ORENCIA is a First-in-Class Biologic Treatment Option Now Available for
Use in Pediatric Patients with JIA
MONTREAL, July 29 /CNW Telbec/ - Bristol-Myers Squibb Canada today
announced that Health Canada has approved ORENCIA(R) (abatacept) for reducing
signs and symptoms of moderately to severely active juvenile idiopathic
arthritis (JIA)/juvenile rheumatoid arthritis in pediatric patients 6 years of
age and older who have had an inadequate response to one or more DMARDs, such
as MTX . ORENCIA should not be administered concomitantly with tumor necrosis
factor (TNF) antagonists. This new indication for ORENCIA provides significant
evidence of its durable efficacy and long-term safety in pediatric patients,
including those initiating biologic therapy for the first time. The safety and
efficacy of ORENCIA in JIA were assessed in a three-part study through one
year. The approval of ORENCIA in JIA represents the ongoing commitment of
Bristol-Myers Squibb in this therapeutic area - autoimmune diseases.
The approval is based on the AWAKEN (Abatacept Withdrawal study to Assess
efficacy and safety in Key Endpoints in juvenile idiopathic arthritis Not
responding to current treatment) trial, which evaluated the efficacy and
safety of ORENCIA (abatacept) in patients six to 17 years of age with
moderately to severely active JIA who had an inadequate response to one or
more disease-modifying anti-rheumatic drugs (DMARDs), such as MTX or TNF
"Juvenile idiopathic arthritis is the most prevalent form of arthritis in
children,"(1) said Jean-Paul Bédard, Vice-president of Corporate Affairs at
Bristol-Myers Squibb Canada. "This new indication for ORENCIA offers another
treatment option to help improve signs and symptoms of this serious disease in
pediatric and adolescent patients."
ORENCIA JIA Study (AWAKEN Trial)
The AWAKEN trial was a three-part study which included patients with
subtypes of JIA that at disease onset included Oligoarticular JIA
(16 percent), Polyarticular JIA (64 percent; 20 percent were rheumatoid factor
(RF) positive) and Systemic JIA with polyarticular course (20 percent) who had
not responded adequately to other JIA therapies. In the first phase of this
study (Period A), a total of 190 patients aged six to 17 years, with disease
duration of approximately four years with moderately to severely active
disease at study entry, were enrolled in this open-label, four-month, lead-in
phase of the study. The majority (70 percent) of these study patients were new
to biologic treatments. Nearly 30 percent of patients had previously had an
inadequate response to a TNF antagonist or anakinra. Patients received ORENCIA
(abatacept) intravenously (10 mg/kg; maximum 1,000 mg) on Days 1, 15, 29 and
every month thereafter. Response was assessed utilizing the ACR Pediatric 30
definition of improvement, defined as greater than or equal to 30 percent
improvement in at least three of the six JIA core set variables and greater
than or equal to 30 percent worsening in not more than one of the JIA core set
In Period A of the study, ORENCIA demonstrated consistent improvement in
ACR Pedi 30 with similar responses across all JIA subtypes (Oligoarticular
extended, 59.3 percent; Polyarticular-RF positive, 68.4 percent;
Polyarticular-RF negative 64.3 percent; and Systemic JIA with polyarticular
course, 64.9 percent). In patients who were inadequate responders to DMARDs
including MTX and were new to biologic treatment, ORENCIA demonstrated
meaningful ACR Pedi response rates with 65 percent of patients achieving an
ACR Pedi 30 response rate, 50 percent achieving an ACR Pedi 50 response rate,
28 percent achieving an ACR Pedi 70 response rate and 17 percent achieving an
ACR Pedi 90 response rate. In patients who received prior biological
treatment, 38.6 percent achieved an ACR Pedi 30 response rate, 24.6 percent
achieved an ACR Pedi 50 response rate, 10.5 percent achieved an ACR Pedi 70
response rate and 1.8 percent achieved an ACR Pedi 90 response rate.
In Period B of the study, patients who completed Period A and achieved an
ACR Pedi 30 response were eligible to enter this six-month, double-blind
phase. Patients entering Period B (n=122) were randomized to remain on ORENCIA
(n=60) or receive placebo (n=62) for six months.
The primary endpoint of the study was time to occurrence of disease
flare. Disease flare was defined as a greater than or equal to 30 percent
worsening in at least three of the six JIA core set variables with greater
than or equal to 30 percent improvement in not more than one of the six JIA
core set variables; greater than or equal to two centimeters of worsening of
the Physician or Parent Global Assessment was necessary if used as one of the
three JIA core set variables used to define flare, and worsening in greater
than or equal to two joints was necessary if the number of active joints or
joints with limitation of motion was used as one of the three JIA core set
variables used to define flare.
Efficacy results included:
- Time difference to occurrence of disease flare was statistically
significant based on the log-rank test in patients treated with placebo
compared with ORENCIA(R) (abatacept)
(p-value equals 0.0002).
- Patients treated with ORENCIA experienced significantly fewer disease
flares compared to placebo-treated patients (20 percent vs. 53 percent,
respectively, p-value less than 0.001).
- The risk of disease flare among patients continuing on ORENCIA was less
than one-third than that for patients who withdrew from ORENCIA
treatment (Hazard Ratio: 0.31, 95 percent CI (0.16, 0.59)).
In patients receiving ORENCIA treatment throughout the study (Period A,
Period B and the open-label extension Period C), the proportion of ACR Pedi
30, 50 and 70 responders remained consistent through one year.
In both the open-label, lead-in (Period A) and double-blind (Period B)
phases of the study, the adverse reactions in pediatric patients were similar
in type and frequency to those seen in adult patients. This was also seen in
patients who participated in the open-label (Period C) extension period.
The overall frequency of adverse events in Period A was 70 percent;
infections occurred at a frequency of 36 percent. The most common infections
were upper respiratory tract infection and nasopharyngitis. Infections
resolved without sequelae, and the types of infections were consistent with
those commonly seen in outpatient pediatric populations. Other events that
occurred at a prevalence of at least five percent were headache, nausea,
diarrhea, cough, pyrexia and abdominal pain. A total of six serious adverse
events (acute lymphocytic leukemia, ovarian cyst, varicella infection, disease
flare (2) and joint wear) were reported during the initial four months of
treatment with ORENCIA. There was one case of a hypersensitivity reaction
(0.5 percent). During Periods A, B and C, acute infusion-related events
occurred at a frequency of four percent, two percent and three percent,
respectively, and were consistent with the types of events reported in adults.
Upon continued treatment in the open-label extension period, the types of
adverse events were similar except for a single patient diagnosed with
multiple sclerosis while on open-label treatment.
About Juvenile Idiopathic Arthritis (JIA)
JIA - also commonly known as Juvenile Rheumatoid Arthritis (JRA) - is the
most common chronic rheumatic disease in children, and it is an important
cause of short-term and long-term disability.(1) It is an autoimmune disease
that causes chronic pain, stiffness and swelling of the joints,(2) which may
ultimately lead to joint damage and deformities.(3) The disease usually begins
before the age of 16.(4) In Canada, one in 1,000 babies, toddlers and children
below age 16 suffer from JIA.(5)
ORENCIA(R) (abatacept) is one treatment option indicated in pediatric
patients ages six and older with moderately to severely active polyarticular
JIA. ORENCIA should not be administered concomitantly with other biologic RA
For more information, please visit www.BMScanada.ca
About Bristol-Myers Squibb
Bristol-Myers Squibb Company is a global biopharmaceutical and related
health care products company whose mission is to extend and enhance human
(1) Ravelli A. Juvenile Idiopathic Arthritis. The Lancet.
(2) Medline Plus. Juvenile Rheumatoid Arthritis. US National Library of
Medicine, National Institute of Health. Available at
Accessed March 10, 2008.
(3) Zeginni E. Association of HLA-DRB1(*)13 with susceptibility to
uveitis in juvenile idiopathic arthritis in two independent data
sets. Rheumatology. 2006;45:972-974.
(4) American College of Rheumatology Web site. Arthritis in Children.
Accessed March 11, 2008.
For further information:
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