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
PRINCETON, N.J.--(BUSINESS WIRE)--
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
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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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Source: Bristol-Myers Squibb Company