New Study Shows Biologic Therapy Enbrel(R) (etanercept) Effective in Treating Psoriasis in Children and Adolescents
17/01/2008 01:02
PR Newswire
MAIDENHEAD, England, January 17 /PRNewswire/ -- Wyeth (WYE) today announced data from a Phase 3 study which showed that
Enbrel significantly reduces the symptoms and signs of plaque psoriasis in
children and adolescents with the disease.(1) This study was published in
the January 17, 2008, issue of The New England Journal of Medicine.
The trial - the first time any biological treatment has been tested in
children and adolescents with plaque psoriasis - showed 57% of patients on
etanercept for 12 weeks achieved the 'gold-standard' in improvement compared
to 11% of patients who received the placebo.(1) 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.
5.1 million people have psoriasis across EU, a distressing chronic
inflammatory disease.(2) Approximately 80 percent of these patients have
plaque psoriasis, which is characterized 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).
"Biologics have dramatically improved how we manage adult psoriasis.
Adult patients have benefited from treatment with Enbrel for many years and
it is proven to be effective at managing this debilitating disease" said
Professor Alberto Giannetti, M.D, Department of Dermatology, University of
Modena and Reggio Emilia, Italy.
"The news of this study in children and adolescents is greatly welcomed -
currently approved treatments are limited and many are suffering through the
lack of effective therapies."
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 randomized to receive ENBREL and 105 patients
randomized to receive placebo.
- At week 12, 57% (n equals 60) of pediatric patients treated with ENBREL
achieved PASI 75, compared with 11% (n equals 12) of pediatric patients who
received placebo (p less than or equal to 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%
(n equals 71) of the patients initially treated with ENBREL from the start of
the study and 65% (n equals 67) 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-randomized 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.
Commenting on the study, Professor Alberto Giannetti noted: "Enbrel has
been used for over 9 years and has an abundance of clinical efficacy and
safety data - it is already approved for use in juvenile arthritis. The NEJM
data adds to the vast weight of clinical evidence and shows it is an
effective therapy option for the children and adolescents with plaque
psoriasis. I hope to see it approved for use in this patient population
across Europe in the near future".
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 tumor necrosis factor (TNF) receptor.
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.
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 pediatric psoriasis patients were initially
randomized 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-randomized 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)
(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
For further information, please contact: Wyeth: Gill Markham, Communications - Europe, Middle East and Africa, Direct tel: +44(0)1628-692536, Email: markhagl@wyeth.com,; OgilvyHealthPR: Karen Crum, Direct Tel: +44(0)207-108-6411, Email: karen.crum@ohpr.com; Jodi Lewis, Direct Tel: +44(0)207-108-6086, Email: jodi.lewis@ohpr.com