Data suggest potential steroid-free treatment as foundation therapy in long-term management of eczema

Novel Study Design Compares Therapeutic Concepts in Long-term Management of Atopic Dermatitis

Analysis of the six-month data from an international study involving more than 700 patients (between the ages of 1 and 17) shows that the ascomycin macrolactam ASM 981 (pimecrolimus) cream 1%, a selective inflammatory cytokine inhibitor, is superior to the current standard of care in the long-term management of atopic dermatitis (commonly referred to as eczema). Data presented at the 59th Annual American Academy of Dermatology meeting show that ASM 981 was found to be effective in reducing the number of disease flares and resulted in significantly less corticosteroid use.

"We're very excited by these results, because they suggest a new potential therapy as an alternative to topical steroid treatment in the long-term management of pediatric atopic dermatitis. This may fundamentally change the way in which eczema will be treated," said Adelaide Hebert, MD, University of Texas Health Sciences Center, Houston, Texas.

The study is a one-year, multi-center, randomized, parallel group, double blind trial comparing the efficacy and safety of ASM 981 cream 1% as foundation therapy versus the current standard of care. The standard of care is defined as the use of emollients to treat dry skin and the reactive use of mid-potency corticosteroids to treat disease flares. This study investigated a new potential treatment concept called foundation therapy -- defined as emollients for dry skin and the use of ASM 981 as soon as signs (e.g., redness) and symptoms (e.g., itching) of eczema appear. For all patients who experienced uncontrolled flares, second-line corticosteroids were allowed.

The data show that ASM 981 foundation therapy-patients experienced a longer period before their first flare occurred and fewer flares compared with standard of care-treated patients. Sixty-one percent of the ASM 981 group, as compared to 35 percent of the standard of care group, went six months without a flare and, consequently, did not need steroid treatment. For each disease severity category - mild through severe - the proportion of patients that experienced no flare was always higher in the ASM 981 group compared to the standard of care group.

This is the first time a well-controlled, well-powered, blinded study has been performed comparing a potential new therapy to the standard of care for the long-term management of eczema. It was conducted in a total of 52 centers in 12 countries, including the U.S.

In this long-term study, there was a comparably low incidence of discontinuation due to adverse events (3.4 percent for ASM 981, 3.8 percent for standard of care group), and both groups exhibited similar local tolerability profiles. Only 0.6 percent of the ASM 981 group discontinued due to application site reactions as compared to 2.5 percent in the standard of care group.

These safety results support the potential use of ASM 981 as a foundation therapy in the long-term management of eczema. ASM 981, a selective inflammatory cytokine inhibitor, has a unique skin-specific pharmacological profile. It selectively blocks the synthesis and release of inflammatory cytokines and thereby prevents skin inflammation. ASM 981 is being developed by Novartis Pharmaceuticals Corporation and represents a new class of steroid-free potential treatments for eczema. 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 eczema in 40 years.

About Novartis
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of the Novartis Group, a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Group's ongoing businesses achieved sales of CHF 29.1 billion (USD 17.2 billion) and invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs about 67,600 people and operates in over 140 countries around the world. For further information please consult www.novartis.com.

Source: Novartis Pharmaceuticals Corporation