BARCELONA, Spain, June 15 /PRNewswire-FirstCall/ -- Bristol-Myers
Squibb Company (NYSE: BMY) today announced results regarding the efficacy
and safety of ORENCIA(R) (abatacept) from the open-label phase of an
ongoing investigational study in children with juvenile idiopathic
arthritis (JIA) who have had an inadequate response to one or more
disease-modifying anti- rheumatic drugs (DMARDs), such as methotrexate
(MTX) or tumor necrosis factor (TNF) antagonists. The results demonstrated
that, after a study protocol- mandated withdrawal period of up to six
months, the re-introduction of ORENCIA was associated with a
re-establishment of clinical improvement as measured by the American
College of Rheumatology's Pediatric (ACR Pedi) criteria for improvement in
children with JIA. The data will be presented tomorrow at the Annual
Congress of the European League Against Rheumatism.
"Children with JIA can have long periods of inactive disease and
clinical remission, which makes it important to study the efficacy and
safety of re- starting a treatment after a withdrawal period," said Edward
H. Giannini, M.Sc., Dr.P.H., Professor of Pediatrics, Division of
Rheumatology, Cincinnati Children's Hospital Medical Center, OH,
co-principal investigator of the study. "The results of this
investigational study suggest that, in these children with JIA who had
disease flares while taking placebo during the mandated withdrawal phase,
resuming therapy with ORENCIA was associated with a re-establishment of
clinical improvement."
The study, designed to assess the efficacy, safety and tolerability of
ORENCIA in children and adolescents (ages 6-17 years) with JIA, consisted
of three periods: a four-month open-label lead-in treatment period in which
all participants received ORENCIA and both a clinical response and safety
were assessed (Period A), a six-month randomized double-blind withdrawal
phase where responders received either ORENCIA(R) (abatacept) or placebo
(Period B) and time to disease flare and safety were assessed, and an
open-label phase designed to assess efficacy and long-term safety (Period
C). Children in periods A and B remained on a stable dose of MTX and
children in Period C were permitted one of three DMARDs in addition to
ORENCIA. Data from Period C will be presented tomorrow. Results from
Periods A and B were presented at the American College of Rheumatology
Annual Scientific Meeting in November 2006.
Fifty-nine children randomized to placebo in Period B participated in
Period C to receive open label treatment with ORENCIA. Thirty-three of them
experienced a flare while 26 did not.
Everyone in Period C received 10 mg/kg of ORENCIA approximately every
28 days. Of the 33 children who received placebo and experienced disease
flares during the Period B protocol-mandated withdrawal phase of up to six
months, 80 percent had an ACR Pedi 30 response, 70 percent had an ACR Pedi
50 response, 50 percent had an ACR Pedi 70 Response and 27 percent had an
ACR Pedi 90 response after re-introduction of therapy with ORENCIA in
Period C.
Of the 26 children who received placebo during Period B who did not
experience disease flares and then chose to receive open-label ORENCIA
treatment during Period C, 76 percent had an ACR Pedi 30 response, 68
percent had an ACR Pedi 50 response, 60 percent had an ACR Pedi 70 Response
and 36 percent had an ACR Pedi 90 response after re-introduction of therapy
with ORENCIA in Period C.
Of the children who completed Period C, four (6.7 percent) children
previously treated with placebo in Period B reported serious adverse events
(SAEs) versus five (5.5 percent) children continuously treated with
ORENCIA. All SAEs were considered unrelated to ORENCIA according to the
investigator. None of these children discontinued due to an adverse event
(AE). In addition, no child previously treated with placebo in Period B had
an acute infusion reaction during the first infusion of ORENCIA in Period
C. There was one acute infusion reaction (palpebral edema, pruritus and
rash) later during Period C. No deaths or malignant neoplasms were reported
during this Period. The overall safety profile after re-establishing
therapy with ORENCIA was similar to that observed in patients who were
continuously treated with ORENCIA and who entered Period C.
Important Safety Information about ORENCIA
Before receiving treatment with ORENCIA individuals should tell their
doctor if they are taking a TNF blocker (e.g., Enbrel(R), Humira(R),
Remicade(R)) to treat rheumatoid arthritis (RA). ORENCIA(R) (abatacept)
should not be taken with these medications because of a higher chance of
getting a serious infection. Individuals should also tell their doctor if
they are taking Kineret(R) to treat RA. ORENCIA should not be taken with
Kineret. People taking ORENCIA should notify their doctor if they are
taking any other medications including hormones, over-the-counter
medicines, vitamins, supplements or herbal products.
Individuals should let their doctor know if they have any kind of
infection including an infection that is in only one place of the body
(such as an open cut or sore) or an infection that is in the whole body
(such as the flu). Having an infection could increase the risk for serious
side effects from ORENCIA. It is also important for individuals to let
their doctor know if they have an infection that won't go away or a history
of infections that keep coming back.
People who have had tuberculosis (TB), a positive skin test for TB,
recent close contact with someone who has had TB or develop any of the
symptoms of TB (a dry cough that doesn't go away, weight loss, fever, night
sweats) should call their doctor right away. Before starting treatment with
ORENCIA, a doctor may examine the individual for TB or perform a skin test.
In addition, individuals should let their doctor know if they are
scheduled to have surgery or any vaccination or have recently received a
vaccination. People should inform their doctor if they have a history of
chronic obstructive pulmonary (lung) disease (COPD). Taking ORENCIA may
cause COPD symptoms to get worse.
People who have diabetes and use a blood glucose monitor to check their
sugar levels should tell their doctor. The infusion of ORENCIA contains
maltose, a sugar that can give falsely high blood glucose readings with
some monitors on the day the infusion is received. The doctor may recommend
a different monitor.
Women who are pregnant, planning to become pregnant or are thinking
about becoming pregnant should tell their doctor. It is not known if
ORENCIA can harm an unborn baby. Women who are breast feeding should also
inform their doctor. They will need to decide to either breast-feed or
receive treatment with ORENCIA, but not both.
Important Information about Side Effects with ORENCIA
Like all medicines that affect your immune system, ORENCIA can cause
serious side effects. The possible serious side effects include serious
infections and allergic reactions. Also, rare cases of certain kinds of
cancers have been reported.
People taking ORENCIA(R) (abatacept) are at increased risk for
developing infections including pneumonia, and other infections caused by
viruses, bacteria, or fungi. Individuals should call their doctor
immediately if they feel sick or get any infection during treatment with
ORENCIA.
Allergic reactions are usually mild or moderate, generally occur within
the first 24 hours of an infusion, and include hives, swollen face,
eyelids, lips, tongue, throat, or trouble breathing. There have been some
serious allergic reactions reported after receiving an infusion of ORENCIA.
There have been rare cases of certain kinds of cancer. The role of
ORENCIA in the development of cancer is not known.
The more common side effects with ORENCIA are headache, upper
respiratory tract infection, sore throat, and nausea.
For Full Prescribing Information, please visit http://www.ORENCIA.com or
http://www.bms.com
Dosing and Administration
ORENCIA is administered by a healthcare professional as a 30-minute
intravenous infusion at a fixed dose based on body weight range
approximating 10 mg/kg at day 0, 2 weeks, 4 weeks, and every 4 weeks
thereafter. Acute infusion-related reactions were experienced in nine
percent of people treated with ORENCIA and in six percent of people treated
with placebo. According to the full prescribing information, the most
frequently reported infusion- related adverse events (1 percent to 2
percent) were dizziness, headache, and hypertension. In pivotal studies,
premedications were not required. However, appropriate medical support
measures for the treatment of hypersensitivity reactions should be
available for immediate use in the event of a reaction.
About Juvenile Idiopathic Arthritis
ORENCIA is not FDA-approved for use in children with juvenile
idiopathic arthritis (JIA).
JIA - also commonly known as juvenile rheumatoid arthritis (JRA) - is a
chronic, autoimmune disease, causing chronic pain, stiffness and swelling
of the joints, which may ultimately lead to joint damage and deformities.
The disease usually begins before the age of 16 and may affect up to 1
child in every 1,000 in the United States. Despite current therapies, some
individuals with JIA experience ongoing disease and many eventually worsen,
resulting in severe joint damage and abnormal joint function.
About ORENCIA(R) (abatacept)
ORENCIA is indicated in the United States for reducing signs and
symptoms, inducing major clinical response, inhibiting the progression of
structural damage, and improving physical function in adults with
moderately to severely active rheumatoid arthritis who have had an
inadequate response to one or more DMARDs, such as methotrexate or TNF
antagonists. ORENCIA may be used as monotherapy or concomitantly with
DMARDs other than TNF antagonists. ORENCIA should not be administered
concomitantly with TNF antagonists and is not recommended for use
concomitantly with anakinra.
ORENCIA, which was discovered and developed by Bristol-Myers Squibb
Company, is a selective modulator of a co-stimulatory signal required for
full T-cell activation and works in a fundamentally different way than
cytokine antagonists, including TNF antagonists.
Bristol-Myers Squibb Company is a global pharmaceutical and related
health care products company whose mission is to extend and enhance human
life.
SOURCE Bristol-Myers Squibb Company
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Related links:
http://www.bms.com
http://www.ORENCIA.com
CONTACT:
media, Sarah Koenig, +1-609-252-4145, or
+1-908-397-5379, or sarah.koenig@bms.com, or investors, John
Elicker, +1-212-546-3775, or john.elicker@bms.com, both of
Bristol-Myers Squibb Company
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