"Elidel (Pimecrolimus) Promising Treatment For Infants With Eczema"
[Journal of Pediatrics Says Elidel is Safe and Effective in Infants
EAST HANOVER, NJ, February 24, 2003 /PR Newswire/ -- Newly published data suggest that Elidel® (pimecrolimus) Cream 1% is a safe and effective treatment for eczema (atopic dermatitis) in infants, according to a report in the February issue of the Journal of Pediatrics. The study found that after six weeks of treatment, more than twice as many patients treated with Elidel were clear or almost clear of eczema, compared with those treated with the vehicle (Elidel cream base without the active ingredient). The authors concluded that Elidel holds promise as a valuable potential treatment option for the youngest patients.
According to the report, approximately 10 percent to 15 percent of children under age 5 in developed countries are estimated to have eczema. Of these, 48 percent to 75 percent show initial signs and symptoms within the first six months of life. Left untreated, eczema in infants and young children can have serious long-term consequences. Traditional therapy has included liberal use of moisturizers and the short-term use of topical corticosteroids. However, excessive use of corticosteroids may be associated with local and systemic side effects, and infants are more susceptible than older children to these adverse effects.
"Parents and physicians alike have long been concerned about applying corticosteroids to infant skin, particularly to treat a chronic condition like eczema," said pediatrician and dermatologist Lawrence Eichenfield, M.D., Chief of Pediatric and Adolescent Dermatology, Children's Hospital, San Diego and Clinical Professor of Pediatrics and Medicine (Dermatology), University of California, San Diego. Dr. Eichenfield is an independent expert and was not one of the authors of this article. "These data further support Elidel as a promising potential treatment of eczema in infants."
Study Details The randomized, double-blind, vehicle-controlled study enrolled 186 infants, aged three to 23 months. The patients, who had a diagnosis of mild to moderate eczema affecting at least 5 percent of their total body surface area, were treated with either Elidel (n=123) or vehicle (n=63) twice daily, approximately 12 hours apart. Unaffected areas or affected skin areas that had cleared were not treated with study medication. The initial, double-blind phase of the study lasted for six weeks, followed by a 20-week open-label phase, during which patients from the vehicle group were permitted to switch to Elidel.
At the end of the six-week double-blind phase, more than twice as many patients in the Elidel (54.5 percent) group were clear or almost clear of eczema, compared with those in the vehicle group (23.8 percent; P<.001). Clinically relevant improvements were observed by investigators as early as the first study return visit on day eight, with statistically significant differences between groups detected by the next visit on day 15. Similar improvements were seen across all assessments used in the study. Efficacy seen during the double-blind phase was maintained throughout the open-label phase. In addition, patients in the vehicle group who transferred to treatment with open-label Elidel (56 patients) achieved similar disease control to those who had received continuous treatment with Elidel.
Application site reactions and skin infections were infrequent (less than 5 percent of the patients studied) and there were no significant differences between groups in the incidences of these events. Most adverse events were mild or moderate and unrelated to treatment.
About Elidel
Elidel is the first steroid-free prescription cream indicated for the treatment of mild to moderate eczema in patients as young as two years old. It is approved for the short-term and intermittent long-term treatment of mild to moderate eczema in non-immunocompromised patients, for whom conventional therapies are inadvisable because of potential risks, inadequate response, or intolerance. It is manufactured and marketed by Novartis.
Currently, eczema affects up to 17 percent of the U.S. population. Mild to moderate sufferers age 2 and older make up the vast majority of this eczema patient population. As conventional therapies can be inadvisable and/or ineffective for many of these eczema patients, Elidel serves as a valuable treatment option for this large population.
The most common side effect on the skin was a mild to moderate, temporary feeling of warmth or burning (occurring in 8 percent of children aged 2-17 years and in 26 percent of adults). This side effect was temporary and its occurrences were comparable to those experienced by patients on vehicle cream.
Other common side effects included headache and cold symptoms, such as stuffy nose, sore throat and cough. Elidel did not induce contact sensitization, phototoxicity or photoallergy, nor did it show any cumulative irritation. Elidel did not elicit skin atrophy, sometimes seen with long-term topical corticosteroid use.
Developed by the Novartis Research Institute, Elidel may be used on all skin surfaces, including delicate areas such as the face, neck and skin folds. The active ingredient is pimecrolimus, which is derived from ascomycin, a natural substance produced by the fungus Streptomyces hygroscopicus var. ascomyceticus. Pimecrolimus selectively blocks the production and release of cytokines from T-cells. These cytokines in the skin cause the inflammation, redness and itching associated with eczema.
This release contains certain forward-looking statements, relating to the Company's business, which can be identified by the use of forward-looking terminology such as "promising," "holds promise," "shown," "significant," "valuable," "potential" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the potential benefit of Elidel (pimecrolimus) Cream 1% as evidenced by clinical trial results and FDA approval. Those statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. There are no guarantees that the aforementioned events will result in the commercial success of Elidel (pimecrolimus) Cream 1% in any market. Any such success can be affected by, among other things, uncertainties relating to product development, adverse results in clinical trials regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection, competition in general and other risks and factors referred to in the Company's current Form 20-F on file with the Securities and Exchange Commission of the United States.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufacturers 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 Novartis AG (NYSE: NVS), a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of CHF 32.4 billion (USD 20.9 billion) and a net income of CHF 7.3 billion (USD 4.7 billion). The Group invested approximately CHF 4.3 billion (USD 2.8 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 72,900 people and operate in over 140 countries around the world. For further information please consult http://www.pharma.us.novartis.com or http://www.novartis.com.
SOURCE: Novartis Pharmaceuticals Corporation
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