LONDON, March 6, 2017 /PRNewswire/ -- GlaxoSmithKline plc
(LSE/NYSE:GSK) today announced data demonstrating that severe
asthma patients, whose disease is driven by eosinophilic
inflammation, treated with first-in-class biologic
Nucala® (mepolizumab) added-on to standard of
care, achieved clinically and statistically significant
improvements in their health-related quality of life and lung
function, when compared to patients treated with placebo and
standard of care. These results are from the phase IIIb MUSCA study
(NCT02281318, 200862), which successfully met all its primary and
secondary endpoints.
Results of the study, presented at the American Academy of
Allergy, Asthma & Immunology (AAAAI) Annual Meeting, showed in
patients treated with mepolizumab as an add on to standard
care:
- St. Georges Respiratory Questionnaire (SGRQ) score (primary
endpoint), a measure of quality of life, improved by 7.7 units from
baseline vs. placebo (p=0.001) after 24 weeks – nearly double the
defined clinically meaningful difference of ≥4.0 units.
- Lung function (first secondary endpoint), as measured by
pre-bronchodilator FEV1, increased by 120mL (p=0.001)
more than in placebo patients at week 24 – a clinically relevant
and statistically significant improvement.
- FEV1 and SGRQ scores were also measured during the
study, with improvements seen at the first measurement interval,
after the first four weeks and sustained throughout the 24-week
trial.
- Asthma control, as measured by the Asthma Control
Questionnaire-5 (ACQ-5) (additional secondary endpoint), showed a
significant improvement vs. placebo in the mepolizumab treatment
group by 0.40 units (p<0.001).
SGRQ score is an important patient-reported outcome measure used
to understand how severe asthma affects a patient's quality of
life. It looks at symptoms, activity levels and the impact asthma
is having on people with the disease from a physiological and
social perspective. MUSCA is the first mepolizumab clinical trial
to specifically look at health-related quality of life as a primary
endpoint and assess SGRQ score on multiple occasions throughout the
study. FEV1 is a measure of how much air a person can
forcefully blow out of their lungs and is used to assess how a
patient's breathing is improving. In the clinical development
program, mepolizumab did not provide consistent improvements in
mean change from baseline in FEV1.
Dr Frank Albers, Medical Affairs
Lead for Nucala, GSK said: "The data from the MUSCA study
underscore the importance of Nucala as a treatment option for
patients with severe asthma with an eosinophilic phenotype. These
are patients who have very limited treatment options to control
their asthma. For them shortness of breath, wheezing, coughing and
the risk of an asthma attack is an ever present occurrence and one
that can have a severe impact their life on a daily basis. By
demonstrating improvements in a range of important markers of
asthma control, including quality of life and lung function, these
data reinforce the valuable role Nucala can play in the treatment
of some of the most severe asthma patients."
Exploratory endpoints were the annual rate of exacerbations
(asthma attacks), which was reduced by 58%, and the number of
exacerbations requiring emergency room visits or hospitalisation,
which was reduced by 68% for people treated with mepolizumab
compared with placebo. These results were comparable to those seen
in the pivotal phase III MENSA study. Safety was also assessed and
the safety profile of mepolizumab in the MUSCA study was consistent
with the product label for Nucala.
About the MUSCA study (200862) – Poster no. L17 and
L18
The MUSCA study (Mepolizumab adjUnctive
therapy in subjects with Severe eosinophiliC Asthma)
involved 551 patients treated with Nucala 100mg subcutaneous
injection, every 4 weeks for a 24 week period. The MUSCA study is
the first clinical trial designed primarily to assess the effect of
mepolizumab on disease-specific health-related quality of life
using the St George's Respiratory Questionnaire (SGRQ) in
patients with severe asthma with an eosinophilic phenotype. Using a
series of questions that patients complete themselves, the SGRQ
looks at how a patient's asthma symptoms impact on everyday
activities, such as walking, housework, going to the shops,
gardening or light exercise, and whether their severe asthma
prevents them from doing activities they might otherwise expect to
do.
For more information about the MUSCA study design please see
MUSCA infographic.
About severe asthma with an eosinophilic phenotype
Severe asthma is a chronic condition that affects a small, but
significant, number of patients who need to take multiple
medications to control their day-to-day symptoms and reduce the
risk of frequent and serious asthma attacks. It is estimated that 5
- 10% of all asthma patients have severe asthma. In a sub-set of
severe asthma patients, the over-production of eosinophils (a type
of white blood cell) is known to cause inflammation in the lungs
that can affect the airways, making breathing difficult and
increasing the frequency of asthma attacks. People who have severe
asthma with an eosinophilic phenotype are some of the most
difficult asthma patients to treat.
For more information on the role of eosinophils in severe asthma
please see GSK's infographic.
About Nucala
Nucala is the first-in-class anti-IL-5
biologic therapy. Nucala was specifically developed to treat
appropriate severe asthma patients whose condition is driven by
inflammation caused by eosinophils. Nucala binds to the signalling
protein IL-5, preventing it from binding to its receptor on the
surface of eosinophils. Inhibiting IL-5 binding in this way reduces
blood, tissue and sputum eosinophil levels. The mechanism of
mepolizumab action in asthma has not been definitively
established.
In the US, Nucala (100mg fixed dose subcutaneous injection of
mepolizumab) is licensed as an add-on maintenance treatment for
patients with severe asthma aged 12 years and older, and with an
eosinophilic phenotype. Nucala is not approved for the treatment of
other eosinophilic conditions or relief of acute bronchospasm or
status asthmaticus. Full US Prescribing Information is available
at US Prescribing Information Nucala.
In the EU, Nucala (100mg fixed dose subcutaneous injection of
mepolizumab) is licensed as an add-on treatment for severe
refractory eosinophilic asthma in adult patients. For the EU
Summary of Product Characteristics for Nucala, please visit:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003860/WC500198037.pdf
Nucala has also been approved in Canada, Australia, Japan, Switzerland, Chile, South
Korea and Taiwan. Further
regulatory applications have been submitted and are under review in
other countries.
Nucala® is a registered trade mark of the GSK
group of companies.
Important Safety Information for Nucala
Please
consult the full Prescribing Information for all the labelled
safety information for Nucala.
CONTRAINDICATIONS
Nucala should not be administered to patients with a history of
hypersensitivity to mepolizumab or excipients in the
formulation.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions
(e.g. anaphylaxis, angioedema, bronchospasm, hypotension,
urticaria, rash) have occurred following administration of Nucala.
These reactions generally occur within hours of administration but
in some instances can have a delayed onset (i.e. days). In the
event of a hypersensitivity reaction, Nucala should be
discontinued.
Acute Asthma Symptoms or Deteriorating
Disease
Nucala should not be
used to treat acute asthma symptoms, acute exacerbations, or acute
bronchospasm.
Opportunistic Infections: Herpes Zoster
In controlled
clinical trials, 2 serious adverse reactions of herpes zoster
occurred in subjects treated with Nucala compared to none in
placebo. Consider varicella vaccination if medically appropriate
prior to starting therapy with Nucala.
Reduction of Corticosteroid Dosage
Do not discontinue
systemic or inhaled corticosteroids (ICS) abruptly upon initiation
of therapy with Nucala. Decreases in corticosteroid doses, if
appropriate, should be gradual and 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
Nucala will influence a patient's response against parasites. Treat
patients with pre-existing helminth infections before initiating
therapy with Nucala. If patients become infected while receiving
treatment with Nucala and do not respond to anti-helminth
treatment, discontinue treatment with Nucala until infection
resolves.
ADVERSE REACTIONS
The most common adverse reactions (≥3% and more common than
placebo) reported in the first 24 weeks of two clinical trials with
Nucala (and placebo) were: headache, 19% (18%); injection site
reaction, 8% (3%); back pain, 5% (4%); fatigue, 5% (4%); influenza,
3% (2%); urinary tract infection 3% (2%); abdominal pain upper, 3%
(2%); pruritus, 3% (2%); eczema, 3% (<1%); and muscle spasm, 3%
(<1%).
Systemic Reactions, including Hypersensitivity Reactions:
In 3 clinical trials, 3% of subjects who received Nucala
experienced systemic (allergic and nonallergic) reactions compared
to 5% in the placebo group. Systemic allergic/hypersensitivity
reactions were reported by 1% of subjects who received Nucala
compared to 2% of subjects in the placebo group. Manifestations
included rash, pruritus, headache, and myalgia. Systemic
nonallergic reactions were reported by 2% of subjects who received
Nucala and 3% of subjects in the placebo group. Manifestations
included rash, flushing, and myalgia. A majority of the systemic
reactions were experienced on the day of dosing.
Injection site reactions (e.g. pain, erythema, swelling,
itching, burning sensation) occurred at a rate of 8% in subjects
treated with Nucala compared with 3% in subjects treated with
placebo.
INFORMATION FOR US AUDIENCES ONLY - USE IN SPECIFIC
POPULATIONS
A pregnancy exposure registry monitors pregnancy outcomes in
women exposed to Nucala during pregnancy. Healthcare providers can
enrol patients or encourage patients to enrol themselves by calling
1-877-311-8972 or visiting www.mothertobaby.org/asthma.
The data on pregnancy exposures from the clinical trials are
insufficient to inform on drug-associated risk. Monoclonal
antibodies, such as mepolizumab, are progressively transported
across the placenta in a linear fashion as pregnancy progresses;
therefore, potential effects on a foetus are likely to be greater
during the second and third trimesters of pregnancy.
GSK – one of the world's leading research-based
pharmaceutical and healthcare companies – is committed to improving
the quality of human life by enabling people to do more, feel
better and live longer. For further information please visit
www.gsk.com.
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Cautionary statement regarding forward-looking
statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
'Risk factors' in the company's Annual Report on Form 20-F for
2015.
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SOURCE GSK