ORENCIA demonstrated symptom improvement in two randomized,
double-blind, placebo-controlled trials that included adult PsA
patients with active musculoskeletal symptoms
ORENCIA now approved in three autoimmune diseases
Bristol-Myers Squibb Company (NYSE:BMY) announced today the U.S.
Food and Drug Administration (FDA) has approved ORENCIA for the
treatment of adults with active Psoriatic Arthritis (PsA)1, a
chronic2, inflammatory disease that can affect both the skin and
musculoskeletal system.3 ORENCIA is approved and available in both
intravenous and subcutaneous (SC) injection formulations.1 ORENCIA
should not be administered concomitantly with TNF antagonists, and
is not recommended for use concomitantly with other biologic
Rheumatoid Arthritis (RA) therapy, such as anakinra.1 This approval
marks the third autoimmune disease indication for ORENCIA.1
“This approval underscores the efficacy of ORENCIA in adult
patients with active Psoriatic Arthritis, who have been in need of
new treatments,” said Brian J. Gavin, Vice President, ORENCIA
Development Lead at Bristol-Myers Squibb. “Helping to advance
clinical understanding of autoimmune conditions is a key focus of
our immunoscience research, and we’re proud to introduce ORENCIA, a
selective T-cell co-stimulation modulator, as an additional
treatment option for PsA.”
The co-stimulation blockade of ORENCIA inhibits T-cell
activation and the resulting cascade of events that contribute to
inflammation. T-cell activation is involved in the pathogenesis of
PsA.4
Psoriatic Arthritis can cause joint pain, stiffness and reduced
range of motion3, potentially affecting the ability to do everyday
activities, such as getting dressed and tying shoes.3,5 In PsA, the
immune system attacks healthy joints and skin.6
“Psoriatic Arthritis takes a toll on patients and families over
time,7” said Randy Beranek, president and CEO, National Psoriasis
Foundation. “We welcome the introduction of an additional treatment
option for adults with active Psoriatic Arthritis, because we
believe advancements, along with further research, education and
support services, are critical to helping improve the lives of
those impacted.”
The approval was based on results from two randomized,
double-blind, placebo-controlled trials in which ORENCIA improved
(or reduced) disease activity in both TNF-naive and exposed
patients with high disease activity, high tender and swollen
joints, and a disease duration of more than seven years.1,4,8
ORENCIA PsA IV and SC Studies
Demonstrated Improved Disease Response
The efficacy of ORENCIA was assessed in two randomized,
double-blind, placebo-controlled studies (Studies PsA-I and PsA-II)
in 594 adult patients with disease duration more than seven years.
Patients had active Psoriatic Arthritis (≥ 3 swollen joints and ≥ 3
tender joints) despite prior treatment with DMARD therapy and had
one qualifying psoriatic skin lesion of at least 2 cm in diameter.
In PsA-I and PsA-II, 37% and 61% of patients, respectively, were
treated with TNF inhibitors (TNFi) previously.1 The primary
endpoint for both PsA-I and PsA-II was the proportion of patients
achieving ACR 20 response at Week 24 (Day 169).1
In PsA-I, a dose-ranging study, 170 patients received study drug
IV at Days 1, 15, 29, and then every 28 days thereafter in a
double-blind manner for 24 weeks, followed by open-label ORENCIA
every 28 days. Patients were randomized to receive placebo or
ORENCIA 3 mg/kg, 10 mg/kg (weight range-based dosing: 500 mg for
patients weighing less than 60 kg, 750 mg for patients weighing 60
to 100 kg, and 1000 mg for patients weighing greater than 100 kg),
or two doses of 30 mg/kg followed by weight range-based dosing of
10 mg/kg without escape for 24 weeks. Patients were allowed to
receive stable doses of concomitant methotrexate, low dose
corticosteroids (equivalent to ≤ 10 mg of prednisone) and/or NSAIDs
during the trial. At enrollment, approximately 60% of patients were
receiving methotrexate.1
In PsA-II, 424 patients were randomized 1:1 to receive weekly
doses of SC placebo or ORENCIA 125 mg SC without a loading dose for
24 weeks, followed by open-label ORENCIA 125 mg SC weekly. Patients
were allowed to receive stable doses of concomitant methotrexate,
sulfasalazine, leflunomide, hydroxychloroquine, low dose
corticosteroids (equivalent to ≤ 10 mg of prednisone) and/or NSAIDs
during the trial. At randomization, 60.4% of patients were
receiving methotrexate.1
A higher proportion of patients treated with ORENCIA 10 mg/kg IV
or 125 mg SC achieved an ACR20 response at Week 24 compared to
placebo, 47.5% versus 19.0% and 39.4% versus 22.3% (p< 0.05),
respectively.1 Responses were seen regardless of prior anti-TNFi
treatment and regardless of concomitant non-biologic DMARD
treatment.1 Improvements in enthesitis and dactylitis were seen
with ORENCIA treatment at Week 24 in both IV and SC.1
There was a higher proportion of ORENCIA IV patients with at
least a 0.30 decrease from baseline in Health Assessment
Questionnaire-Disability Index (HAQ-DI) score at Week 24, with an
estimated difference for ORENCIA 10 mg/kg (weight range-based
dosing as described above) (45.0%) vs. placebo (19.0%) of 26.1 (95%
confidence interval: 6.8, 45.5).1 The proportion of ORENCIA SC
patients with at least a 0.35 decrease from baseline in HAQ-DI on
ORENCIA was 31%, as compared to 24% on placebo (estimated
difference: 7%; 95% confidence interval: -1%, 16%).1 There was a
higher adjusted mean change from baseline in HAQ-DI on ORENCIA SC
(-0.33) vs. placebo (-0.20) at Week 24, with an estimated
difference of -0.13 (95% confidence interval: -0.25, -0.01). 1
The safety profile of ORENCIA was comparable between studies
PsA-I and PsA-II and consistent with the safety profile in RA. The
most serious adverse reactions reported in studies of adult RA
patients were serious infections (3% ORENCIA vs 1.9% placebo) and
malignancies (1.3% ORENCIA vs 1.1% placebo). Headache, upper
respiratory tract infection, nasopharyngitis, and nausea were the
most commonly reported adverse events (≥ 10%) in the adult RA
clinical studies. In PsA-II, the most common adverse reactions (≥
5%) were nasopharyngitis, upper respiratory tract infection, and
bronchitis.
“It can be difficult to treat active Psoriatic Arthritis
patients because the disease course is unpredictable, and patients
are often treated with a variety of medications such as classic
DMARDs and TNFs over time.4 Furthermore, once they have been
treated, it may be more difficult to obtain an adequate efficacy
response,” said Philip Mease, M.D., Clinical Professor at the
University of Washington School of Medicine and Director of the
Rheumatology Clinical Research Division of Swedish Medical Center.
“The data that formed the basis of this approval demonstrate that
ORENCIA offers an additional treatment option for patients with
active Psoriatic Arthritis who have already tried a TNF inhibitor,
as well as those who have not.”
About Psoriatic
Arthritis
Psoriatic arthritis (PsA) is a chronic2, inflammatory disease
that can affect both the skin and musculoskeletal system.3 PsA can
cause joint pain, stiffness and reduced range of motion.3 Most
commonly affecting the distal joints (those closest to the nail) of
the fingers or toes, as well as the wrists, knees, ankles and lower
back, the disease usually appears between the ages of 30 to 50, but
can begin as early as childhood.3 Men and women are equally at
risk.3 Early recognition, diagnosis and treatment of Psoriatic
Arthritis are critical to helping relieve pain and
inflammation.3
Indication 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 patients 2 years of age and older
with moderately to severely active polyarticular JIA. ORENCIA may
be used as monotherapy or concomitantly with methotrexate
(MTX).
Adult Psoriatic Arthritis (PsA): ORENCIA® (abatacept) is
indicated for the treatment of adult patients with active PsA.
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 RA 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,
including COPD exacerbations, cough, rhonchi, and dyspnea. In adult
RA studies, 97% of COPD patients treated with ORENCIA developed
adverse reactions versus 88% treated with placebo and 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 adult RA 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 RA patients treated with ORENCIA or
placebo. However, more cases of lung cancer were observed in RA
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 JIA and adult PsA patients were similar in
frequency and type to those seen in adult RA patients.
Note concerning ORENCIA administration
options: Intravenous dosing has not been studied in
patients younger than 6 years of age. The safety and efficacy of
ORENCIA ClickJect™ Autoinjector for subcutaneous injection has not
been studied in patients under 18 years of age.
Please click here
to see the Full Prescribing
Information.
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 medical 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
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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
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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,
2016 in our Quarterly Reports on Form 10-Q and our Current Reports
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of new information, future events or otherwise.
References
1. ORENCIA® Prescribing Information.
Bristol-Myers Squibb Company, Princeton, NJ. June 2017. 2.
Psoriatic Arthritis. American College of
Rheumatology.
https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis.
Accessed May 8, 2017.
3.
Psoriatic Arthritis Overview. National
Institutes of Health.
https://www.niams.nih.gov/Health_info/Psoriatic_Arthritis/default.asp.
Accessed May 8, 2017.
4.
Mease P., Gottlieb A., Heijde H., et al.
Efficacy and safety of abatacept, a T-cell modulator, in a
randomised, double-blind, placebo-controlled, phase 3 study in
psoriatic arthritis. Annals of the Rheumatic Diseases. 2017
5.
About Psoriatic Arthritis. National
Psoriasis Foundation.
https://www.psoriasis.org/about-psoriatic-arthritis. Accessed June
21, 2017.
6.
What is Psoriatic Arthritis? The Arthritis
Foundation.
http://www.arthritis.org/about-arthritis/types/psoriatic-arthritis/what-is-psoriatic-arthritis.php.
Accessed May 8, 2017.
7.
Gladman D, Antoni C, Mease P., et al.
Psoriatic arthritis: epidemiology, clinical features, course, and
outcome. Annals of the Rheumatic Diseases. 2005
8. Mease P, Genovese MC, Gladstein G. Abatacept in the treatment of
patients with psoriatic arthritis: Results of a six-month,
multicenter, randomized, double-blind, placebo-controlled, phase II
trial. Arthritis & Rheumatism. 2011;63(4):939-948.
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Bristol-Myers Squibb CompanyMedia:Erin McMaster,
609-955-2253erin.mcmaster@bms.comorInvestors:Bill Szablewski,
609-252-5894william.szablewski@bms.com
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