Patients demonstrated improved disease response in two
clinical trials that included both TNF-naïve and challenging to
treat TNF-exposed patients with active musculoskeletal
involvement1
Bristol-Myers Squibb Company (NYSE: BMY) announced today that
the European Commission (EC) has approved ORENCIA alone or in
combination with methotrexate for the treatment of active Psoriatic
Arthritis (PsA) in adult patients for whom the response to previous
disease-modifying antirheumatic drug (DMARD) therapy, including
methotrexate, has been inadequate, and additional systemic therapy
for psoriatic skin lesions is not required.1
This approval, which allows for the expanded marketing of
ORENCIA as a treatment for PsA in all 28 Member States of the EU,
marks the second new indication for ORENCIA in less than a year; in
September 2016, the European Commission approved ORENCIA, in
combination with methotrexate (MTX), for the treatment of highly
active and progressive disease in adult patients with rheumatoid
arthritis (RA) not previously treated with MTX. PsA becomes the
third autoimmune condition, along with rheumatoid arthritis and
juvenile idiopathic arthritis, for which ORENCIA is approved to
treat in Europe.1
“This EC approval builds on the well-established profile of
ORENCIA in Rheumatoid Arthritis and exemplifies our commitment to
ongoing clinical research of ORENCIA as a potential treatment for
autoimmune conditions where treatment options are limited or where
patients have not been helped enough by other medications,” said
Brian J. Gavin, Ph.D., Vice President, ORENCIA Development Lead at
Bristol-Myers Squibb. “Despite the current availability of
medications, there are many people with active Psoriatic Arthritis
who are in need of a new treatment option; the approval of ORENCIA
now provides a novel immunotherapy approach that may help these
patients.”
The approval was based on results from two randomized,
double-blind, placebo-controlled studies (Studies PSA-I and PSA-II)
in which a higher proportion of patients achieved an ACR 20
response, the primary endpoint, after treatment with ORENCIA 10
mg/kg intravenous (IV) or 125 mg subcutaneous injection (SC)
compared to placebo at Week 24: 47.5% versus 19.0% and 39.4% versus
22.3% (p< 0.05), respectively.1 Responses were seen regardless
of prior tumor necrosis factor inhibitor (TNFi) treatment in both
studies.1
In the phase 3 study, PsA-II, the proportion of radiographic
non-progressors (≤0 change from baseline) in total PsA-modified SHS
on x-rays at Week 24 was greater with ORENCIA 125 mg SC (42.7%)
than placebo (32.7% (10.0 [1.0, 19.1] estimate of difference [95%
CI]).1 There were no adverse reactions that occurred at ≥ 2% in
either treatment group during the 24-week placebo-controlled
period. The overall safety profile was comparable between studies
PsA-I and PsA-II and consistent with the safety profile in
rheumatoid arthritis.1 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.1
In PsA, the immune system attacks healthy joints and skin.3
T-cell activation is involved in the pathogenesis of PsA.4 The
costimulation blockade of ORENCIA inhibits T-cell activation and
the resulting cascade of events that contribute to joint
destruction. Both IV and SC injection formulations of ORENCIA are
now approved to treat adult patients with active PsA.
Additional Information About Studies
PSA-I and PSA-IIThe efficacy of ORENCIA was assessed in
two randomized, double-blind, placebo-controlled studies (Studies
PsA-I and PsA-II) in 594 adult patients,1 with a disease duration
more than 7 years.4,5 Patients had active PsA (≥ 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.1 In PsA-I and PsA-II, 37% and 61% of patients,
respectively, were treated with 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, 170 patients received placebo or ORENCIA 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 10 mg/kg IV every 28
days.1 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, followed by open label ORENCIA 10
mg/kg monthly IV every month.1 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, also known as ASTRAEA, 424 patients were randomized
1:1 to receive weekly doses of SC placebo or ORENCIA 125 mg without
a loading dose for 24 weeks, followed by open-label ORENCIA 125 mg
SC weekly.1 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
About Psoriatic
ArthritisPsoriatic arthritis (PsA) is a chronic6,
inflammatory disease that can affect both the skin and
musculoskeletal system.2 PsA can cause joint pain, stiffness and
reduced range of motion, and can eventually lead to irreparable
joint damage.2 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.2 Men and
women are equally at risk.2 Early recognition, diagnosis and
treatment of Psoriatic Arthritis are critical to relieve pain and
inflammation and help prevent joint damage.2
U.S. 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 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
ImmunoscienceWith 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
SquibbBristol-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 StatementThis 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,
2016 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.
References1. ORENCIA® Annex I: Summary of
Product Characteristics. Bristol-Myers Squibb Company, Princeton,
NJ. June 2017.2. Psoriatic Arthritis Overview. National Institutes
of Health.
https://www.niams.nih.gov/Health_info/Psoriatic_Arthritis/default.asp.
Accessed May 8, 2017.3. What is Psoriatic Arthritis? The Arthritis
Foundation.
http://www.arthritis.org/about-arthritis/types/psoriatic-arthritis/what-is-psoriatic-arthritis.php.
Accessed May 8, 2017.4. 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. 20175. 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):939-948.6. Psoriatic
Arthritis. American College of Rheumatology.
https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis.
Accessed May 8, 2017.
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Bristol-Myers Squibb CompanyMedia:Robert Perry,
407-492-4616rob.perry@bms.comorInvestors:Tim Power,
609-252-7509timothy.power@bms.comorBill Szablewski,
609-252-5894william.szablewski@bms.com
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