EROS real-world outcomes data show prompt
initiation of BREZTRI is associated with a reduced risk of future
exacerbations in people living with COPD1
EXACOS-CV US data highlights increased risk
of severe cardiovascular events following an acute COPD
exacerbation2
Results from the EROS real-world retrospective study showed that
initiating fixed-dose triple-combination therapy BREZTRI
AEROSPHERE® (budesonide/glycopyrronium/formoterol fumarate) within
30 days of a qualifying moderate or severe exacerbation in patients
with COPD (chronic obstructive pulmonary disease) is associated
with a decreased risk of future exacerbations by 24% vs. delaying
treatment by one to six months, and by 34% vs. delaying treatment
six months to one year.1
The EROS study is the first real-world evidence analysis of
BREZTRI in more than 2,400 patients with COPD from a claims
database registry, and was presented today as a late-breaking
abstract at the ATS 2023 International Conference in Washington,
DC, hosted by the American Thoracic Society. AstraZeneca's presence
at ATS 2023 also includes new data from TEZSPIRE and FASENRA.
Professor Charlie Strange, MD, Medical University of South
Carolina, US and investigator in the EROS study, said: "A key
treatment goal in COPD is to avoid exacerbations that may lead to
increased risk of future exacerbations, possible hospitalization or
even death. The EROS real-world data build on the body of clinical
evidence that BREZTRI is effective in reducing COPD exacerbation
rates and can significantly reduce the risk of future exacerbations
if used as soon as a patient’s COPD symptoms worsen.”
Another late-breaking presentation at ATS 2023, the EXACOS-CV US
retrospective cohort study using the HealthCore Integrated Research
Database of people with COPD showed the risk of an acute severe
cardiovascular (CV) event (including stroke, heart failure,
pulmonary embolism, arrhythmia, or heart attack) increased by 32%
in the first 30 days following a single acute moderate or severe
COPD exacerbation, compared to those without a prior COPD
exacerbation. According to the results, the risk of CV events was
highest in the first 90 days following the COPD exacerbation, the
risk remained elevated for one year, and each subsequent COPD
exacerbation was associated with an even higher risk of acute CV
events (>2 times increased CV risk following two or three COPD
exacerbations).2 These results suggest that patients with COPD
should be considered at risk of cardiopulmonary events following an
acute exacerbation, even those who are newly-diagnosed.
Robert Fogel, Vice President, Global Medical Affairs,
Respiratory & Immunology, AstraZeneca, said: “As the third
leading cause of death worldwide3, improving outcomes for patients
must be an urgent priority for physicians and healthcare systems.
The EROS and EXACOS-CV studies increase our understanding of the
significant cardiopulmonary risk COPD patients face as well as the
opportunity to reduce COPD exacerbations through more proactive
treatment with BREZTRI.”
AstraZeneca Respiratory & Immunology pipeline and
portfolio highlighted in more than 50 abstracts at ATS 2023
Key additional data from AstraZeneca at ATS include:
- Two post hoc analyses from the NAVIGATOR Phase III trial
demonstrating efficacy of TEZSPIRE in patients with severe,
uncontrolled asthma irrespective of prior omalizumab use; and in
improving rhinosinusitis symptoms measured with SNOT-22 in patients
who also have a history of comorbid nasal polyps.4,5
- Real-world evidence from the retrospective RANS trial
supporting the strong clinical efficacy of FASENRA specifically in
patients with severe eosinophilic asthma and nasal polyps; and a
post-hoc analysis of five FASENRA Phase III/IIIb trials showing an
increased rate of achieving clinical remission in patients with
severe eosinophilic asthma and concomitant nasal polyps.6,7
BREZTRI AEROSPHERE® (budesonide/glycopyrronium/formoterol
fumarate) Important Safety Information
- BREZTRI is contraindicated in patients who have a
hypersensitivity to budesonide, glycopyrrolate, formoterol
fumarate, or product excipients
- BREZTRI is not indicated for treatment of asthma. Long-acting
beta2-adrenergic agonist (LABA) monotherapy for asthma is
associated with an increased risk of asthma-related death. These
findings are considered a class effect of LABA monotherapy. When a
LABA is used in fixed-dose combination with ICS, data from large
clinical trials do not show a significant increase in the risk of
serious asthma-related events (hospitalizations, intubations,
death) compared with ICS alone. Available data do not suggest an
increased risk of death with use of LABA in patients with COPD
- BREZTRI should not be initiated in patients with acutely
deteriorating COPD, which may be a life-threatening condition
- BREZTRI is NOT a rescue inhaler. Do NOT use to relieve acute
symptoms; treat with an inhaled short-acting beta2-agonist
- BREZTRI should not be used more often than recommended; at
higher doses than recommended; or in combination with
LABA-containing medicines, due to risk of overdose. Clinically
significant cardiovascular effects and fatalities have been
reported in association with excessive use of inhaled
sympathomimetic drugs
- Oropharyngeal candidiasis has occurred in patients treated with
orally inhaled drug products containing budesonide. Advise patients
to rinse their mouths with water without swallowing after
inhalation
- Lower respiratory tract infections, including pneumonia, have
been reported following ICS. Physicians should remain vigilant for
the possible development of pneumonia in patients with COPD as the
clinical features of pneumonia and exacerbations frequently
overlap
- Due to possible immunosuppression, potential worsening of
infections could occur. Use with caution. A more serious or fatal
course of chickenpox or measles can occur in susceptible
patients
- Particular care is needed for patients transferred from
systemic corticosteroids to ICS because deaths due to adrenal
insufficiency have occurred in patients during and after transfer.
Taper patients slowly from systemic corticosteroids if transferring
to BREZTRI
- Hypercorticism and adrenal suppression may occur with regular
or very high dosage in susceptible individuals. If such changes
occur, consider appropriate therapy
- Caution should be exercised when considering the
coadministration of BREZTRI with long-term ketoconazole and other
known strong CYP3A4 Inhibitors. Adverse effects related to
increased systemic exposure to budesonide may occur
- If paradoxical bronchospasm occurs, discontinue BREZTRI
immediately and institute alternative therapy
- Anaphylaxis and other hypersensitivity reactions (eg,
angioedema, urticaria or rash) have been reported. Discontinue and
consider alternative therapy
- Use caution in patients with cardiovascular disorders,
especially coronary insufficiency, as formoterol fumarate can
produce a clinically significant cardiovascular effect in some
patients as measured by increases in pulse rate, systolic or
diastolic blood pressure, and also cardiac arrhythmias, such as
supraventricular tachycardia and extrasystoles
- Decreases in bone mineral density have been observed with
long-term administration of ICS. Assess initially and periodically
thereafter in patients at high risk for decreased bone mineral
content
- Glaucoma and cataracts may occur with long-term use of ICS.
Worsening of narrow-angle glaucoma may occur, so use with caution.
Consider referral to an ophthalmologist in patients who develop
ocular symptoms or use BREZTRI long term. Instruct patients to
contact a healthcare provider immediately if symptoms occur
- Worsening of urinary retention may occur. Use with caution in
patients with prostatic hyperplasia or bladder-neck obstruction.
Instruct patients to contact a healthcare provider immediately if
symptoms occur
- Use caution in patients with convulsive disorders,
thyrotoxicosis, diabetes mellitus, and ketoacidosis or unusually
responsive to sympathomimetic amines
- Be alert to hypokalemia or hyperglycemia
- Most common adverse reactions in a 52-week trial (incidence ≥
2%) were upper respiratory tract infection (5.7%), pneumonia
(4.6%), back pain (3.1%), oral candidiasis (3.0%), influenza
(2.9%), muscle spasms (2.8%), urinary tract infection (2.7%), cough
(2.7%), sinusitis (2.6%), and diarrhea (2.1%). In a 24-week trial,
adverse reactions (incidence ≥ 2%) were dysphonia (3.3%) and muscle
spasms (3.3%)
- BREZTRI should be administered with extreme caution to patients
being treated with monoamine oxidase inhibitors and tricyclic
antidepressants, as these may potentiate the effect of formoterol
fumarate on the cardiovascular system
- BREZTRI should be administered with caution to patients being
treated with:
- Strong cytochrome P450 3A4 inhibitors (may cause systemic
corticosteroid effects)
- Adrenergic drugs (may potentiate effects of formoterol
fumarate)
- Xanthine derivatives, steroids, or non-potassium sparing
diuretics (may potentiate hypokalemia and/or ECG changes)
- Beta-blockers (may block bronchodilatory effects of
beta-agonists and produce severe bronchospasm)
- Anticholinergic-containing drugs (may interact additively).
Avoid use with BREZTRI
- Use BREZTRI with caution in patients with hepatic impairment,
as budesonide and formoterol fumarate systemic exposure may
increase. Patients with severe hepatic disease should be closely
monitored
INDICATION
BREZTRI AEROSPHERE is indicated for the maintenance treatment of
patients with chronic obstructive pulmonary disease (COPD).
LIMITATIONS OF USE
Not indicated for the relief of acute bronchospasm or for the
treatment of asthma.
Please see full BREZTRI Prescribing
Information, including Patient
Information.
You may report side effects related to AstraZeneca
products.
TEZSPIRE® (tezepelumab-ekko) Important Safety
Information
CONTRAINDICATIONS
Known hypersensitivity to tezepelumab-ekko or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions Hypersensitivity reactions
were observed in the clinical trials (eg, rash and allergic
conjunctivitis) following the administration of TEZSPIRE.
Postmarketing cases of anaphylaxis have been reported. These
reactions can occur within hours of administration, but in some
instances have a delayed onset (ie, days). In the event of a
hypersensitivity reaction, consider the benefits and risks for the
individual patient to determine whether to continue or discontinue
treatment with TEZSPIRE.
Acute Asthma Symptoms or Deteriorating Disease TEZSPIRE
should not be used to treat acute asthma symptoms, acute
exacerbations, acute bronchospasm, or status asthmaticus.
Abrupt Reduction of Corticosteroid Dosage Do not
discontinue systemic or inhaled corticosteroids abruptly upon
initiation of therapy with TEZSPIRE. Reductions in corticosteroid
dose, if appropriate, should be gradual and performed under the
direct supervision of a physician. Reduction in corticosteroid dose
may be associated with systemic withdrawal symptoms and/or unmask
conditions previously suppressed by systemic corticosteroid
therapy.
Parasitic (Helminth) Infection It is unknown if TEZSPIRE
will influence a patient’s response against helminth infections.
Treat patients with pre-existing helminth infections before
initiating therapy with TEZSPIRE. If patients become infected while
receiving TEZSPIRE and do not respond to anti-helminth treatment,
discontinue TEZSPIRE until infection resolves.
Live Attenuated Vaccines The concomitant use of TEZSPIRE
and live attenuated vaccines has not been evaluated. The use of
live attenuated vaccines should be avoided in patients receiving
TEZSPIRE.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥3%) are
pharyngitis, arthralgia, and back pain.
USE IN SPECIFIC POPULATIONS
There are no available data on TEZSPIRE use in pregnant women to
evaluate for any drug-associated risk of major birth defects,
miscarriage, or other adverse maternal or fetal outcomes. Placental
transfer of monoclonal antibodies such as tezepelumab-ekko is
greater during the third trimester of pregnancy; therefore,
potential effects on a fetus are likely to be greater during the
third trimester of pregnancy.
INDICATION
TEZSPIRE is indicated for the add-on maintenance treatment of
adult and pediatric patients aged 12 years and older with severe
asthma.
TEZSPIRE is not indicated for the relief of acute bronchospasm
or status asthmaticus.
Please see full Prescribing Information,
including Patient Information and Instructions
for Use.
You may report side effects related to AstraZeneca products
by clicking here.
FASENRA® (benralizumab) Important Safety Information
CONTRAINDICATIONS
Known hypersensitivity to benralizumab or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions Hypersensitivity reactions
(eg, anaphylaxis, angioedema, urticaria, rash) have occurred after
administration of FASENRA. These reactions generally occur within
hours of administration, but in some instances have a delayed onset
(ie, days). Discontinue in the event of a hypersensitivity
reaction.
Acute Asthma Symptoms or Deteriorating Disease FASENRA
should not be used to treat acute asthma symptoms, acute
exacerbations, or acute bronchospasm.
Reduction of Corticosteroid Dosage Do not discontinue
systemic or inhaled corticosteroids abruptly upon initiation of
therapy with FASENRA. Reductions in corticosteroid dose, if
appropriate, should be gradual and performed under the direct
supervision of a physician. Reduction in corticosteroid dose may be
associated with systemic withdrawal symptoms and/or unmask
conditions previously suppressed by systemic corticosteroid
therapy.
Parasitic (Helminth) Infection It is unknown if FASENRA
will influence a patient’s response against helminth infections.
Treat patients with pre-existing helminth infections before
initiating therapy with FASENRA. If patients become infected while
receiving FASENRA and do not respond to anti-helminth treatment,
discontinue FASENRA until infection resolves.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 5%) include
headache and pharyngitis. Injection site reactions (eg, pain,
erythema, pruritus, papule) occurred at a rate of 2.2% in patients
treated with FASENRA compared with 1.9% in patients treated with
placebo.
USE IN SPECIFIC POPULATIONS
A pregnancy exposure registry monitors pregnancy outcomes in
women exposed to FASENRA during pregnancy. To enroll call
1-877-311-8972 or visit
www.mothertobaby.org/fasenra.
The data on pregnancy exposure from the clinical trials are
insufficient to inform on drug-associated risk. Monoclonal
antibodies such as benralizumab are transported across the placenta
during the third trimester of pregnancy; therefore, potential
effects on a fetus are likely to be greater during the third
trimester of pregnancy.
INDICATION
FASENRA is indicated for the add-on maintenance treatment of
patients with severe asthma aged 12 years and older, and with an
eosinophilic phenotype.
- FASENRA is not indicated for treatment of other eosinophilic
conditions
- FASENRA is not indicated for the relief of acute bronchospasm
or status asthmaticus
Please see full Prescribing Information,
including Patient Information and Instructions
for Use.
You may report side effects related to AstraZeneca
products.
Notes
COPD COPD refers to a group of lung diseases, including
chronic bronchitis and emphysema, that cause airflow blockage and
breathing-related problems.8 It affects an estimated 391 million
people around the world and is the third leading cause of death
globally.3,9
EROS The EROS (Exacerbations and Real-World Outcomes)
study is a retrospective analysis of real-world outcomes in 2,409
COPD patients appearing in the MORE2 Registry® claims database in
the US to examine whether prompt initiation of BREZTRI following an
exacerbation lowers risk of future exacerbations compared to
delayed and very delayed initiation.1 In the study, qualifying
exacerbations included: one moderate exacerbation while on
maintenance treatment, the second of two moderate events without
any maintenance treatment, and severe events defined as COPD
hospitalizations.
EXACOS-CV US EXACOS-CV US (EXACerbations and their
OutcomeS – CardioVascular) is a retrospective cohort study of
355,978 patients 40 years and older who were diagnosed with COPD
between 1 January 2012 and 31 December 2019. The study used US
administrative claims data from the Healthcare Integrated Research
Database, managed by Carelon Research (formerly HealthCore), to
investigate a correlation between cardiovascular events and
moderate-to-severe COPD exacerbations.2
BREZTRI AEROSPHERE® BREZTRI AEROSPHERE
(budesonide/glycopyrronium/formoterol fumarate) is a
single-inhaler, fixed-dose triple-combination of formoterol
fumarate, a LABA, glycopyrronium bromide, a LAMA, with budesonide,
an ICS, and delivered in a pressurized metered-dose inhaler.
BREZTRI AEROSPHERE is approved to treat COPD in more than 50
countries worldwide including the US, EU, China and Japan, and is
currently being studied in Phase III trials for asthma.
TEZSPIRE® TEZSPIRE (tezepelumab) is being developed by
AstraZeneca in collaboration with Amgen as a first-in-class human
monoclonal antibody that inhibits the action of TSLP, a key
epithelial cytokine that sits at the top of multiple inflammatory
cascades and is critical in the initiation and persistence of
allergic, eosinophilic and other types of airway inflammation
associated with severe asthma, including airway
hyperresponsiveness.10,11 TEZSPIRE is approved in the US, EU, Japan
and other countries for the treatment of severe asthma.12-14
NAVIGATOR NAVIGATOR is a Phase III, randomized,
double-blinded, placebo-controlled trial to evaluate the efficacy
and safety of TEZSPIRE (210mg every four weeks) compared to placebo
added to SoC in adults and adolescents with severe, uncontrolled
asthma.15 Two post hoc analyses from the NAVIGATOR trial evaluated
the effect of TEZSPIRE on the annualized asthma exacerbation rate
(AAER) over 52 weeks with and without prior omalizumab, and changes
in total and domain SNOT-22 scores from baseline to week 52 in
patients with a history of nasal polyps.4,5
Amgen collaboration In 2020, Amgen and AstraZeneca
updated a 2012 collaboration agreement for TEZSPIRE. Both companies
will continue to share costs and profits equally after payment by
AstraZeneca of a mid single-digit inventor royalty to Amgen.
AstraZeneca continues to lead development and Amgen continues to
lead manufacturing. All aspects of the collaboration are under the
oversight of joint governing bodies. Under the amended agreement,
Amgen and AstraZeneca will jointly commercialize TEZSPIRE in North
America. Amgen will record product sales in the US, with AZ
recording its share of US profits as Collaboration Revenue. Outside
of the US, AstraZeneca will record product sales, with Amgen
recording profit share as Other/Collaboration revenue.
FASENRA® FASENRA (benralizumab) is a monoclonal antibody
that binds directly to IL-5 receptor alpha on eosinophils and
attracts natural killer cells to induce rapid and near-complete
depletion of eosinophils via apoptosis (programmed cell death).16
FASENRA is currently approved as an add-on maintenance treatment
for severe eosinophilic asthma in the US, EU, Japan and other
countries, and is approved for self-administration in the US, EU
and other countries.
FASENRA was developed by AstraZeneca and is in-licensed from
BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., Ltd.,
Japan.
AstraZeneca in Respiratory & Immunology Respiratory
& Immunology, part of AstraZeneca BioPharmaceuticals is a key
disease area and growth driver to the Company.
AstraZeneca is an established leader in respiratory care with a
50-year heritage and a growing portfolio of medicines in
immune-mediated diseases. The Company is committed to addressing
the vast unmet needs of these chronic, often debilitating, diseases
with a pipeline and portfolio of inhaled medicines, biologics and
new modalities aimed at previously unreachable biologic targets.
Our ambition is to deliver life-changing medicines that help
eliminate COPD as a leading cause of death, eliminate asthma
attacks and achieve clinical remission in immune-mediated
diseases.
AstraZeneca AstraZeneca is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialization of prescription medicines in
Oncology, Rare Diseases, and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca-us.com and follow the
Company on Twitter @AstraZenecaUS.
References
- Pollack, M, Tkacz, J, Schinkel, J. et al. Exacerbations and
real-world outcomes (EROS) among patients with COPD receiving
single inhaler triple therapy of
budesonide/glycopyrrolate/formoterol fumarate [Poster Discussion].
Presented at the American Thoracic Society International Conference
2023 (19-24 May)
- Daniels, K, Tave, A., Neikirk, A., et al. Incidence of acute
cardiovascular events following acute exacerbation of chronic
obstructive pulmonary disease in a large US claims database
[Thematic Poster Session]. Presented at the American Thoracic
Society International Conference 2023 (19-24 May).
- World Health Organization. The Top 10 Causes of Death.
Accessible at:
https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death
[last accessed May 2023]
- Menzies-Gow, A, Colice, G, Ambrose, C, et al. Efficacy of
tezepelumab in patients with severe, uncontrolled asthma by prior
omalizumab use: a post hoc analysis of the phase 3 NAVIGATOR study.
[Mini Symposium] Presented at the American Thoracic Society
International Conference 2023 (19-24 May)
- Spahn, J, Jacobs, J, Hoyte, F, et al. Tezepelumab efficacy by
SNOT-22 domain scores in patients with severe, uncontrolled asthma
and comorbid nasal polyps in the phase 3 NAVIGATOR study. [Poster
Discussion] Presented at the American Thoracic Society
International Conference 2023 (19-24 May)
- Le TT, et al. Real-World Evidence of Benralizumab in Patients
with Severe Eosinophilic Asthma and Nasal Polyps: Initial Results
of the RANS Study. [Poster discussion]. Presented at the American
Thoracic Society International Conference 2023, 23 May 2023,
14:15-16:15 EST
- Louis R, et al. Approaching clinical remission in severe
asthma: An analysis of patients with chronic rhinosinusitis with
nasal polyps (CRSwNP) treated with benralizumab across five
clinical trials. [Poster discussion]. Presented at the American
Thoracic Society International Conference 2023, 23 May 2023,
9:00-16:15 EST
- GOLD. Global Strategy for the Diagnosis, Management and
Prevention of COPD, Global Initiative for Chronic Obstructive Lung
Disease (GOLD) 2023. [Online]. Available at:
https://goldcopd.org/2023-gold-report-2/ [last accessed May
2023]
- Adeloye D, Song P, Zhu Y, et al. Global, regional, and national
prevalence of, and risk factors for, chronic obstructive pulmonary
disease (COPD) in 2019: a systematic review and modelling analysis.
Lancet Respir Med. (2022) Vol 10(5); 447-458
- Corren J, et al. Tezepelumab in adults with uncontrolled asthma
[supplementary appendix; updated April 18, 2019]. N Engl J Med.
2017;377:936-946.
- Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms,
Inflammatory Disorders, and Cancer. Front Immunol.
2018;9:1595.
- AstraZeneca plc. Tezspire (tezepelumab) approved in the US for
severe asthma. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2021/Tezspire-tezepelumab-approved-in-the-us-for-severe-asthma.html.
[Last accessed: May 2023].
- AstraZeneca plc. Tezspire approved in the EU for the treatment
of severe asthma. 2022. Available at:
https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/tezspire-approved-in-the-eu-for-the-treatment-of-severe-asthma.html.
[Last accessed: May 2023].
- AstraZeneca plc. Tezspire approved in Japan for the treatment
of severe asthma. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html.
[Last accessed: May 2023].
- Menzies-Gow A, et al. Tezepelumab in Adults and Adolescents
with Severe, Uncontrolled Asthma. N Engl J Med. 2021;384:
1800-1809. DOI: 10.1056/NEJMoa2034975.
- AstraZeneca. Fasenra Summary of Product Characteristics.
Available at:
https://www.ema.europa.eu/en/documents/product-information/fasenra-epar-product-information_en.pdf
[Last accessed: May 2023].
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