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Eczema Improves in Adults Treated with Elidel (Pimecrolimus) Cream: Presented at AAD

BASEL, SWITZERLAND -- February 25, 2002 -- Four out of five adults with the itching skin disease, atopic eczema, experienced improvement of their condition with a new treatment based on the non-steroid cream, Elidel® (pimecrolimus), according to study results released today. The study, presented at the annual meeting of the American Academy of Dermatology in New Orleans, USA, also showed that seven out of 10 adults were considered by their doctors to have been successfully treated with the cream-based regimen, and the itching associated with eczema began to ease on average within two days of starting Elidel.

The results build on the efficacy seen with younger patients. In previous studies, itching was relieved within one week in up to 70 percent of babies aged three to 23 months treated with Elidel. Seven out of 10 babies, and 61 percent of children aged two to 17 years, had their eczema under control over six months without any steroids, by using Elidel at the first signs of disease - such as redness and swelling - or itching.

"Itching is the most bothersome symptom of this disease and patients are looking for quick relief," said the study's lead investigator, Professor Michael Meurer, Professor of Dermatology at the University of Dresden, Germany. "In addition, many patients would like treatments that are free of the steroids we currently prescribe, because they fear the side effects associated with long-term steroid use, such as skin thinning. For the last half-century, we have really had nothing else to offer. I am sure those patients, and physicians, who do not like to use steroids will welcome the new generation of topical therapies such as Elidel because they do not contain steroids and are free of steroid side-effects."

Discovered and developed by Novartis, Elidel was approved last December by the US Food and Drug Administration for the short-term and intermittent long-term treatment of mild to moderate atopic dermatitis in patients aged two years and older in whom conventional therapies are inadvisable. Applications for marketing approvals are under consideration in Canada, Switzerland and Denmark (the reference member state for the European Union).

In the German multi-centre study reported by Professor Meurer, half of the 192 participating adults with moderate to severe disease were treated with an Elidel-based regimen, consisting of emollients (moisturisers) for dry skin and Elidel applied twice daily from the first sign or symptom of eczema until the skin cleared. In cases where the eczema was not controlled and flared - worsened to the stage that it was unacceptable to the patient - topical steroids were used. The control group was treated with a regimen representing the current standard eczema therapy - emollients, with a vehicle cream containing no drug being applied at the first sign or symptom, and topical steroids for disease flares.

In the Elidel group, 82 percent of patients experienced improvement in their condition over the six months, according to their doctor, but only 51 percent did so in the group receiving the equivalent of current steroid-based therapy. By the end of the study, 69 percent of patients were considered by their doctors to have been successfully treated with the Elidel-based regimen, compared with 37 percent in the control group - although 49 percent of Elidel-treated patients did not use any steroids, compared with 22 percent in the control group. While itching began to ease within two days of starting treatment in the Elidel group, it worsened in the control group.

The most commonly reported drug-related adverse event was application site warmth or burning, occurring in 15 percent of Elidel-treated patients and in 5 percent of the control group; this usually resolved within 1 to 7 days in the Elidel-treated patients, and in 1-9 days in the control group. Other data presented at the AAD congress showed the incidence of application site burning with Elidel is much lower than the 34-43 percent reported in pediatric patients treated with another new non-steroid treatment.

There is no cure for eczema and its causes are unknown, although patients often have a family history of eczema, hay fever and/or asthma. Affecting approximately 20 percent of the population at some time in their life, eczema usually begins in childhood and may last until the late teenage years or even for life.

In the study, Elidel was used as soon as the first signs and symptoms appear, to prevent the condition worsening, enabling steroids to be reserved for short-term treatment if the disease is severe. Elidel is a skin-selective inflammatory cytokine inhibitor and works by selectively targeting T-cells in the skin, stopping them producing the cytokines which cause the inflammation, redness and itching associated with atopic eczema (also known as atopic dermatitis).

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