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Elidel Appears to Provide Fast, Effective Eczema Itch Relief in Children: Presented at AAD

Additional Studies Presented at American Academy of Dermatology Meeting Highlight Safety and Tolerability

WASHINGTON, DC -- February 20, 2004 -- New data demonstrate that Elidel® (pimecrolimus) Cream 1% provides fast and effective itch relief in pediatric patients ages 2-17 years with mild to moderate atopic dermatitis (AD), while another study reinforces the drug's tolerability compared to tacrolimus ointment 0.03 percent.

In a seven-day study of 174 pediatric patients aged 2-17 years with atopic dermatitis presented last week at the 2004 American Academy of Dermatology (AAD) meeting in Washington, DC, patients treated with Elidel cream experienced significant relief from pruritus (itch) associated with their eczema beginning on Day 2 of treatment. A significant percentage of those treated with Elidel reported complete resolution of their pruritus by
Day 3, with 35 percent experiencing complete pruritus relief by Day 7 of treatment.

"Itch is often a driving factor in the decision to seek treatment for AD. Fast and effective itch relief is especially important for children who may be less equipped to express and deal with their discomfort than adult counterparts," says Joseph Fowler, MD, principle investigator of the study. "These results reinforce Elidel as an effective treatment choice for children over two who suffer from the itch associated with mild to moderate AD, as well as other common symptoms such as extremely dry, irritated skin patches."

In a six-week study also presented at the meeting, patients reported Elidel was easy to apply and had better tolerability than tacrolimus ointment 0.03 percent while maintaining similar efficacy in 141 pediatric patients aged 2-17 years with moderate AD. While local application site reactions (ASRs) occurred in both treatment groups during the first week of the study, they were more common with tacrolimus than with Elidel throughout the study. Of greater difference was the duration of the application site reactions with tacrolimus compared to Elidel.

At Day 4 (when both groups had sufficient data to allow analysis), the incidence of increased redness/irritation with tacrolimus was 18.6 percent (13/70), compared with only 8.5 percent (6/71) with Elidel (p=0.039). Importantly, more patients applying tacrolimus ( 85 %, 11/13) reported increased redness/irritation lasting >30 minutes compared with those using Elidel (0%, 0/6) (p<0.001). The incidence of warmth, stinging and burning was similar in the two treatment groups on Day 4; however, reactions lasting >30 minutes were more frequent with tacrolimus ointment ( 67 %, 8/12) than with Elidel (0/14) (p<0.001). Also on Day 4, more patients in the tacrolimus group (20%; 14/70) reported increased itching of their eczema compared to the Elidel group (8.5%; 6/71) (p=0.073). At the end of the study (Day 43), more patients in the Elidel group rated the ease of application as excellent or very good compared with the tacrolimus group (76% versus 58.6%) (p<0.02).

In another 13-day study, results demonstrated that blood levels were low in both the Elidel and tacrolimus treatment groups. Systemic exposure to active drug was lower for patients receiving Elidel compared to patients receiving tacrolimus ointment 0.1%. This study involved 37 adult patients with moderate to severe atopic dermatitis. The mean percent of body surface area involved at baseline in both treatment groups was >30 percent. Only 12 percent of the patients applying Elidel had blood concentrations above the assay's lower limit of quantitation (LoQ) compared to 36 percent of patients taking tacrolimus, and the resulting systemic exposure to the topically applied drugs was lower in the Elidel group than in the tacrolimus group. Both regimens resulted in a low incidence of adverse events and no serious adverse events occurred.

"The results of this study are important, because although Elidel penetrates into the skin equally as well as tacrolimus ointment, a lower amount of Elidel passes all the way through the skin into the bloodstream," says Zoe Draelos, MD, principle investigator of the study. "These data further support existing evidence demonstrating the favorable safety and efficacy profile of Elidel."

About Elidel
Elidel is the only steroid-free prescription cream for eczema. Elidel is currently available and approved for the short-term and intermittent long-term treatment of mild to moderate eczema in patients as young as two years old that do not respond well to, or may have side effects with, conventional treatments. Elidel is the number one prescribed brand for eczema.

Elidel is manufactured and marketed by Novartis.

About Eczema
Currently, eczema affects up to 17 percent of the U.S. population. Mild to moderate sufferers age two 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.

Contraindications and Adverse Events
In clinical trials with Elidel, the most common side effect on the skin was a mild to moderate, temporary feeling of warmth or burning (occurring in 8% of children aged 2-7 years and in 26% 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, cough and rarely viral skin infections. 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.


SOURCE: Novartis Corporation

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