Preliminary Studies Suggest Safety and Efficacy for Pediatric Atopic
Dermatitis
SAN FRANCISCO, March 10 /PRNewswire/ -- Three preliminary studies suggest
that a new investigational therapy may safely and effectively reduce symptoms
of pediatric and adult eczema, including atopic dermatitis and chronic hand
dermatitis.
One study to be presented Saturday at the 58th annual meeting of the
American Academy of Dermatology suggests that SDZ ASM 981 topical cream could
safely and effectively improve the signs and symptoms of chronic irritant hand
dermatitis, a condition currently treated with corticosteroids. Chronic
irritant hand dermatitis, or hand eczema, is characterized by bright red,
scaly cracks that make skin very sensitive, causing it to sting and bleed.
In the small efficacy study, all patients (n=12) treated twice daily with
SDZ ASM 981 cream followed by a nightly occlusive covering (gloves) noted up
to 40 percent improvement within the first week of treatment.
"Based on these encouraging results, we have worked with key experts in
this area to design a large Phase III trial in chronic irritant hand
dermatitis, and we are moving forward as swiftly as possible," said Robert J.
Cherill, MS, Associate Director, Clinical Research, Novartis Pharmaceuticals
Corporation.
Implications for Use in Children and Adults
Two additional studies offer important implications for the management of
atopic dermatitis, which is now most commonly treated with corticosteroids of
varying potency. The studies found that SDZ ASM 981 does not accumulate in
the bloodstream and, furthermore, that its prolonged use does not induce skin
atrophy (an excessive thinning of skin) when compared to the medium- to-high-
potency corticosteroids studied (triamcinolone acetonide and betamethasone-17-
valerate).
Infants and children make up 80 percent of patients with atopic
dermatitis, which is characterized by a dry, itchy, scaly skin rash. Systemic
absorption -- which refers to how a medication is absorbed into the
bloodstream -- is of more concern for children because their ratio of body
surface area to weight is higher than it is in adults.
"Data from these studies support other recent findings showing SDZ ASM 981
cream to have low systemic exposure, even when applied over an extensive body
surface area," said Carle Paul, MD, Department of Dermatology, Mulhouse
Hospital, France, who is one of the study authors.
Further studies are under way to support the efficacy and safety of SDZ
ASM 981 cream in children with atopic dermatitis.
SDZ ASM 981 is a new molecule that is derived from the macrolactam
ascomycin and selectively inhibits inflammatory cytokines released from
activated T cells and mast cells. It was specifically developed for the
treatment of inflammatory skin diseases(1), and has been shown to be effective
in atopic dermatitis(2), allergic contact dermatitis(3), and psoriasis (under
semi-occlusive conditions)(4).
In SDZ ASM 981 studies to date, the most frequently experienced side
effect was a sensation of warmth at the site of application. That sensation
usually subsides after the first three days of treatment.
Novartis Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including central nervous system disorders, organ
transplantation, cardiovascular diseases, dermatological diseases, respiratory
disorders, cancer and arthritis. The company's mission is to improve people's
lives by pioneering novel healthcare solutions.
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 1999, the Group (including Agribusiness) achieved sales of
USD 21.7 billion and invested more than USD 2.8 billion in R&D. Headquartered
in Basel, Switzerland, Novartis employs about 82,400 people and operates in
over 140 countries around the world. The Group recently announced plans to
spin off its Crop Protection and Seeds sectors and to merge them with the
agrochemicals business of AstraZeneca in the second half of 2000.
References
1 Grassberger, et al, Br J Dermatol 1999;141:264-73.
2 Van Leent, et al, Arch Dermatol 1998;134:805-809.
3 Quielle-Roussel, et al, Australas J Dermatol 1997;38(suppl 2):55.
4 Mrowietz, et al, Br J Dermatol 1998;139:992-996.
SOURCE Novartis Pharmaceutical Corporation
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CONTACT:
Judi Glova of Novartis Pharmaceuticals
Corporation, 973-781-5588; or Susan Hirsch of Chandler Chicco
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