Register for New Non-Steroid Cream Could Provide Alternative Treatment For Children
EczemaOctober 8, 2001
2001 OCT 8 - (NewsRx.com & NewsRx.net) -- A new steroid-free approach to controlling the itching skin disease, eczema, in most children was outlined in September (2001), to the world's leading specialists at the International Symposium on Atopic Dermatitis in Portland, Oregon.
Thomas Luger, professor of dermatology at the University of Muenster, Germany, reported that 6 out of 10 children, enrolled in clinical trials, who used the new non-steroid cream Elidel at the first itching or other signs of eczema, did not have any flares and did not use any topical corticosteroids.
"Until now, the conventional treatment for eczema has been emollients for the dry skin stage, and intermittent use of topical corticosteroids to treat flares," Luger said. "While topical corticosteroids are effective, their long-term use has been linked to side-effects such as skin thinning and growth retardation and many parents are reluctant to use corticosteroids on their children. This study shows an alternative way of successfully managing eczema, without the side-effects of steroids, for many patients. We can expect that more than half of the children treated with Elidel will not need any topical corticosteroids."
In the international study, the first of its kind and one of the largest ever performed in children with eczema, 713 patients ages 2-17 received either an Elidel-based regimen or a conventional treatment. In the first group, Elidel was applied at the first signs of itching, redness or skin thickening, in order to prevent the eczema progressing to a flare. If needed, topical corticosteroids were allowed as rescue therapy for flares. The conventional treatment group was allowed to use emollients and topical corticosteroids.
The study showed that the Elidel-based regimen offered more effective control: 61% of patients in the Elidel-treated group completed six months without a flare, compared with only 35% in the conventional treatment group.
Another patient study showed that Elidel is also effective in treating eczema in babies ages 3-23 months. Itching - the most troublesome symptom of eczema - was reported to have stopped or to be merely mild in 70% of the Elidel-treated babies within the first week.
In studies to date, approximately 1700 patients have been treated with Elidel and the cream has been well-tolerated, with no clinically important systemic side effects reported. The most frequent side-effect, occurring in approximately 10% of children, is a transient feeling of warmth or mild sensation of burning on the skin where the cream is applied, but this usually disappears within a few days of treatment.
Elidel (pimecrolimus, SDZ ASM 981), which is being developed by Novartis, is the first treatment proven to reduce the incidence of eczema flares and the need for topical corticosteroids. As a skin-selective inflammatory cytokine inhibitor, Elidel works by selectively targeting those cells which release the pro-inflammatory mediators in atopic eczema.
Novartis has filed applications with the Food and Drug Administration in the U.S., in Canada, and with health authorities in Switzerland and Denmark (the reference member state for the European Union), for authorization to market Elidel.
This article was prepared by Health & Medicine Week editors from staff and other reports.
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