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
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