Corticosteroid therapy in the treatment of pediatric patients with atopic dermatitis.

Health political background: In developed countries 2.5% of the population - mainly children - are affected by atopic dermatitis. During the past few years its prevalence amongst school children has risen decisively and now lies between 8% to 16%. It is the most frequent chronic skin disease amongst school-aged children.

Scientific background: Current methods of treating atopic dermatitis among children focus on containing and preventing the illness's further progression. Preventing dry skin, relieving symptoms (such as pruritis and inflammation of the skin) and identifying and avoiding provocating factors are elementary goals of treatment. Successful treatment can substantially increase the children's quality of life. Possible therapies of children affected by atopic dermatitis include both topically and systemically applied pharmaceuticals. During the past ten years the use of corticosteroids has been the standard topical anti-inflammatory therapy in case of aggravating inflammations. In 2002 a new group of pharmaceutical substances (topical calcineurin inhibitors tacrolimus and pimecrolimus) was authorised in Germany for topical anti-inflammatory treatment of patients. Because of its high prevalence atopic dermatitis represents a major expense factor to the German health care system. In 1999 the costs of the treatment of atopic dermatitis with corticosteroids in Germany amounted to 230 million Euro. If other direct costs for the treatment are included, for example hospitalisation or doctor appointments, the total costs amount to 3.57 billion Euro.

Research question: How effective and efficient are topical anti-inflammatory treatments of children with atopic dermatitis?

Methods: A systematic literature search was performed in 35 international databases which yielded 1335 articles. Following a two-part selection process according to predefined criteria 24 publications were included in the assessment.

Results: Of 19 randomised controlled clinical trials, which were included in the assessment, only two evaluated the effect of topical corticosteroids in comparison to tacrolimus, which is one of the calcineurin inhibitors. Both studies show that tacrolimus is more effective than hydrocortisone acetate in children with moderate to severe atopic dermatitis. No study was found that directly compares corticosteroids with pimecrolimus in the treatment of paediatric patients with atopic dermatitis. However, two trials show that an intermittent treatment with pimecrolimus can reduce the need for topical corticosteroids. Two publications focusing on the costs of atopic dermatitis, provide model calculations comparing the use of topical corticosteroids and calcineurin inhibitors. The calculations show that the treatment with topical corticosteroids is inferior to the treatment with pimecrolimus in children with mild to moderate atopic dermatitis. Furthermore the treatment with tacrolimus appears to be more expensive however also more effective in comparison to topical corticosteroids.

Discussion: During the past five decades topical corticosteroids have represented the first choice therapy when it comes to atopic dermatitis. Their effectiveness has been proven by several studies. Amongst newer generations of topical corticosteroids the occurrence of adverse side effects seems to be less frequent. Due to the fact that they have only recently been authorised experience with tacrolimus and pimecrolimus is limited. So far the only adverse side effect of the calcineurin inhibitors appears to be a burning sensation of the skin. One point for discussion concerns the economical aspects of the treatment of atopic dermatitis. The cost-effectiveness of pimecrolimus has been based on the calculated costs per quality-adjusted life year, which were lower than the frequently hawked value of 50,000 USD. It is up to policy makers to decide on the actual value of a quality-adjusted life year.

Conclusions/recommendations: From a medical as well as an economical viewpoint, there appears to be insufficient evidence stating that inflammatory steroid-free substances are more effective and/or efficient than topical corticosteroids. Based on the results of the studies that have been included in this assessment therapies based on calcineurin inhibitors seem to constitute a good alternative in case a child is unresponsive or intolerable to topical corticosteroids and for the treatment of intertriginous areas.