FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
period ending 22 May
2017
GlaxoSmithKline plc
(Name
of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or
will
file annual reports under cover Form 20-F or Form 40-F
Form
20-F x Form 40-F
--
Indicate
by check mark whether the registrant by furnishing the
information
contained in this Form is also thereby furnishing the
information
to the Commission pursuant to Rule 12g3-2(b) under the
Securities
Exchange Act of 1934.
Yes
No x
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/µL 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/ L 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
FEV1,
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/ L 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/µL 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/ L
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. 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 programme, mepolizumab did not provide
consistent improvements in mean change from baseline in
FEV1.
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
FEV1),
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/
L) 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:
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UK
Media enquiries:
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David
Mawdsley
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+44 (0)
20 8047 5502
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(London)
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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David
Daley
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+44 (0)
20 8047 5502
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(London)
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Anna
Gibbins
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+44 (0)
20 8047 5502
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(London)
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US
Media enquiries:
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Sarah
Alspach
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+1 202
715 1048
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(Washington,
DC)
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Sarah
Spencer
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+1 215
751 3335
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(Philadelphia)
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Karen
Hagens
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+1 919
483 2863
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(North
Carolina)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
20 8047 5194
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(London)
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Tom
Curry
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+ 1 215
751 5419
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(Philadelphia)
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Gary
Davies
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+44 (0)
20 8047 5503
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Cautionary statement regarding forward-looking statementsGSK
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.
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Registered in England & Wales:
No. 3888792
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Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: May
22, 2017
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By: VICTORIA
WHYTE--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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