Basel, 24 February 2003 - A new publication suggests that Elidel® (pimecrolimus) cream 1% is an effective treatment with a proven safety profile for eczema (atopic dermatitis) in infants as young as 3 months, according to a report in the February issue of the Journal of Pediatrics (February 2003, 142(2):155-162). The study found that after six weeks, 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). In the context of other favorable efficacy and safety results, the authors conclude that Elidel holds promise as a valuable treatment option for the youngest patients.
According to the report, approximately 10% to 15% of children under age 5 in developed countries are estimated to have eczema. Of these 48% to 75% show initial signs and symptoms within the first six months of life. Left untreated, eczema in infants and young children can potentially have serious long-term consequences. Traditional therapy has included liberal use of moisturizers and short-term use of topical corticosteroids. However, corticosteroids have been associated with serious local and systemic side effects, and infants are more susceptible than older children to these adverse effects.
"These data further support Elidel as a promising option for the treatment of eczema in infants," said Professor Roland Kaufmann, Chair of the Department of Dermatology and Venereology of the University Hospital Frankfurt and one of the lead authors of the publication. "Parents and physicians alike have long been concerned about applying steroids to infant skin, particularly to treat a chronic condition like eczema. The potential value of Elidel for this patient population is significant."
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% of their total body 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%) group were clear or almost clear of eczema, as compared to those in the vehicle group (23.8%; P<.001). Clinically relevant improvements were observed by investigators as early as the first study return visit on day eight. 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 achieved similar disease control to those who had received continuous treatment with Elidel.
Application site reactions and skin infections were infrequent (less than 5% of the patients studied) and there were no significant differences between groups in the incidences of these events.
About Elidel
Discovered by the Novartis Research Institute in Vienna, Austria, Elidel contains the active ingredient pimecrolimus, which is derived from ascomycin, a natural substance produced by the bacterium Streptomyces hygroscopicus var. ascomyceticus. Pimecrolimus selectively blocks the production and release of inflammatory cytokines from T-cells in the skin. It is these cytokines which trigger processes leading to the inflammation, redness and itching associated with eczema.
This press release contains forward-looking statements which can be identified by the use of forward-looking terminology such as "promising new option", "holds promise", "potential value", or similar expressions, or by express or implied statements regarding potential new indications for Elidel, or potential approvals to market Elidel in additional markets. Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There are no guarantees that the aforementioned clinical trials will result in any new indications for Elidel in any market, or that Elidel cream will be commercialized in any additional market. Any such results can be affected by, amongst other things, uncertainties relating to the product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in Novartis AG's Form 20-F filed with the US Securities and Exchange Commission. Any of these and other factors can cause the actual results to differ materially from the expected or predicted results.
Novartis AG (NYSE: NVS) is 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.novartis.com.
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