TAPLOW, England, January 8 /PRNewswire/ --

- Benefits of Biologic Therapy Now Available for Children With Severe Psoriasis

Wyeth Pharmaceuticals has today announced that Enbrel(R) (etanercept) is approved for the treatment of chronic severe plaque psoriasis in children aged 8 years and above, making it the only biologic treatment approved for use in children.1 Etanercept has been shown to significantly reduce the symptoms of psoriasis in these children.2 As many of the therapies for severe psoriasis are not licensed for children or adolescents,2,3 this approval is a step forward in the treatment of paediatric patients with this highly impactful, debilitating disease.4

Psoriasis is one of the most debilitating skin conditions and its impact on children's lives can be similar to that of asthma and epilepsy.4,5 It often leads to children being alienated, bullied, lacking in self-confidence and having poor self-esteem. This is particularly apparent as children get older and become conscious of their appearance.4,5 It can also have a long term negative psychological effect extending into adulthood.6 Despite this significant psychological burden, access to clinical psychology services for children and adults with this condition is still limited in the UK.7

Managing paediatric psoriasis is a great clinical challenge as many therapies are not licensed for children or adolescents or have limited use due to their low tolerability and adverse reactions, said Dr Ruth Murphy, Consultant Dermatologist, Queen's Medical Centre, Nottingham. Today's announcement is good news not only for children affected by severe psoriasis, but also for their parents and carers. It will give them confidence that their children are receiving an effective treatment which is well tolerated and has been specifically investigated in children.

Children and adolescents who have been treated with etanercept experienced significant improvements in their signs and symptoms of psoriasis, which had a positive impact on their quality of life. According to physician's assessment, over half the children taking etanercept were clear or almost clear of visible symptoms i.e. redness, thickness and scaliness of the lesions caused by plaque psoriasis.2

The psychological impact of psoriasis should not be underestimated. Children with psoriasis may find it has a profound impact on their day to day lives. said Gladys Edwards, Chief Executive of The Psoriasis Association. Having psoriasis may prevent them not only going to the pool or to the beach but may influence their career and personal choices. It is therefore crucial that the symptoms of psoriasis are effectively managed from childhood to adulthood.

Enbrel has been used to treat adults with moderate to severe psoriasis since receiving its licence in 2004. It has an established efficacy profile and is generally well-tolerated.8

More information about psoriasis in children and how to cope with the disease can be found by visiting the Psoriasis Association website or calling +44(0)845-676-0076.

Notes for Editors

About Enbrel in children and adolescents

Enbrel licence in chronic severe plaque psoriasis in children aged 8 years and above is based on results from a Phase III study, the first trial of a biologic treatment in children aged 17 and under.4 Results from the 48 week study showed that patients treated with Enbrel experienced a significant improvement of their psoriasis compared with those treated with placebo.

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. 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.

Enbrel is already licensed for use in children with juvenile idiopathic arthritis.1

Psoriasis Area and Severity Index (PASI) is a measure of the average redness, thickness and scaliness of the lesions (each graded on a 0-4 scale), which is weighted by the extent of plaque coverage on the head, trunk, and upper and lower extremities. The PASI ranges from 0 to 72, with higher scores indicating more severe disease.

References 1. Enbrel DRAFT Summary of Product Characteristics (SPC), December 2008. SPC reflects that adopted by the CHMP in November 2008; the corresponding Commission Decision may not have been adopted on the date of distribution of this document. 2. Paller AS et al. Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med 2008;358:241-51 3. Burden AD. Management of psoriasis in childhood, Clinical and Experimental Dermatology, 24, 341-345 4. Beattie PE, Lewis-Jones MS. A comparative study of impairment of quality of life in children with skin disease and children with other chronic childhood diseases. Br J Dermatol 2006;155(1):145-151 5. Lewis-Jones MS, Finlay AY. The Children's Dermatology Life Quality Intex (CDLQI): initial validation and practical use, B J Dermatol 1995; 132:942-949 6. Richards HL et al. Stigmatization and psoriasis. British Journal of Dermatology 2003;149:193-227 7. British Association of Dermatologists. BAD Audit, 2008 8. Van de Kerkhof PCM et al. Once weekly administration of etanercept 50 mg is efficacious and well tolerated in patients with moderate-to-severe plaque psoriasis: a randomised controlled trial with open-label extension. Br J Dermatol 2008;159(5):1177-85

For further information, or interviews, please contact: Emily Day Wyeth Pharmaceuticals Tel: +44(0)1628-414748 Email: daye@wyeth.com

For further information, or interviews, please contact:, Emily Day, Wyeth Pharmaceuticals, Tel: +44(0)1628-414748, Email: daye@wyeth.com