Elidel Cream 1% Shown Effective for Eczema!

Elidel Cream 1% Shown Effective Treatment With Proven Safety Profile For Infant Eczema, Study Reports

Journal of Pediatrics Cites Elidel as 'Promising' New Option for Infants

BASEL, Switzerland, Feb. 25 /CNW/ - A new publication suggests that
Elidel(R) (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 less than .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.