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
10 September
2018
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: 10 September 2018, London UK - LSE
announcement
GSK announces results of indirect treatment comparisons of Nucala
to benralizumab and reslizumab for severe eosinophilic
asthma
Nucala demonstrated greater reduction in exacerbations and improved
asthma control
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced results from an
indirect treatment comparison of the licensed doses of Nucala
(mepolizumab), versus benralizumab and reslizumab in patients with
severe eosinophilic asthma. The data, published today
in
The
Journal of Allergy and Clinical Immunology
(JACI),
showed that in
patients with similar blood eosinophil counts, mepolizumab
significantly reduced clinically significant exacerbations and
improved asthma control compared with both benralizumab and
reslizumab.
Dr William Busse, Professor of Medicine, Division of Allergy,
Pulmonary and Critical Care Medicine, Department at the University
of Wisconsin Medical School in Madison, Wisconsin, said: "This
analysis was undertaken to try to dissect an important clinical
question: how can the various anti-IL5 approaches be
evaluated? As a consequence, this study helps improve our
understanding of the relative efficacy of the three available
anti-IL5 pathway directed treatments for patients with severe
eosinophilic asthma when grouped by patients' blood eosinophil
counts, which are known to influence treatment effect. Only
licensed doses used in clinical practice were included and patients
were matched according to blood eosinophil counts and asthma
control scores. This approach ensured a robust comparison, which
will help inform doctors when making clinical decisions about
treating their patients."
Results from the primary data analysis demonstrated that patients
treated with Nucala experienced a reduction in clinically
significant exacerbations compared to both benralizumab and
reslizumab across all eosinophil levels in the adjusted analysis.
Reduction of exacerbations is important because this sudden
worsening results in greater
difficulty breathing, which in the worst
cases can be life-threatening and lungs can suffer long-term
damage
:
- Mepolizumab reduced
clinically significant exacerbations by 34%-45
%
versus benralizumab across subgroups
(≥400cells/µL- 45%, ≥300cells/µL-39%,
≥150cells/µL-34%, p<0.05)
- Mepolizumab reduced
clinically significant exacerbations by 45
%
versus reslizumab in the
≥400cells/µL subgroup (p<0.007)
Mepolizumab also demonstrated significantly greater improvements in
asthma control as assessed by the Asthma Control Questionnaire
(ACQ) score, compared with reslizumab and benralizumab in the
adjusted analysis by baseline blood eosinophils. There were no
significant differences between mepolizumab and benralizumab
or reslizumab in lung function measured by change from
baseline in pre-bronchodilator forced expiratory volume in 1
second (FEV
1
)
or on reducing exacerbations requiring emergency room visits and/or
hospitalisation.
Severe eosinophilic asthma is a clinically recognised
phenotype of severe asthma characterised by recurrent
exacerbations, poor disease control and eosinophilic inflammation.
Eosinophil proliferation, maturation, and activation are controlled
by the cytokine interleukin 5 (IL-5). Three anti-IL5
pathway-directed therapies have been developed and approved for use
in patients with severe eosinophilic asthma. Mepolizumab and
reslizumab are monoclonal antibodies that target IL5, and the
monoclonal antibody benralizumab binds to the IL5
receptor.
Study design and primary endpoint results
This indirect treatment comparison used data from 11 separate
studies identified through a Cochrane review process of anti-IL5
pathway directed therapies and additional literature searches.
Eligible studies were randomised, controlled trials in
patients aged ≥12 years with severe eosinophilic asthma that
met predefined selection criteria (see publication for more
details).
The comparison employed robust methodology, following ISPOR
guidelines, to account for differences in trial populations.
The analysis was limited to only the licensed presentation and
doses of each anti-IL5 pathway-directed treatment, with the aim of
evaluating the clinical effects of the three treatments available
in clinical practice. Furthermore, the comparisons were carried out
on patient populations grouped by baseline blood eosinophil count,
which is known to influence treatment effect, and matched according
to baseline ACQ score to allow like-for-like comparisons between
treatments.
Endpoints included annualised rate of clinically significant
exacerbations, change from baseline in ACQ score and
FEV
1
.
An indirect treatment comparison (ITC) was performed in all
patients with ACQ ≥1.5 and stratified by baseline blood
eosinophil counts. Mepolizumab 100mg SC was compared
to:
- Reslizumab
3mg/kg for eosinophilic subgroup ≥400 cells/lL
- Benralizumab
30 mg for eosinophilic subgroups ≥150, ≥300, ≥400
cells/lL
(Note that only data from patients with ≥450
cells/lL were available from benralizumab studies and used in
the ≥400 cells/lL comparison.)
Mepolizumab reduced clinically significant exacerbations by 34%-45%
versus benralizumab across subgroups (rate ratio[RR] [95%CI]:
≥400 cells/µL: 0.55[0.35,0.87]; ≥300
cells/µL: 0.61[0.37,0.99]; ≥150 cells/µL:
0.66[0.49,0.89]; all p<0.05) and by 45% versus reslizumab in the
≥400 cells/lL subgroup (RR[95%CI]:
0.55[0.36,0.85], p=0.007). Asthma control was significantly
improved with mepolizumab versus benralizumab (all subgroups:
p<0.05), and versus reslizumab in the ≥400 cells/lL
subgroup (p=0.004). Benralizumab significantly improved lung
function versus reslizumab in the ≥400 cells/lL subgroup
(p=0.025).
About severe asthma and eosinophilic inflammation
Severe asthma is defined as asthma which requires treatment with
high dose inhaled corticosteroids (ICS) plus a second controller
(and/or systemic corticosteroids) to prevent it from becoming
'uncontrolled' or which remains 'uncontrolled' despite this
therapy. Severe asthma patients are also often categorised by
long-term use of oral corticosteroids (OCS). 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.
Interleukin-5 (IL-5) is the main promoter of eosinophil growth,
activation and survival and provides an essential signal for the
movement of eosinophils from the bone marrow into the lung. Studies
suggest that approximately 60% of patients with severe asthma have
eosinophilic airway inflammation.
For more information please see GSK's
infographic
about severe asthma and role of eosinophils
.
About Nucala (mepolizumab)
First approved in 2015 for severe eosinophilic asthma, mepolizumab
is the first-in-class monoclonal antibody that targets IL-5. It is
believed to work by preventing IL-5 from binding to its receptor on
the surface of eosinophils. Inhibiting IL-5 binding in this way
reduces blood eosinophils.
Mepolizumab has been developed for the treatment of diseases that
are driven by inflammation caused by eosinophils. It has been
studied in over 3,000 patients in 16 clinical trials across a
number of eosinophilic indications and has been approved (under the
brand name Nucala) in the US, Europe and in over 20 other markets,
as an add-on maintenance treatment for patients with severe
eosinophilic asthma and is the leading biologic in this indication.
It is also the only anti IL-5 biologic therapy approved for
paediatric use from aged six to 17 in Europe in severe eosinophilic
asthma. In the US, Japan and Canada, it is approved as add-on
maintenance treatment for patients with eosinophilic granulomatosis
with polyangiitis (EGPA). Mepolizumab is currently being
investigated for severe hypereosinophilic syndrome, nasal polyposis
and COPD.
GSK's commitment to respiratory disease
GSK has led the way in developing innovative medicines to advance
the management of asthma and COPD for nearly 50 years. Over the
last five years we have launched six innovative medicines
responding to continued unmet patient need, despite existing
therapies. This is an industry leading portfolio in breadth, depth
and innovation, developed to reach the right patients, with the
right treatment.
Important safety information for Nucala (mepolizumab)
The following Important Safety Information is based on a summary of
the European Summary of Product Characteristics and Prescribing
Information for Nucala. For the full EU Summary of Product
Characteristics for Nucala, please visit:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003860/human_med_001933.jsp&mid=WC0b01ac058001d124
.
Nucala is contraindicated in patients with hypersensitivity to
mepolizumab or to any of the excipients.
Nucala should not be used to treat acute asthma
exacerbations.
Asthma-related adverse events or exacerbations may occur during
treatment. Patients should be instructed to seek medical advice if
their asthma remains uncontrolled or worsens after initiation of
treatment.
Abrupt discontinuation of corticosteroids after initiation of
Nucala therapy is not recommended. Reduction in corticosteroid
doses, if required, should be gradual and performed under the
supervision of a physician.
Acute and delayed systemic reactions, including hypersensitivity
reactions (e.g. anaphylaxis, urticaria, angioedema, rash,
bronchospasm, hypotension), have occurred following administration
of Nucala. These reactions generally occur within hours of
administration, but in some instances have a delayed onset (i.e.,
typically within several days). These reactions may occur for the
first time after a long duration of treatment.
Herpes zoster has occurred in subjects receiving Nucala in
controlled clinical trials. Consider vaccination if medically
appropriate.
Eosinophils may be involved in the immunological response to some
helminth infections. Patients with pre-existing helminth infections
should be treated for the helminth infection before starting
therapy with Nucala. If patients become infected whilst receiving
treatment with Nucala and do not respond to anti-helminth
treatment, temporary discontinuation of therapy should be
considered.
In clinical studies in subjects with severe refractory eosinophilic
asthma, the most commonly reported adverse reactions during
treatment were headache, injection site reactions and back
pain. Headache was considered very common, occurring with a
frequency of ≥1/10. Common adverse drug reactions
(≥1/100 to <1/10) included: lower respiratory tract
infection, urinary tract infection, pharyngitis, hypersensitivity
reactions (systemic, allergic), nasal congestion, upper abdominal
pain, eczema, back pain, administration-related reaction (systemic,
non-allergic), local injection site reactions, and
pyrexia.
Injection site reactions (e.g., pain, erythema, swelling, itching,
and burning sensation) occurred at a rate of 8% in subjects treated
with Nucala compared with 3% in subjects treated with
placebo.
GSK
-
a science-led global healthcare company with a special purpose: to
help people do more, feel better, live longer. For further
information please visit www.gsk.com
Trademarks are owned by or licensed to the GSK group of
companies.
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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 Principal risks and
uncertainties in the company's Annual Report on Form 20-F for
2017.
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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: September
10, 2018
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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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