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    S0190962206X02220 S0190962206032002 Main

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    This randomized, double-blind, vehicle-controlled study evaluated the safety and efficacy of AN0128 cream, a novel anti-inflammatory drug, for the treatment of mild to moderate atopic dermatitis. 103 subjects were randomized to receive either AN0128 cream 1% or vehicle cream twice daily for 4 weeks. At the end of treatment, 51% of subjects receiving AN0128 cream and 37% receiving vehicle cream achieved clear or almost clear skin, though the difference was not statistically significant. For subjects with moderate dermatitis at baseline, 47% receiving AN0128 cream and 29% receiving vehicle cream achieved at least a two-grade improvement, with a p-value of 0.15. Both treatments were well

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    S0190962206X02220 S0190962206032002 Main

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    This randomized, double-blind, vehicle-controlled study evaluated the safety and efficacy of AN0128 cream, a novel anti-inflammatory drug, for the treatment of mild to moderate atopic dermatitis. 103 subjects were randomized to receive either AN0128 cream 1% or vehicle cream twice daily for 4 weeks. At the end of treatment, 51% of subjects receiving AN0128 cream and 37% receiving vehicle cream achieved clear or almost clear skin, though the difference was not statistically significant. For subjects with moderate dermatitis at baseline, 47% receiving AN0128 cream and 29% receiving vehicle cream achieved at least a two-grade improvement, with a p-value of 0.15. Both treatments were well

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    This randomized, double-blind, vehicle-controlled study evaluated the safety and efficacy of AN0128 cream, a novel anti-inflammatory drug, for the treatment of mild to moderate atopic dermatitis. 103 subjects were randomized to receive either AN0128 cream 1% or vehicle cream twice daily for 4 weeks. At the end of treatment, 51% of subjects receiving AN0128 cream and 37% receiving vehicle cream achieved clear or almost clear skin, though the difference was not statistically significant. For subjects with moderate dermatitis at baseline, 47% receiving AN0128 cream and 29% receiving vehicle cream achieved at least a two-grade improvement, with a p-value of 0.15. Both treatments were well

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    25 views1 page

    S0190962206X02220 S0190962206032002 Main

    Uploaded by

    macan77
    This randomized, double-blind, vehicle-controlled study evaluated the safety and efficacy of AN0128 cream, a novel anti-inflammatory drug, for the treatment of mild to moderate atopic dermatitis. 103 subjects were randomized to receive either AN0128 cream 1% or vehicle cream twice daily for 4 weeks. At the end of treatment, 51% of subjects receiving AN0128 cream and 37% receiving vehicle cream achieved clear or almost clear skin, though the difference was not statistically significant. For subjects with moderate dermatitis at baseline, 47% receiving AN0128 cream and 29% receiving vehicle cream achieved at least a two-grade improvement, with a p-value of 0.15. Both treatments were well

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    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

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