TIDMGSK
RNS Number : 8589F
GlaxoSmithKline PLC
22 May 2017
Issued: Monday 22 May, 2017, London UK - LSE Announcement
GSK presents data at ATS on treatment effect of Nucala
(mepolizumab) in severe asthma according to blood eosinophil
level
GlaxoSmithKline plc (LSE/NYSE:GSK) today presented data from a
post-hoc analysis of the phase IIIb MUSCA study in which
first-in-class biologic Nucala (mepolizumab) consistently improved
health-related quality of life and lung function in patients with
severe asthma across blood eosinophil levels of 150 cells/uL and
above. The data also showed an association between increasing lung
function improvement and increasing eosinophil levels.
The analysis presented at the American Thoracic Society (ATS)
conference, Washington DC, US, looked at treatment response at week
24 in patients treated with mepolizumab compared to placebo, both
added to standard of care (high dose inhaled corticosteroids plus
at least one additional controller). The data showed that for
patients in the mepolizumab arm:
-- Quality of life, as measured by St. George's Respiratory
Questionnaire (SGRQ) score, improved by 7.8 units (95% CI: -11.0,
-4.7), 8.2 units (95% CI: -12.2, -4.2) and 7.7 units (95% CI:
-13.3, -2.1) versus placebo in patients with blood eosinophils of
>=150, >=300 and >=500 cells/mL respectively -
improvements were approximately double the defined clinically
meaningful difference of 4.0 units at each of the three blood
eosinophil thresholds
-- Lung function, as measured by pre-bronchodilator FEV(1) ,
increased by 137mL (95% CI: 56, 218), 165mL (95% CI: 64, 265) and
206mL (95% CI: 77, 335) versus placebo in patients with blood
eosinophils of >=150, >=300 and >=500 cells/mL
respectively - all improvements were clinically relevant.
The MUSCA study is the first study designed to primarily assess
the effect of mepolizumab on disease-specific health-related
quality of life. Lung function was the first secondary endpoint.
The post-hoc analysis also examined exacerbation rate and asthma
control by eosinophil threshold, both of which improved in
mepolizumab-treated patients in line with findings from previous
studies. In addition to providing further data on these endpoints,
the findings of the post-hoc analysis reinforce prior studies
demonstrating the utility of a blood eosinophil threshold of
>=150 cells/uL for the identification of patients with severe
asthma and frequent exacerbations, despite high-dose ICS plus other
controller(s), likely to benefit from treatment with
mepolizumab.
Dr Frank Albers, Global Medical Affairs Lead for Nucala, GSK
said: "Eosinophil levels in the blood are used to help identify
severe asthma patients who may be appropriate for treatment with
Nucala. This post-hoc analysis of the MUSCA study shows that Nucala
has the potential to offer meaningful improvements in important
clinical endpoints, as well as patient-reported outcomes, in severe
asthma patients with blood eosinophil levels of 150 cells/mL and
above. It provides additional useful information for clinicians as
they make important treatment choices for their severe asthma
patients with an eosinophilic phenotype."
SGRQ score is an important patient-reported outcome measure used
to understand how severe asthma affects a patient's quality of
life. Using a series of questions that a patient completes
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. FEV(1) 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
programme, mepolizumab did not provide consistent improvements in
mean change from baseline in FEV(1) .
About the MUSCA post-hoc analysis - Poster no. P1002 (A3185)
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) as a primary endpoint in patients with severe
asthma with an eosinophilic phenotype.
This post-hoc analysis specifically looked at changes to quality
of life (measured by SGRQ score) and lung function (measured by
FEV(1) ), as well as asthma control (measured by ACQ-5 score) and
annualised rate of exacerbations in patients stratified by baseline
eosinophil level (<150, >=150, >=300, or >=500
cells/mL) who were treated with mepolizumab added to standard of
care, when compared to patients treated with placebo and standard
of care (high dose inhaled corticosteroids plus at least one
additional controller).
The post-hoc analysis did not specifically assess safety.
However, safety was assessed in the MUSCA study and the safety
profile of mepolizumab was consistent with the product label for
Nucala.
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 to treat asthma patients.
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.
Trade marks are owned by or licensed to the GSK group of
companies.
Important Safety Information for Nucala
The following information is based on the US Prescribing
Information for Nucala. Please consult the full Prescribing
Information for all the labelled safety information for Nucala.
Nucala should not be administered to patients with a history of
hypersensitivity to mepolizumab or excipients in the
formulation.
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.
Nucala should not be used to treat acute asthma symptoms, acute
exacerbations, or acute bronchospasm.
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.
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.
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.
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.
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.
GSK enquiries:
UK Media enquiries: David Mawdsley +44 (0) 20 (London)
8047 5502
Simon Steel +44 (0) 20 (London)
8047 5502
David Daley +44 (0) 20 (London)
8047 5502
Anna Gibbins +44 (0) 20 (London)
8047 5502
US Media enquiries: Sarah Alspach +1 202 715 (Washington,
1048 DC)
Sarah Spencer +1 215 751 (Philadelphia)
3335
Karen Hagens +1 919 483 (North
2863 Carolina)
Analyst/Investor Sarah Elton-Farr +44 (0) 20 (London)
enquiries: 8047 5194
Tom Curry + 1 215 751 (Philadelphia)
5419
Gary Davies +44 (0) 20 (London)
8047 5503
James Dodwell +44 (0) 20 (London)
8047 2406
Jeff McLaughlin +1 215 751 (Philadelphia)
7002
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 'Principal risks
and uncertainties' in the company's Annual Report
on Form 20-F for 2016.
Registered in England & Wales:
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Registered Office:
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Brentford, Middlesex
TW8 9GS
This information is provided by RNS
The company news service from the London Stock Exchange
END
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