ORENCIA is the only biologic treatment for moderate to severe rheumatoid arthritis that is approved in three administration options – IV infusion, prefilled syringe, and autoinjector 1-10
New ORENCIA ClickJect Autoinjector offers accurate dose self-injection with push button operation, and confirmation that the full dose has been injected 11
Patients with moderate to severe RA who tested the ClickJect Autoinjector found the design comfortable and easy-to-use
Bristol-Myers
Squibb Company (NYSE:BMY) announced today the commercial launch of
the ORENCIA ClickJectTM Autoinjector, a new
self-administered autoinjector for adults with moderate to severe
rheumatoid arthritis (RA). The ORENCIA ClickJect delivers 125 mg
of subcutaneous (SC) ORENCIA with push button operation and
injection confirmation, which may reduce the possibility of user errors.
The ORENCIA ClickJect has an ergonomic design and non-slip grip
that may allow for control by dexterity-compromised patients.11
ORENCIA is the only RA biologic that offers three administration
options: IV infusion, prefilled syringe and Autoinjector.1-10 ORENCIA
is a prescription medicine 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
should not be administered concomitantly with tumor necrosis factor
(TNF) antagonists, and is not recommended for use concomitantly with
other biologic RA therapy, such as anakinra.
“Today’s launch of the ORENCIA ClickJect is an example of our
continued commitment to offering patients with moderate to severe
rheumatoid arthritis a treatment option that may be appropriate for
them, now available as an autoinjector,” said Chris Boerner, Head of
U.S. Commercial, Bristol-Myers Squibb. “This approval offers more
options for healthcare providers and members of the arthritis community
to consider when selecting the optimal treatment and administration
option for each individual.”
In a summative study, patients (n=48) evaluated the ORENCIA
ClickJect Autoinjector usability and acceptability based on key
attributes, including comfort (patients, P=0.0157), control (patients,
P=0.0002), ease of use (patients, P=0.0210) and confidence of dose
(patients, P=0.896). The mean scores for the device across criteria
ranged from 6.4-6.9 with the patient group, where user experience was
measured using a 7-point scale (1=very unacceptable, 4=neutral, 7=very
acceptable). Studies were conducted by an independent company and
participants were informed that a new RA autoinjector was being tested
but were blinded to the intended drug and sponsor identity.11
For patients with early, rapidly progressing moderate to severe RA,
treatment with ORENCIA may be an appropriate option. In a
12-month, multinational, double-blind, randomized, Phase IIIB study of
methotrexate (MTX)-naïve patients with early, rapidly progressing RA, ORENCIA
IV + MTX demonstrated significant efficacy vs MTX alone for those with
moderate to severe RA. The study, AGREE, met its co-primary endpoints as
defined by proportion of patients achieving DAS28-CRP < 2.6 at 1 year
(41% vs 23%, P<0.001) and inhibition of radiographic progression at 1
year (mean change in total symptoms scores: 0.6 vs 1.1, P=0.04).
Headache, upper respiratory tract infection, nasopharyngitis, and nausea
were the most commonly reported adverse events occurring at a rate of ≥
10% in patients taking ORENCIA in the adult RA clinical studies.13
“Rheumatoid arthritis often affects joints in the hand and impairs
dexterity.12 Through the new ORENCIA ClickJect, we are
able to offer the proven benefits of ORENCIA in an accurate dose
self-injection and provide an additional option for healthcare providers
when selecting treatment options for their patients,” said Sheila Kelly,
M.D., U.S. ORENCIA Medical Lead, Bristol-Myers Squibb.
The new ORENCIA ClickJect comes with push button operation and
step-by-step instructions to help the injection process for patients.
The Autoinjector's sturdy, lightweight design may allow patients with RA
to firmly hold, operate and control the device.11 It
automatically delivers the full dose of ORENCIA with one push of
a button and the user holding for fifteen seconds. Also, the ClickJect
Autoinjector’s large viewing window and blue indicator help confirm the
full dose of ORENCIA has been injected.11 The
ClickJect’s Autoinjector’s transparent tip automatically locks and
covers the needle after injection to help prevent accidental needle
sticks.11
Physicians and patients interested in receiving more information about
the ORENCIA ClickJect should visit www.ORENCIAHCP.com
or call 1-800-ORENCIA.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a systemic, chronic, autoimmune disease
characterized by inflammation in the lining of the joints (or synovium),
causing joint damage with chronic pain, stiffness, and swelling.12
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.12
About ORENCIA
ORENCIA SC and IV 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 rheumatoid arthritis. ORENCIA
may be used as monotherapy or concomitantly with disease-modifying
antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF)
antagonists.
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
healthcare practitioner.
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
.
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 for patients suffering from immune-mediated disease. As we
learn more about the immune system in diseases with substantial unmet
needs, the potential for new therapies that modulate 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.
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ORENCIA
® and ClickJect are trademarks of Bristol-Myers
Squibb Company.
Bristol-Myers Squibb Company Media: Erin McMaster, 609-897-2657 erin.mcmaster@bms.com or Investors: Bill Szablewski, 609-252-5894 william.szablewski@bms.com