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2019-05-20

AstraZeneca: New data show Symbicort reduces attacks in mild asthma when used as an anti-inflammatory reliever

Trial reflecting real-world practice showed a reduction in the rate of
asthma attacks compared to the most commonly used reliever therapy

New data from Novel START, an open-label trial designed to reflect
real-world practice, has demonstrated the effectiveness of Symbicort
Turbuhaler (budesonide/formoterol) as a potential anti-inflammatory
reliever in mild asthma.1

These results are published in the New England Journal of Medicine and
are being presented at the American Thoracic Society 2019
International Conference.1

The trial compared Symbicort Turbuhaler with two commonly used
treatment regimens in mild asthma. In real-world practice, patients
typically use a short-acting beta2-agonist (SABA) reliever in
response to symptoms or daily low-dose inhaled corticosteroid (ICS)
maintenance therapy with a SABA reliever. In this trial, patients
with mild asthma were randomised to receive either albuterol (a SABA
reliever) taken as-needed, or budesonide (an ICS maintenance
treatment) plus albuterol as-needed, or Symbicort Turbuhaler used as
an anti-inflammatory reliever therapy taken as-needed.1

Symbicort Turbuhaler demonstrated a 51% reduction in the rate of
annual asthma exacerbations compared to albuterol. There was no
difference in the exacerbation rate between Symbicort Turbuhaler and
twice-daily maintenance budesonide plus albuterol, despite a 52%
reduction in the mean steroid dose with Symbicort Turbuhaler.1 These
data support the findings of the SYGMA 1 and 2 trials published in
May 2018.2,3

Alex de Giorgio-Miller, Therapy Area Vice President, Respiratory,
Global Medical Affairs, said: "There are an estimated 176 million
asthma attacks globally each year and all asthma patients, regardless
of their disease severity, are at risk of severe attacks. The Novel
START trial demonstrates the effectiveness of Symbicort as an
anti-inflammatory reliever to reduce the risk of asthma attacks in
patients with mild disease, compared with the most commonly used
asthma reliever. In a trial that reflects real-world practice, these
data reinforce evidence from the SYGMA trials and build on the
established clinical profile of Symbicort in moderate-to-severe
disease."

Professor Richard Beasley, Director of the Medical Research Institute
of New Zealand said: "Asthma attacks are a major burden in mild
disease. SABA relievers do not address the underlying inflammation in
asthma, and patients with mild disease who rely on SABA alone are at
greater risk of asthma attacks than those taking an anti-inflammatory
therapy. Novel START showed that Symbicort used as an
anti-inflammatory reliever was superior to as-needed SABA for the
prevention of asthma attacks in mild disease."

Novel START was conducted by the Medical Research Institute of New
Zealand and was funded by a research grant from AstraZeneca and core
institutional funding from the Health Research Council of New
Zealand.

Safety and tolerability data for Symbicort Turbuhaler as-needed were
consistent with the known profile of the medicine. The most commonly
reported adverse events in the Novel START trial were upper
respiratory tract infection, nasopharyngitis and asthma.1

Symbicort Turbuhaler is approved as a maintenance and reliever therapy
in many countries for moderate-to-severe asthma, and as an
anti-inflammatory reliever as-needed in patients with mild asthma in
Brazil and Russia. A regulatory submission to expand the indication
for Symbicort Turbuhaler as an anti-inflammatory reliever in mild
asthma has been accepted in Europe. In the US, Symbicort is approved
for use in a pressurised metered-dose inhaler device, but not the
Turbuhaler device.

About Novel START

Novel START (Novel Symbicort Turbuhaler Asthma Reliever Therapy) is
Externally Sponsored Scientific Research (ESR). The primary objective
of the trial was to assess the efficacy of Symbicort Turbuhaler given
as an anti-inflammatory reliever as-needed in adults with mild
asthma.

The 52-week pragmatic trial supports the findings of the double-blind,
double-dummy SYGMA trials (also published in the New England Journal
of Medicine), but in an open-label treatment regimen reflecting
real-world practice in 668 patients aged 18-75 years in Australia,
Italy, New Zealand and the UK with a self-reported doctor-diagnosis
of asthma. Patients were enrolled if they had used a SABA inhaler as
sole asthma therapy in the previous 3 months and required use of SABA
on ?2 occasions in the previous 4 weeks (but on average ?2 occasions
per day in the previous 4 weeks). In the trial, Symbicort Turbuhaler
as-needed (200/6 µg; n=220) was compared to SABA treatment with
albuterol (known as salbutamol in many countries) as-needed (100 ?g;
n=223), and maintenance ICS therapy with budesonide twice-daily plus
albuterol as-needed (200 µg and 100 ?g, respectively; n=225). These
comparators reflect two of the treatment options most commonly used
in clinical practice for the management of mild asthma.

The results of the primary outcome measurements are:

· Symbicort Turbuhaler demonstrated a 51% reduction in the rate of
annual asthma exacerbations versus SABA treatment with albuterol
as-needed (absolute rate 0.195 vs 0.400 per patient per year,
respectively; relative rate 0.49 (95% CI 0.33 to 0.72), P<0.001).

· There was no difference in the exacerbation rate between Symbicort
Turbuhaler as-needed and maintenance budesonide plus as-needed
albuterol (absolute rate 0.195 and 0.175 per patient per year,
respectively; relative rate 1.12 (95% CI 0.70 to 1.79), P=0.65). (The
mean budesonide dose with Symbicort Turbuhaler as-needed and
maintenance budesonide was 107 µg/day and 222 µg/day, respectively.)

About asthma

Asthma is a common chronic respiratory disease, and it affects the
health and day-to-day lives of as many as 339 million adults and
children worldwide.4 It is characterised by recurrent breathlessness
and wheezing which varies over time, and which varies in severity and
frequency from person to person.5

All asthma patients are at risk of severe attacks, regardless of their
disease severity, adherence to treatment or level of control.6,7,8
There are an estimated 176 million asthma attacks globally per year;9
these attacks are physically threatening and emotionally significant
for many patients.10 However, despite the fact that asthma is a
chronic, variable inflammatory disease, patients are either
under-prescribed or under-use their anti-inflammatory `preventer'
therapy and over-rely on their SABA reliever, which can mask symptom
worsening.11,12,13,14 Taking a SABA inhaler alone during or after a
worsening of symptoms does not address the underlying inflammation,
leaving patients at risk of asthma attack and potential exposure to
frequent bursts of oral corticosteroids.15

About Symbicort

Symbicort is a combination formulation containing budesonide, an
inhaled corticosteroid (ICS) that treats underlying inflammation, and
formoterol, a long-acting beta2-agonist bronchodilator (LABA) with a
fast onset of action, in a single inhaler. Symbicort is approved as a
treatment regimen for patients with moderate to severe disease.
Symbicort was launched in 2000 and is approved in approximately 120
countries to treat asthma and/or COPD either as Symbicort Turbuhaler
or Symbicort pMDI (pressurised metered-dose inhaler).

About AstraZeneca in respiratory diseases

Respiratory is one of AstraZeneca's main therapy areas, and our
medicines reached more than 18 million patients as maintenance
therapy in 2018. AstraZeneca's aim is to transform asthma and COPD
treatment through inhaled combinations at the core of care, biologics
for the unmet needs of specific patient populations, and scientific
advancements in disease modification.

The Company is building on a 40-year heritage in respiratory disease
and AstraZeneca's capability in inhalation technology spans
pressurised metered-dose inhalers and dry powder inhalers, as well as
the Aerosphere delivery technology. The company also has a growing
portfolio of respiratory biologics including Fasenra
(anti-eosinophil, anti-IL-5R?), now approved for severe, eosinophilic
asthma and in development for severe nasal polyposis and other
potential indications, and tezepelumab (anti-TSLP), which has been
granted Breakthrough Therapy Designation by the US Food and Drug
Administration in patients with severe asthma and is in Phase III
trials. AstraZeneca's research aims at addressing underlying disease
drivers by focusing on the lung epithelium, lung immunity, lung
regeneration and neuronal functions.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal & Metabolism
and Respiratory. AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide. For
more information, please visit astrazeneca.com
(http://www.astrazeneca.com/) and follow us on Twitter @AstraZeneca
(https://twitter.com/AstraZeneca).

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References

1. Beasley RW, Holliday M, Reddel HK, et al. Controlled trial of as-needed budesonide/formoterol in mild adult asthma. N Engl J Med. 2019 [In Press].

2. O'Byrne PM, FitzGerald JM, Bateman ED, et al. Inhaled combined budesonide-formoterol as needed in mild asthma. N Engl J Med. 2018; 378: 1865-76.

3. Bateman ED, Reddel HK, O'Byrne PM, et al. As-needed budesonide-formoterol versus...

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