Form 6-K GLAXOSMITHKLINE PLC For: Nov 16
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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 16 November 2016
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:
Wednesday 16 November 2016, London UK - LSE
announcement
GSK announces new data from phase III studies of sirukumab in adult
patients with moderately to severely active rheumatoid
arthritis
GlaxoSmithKline
plc (LSE/NYSE: GSK) today announced results from two pivotal phase
III studies evaluating subcutaneous sirukumab, a human
anti-interleukin (IL)-6 monoclonal antibody in development for the
treatment of adults with moderately to severely active rheumatoid
arthritis (RA).
The
first study (SIRROUND-T), in patients who were refractory to or
intolerant to one or more anti-tumor necrosis factor (TNF) agents,
demonstrated that sirukumab met the primary endpoint showing
significant improvement in the signs and symptoms of moderately to
severely active RA compared to placebo. The second study
(SIRROUND-H), a head-to-head study in patients who were refractory
to or intolerant to methotrexate (MTX), demonstrated that sirukumab
monotherapy met the first of two co-primary endpoints showing
significant improvement in disease activity compared to adalimumab
monotherapy.
The
full results are being presented for the first time during oral
sessions at the Annual Meeting of the American College of
Rheumatology/Association for Rheumatology Health Professionals
Meeting (ACR/ARHP 2016).
Sirukumab
is being co-developed as part of a collaboration with Janssen
Biologics (Ireland) [Janssen].
The
SIRROUND-T study investigated sirukumab in adult patients with
moderately to severely active RA who were refractory to or
intolerant to one or more anti-TNF agents, which are often the
first biological agents prescribed when a patient has failed
treatment with a disease-modifying anti-rheumatic drug (DMARD).
Approximately 40 percent of patients had prior exposure to both
anti-TNF therapy and biologic therapy other than anti-TNFs, and 19
percent of patients were receiving sirukumab as monotherapy. Key
results reported (Abstract 3223):
-
A significantly higher proportion of sirukumab treated patients (40
percent with 50mg every four weeks and 45 percent with 100mg every
two weeks) achieved at least a 20 percent improvement in signs and
symptoms (ACR20) at week 16, the study's primary endpoint, compared
with placebo (24 percent);
P ≤
0.001.
-
Statistically significant improvements for all major secondary
endpoints for sirukumab treated patients compared with placebo.
These were the change from baseline in the health assessment
questionnaire disability index (HAQ-DI), percentage of patients
achieving at least a 50 percent improvement in signs and symptoms
(ACR50) and percentage of patients with improved disease activity
score in 28 joints (DAS28 remission) at week 24; P ≤ 0.001
for all measures. These improvements were seen as early as week 4
and maintained with sirukumab therapy through week 52.
-
Statistically significant improvements were also observed for
sirukumab treated patients compared to placebo for other patient
reported outcomes including the physical and mental components of
the SF-36, a patient reported survey of health status from baseline
at week 24; P < 0.01.
The
SIRROUND-H study compared sirukumab monotherapy with adalimumab
monotherapy, an approved anti-TNF agent, in adult patients with
moderately to severely active RA who were refractory to, or were
intolerant to or inappropriate for MTX, a type of DMARD. Key
results reported
(Abstract
3222):
-
Significantly greater improvements in disease activity, as assessed
by DAS28, in sirukumab treated patients (mean change from baseline
of -2.58 with 50mg, -2.96 with 100mg) at week 24, the first of two
co-primary endpoints of the study, compared to adalimumab treated
patients (-2.19 with 40mg every 2 weeks); P = 0.013 and P <
0.001, respectively.
-
Clinically relevant improvements in signs and symptoms of disease,
as assessed by ACR50, the second of two co-primary endpoints, at
week 24 for all treatment groups, although differences were not
statistically significant between sirukumab 50mg, sirukumab 100mg
and adalimumab 40mg (27 percent, 35 percent and 32 percent,
respectively; P > 0.05).
-
A clinically relevant proportion of patients in all three treatment
groups attained both major secondary endpoints of DAS28 remission
(13 percent with sirukumab 50mg, 20 percent with sirukumab 100mg, 8
percent with adalimumab 40mg) and ACR20 response at week
24
(54 percent with
sirukumab 50mg, 59 percent with sirukumab 100mg, 57 percent with
adalimumab; P > 0.05).
Paul-Peter
Tak, GSK's Chief Immunology Officer & Senior Vice President,
R&D Pipeline, said: "Patients suffering with rheumatoid
arthritis need access to a range of treatment options during
different stages of their long-term disease. The results presented
today show that both doses of sirukumab tested, including a 50mg
subcutaneous dose taken every four weeks, reduced the signs and
symptoms and disease activity in difficult-to-treat patients who
had failed both conventional and biologic therapy."
In the
SIRROUND-T study, through week 24 of the study (the placebo
controlled phase), the incidence of patients reporting adverse
events (AEs) was 66 percent, 71 percent and 62 percent for
sirukumab 50mg, sirukumab 100mg and placebo, respectively. The
incidence of patients reporting serious AEs was 10 percent, 8
percent and 5 percent for sirukumab 50mg, sirukumab 100mg and
placebo, respectively. Most common AEs (incidence >5% in any
treatment group) were injection-site erythema, ALT increased,
nasopharyngitis, injection-sire pruritus, upper respiratory
infection, rheumatoid arthritis, and injection-site reaction. No
deaths were reported through week 24. Through week 52 (not
placebo-controlled), the incidences of AEs was 80 percent and 81
percent for sirukumab 50mg and sirukumab 100mg, respectively. The
incidence of patients reporting serious AEs were 14 percent and 13
percent, for sirukumab 50mg and sirukumab 100mg, respectively.
There were five deaths reported through week 52 (two in the
sirukumab 50mg group and three in the sirukumab 100mg
group).
In the
SIRROUND-H study, through week 24 of the study, the incidence of
patients reporting AEs was 57 percent, 64 percent and 55 percent
for sirukumab 50mg, sirukumab 100mg and adalimumab, respectively.
The incidence of patients reporting serious AEs was 7 percent, 3
percent and 4 percent with sirukumab 50mg, sirukumab 100mg and
adalimumab, respectively. There were no deaths reported through
week 24. The rate of reported infections was 20 percent, 24 percent
and 19 percent for sirukumab 50mg, sirukumab 100mg and adalimumab,
respectively. The rate of serious infections was 3 percent, 0
percent and 1 percent for sirukumab 50mg, sirukumab 100mg and
adalimumab, respectively. The reported incidence of injection-site
reactions was dose-related for sirukumab with
21
percent and 11 percent for sirukumab 100mg and sirukumab 50mg,
respectively and 8 percent for adalimumab. No injection-site
reactions were considered serious. Most common AEs for sirukumab
(incidence >5% in any treatment group) were injection site
erythema, ALT increased, AST increased, injection site pruritus,
and neutropenia; the only AE that occurred at an incidence >5%
for adalimumab was injection site erythema.
Additional
abstracts reporting patient-reported outcomes (PRO) and other
clinical efficacy and safety data from the SIRROUND-D and
SIRROUND-T studies will be presented
at the meeting and/or published in the ACR program
book.
About SIRROUND-T and SIRROUND-H study designs
SIRROUND-T
is a phase III randomised, double-blind, placebo-controlled study
in 878 adult patients with moderately to severely active RA who
were intolerant or refractory to anti-TNF therapy. The primary
objective was to assess the safety and efficacy of sirukumab as
measured by the reduction of the signs and symptoms of RA. Patients
were randomised to receive sirukumab 50mg every 4 weeks or
sirukumab 100mg every 2 weeks or placebo every 2 weeks. Patients
with less than 20 percent improvement from baseline in both swollen
and tender joint counts at weeks 18, or those still on placebo at
week 24, were re-randomised to receive sirukumab 50mg every 4 weeks
or 100mg every 2 weeks through week 52.
SIRROUND-H
is a phase III randomised, double-blind, parallel-group study in
559 biologic-naive adult patients with moderately to severely
active RA who were intolerant to MTX, considered inappropriate for
MTX treatment for safety reasons or were inadequate responders to
MTX. The primary objective was to evaluate the safety and efficacy
of sirukumab monotherapy compared with adalimumab monotherapy as
measured by the reduction in disease activity and signs and
symptoms of RA. Patients were randomised to receive sirukumab 50mg
every 4 weeks or sirukumab 100mg every 2 weeks or adalimumab 40mg
every 2 weeks as monotherapy.
About the phase III programme in rheumatoid arthritis
The
phase III clinical programme in patients with active RA includes
five studies investigating sirukumab 50mg and 100mg administered
subcutaneously in combination with conventional DMARDs or as a
monotherapy every four or two weeks, respectively. The
comprehensive development program involves more than 3,000
patients.
-
SIRROUND-D study: in patients who had an inadequate response to
disease-modifying antirheumatic drugs (DMARDs).
-
SIRROUND-T study: in patients who had an inadequate response or
were intolerant to anti-TNFa agents
-
SIRROUND-H study: in patients with an inadequate response or who
were intolerant to methotrexate (MTX) or for whom MTX was
inappropriate.
-
SIRROUND-M study: in Japanese patients who had an inadequate
response to MTX or sulfasalazine.
-
SIRROUND-LTE study: a long-term extension study for patients
completing SIRROUND-D and SIRROUND-T.
Top-line
results of SIRROUND-D, SIRROUND-T and SIRROUND-H were announced
in
December
2015 and primary results from the SIRROUND-D study were announced
in June 2016.
About Sirukumab
Sirukumab
is a human monoclonal IgG1 kappa antibody that targets the cytokine
IL-6, a naturally occurring protein that is believed to play a role
in autoimmune conditions like RA. It is not approved as a treatment
for RA or any other indication anywhere in the world.
In
December 2011, Janssen and GSK entered into a licensing and
co-development agreement with respect to sirukumab. Under the
terms, Janssen retains commercialization rights in territories
outside of the Americas including Europe and Asia Pacific, while
GSK has exclusive rights to commercialize sirukumab in North,
Central and South America. The agreement gives both companies
the option to investigate sirukumab for other indications beyond
RA. Sirukumab is currently being evaluated by health authorities in
the U.S., EU and Japan as a subcutaneous therapy for the treatment
of certain adult patients with moderately to severely active
RA.
About Rheumatoid Arthritis
Rheumatoid
arthritis is a chronic, systemic inflammatory condition that is
characterized by pain, joint swelling, stiffness, joint destruction
and disability. It is estimated that more than 23.5 million
people worldwide are affected by the condition, for which there is
no cure.[i]
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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GSK enquiries:
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UK
Media enquiries:
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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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Namrata
Taak
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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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Mary
Anne Rhyne
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+1 919
483 0492
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(North
Carolina)
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Jenni
Ligday
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+1 202
715 1049
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(Washington,
DC)
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Analyst/Investor
enquiries:
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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
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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Registered in England & Wales:
No. 3888792
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Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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[i] Centers for Disease Control and Prevention.
"Rheumatoid Arthritis (RA)," Available at: http://www.cdc.gov/arthritis/basics/rheumatoid.htm.
Accessed August 16, 2016.
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.
GlaxoSmithKline plc
(Registrant)
Date: November
16, 2016
By: VICTORIA
WHYTE
----------------------
Victoria Whyte
Authorised
Signatory for and on
behalf
of GlaxoSmithKline plc
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