If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  EDVC: New Non-Steroid Cream, Elidel (Pimecrolimus), Relieves Infant Eczema BASEL, SWITZERLAND -- October 11, 2001 -- Atopic eczema, the itching skin condition, can be kept under control in seven out of 10 babies with the new non-steroid cream Elidel® (pimecrolimus, formerly known as SDZ ASM 981), one of the first new treatments to be developed for eczema in almost 50 years. Study results presented this week at the European Dermatology and Venereology Congress in Munich, showed that one week after starting treatment with Elidel, itching stopped or was only mild in 70 percent of three- to 23-month-olds. By using the cream as soon as the first signs of eczema or itching recurred, disease flares were prevented in 70 percent of the babies and topical corticosteroid treatment was not required during the six month study. These results build on existing data already presented in patients aged two - 17. "Eczema in infants has a huge impact on the entire family," said one of the investigators taking part in the 250-patient study, Dr. Mark Goodfield, Consultant Dermatologist at Leeds General Infirmary in England. "For many patients, the itch is unbearable, the babies cannot sleep and their crying is upsetting for the whole family. When the infants are old enough to scratch themselves, they may scratch until they bleed and this, too, is particularly distressing for parents. So any relief for the baby brings relief for the whole family." Eczema has typically been treated with moisturisers for the dry skin stage, and intermittent use of corticosteroids to treat disease flares in which the skin becomes increasingly red, swollen, and may weep and form crusts. However, corticosteroids have to be used with caution in infants or young children, and their long-term use can cause side-effects such as skin thinning and growth retardation. "Many parents are reluctant to use corticosteroids on children, and so there is a great need for an effective alternative," Dr. Goodfield said. "This study shows that Elidel cream has the potential to provide the sought-after alternative treatment which does not have steroid-associated side effects." Novartis has filed applications with the Food and Drug Administration in the US, in Canada, and with health authorities in Switzerland and Denmark (the reference member state for the European Union), for authorisation to market Elidel. Other data reported at the congress showed the following: · In this study with 250 infants, only 32 percent of those receiving a conventional treatment (emollients for dry skin and corticosteroids for flares) were flare-free over six months. · In a year-long study involving 713 patients aged two-17 years, 51 percent of the children using Elidel at the first signs and symptoms of eczema did not have any disease flares or need topical corticosteroids. Only 28 percent of patients receiving the conventional treatment were flare-free over the same period. The most common adverse event reported by the 1700 patients treated with Elidel to date is a sensation of warmth or burning where the cream is applied. This is usually mild and disappears within a few days of treatment. It occurred in one of 10 children aged two-17 years. Elidel, which is being developed by Novartis, is the first treatment proven to affect the long-term course of atopic eczema by reducing the incidence of eczema flares and the need for topical corticosteroids. As a skin-selective inflammatory cytokine inhibitor, Elidel works by selectively targeting those cells in the skin which release the pro-inflammatory mediators in atopic eczema. SOURCE: Novartis Pharma AG Related Link: Novartis Pharma AG.
|
