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Optimal practice review: recommendation reminders detail

Recommendation reminder 1: Topical tacrolimus and pimecrolimus are not recommended for the treatment of mild atopic eczema or as first-line treatments for atopic eczema of any severity.

Guidance:Atopic dermatitis (eczema) - pimecrolimus and tacrolimus
Date issued:August 2004

Atopic eczema (also known as atopic dermatitis) is a chronic relapsing skin condition characterised by intense itching, dry skin, redness and inflammation. Estimates of prevalence vary but suggest that the condition may affect as many as 15-20% of school-age children and 2-10% of adults. Most people with atopic eczema experience mild disease; only around 2-4% of people with eczema have a severe form of the disease. Sixty per cent of eczema cases occur before the age of one; by adulthood, many patients will have grown out of the condition although may retain a propensity for eczema later in life. The incidence of eczema has been increasing in recent years.

The impact of atopic eczema on quality of life can be considerable, and varies according to disease severity. In addition to the burden imposed by daily treatment, the condition can affect everyday activities such as work or school and social relationships. Furthermore, people with atopic eczema may also experience anxiety, depression and other psychological problems. Sleep disturbance is common, especially during flare-ups, which in turn can lead to problems with irritability and lack of concentration. Severe atopic eczema in children can also have a significant impact on family life, with parents/carers having to cope with the demands associated with caring for a child with a chronic illness.

Management of atopic eczema takes place predominantly in primary care, and aims to relieve symptoms and prevent complications such as infections until remission occurs. Providing people with good-quality information is essential to successfully managing and treating atopic eczema. Referral to secondary care is advised only if the condition is severe and has not responded to appropriate therapy. Topical corticosteroids are the first-line treatment for flare-ups of atopic eczema. In order to reduce exposure to topical corticosteroids, they are used only intermittently to control exacerbations.

Tacrolimus and pimecrolimus are immunosuppressant drugs licensed only for atopic dermatitis; however, compared to tacrolimus, the use of pimecrolimus is recommended, within its licensed indications, only for moderate eczema in children between 2 and 16 years of age and to the face and neck.

Topical corticosteroids provide effective first-line management of atopic eczema. Because of the higher cost of tacrolimus and pimecrolimus and their potential unknown long-term adverse effects, particularly the possibility that they might increase the risk of skin malignancy, neither of these products should be used as first-line treatments -that is, they should not be used before other treatments have been tried. Concern about adverse effects associated with long-term use of topical corticosteroids, particularly the risk of skin atrophy, causes significant anxiety in people with atopic eczema. However, this anxiety should not be an indication for treatment with topical immunomodulators, but should be addressed through effective patient information and education.

Mild eczema

Taking into account the evidence on the cost and effectiveness of topical immunomodulators, and the views of the clinical experts, the NICE advisory committee agreed that tacrolimus and pimecrolimus should not be used to treat mild atopic eczema.

Moderate or severe eczema

When atopic eczema is moderate or severe, tacrolimus and pimecrolimus should not be used as 'first-line' treatments. However, they may be considered in the circumstances below:

  • Tacrolimus may be considered to treat moderate or severe atopic eczema for adults or children aged 2 years or older if the maximum strength and potency of topical corticosteroid that is appropriate for the patient's age and the area being treated has been adequately tried and has not worked, where there is serious risk of important side effects from further use of topical corticosteroids (particularly permanent damage to the skin).
  • Pimecrolimus may be considered to treat moderate atopic eczema on the face and neck for children aged between 2 and 16 years if the maximum strength and potency of topical corticosteroid that is appropriate for the patient's age and the area being treated has been adequately tried and has not worked, where there is serious risk of important side effects from further use of topical corticosteroids (particularly permanent damage to the skin).

Finally, because of the uncertainties around the long-term effects of this class of drug, the committee agreed that it would be appropriate to recommend that they be initiated only by physicians (including general practitioners) with a special interest and experience in dermatology, and only after careful discussion with the patient of the potential risks and benefits of all appropriate second-line treatment options.

More evidence is needed

More information on the comparative effectiveness and safety of tacrolimus and pimecrolimus will support more efficient use of resources across the NHS in the future:

  • High-quality RCTs comparing tacrolimus and pimecrolimus compared with appropriate potencies of topical corticosteroids should be undertaken in children and adults with atopic eczema.
  • Head-to-head studies of tacrolimus and pimecrolimus should be conducted to enable further direct comparisons of efficacy to be made.
  • Careful and long-term surveillance for adverse effects of tacrolimus and pimecrolimus, including skin and other types of malignancy, is needed to assess the safety profile of these drugs.

This page was last updated: 18 October 2007

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.