Data Presented at International Psoriasis Meeting Support Potential New Role for Biologic Treatment Etanercept in Management of Childhood Psoriasis
MADRID, March 17/PRNewswire/ -- Data presented today from the
first ever Phase III study using a biological treatment in children
and adolescents with plaque psoriasis indicate that etanercept
(Enbrel(R)) significantly reduces the symptoms in these patient
groups.(1) Over half the patients (57 per cent) treated with
etanercept for 12 weeks achieved the 'gold standard' in improvement
compared to eleven per cent of patients who received
placebo.(1)
Key trial investigator Professor Alice B. Gottlieb, Chair of
Dermatology and Dermatologist-in-Chief, Tufts Medical Center,
Boston, MA, USA presented the study results to an audience of over
350 specialists in Madrid at the 'Progress and Promise Summit -
Managing for Optimal Outcomes with Biologics'. Commenting on the
results she said, "Current approved therapeutic interventions for
children with plaque psoriasis are limited and there is a general
lack of paediatric studies in this area. These results are
therefore significant because they indicate that biological
treatments such as etanercept can provide effective treatment for
this debilitating condition. Psoriasis is not a rare disease in the
paediatric population and we need effective medicines to control
the condition."
5.1 million people have psoriasis across the EU, a distressing
chronic inflammatory disease.(2) Approximately 80 per cent of these
patients have plaque psoriasis, which is characterised by painful
and itchy, red, scaly patches.(3) One third of these cases begins
in childhood, and can start as young as infancy.(4) Psoriasis is
frequently physically and psychologically disabling and in adults
is also associated with an increased risk of obesity, type 2
diabetes, liver disease(5) and clinical depression.(6)
Key Findings
During the 48-week study, the standard Psoriasis Area and
Severity Index (PASI 75), was used to evaluate the efficacy of
ENBREL in patients between 4 and 17 years old. The primary efficacy
endpoint was PASI 75 at week 12. There were 106 patients initially
randomised to receive ENBREL and 105 patients randomised to receive
placebo.
- At week 12, 57% (n=60) of paediatric patients treated with
ENBREL achieved PASI 75, compared with 11% (n=12) of paediatric
patients who received placebo (p<0.001).
- At week 36, after 24 weeks of open-label treatment during
which all patients in the study received ENBREL, PASI 75 was
achieved by 68% of the patients initially treated with ENBREL from
the start of the study and 65% of those who initially received
placebo from the start of the study.
- At the conclusion of the open-label treatment period (week
36), 138 patients were re-randomised to receive either ENBREL or
placebo. During this period, patients who lost PASI 75 were
re-treated and no patient had a rebound of psoriasis or a change in
the type of their psoriasis. In addition, the ENBREL response rates
were similar during re-treatment compared to the initial
double-blind period.
There were no serious adverse events or serious infections
during the 12-week placebo-controlled period and rates of adverse
events were similar for ENBREL and placebo. During open-label
treatment, three patients developed four serious adverse events,
one of which (pneumonia) was deemed by investigators to be related
to ENBREL. No deaths, cancers, opportunistic infections,
tuberculosis or demyelination events were reported. The most common
adverse events observed during the 48-week trial in patients
treated with ENBREL were upper respiratory tract infection,
headache, and nasopharyngitis.
Data from this study were first published earlier this year in
The New England Journal of Medicine. For full study details, please
access The New England Journal of Medicine online:
http://content.nejm.org/
Notes to Editors
About Enbrel(7)
Enbrel is a fully human soluble tumour necrosis factor (TNF)
receptor antagonist. Enbrel was first approved in 1998 for moderate
to severe rheumatoid arthritis and has since been used in nearly
500,000 patients worldwide across indications.
Enbrel is NOT currently indicated for the treatment of psoriasis
in children of adolescents. An application for use of Enbrel in
managing psoriasis in children and adolescents has been submitted
by Wyeth to the European Medicines Authority and is under
review.
Enbrel in the EU is approved for the following
indications:
Rheumatoid arthritis
Enbrel in combination with methotrexate is indicated for the
treatment of moderate to severe active rheumatoid arthritis in
adults when the response to disease-modifying antirheumatic drugs,
including methotrexate (unless contraindicated), has been
inadequate.
Enbrel can be given as monotherapy in case of intolerance to
methotrexate or when continued treatment with methotrexate is
inappropriate.
Enbrel is also indicated in the treatment of severe, active and
progressive rheumatoid arthritis in adults not previously treated
with methotrexate.
Enbrel, alone or in combination with methotrexate, has been
shown to reduce the rate of progression of joint damage as measured
by X-ray and to improve physical function.
Polyarticular juvenile idiopathic arthritis
Treatment of active polyarticular juvenile idiopathic arthritis
in children and adolescents aged 4 to 17 years who have had an
inadequate response to, or who have proved intolerant of,
methotrexate. Enbrel has not been studied in children aged less
than 4 years.
Psoriatic arthritis
Treatment of active and progressive psoriatic arthritis in
adults when the response to previous disease-modifying
antirheumatic drug therapy has been inadequate. Enbrel has been
shown to improve physical function in patients with psoriatic
arthritis, and to reduce the rate of progression of peripheral
joint damage as measured by X-ray in patients with polyarticular
symmetrical subtypes of the disease.
Ankylosing spondylitis
Treatment of adults with severe active ankylosing spondylitis
who have had an inadequate response to conventional
therapy.
Plaque psoriasis
Treatment of adults with moderate to severe plaque psoriasis who
failed to respond to, or who have a contraindication to, or are
intolerant to other systemic therapy including cyclosporine,
methotrexate or PUVA
Study Details:
This study was designed to assess the safety and efficacy of
ENBREL therapy in children and adolescents between 4 and 17 years
old with moderate to severe plaque psoriasis whose disease had been
inadequately controlled with topical therapy or who received
systemic therapy or phototherapy. In this 48-week study, 211
paediatric psoriasis patients were initially randomised to receive
12 once-weekly weight-based doses of ENBREL (0.8 mg/kg up to 50 mg)
or placebo. After this double-blind portion, 208 patients entered a
24-week period of open-label ENBREL treatment once-weekly. At week
36, 138 patients were re-randomised to receive either ENBREL or
placebo, to investigate withdrawal and re-treatment.
About Wyeth:
Wyeth is one of the world's largest research-based
pharmaceutical and health care products companies. It is a leader
in the discovery, development, manufacturing, and marketing of
prescription drugs and over-the-counter medications. It is also a
global leader in vaccines, biotechnology and animal health
care.
(1) Paller, AS et al. Etanercept treatment for children and
adolescents with plaque psoriasis. N Engl J Med
2008;358:241-51
(2) Christophers, E. Psoriasis - Epidemiology and Clinical
Spectrum. Clin Exp Dermatol 2001;26:314-320
(3) Gottlieb, A. Psoriasis: Emerging Therapeutic Strategies,
Nature Reviews volume 4, January 2005
(4) National Psoriasis Foundation. Medical facts about psoriasis
in childhood. 2007. Available at:
http://www.psoriasis.org/about/youth/parents/medicalfacts.php.
(Accessed January 2008)
(5) Mrowietz, U et al. The importance of disease associations
and concomitant therapy for the long-term management of psoriasis
patients Arch Dermatol Res 2006 Dec;298(7):309-19
(6) Rapp SR, Feldman SR, Exum ML et al. Psoriasis causes as much
disability as other major medical diseases. J Am Acad Dermatol
1999; 41:401-7
(7) Enbrel EMEA SPC
Source: Wyeth Pharmaceuticals Limited
For further information please contact: Wyeth: Gill Markham,
Communications - Europe, Middle East and Africa, Direct Tel:
+44-1628-692536, Email: markhagl@wyeth.com. OgilvyHealthPR: Karen
Crum, Direct Tel: +44-207-108-6411, Email: karen.crum@ohpr.com;
Jodi Lewis, Direct Tel: +44-207-108-6086, Email:
jodi.lewis@ohpr.com.
Posted: March 2008
