Squibb Company (NYSE: BMY) today announced that new data from
company-sponsored studies on Orencia SC in patients with
rheumatoid arthritis (RA) and Orencia IV in juvenile idiopathic
arthritis (JIA) will be presented at the American College of
Rheumatology (ACR) Annual Scientific Meeting in Washington, D.C.,
November 10-14. Data from the company-sponsored studies will include new
results from the AMPLE study examining changes in patient reported
outcomes (PROs), including patient pain, patient global assessment and
fatigue, and measures of remission. AMPLE (Abatacept
Versus Adalimumab Comparison
rheumatoid arthritis Subjects With Background Methotrexate) is a
head-to-head Phase III non-inferiority clinical trial comparing
subcutaneous (SC) Orencia to Humira® (adalimumab),
each on a background of methotrexate. Additionally, investigator
sponsored research, supported by BMS, studying Orencia IV in mild
relapsing granulomatosis with polyangiitis (Wegener’s) will be presented.
Other new data being presented on Orencia
“The one-year AMPLE results offer a more extensive and in-depth
comparative analysis than previously reported between Orencia SC
and Humira, and the patient reported outcomes continue to expand our
understanding Orencia in moderate to severe RA,” said Brian
Daniels, M.D., senior vice president, Global Development and Medical
Affairs, Bristol-Myers Squibb. “The breadth of data at ACR is an example
of our commitment to patients and to our continued research in RA and
Company-sponsored studies presented at the ACR Annual Scientific Meeting
are shown below. Abstracts can be accessed on the ACR website at http://www.acrannualmeeting.org/.
Key Orencia Data in Oral/Poster Presentations:
Location: Poster Hall (Hall B)
Palo Alto, CA
Oral Presentation time: 5:15 PM – 5:30 PM
Location: Salon B
Oral presentation time: 5:30 PM – 5:45 PM
Presentation time: 5:15 PM – 5:30 PM
Location: 207 A
Presentation time: 4:45 PM – 5:00 PM
Location: Hall E
Presentation time: 11:00 AM – 11:15 AM
Presentation time: 5:00 PM – 5:15 PM
About Orencia ® (abatacept)
Orencia SC and IV are 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)
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
Important Safety Information
Concomitant Use with TNF antagonists: Concurrent therapy with
ORENCIA and a biologic DMARD 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
Hypersensitivity: Less than 1% of adult patients treated with
ORENCIA experienced hypersensitivity reactions, including some cases of
anaphylaxis or anaphylactoid reactions. Other events potentially
associated with drug hypersensitivity, such as hypotension, urticaria,
and dyspnea, each occurred in less than 0.9% of patients treated with
ORENCIA® (abatacept) and generally occurred within
24 hours of infusion. There was 1 case of a hypersensitivity reaction
with ORENCIA in JIA clinical trials (0.5%; n =190). Appropriate medical
support measures for treating hypersensitivity reactions should be
available for immediate use in the event of a reaction.
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
Immunizations: Live vaccines should not be given concurrently
with ORENCIA or within 3 months of its discontinuation as it 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 exacerbations, 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
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 pyrroloquinolinequinone
(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
administration does not contain maltose; therefore, patients do not need
to alter their glucose monitoring.
Pregnant and Nursing Mothers: ORENCIA® (abatacept)
should be used during pregnancy only if clearly needed. The risk for
development of autoimmune diseases in humans exposed in utero to
abatacept has not been determined. Nursing mothers should be informed of
the risk/benefit of continued breast-feeding or discontinuation of the
drug. A pregnancy registry has been established to monitor fetal
outcomes. Healthcare professionals are encouraged to register pregnant
patients exposed to ORENCIA by calling 1-877-311-8972.
Most Serious Adverse Reactions: Serious infections (3% ORENCIA
vs. 1.9% placebo) and malignancies (1.3% ORENCIA vs. 1.1% placebo). In
general, adverse events in pediatric and adolescent patients were
similar in frequency and type to those seen in adult patients.
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.
For US Full
Prescribing Information, visit http://packageinserts.bms.com/pi/pi_orencia.pdf.
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, swelling and fatigue.
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 Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company committed to
discovering, developing and delivering innovative medicines that help
patients prevail over serious diseases.
For more information about Bristol-Myers Squibb, visit www.bms.com,
or follow us on Twitter at http://twitter.com/bmsnews.
Orencia is a registered trademark of Bristol-Myers Squibb
Company. All other trademarks are property of their respective owners.