the largest RA cohort
prospectively followed in North America. One analysis showed a
significant relationship between poor prognostic factors for RA and
work status over 12 months. Patients with the worst prognostic
factors were less likely to have a part-time or full-time job
compared with those having a better RA prognosis. Despite the
association between poor prognostic factors and work limitations,
the other analysis found no significant association between the
presence of 0-1, 2, or 3+ poor prognostic factors for RA and
treatment initiation with a biologic therapy over 12 months,
suggesting that poor prognostic status does not currently influence
RA treatment decisions.
“These data analyses represent clinically meaningful RA research
that enrich our understanding of the disease and suggest an
important role for the evaluation of RA patients’ status with
regard to poor prognostic factors. Patients with a greater number
of poor prognostic factors despite treatment had smaller reductions
in clinical disease activity index (CDAI) and were less likely to
achieve low disease activity (LDA)/remission following their
treatment,” said Joel M. Kremer, M.D., Founder and Chief
Medical Officer of the Corrona RA registry, as well as a practicing
rheumatologist at Center for Rheumatology, LLP in Albany, NY and
Pfaff Family Professor of Medicine at the Albany Medical College.
“Findings like these demonstrate how poor prognostic factors may
inform the way the rheumatology community approaches the
disease.”
Bristol-Myers Squibb will also present data at the ACR/ARHP
Annual Meeting from the Phase 4 ACTION (AbataCepT In rOutiNe
clinical practice) trial, the first international, prospective
study to evaluate long-term ORENCIA retention in real-world
settings. This includes an interim analysis which assessed the
impact of body mass index (BMI) on treatment retention in
biologic-naïve RA patients who were double seropositive for
rheumatoid factor (RF) and ACPA at baseline. The results showed
that the 12-month ORENCIA retention rate was 78.1% (95% CI, 74.7 to
81.2), and that BMI did not significantly impact retention in
ORENCIA patients with poor prognostic factors. In addition, the
interim data indicate that RF/ACPA double seropositivity is
predictive of ORENCIA retention in biologic-naïve patients,
particularly in patients with erosive disease at baseline.
“Bristol-Myers Squibb is sharing a comprehensive set of
trial-based and real-world research at this year’s ACR/ARHP Annual
Meeting, supporting the use of ORENCIA in the treatment of RA –
particularly for those with rapidly progressing disease and poor
prognostic factors,” said Brian J. Gavin, Vice President, ORENCIA
Development Lead at Bristol-Myers Squibb. “The breadth of these
data – in combination with our industry-leading research in
biomarkers that affect treatment outcomes – offer meaningful
insights into improving patient prognosis and addressing the unmet
needs of people living with autoimmune diseases like RA.”
New PsA and pJIA Data Among Bristol-Myers Squibb
Presentations at the ACR/ARHP Annual Meeting
In addition to sharing RA-related data, Bristol-Myers Squibb
will present new Phase 3 data on the results of abatacept in the
treatment of psoriatic arthritis (PsA), as well as polyarticular
juvenile idiopathic arthritis (pJIA).
In an oral presentation, investigators will reveal topline
results from the ASTRAEA (Active pSoriaTic aRthritis rAndomizEd
triAl) study, an international, double-blind, multicenter Phase 3
study evaluating abatacept treatment vs. placebo in 424 patients
with PsA. Patients were randomized 1:1 to receive subcutaneous (SC)
abatacept 125 mg weekly or placebo for 24 weeks. Treatment with
abatacept demonstrated superior efficacy (as measured by ACR20
response) at Week 24 vs. placebo (95% CI, 17.2 (8.7, 25.6) with
p<0.001) and maintained efficacy at one year, regardless of
previous treatment with a tumor necrosis factor inhibitor (TNFi).
More than 60% of patients studied had prior exposure to a TNFi. In
addition, the study showed abatacept had a similar safety profile
as placebo. Based on these data, BMS has submitted a Supplemental
Biologics License Application (sBLA) with the Food and Drug
Administration (FDA), as well as a Variation Application (VA) with
the European Medicines Agency (EMA) to extend the indication for
abatacept to include the treatment of adult PsA.
Researchers also will share an encore oral presentation on Phase
3 abatacept data in pJIA. These data showed that subcutaneous (SC)
abatacept had equivalent efficacy and comparable safety to
intravenous (IV) abatacept in patients with pJIA. After four
months, more than 80% of patients taking SC abatacept achieved an
ACR30 response. In addition, SC abatacept showed no new safety
signals compared to IV ORENCIA.
Additional research Bristol-Myers Squibb will present at the
ACR/ARHP Annual Meeting includes late-breaking data exploring
preclinical models of systemic lupus erythematosus and inflammatory
bowel disease.
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20161114005279/en/
Bristol-Myers Squibb CompanyMedia:Erin McMaster,
609-955-2253erin.mcmaster@bms.comorInvestors:Bill Szablewski,
609-252-5894william.szablewski@bms.com
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