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| |  AAD: Ascomycin Macrolactam, ASM 981 Cream 1% (Pimecrolimus) Promising in Eczema Treatment WASHINGTON, DC -- March 5, 2001 -- Data presented at the 59th Annual American Academy of Dermatology (AAD) meeting support the potential use of an ascomycin macrolactam, ASM 981 cream 1% (pimecrolimus), a selective inflammatory cytokine inhibitor, as first-line treatment for mild to moderate pediatric atopic dermatitis. These pivotal Phase III pediatric trials present results regarding the safety and efficacy of ASM 981 in patients as young as two years of age. Atopic dermatitis (commonly known as eczema) can be both physically and emotionally devastating. The effects of this condition are particularly prevalent and distressing in young children. The potential for a new safe and effective therapy for use in pediatric patients would represent a significant step forward. The disease develops within the first year of life in half of the cases, with an additional 30 percent being diagnosed between one and five year of age. Studies from Europe, Japan and the U.S. have identified atopic dermatitis as a major public health problem. "Given the substantial degree of concern over the use of corticosteroids in young patients there is a real need for treatment alternatives. These data provide strong support for ASM 981 as a potential new treatment," commented Dr. Jon Hanifin, Oregon Health Sciences University, Portland, Oregon. "Health professionals await the availability of ASM 981, which may provide them with a new option for pediatric patients who currently suffer significantly from the distressing effects of atopic dermatitis." Data from three key pediatric trials investigating ASM 981 cream 1% were presented at the AAD meeting, including two studies focusing on the efficacy and safety of ASM 981 and one pharmacokinetic study that reported on the low blood concentrations of ASM 981 in infants (three to 23 months) with atopic dermatitis who were treated with medications over extensive body surface areas. Two of the three studies were identical multicenter, vehicle-controlled trials, evaluating the short-term efficacy and safety of ASM 981 cream 1%. The studies were completed in patients aged two to 17-years old, and both studies consisted of a six-week randomized, multicenter, double-blind, parallel-group phase followed by a 20-week open-label phase. Only the six-week double-blinded data were presented at the meeting. The combined results of these two studies show the superior efficacy of ASM 981 cream 1% over vehicle. Significant efficacy, as assessed by the Investigators Global Assessment (IGA) scale, was evident as early as the first study visit (Day eight). By the end of the six-week, double-blind phase, the percent of patients who rated clear or almost clear (IGA = 0 or 1) was significantly greater in ASM 981 patients than vehicle patients. ASM 981 treated patients showed a significantly greater reduction in the extent and severity of disease signs compared to the vehicle group as early as Day eight. The treatment effect continued throughout the course of the study. Pruritus (itching), the hallmark symptom of atopic dermatitis, was assessed. By Day eight, there was a significantly greater percent of ASM 981-treated patients with absent or mild pruritus than vehicle-treated patients. That difference continued to grow over the treatment course. Local tolerability was comparable between treatment groups as shown by the low incidence of application site burning (10 percent ASM 981 compared to 13 percent vehicle). The third study was a pharmacokinetic study in infants aged three to 23 months with extensive atopic dermatitis designed to investigate the systemic exposure and clinical tolerability of ASM 981 cream 1%. Results of the study demonstrated that three weeks' treatment over large body surface areas involved with atopic dermatitis resulted in very low blood concentrations, with the majority below the limit of quantitation. In addition, patients exhibited good local and systemic tolerability. Dr. Jon Hanifin commented on the results, saying, "These results demonstrate low blood concentrations of ASM 981 in infants, which is particularly encouraging given that safety is a primary concern in this population." Additional efficacy and safety trials with ASM 981 cream 1% in infants are currently underway. ASM 981 is a selective inflammatory cytokine inhibitor being developed by Novartis Pharmaceuticals Corporation and represents a new class of steroid- free potential treatments for atopic dermatitis. ASM 981 is being studied specifically for the treatment of inflammatory skin disorders and, if approved by the FDA, will be one of the first new treatment options for atopic dermatitis in 40 years.
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