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Title: National Institute for Clinical Excellence Recommends Protopic (Tacrolimus) as Treatment for Moderate to Severe Atopic Eczema

"National Institute for Clinical Excellence Recommends Protopic (Tacrolimus) as Treatment for Moderate to Severe Atopic Eczema"

MUNICH, GERMANY -- August 26, 2004 -- In its final Guidance issued, the National Institute for Clinical Excellence (NICE) in the UK recommends tacrolimus ointment (Protopic®) as a second-line treatment of moderate to severe atopic dermatitis (AD [eczema]) in both adults and children aged 2 years and older. Treatment with Protopic® can be continued until complete clearance of the lesions and there are no restrictions on the total body surface area that can be treated with Protopic®1,2. AD affects 10-20% of children worldwide3 and topical corticosteroids form the mainstay of treatment. However, eczema control frequently cannot be achieved with conventional therapy4. The NICE Guidance recommends the use of Protopic® in patients where the eczema has not been controlled by topical corticosteroids, where there is a serious risk of adverse effects from further topical corticosteroid use, particularly irreversible skin atrophy. Protopic® has also recently received a change of licence in Europe and can now be prescribed by any physician who has experience of treating AD. This includes not only dermatologists, but also paediatricians and general practitioners (GPs). The change of licence was granted by the European Medicines Agency (EMEA) in response to the extensive safety data gathered following the use of Protopic® in over one million patients. Dr Stephen Kownacki from the Primary Care Dermatology Society in the UK said: "Most patients with atopic eczema are managed by their GP and the NICE recommendations support the important role that steroid-free therapies, such as Protopic, are now playing in the management of AD in primary care." The concurrent recommendation for Pimecrolimus (Elidel®) by NICE, limits its use to second-line treatment of moderate atopic eczema that has not been controlled by topical corticosteroids, where there is a serious risk of adverse effects from further topical corticosteroid use, particularly irreversible skin atrophy.. Furthermore, it specifies that Pimecrolimus is to be used only in children aged 2 to 16 years and only on the face and neck area. NICE have recommended that Pimecrolimus should not be used at all in adults or in mild and severe cases. Protopic® is proven to be more effective than a mild corticosteroid therapy in children5 and at least as effective as a potent corticosteroid1, 6, in adults. Protopic® offers adequate potency for disease control in moderate to severe patients failing on conventional therapy with no evidence of compromising patient safety. · Protopic® 0.03% is indicated for the treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies. Protopic® 0.1% and 0.03% ointment are indicated in the treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies. References: 1. Protopic® 0.1% Ointment Summary of Product Characteristics 2. Protopic® 0.03% Ointment Summary of Product Characteristics 3. DYM Leung, "Atopic dermatitis", The Lancet, 2003; 361: 151-160 4. Furue, M et al. British Journal of Dermatology 2003, 148: 128-133 5. Reitamo S et al. Arch Dermatol 2002; 109: 539-546 6. Reitamo S et al. J Allergy Clin Immunol, 2002; 109: 547-555 SOURCE: ACUMED

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