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| |  DG DISPATCH - EADV: Experimental Drug, SDZ-ASM-981, Promising In Pediatric Atopic Dermatitis, Psoriasis By Cameron Johnston Special to DG News
GENEVA, SWITZERLAND -- October 17, 2000 -- An experimental drug, SDZ-ASM-981, could prove beneficial in treating children with atopic dermatitis. This treatment would be an important breakthrough in a condition that costs the health care system an estimated $6,000 US per patient per year, in the United Kingdom alone. The drug could be available in Germany as early as next year. The drug belongs to the family of drugs known as ascomycin macrolactams and is a selective cytokine inhibitor developed especially for the treatment of inflammatory skin diseases. The drug works by inhibiting Th1 and Th2 cytokine synthesis, which is activated after the T-cells have been challenged by antigen specific activation. It also prevents the release of cytokines and pro-inflammatory mediators from mast cells after stimulation by immunoglobulin (Ig) E/antigen. At the annual meeting of the European Association for the study of Dermatology and Venereology (EADV), held in Geneva, Switzerland, investigators in a Novartis satellite symposium outlined some of the more important findings concerning the new drug. Dr. Roger Allen, of the Queen’s Medical Center, in Nottingham, UK, said the drug was pharmacokinetically safe in a small study of patients who were treated over a three-week period. Subjects had blood concentrations of the drug that were 77 percent below the limit of quantitation, meaning that even after the patient has been using the drug for a period of three weeks, there was no systemic accumulation of the drug when delivered in 1% cream formulation. Blood concentrations were measured in children who had atopic dermatitis covering up to 80 percent of their body surface area. Readings were taken through blood tests at days 4 and 22 of a 21-day cycle. Another study, presented by Dr. Anne Lucky, of Dermatology Research Associates, in Cincinnati, Ohio, used ASM-981 to treat two groups of children -- one group aged one to four and another aged five to 16 -- who had severe atopic dermatitis. Results showed significant reductions in mean Eczema Area Severity Indices. At baseline, the children all had atopic dermatitis covering an average of 69 percent of their total body surface area. Reductions in eczema index scores varied from 57 percent to 69 percent, respectively, for the two age groups. When used in an oral formulation for patients with psoriasis, ASM-981 produced a mean reduction in psoriasis anxiety and severity index of 60 percent and 75 percent for patients who were treated with daily doses of 40 mg and 60 mg, respectively. "This clearly indicates clinical efficacy," said Dr. Klaus Wolff, of the department of dermatology at the University of Vienna, in Austria. Results from repeated doses, he said, produced good safety and efficacy profiles, dose-proportionate pharmacokinetics and efficacy at the 40-mg and 60-mg dose level for patients with moderate to severe psoriasis. "ASM-981 promises to be a novel systemic anti-inflammatory drug for the effective control of psoriasis and possibly other immune mediated conditions such as atopic dermatitis," he said. The formal indication for the use of this drug for the treatment of psoriasis may not come until some time in 2004, he said.
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