P717

A randomized, double-blind, vehicle-controlled, multi-center study to

evaluate the safety and efcacy of topically applied AN0128 cream, 1%
for the treatment of mild to moderate atopic dermatitis
Karl Beutner, MD, PhD, Anacor Pharmaceuticals, Inc, Palo Alto, CA, United
States; Terry Jones, MD, J & S Studies, Bryan, TX, United States; Alicia Bucko, DO,
Academic Dermatology Associates, Albuquerque, NM, United States; Robert
Loss, MD, Dermatology Associates of Rochester, Rochester, NY, United States
AN0128 is a novel topical anti-inammatory drug which blocks pro-inammatory
cytokines in vitro and in preclinical studies demonstrates an excellent topical and
systemic safety prole. As the rst clinical trial of this new therapy in the treatment
of atopic dermatitis, this trial was considered exploratory in nature and thus there
were no formal power calculations. Eight centers enrolled 103 subjects over 18
years of age with mild to moderate atopic dermatitis (AD) and a body surface area of
3% to 10% to be randomized 2:1 to twice daily treatment for 4 weeks with either
AN0128 cream 1% or the vehicle cream. At baseline, 67% of subjects were evaluated
as moderate in severity. An intent to treat analysis of all subjects randomized, at the
end of the treatment period showed that 51% (30/59) of the AN0128 treated
subjects vs. 37% (13/35) of the vehicle treated group reached a level of clear or
almost clear (P = .19) based on a 5-point (clear, almost clear, mild, moderate, or
severe) investigator static global assessment (ISGA). In a modified intend to treat
population of only those subjects who were of moderate severity at baseline, 47%
(18/38) of the AN0128 treated group and 29%(7/24) of the vehicle group reached at
least a two grade improvement in their ISGA (P = .15). Both treatments were well
tolerated with only rare application site reactions and no serious adverse events
report. The results of this study would indicate that AN0128 represents a potential
newtherapy for ADand this study provides the necessary data to power future trials.
Commercial support: None identified.
P718
Efcacy and safety of a new hydrogel formulation of desonide 0.05% in
pediatric subjects with atopic dermatitis
Adelaide Hebert, MD, Department of Dermatology, University of Texas Medical
School, Houston, TX, United States; Fran Cook-Bolden, MD, The Skin Specialty
Group and The Department of Dermatology, The College of Physicians and
Surgeons of Columbia University, New York, NY, United States; Barry Calvarese,
MS, Dow Pharmaceutical Sciences, Inc., Petaluma, CA, United States; Ronald
Trancik, PhD, SkinMedica, Inc, Carlsbad, CA, United States
The low potency topical corticosteroid desonide has been widely used in the
treatment of atopic dermatitis (AD) for over 30 years. Currently only traditional
creams, ointments and lotions are available in this potency class. However, a new
hydrogel formulation of desonide has been developed. It is distinguished as an
alcohol and surfactant-free, carbopol-based polymer that contains 0.05% (w/w) of
micronized desonide and is composed of 89% water. This hydrogel formulation was
designed to be mild, free from sensitizing ingredients, moisturizing, cosmetically
elegant, and easily applied for use in AD patients aged 3 months and older. Recently,
two phase III clinical trials in mild-to-moderate AD subjects aged 3 months to 18
years were conducted. The mean age of subjects was 6.7 years with 30% of subjects
being under 3 years of age. A total of 425 subjects were treated with desonide
hydrogel and 157 subjects with the hydrogel vehicle twice daily for 4 weeks.
Desonide hydrogel 0.05% was extremely well tolerated and provided statistically
signicant improvements in all primary (P\.001) and secondary (P\.006) efficacy
endpoints in both studies. Subjects in the active group experienced significant
clearing of their disease with a rapid reduction of body surface area affected as early
as week 2. At the end of treatment, 58% of desonide hydrogel treated subjects had
their disease assessed as clear or almost clear by investigators assessment. This
novel desonide formulation represents an important advancement in the treatment
of AD.
100% is sponsored by SkinMedica, Inc.
P719
Effect of pimecrolimus on health-care costs in pediatric patients with
mild-to-moderate atopic dermatitis
Charu Taneja, MS, MPH, Policy Analysis Inc, Brookline, MA, United States; Tom
Delea, MBA, Policy Analysis Inc, Brookline, MA, United States; Francis Lobo, PhD,
MS, Novartis Pharmaceuticals, East Hanover, NJ, United States; Mark Jackson,
MD, MD, University of Louisville, Louisville, KY, United States
Introduction: The efcacy and safety of pimecrolimus (PIM) cream 1% in pediatric
patients with mild-to-moderate atopic dermatitis (AD) was recently accessed in a 26
week randomized, double-blind, vehicle-controlled trial. Patients aged 2-17 years
were randomized to receive PIM cream 1% b.i.d or vehicle bid at rst signs/
symptoms of AD, with topical corticosteroid (TCS) to be applied after 3 days
without improvement in symptoms. PIM patients had 41% fewer days with TCS use
(mean 12.9 vs 21.9 days for vehicle), 50% fewer ares (mean 0.84 vs 1.68
respectively), and 2/3 fewer unscheduled outpatient visits (mean 0.34 vs 0.93
respectively). This study estimates differences in healthcare costs between the two
study arms based on utilization data collected in this trial and unit costs from
secondary sources.
Methods: Measures of interest included the utilization and costs of PIM, TCS, and
unscheduled outpatient visits. Because utilization (g) of PIM and TCS were not
collected in the trial, they were estimated by combining data from the trial on
therapy days and body surface area involved (BSAI) at each follow-up assessment
with published estimates of g/m
2
BSAI for topical therapies. Patients with missing
data required to estimate BSAI during follow-up were excluded. Numbers of
unscheduled visits in each arm were obtained from the trial. The unit cost of PIM
was based on its wholesale acquisition costs; unit costs of TCS and outpatient visits
were based on data from a large managed-care claims database.
Results: Baseline characteristics for patients in the two treatment groups (n = 234
and 241 for PIM and vehicle respectively) were similar. Patients in the PIM group
used a mean 53.2 g of PIM with a mean cost of $99.57. However, mean utilization of
TCS was lower with PIM vs vehicle (17.9 vs. 37.0 g, P = .006). Costs of TCS were
therefore reduced by $13.59 ($12.68 vs $26.27, P = .005). Costs of unscheduled
visits also were $31.65 lower in the PIM group ($19.18 vs $50.83, P \.001). After
accounting for these savings, total costs (PIM1TCS1visits) were $54.32 greater
with PIM vs vehicle ($131.42 vs $77.10, P = .002). Conclusion. In pediatric patients
with mild-to-moderate AD, PIMis associated with significant reductions in the use of
TCS, numbers of flares, and frequency of unscheduled outpatient visits. These
clinical benefits result in cost savings which offset 55%of the acquisition cost of PIM.
Supported by Novartis Pharmaceuticals.
P720
AB72 J AM ACAD DERMATOL FEBRUARY 2007