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Efficacy

Phase III Study Primary Endpoints

Success in ISGA: Clear or ​​​​​​​almost clear

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ISGA clear or almost clear

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Infant Study: Exploratory efficacy Endpoints

ISGA clear or almost clear

%BSA, EASI & POEM

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Phase III Study Adverse Reactions*

Pivotal trial & 48-week extension study
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Infant Safety Study**

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  • Prescribing Information
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  • EUCRISA Safety Data

    Safety profile established in 4 studies, including pivotal, open-label safety extension, and infant studies

    Infant Open-Label Safety trial in patients aged 3 to <24 months2

    An open-label, single arm study to evaluate the safety of EUCRISA in 137 infants aged 3 to <24 months with mild-to-moderate atopic dermatitis (AD).

    Primary endpoints​​​​​​​

    •  
    • Incidence of treatment-emergent adverse events (TEAEs), including site reactions and serious AEs
    • Clinically significant changes in height, weight, vital signs, physical exam, ECG, clinical laboratory parameters
    •  

    Exploratory PK endpoints

    • Crisaborole maximum observed plasma concentration (Cmax)
    • Crisaborole time to reach maximum observed plasma concentration (Tmax)
    • Crisaborole area under plasma concentration-time profile for the dosing interval (AUCtau)
    • Propylene glycol concentrations

    Exploratory efficacy endpoints

    • Proportion of patients achieving ISGA success (defined as Clear [0] or Almost Clear [1] with ≥2-grade improvement from baseline)
    • Proportion of patients who achieved ISGA Clear or Almost Clear
    • Percent change from baseline in EASI score
    • Change from baseline in %BSA
    • Change from baseline in total POEM

    Study Population

    • Non-PK cohort: mild to moderate AD (ISGA 2 or 3) with ≥5% treatable %BSA, excluding scalp
    • PK cohort: Moderate AD (ISGA 3) with ≥35% treatable %BSA, excluding scalp

    Treatment

    • Crisaborole ointment, 2%, BID applied to all treatable AD-involved areas identified at Baseline/Day 1 and any new AD-involved areas that appeared following Baseline/Day 1
    • Non-PK cohort: Baseline AM dosing at study site followed by BID dosing at home from Baseline PM dose through Day 28
    • PK cohort: BID dosing at study site from Baseline to Day 8 AM dose; BID dosing at home from Day 8 PM dose through Day 28

    Limitations

    • Outcomes were reported by a caregiver or investigator
    • Open-label study without a comparator group

    STUDY DESIGN OVERVIEW 

    Phase 4, multicenter, open-label single-arm study to evaluate the safety of crisaborole ointment, 2%

       * Patients were excluded from the PK cohort if they had lesions below their wrists and ankles or within 2 cm of the mouth.

    Crisaborole​​​​​​​

    Non-PK Cohort 
    n = 116​​​​​​​

     

     PK Cohort 
    n = 21

     

    Total 
    n = 137

     

    Crisaborole​​​​​​​

    Non-PK Cohort 
    n = 116

    PK Cohort 
    n = 21

    Total 
    n = 137

    Age (months)

    3 to < 9, n (%)

    36 (31.0)

    7 (33.3)

    43 (31.4)

    9 to < 24, n (%)

    80 (69.0)

    14 (66.7)

    94 (68.6)

    Mean (SD)

    13.7 (6.41)

    12.7 (6.58)

    13.6 (6.42)

    Median (range)

    13.5 (3–23)

    13.0 (3–23)

    13.0 (3–23)

    3 to < 9, n (%)

    36 (31.0)

    7 (33.3)

    43 (31.4)

    9 to < 24, n (%)

    80 (69.0)

    14 (66.7)

    94 (68.6)

    Mean (SD)

    13.7 (6.41)

    12.7 (6.58)

    13.6 (6.42)

    Median (range)

    13.5 (3–23)

    13.0 (3–23)

    13.0 (3–23)

    Sex, n (%)

    Male

    75 (64.7)

    13 (61.9)

    88 (64.2)

    Female

    41 (35.3)

    8 (38.1)

    49 (35.8)

    Male

    75 (64.7)

    13 (61.9)

    88 (64.2)

    Female

    41 (35.3)

    8 (38.1)

    49 (35.8)

    Race, n (%)

    White

    71 (61.2)

    13 (61.9)

    84 (61.3)

    Black or African American 

    9 (7.8)

    2 (9.5)

    11 (8.0)

    Asian

    23 (19.8)

    4 (19.0)

    27 (19.7)

    American Indian or Alaskan native

    1 (0.9)

    0

    1 (0.7)

    Native Hawaiian or other Pacific Islander

    1 (0.9)

    0

    1 (0.7)

    Multiracial

    11 (9.5)

    2 (9.5)

    13 (9.5)

    White

    71 (61.2)

    13 (61.9)

    84 (61.3)

    Black or African American 

    9 (7.8)

    2 (9.5)

    11 (8.0)

    Asian

    23 (19.8)

    4 (19.0)

    27 (19.7)

    American Indian or Alaskan native

    1 (0.9)

    0

    1 (0.7)

    Native Hawaiian or other Pacific Islander

    1 (0.9)

    0

    1 (0.7)

    Multiracial

    11 (9.5)

    2 (9.5)

    13 (9.5)

    ISGA

    2 – Mild, n (%)

    52 (44.8)

    0

    52 (38.0)

    3 – Moderate, n (%)

    64 (55.2)

    20 (95.2)

    84 (61.3)

    4 – Severe,a n (%)

    0

    1 (4.8)

    1 (0.7)

    Mean (SD)

    2.6 (0.50)

    3.0 (0.22)

    2.6 (0.50)

    Median (range)

    3.0 (2–3)

    3.0 (3–4)

    3.0 (2–4)

    2 – Mild, n (%)

    52 (44.8)

    0

    52 (38.0)

    3 – Moderate, n (%)

    64 (55.2)

    20 (95.2)

    84 (61.3)

    4 – Severe,a n (%)

    0

    1 (4.8)

    1 (0.7)

    Mean (SD) 

    2.6 (0.50)

    3.0 (0.22)

    2.6 (0.50)

    Median (range)

    3.0 (2–3)

    3.0 (3–4)

    3.0 (2–4)

    POEM total score

    Mean (SD)

    13.9 (5.86)

    19.7 (5.18)

    14.8 (6.12)

    Median (range)

    14.0 (1–24)

    20.0 (9–27)

    15.0 (1–27)

    Mean (SD)

    13.9 (5.86)

    19.7 (5.18)

    14.8 (6.12)

    Median (range)

    14.0 (1–24)

    20.0 (9–27)

    15.0 (1–27)

    EASI score

    Mean (SD)

    10.4 (8.16)

    19.8 (4.42)

    11.8 (8.41)

    Median (range)

    7.8 (1.6–38.8)

    19.5 (12.5–29.2)

    8.9 (1.6–38.8)

    Mean (SD)

    10.4 (8.16)

    19.8 (4.42)

    11.8 (8.41)

    Median (range)

    7.8 (1.6–38.8)

    19.5 (12.5–29.2)


    8.9 (1.6–38.8)

    %BSA

    Mean (SD)

    23.5 (20.13)

    53.5 (12.61)

    28.1 (22.00)

    Median (range)

    15.5 (5.0–94.0)

    56.0 (35.0–79.0)

    19.0 (5.0–94.0)

    Mean (SD)

    23.5 (20.13)

    53.5 (12.61)

    28.1 (22.00)

    Median (range)

    15.5 (5.0–94.0)

    56.0 (35.0–79.0)

    19.0 (5.0–94.0)

    Duration Since Onset (months) 

    Mean (SD)

    10.4 (6.44)

    9.1 (5.48)

    10.2 (6.3)

    Median (range)

    9.4 (0.03–23.8)

    8.1 (1.4–21.0)

    8.6 (0.03–23.8)

    Mean (SD)

    10.4 (6.44)

    9.1 (5.48)

    10.2 (6.3)

    Median (range)

    9.4 (0.03–23.8)

    8.1 (1.4–21.0)

    8.6 (0.03–23.8)

    Medical History of Other Atopic Conditions, (%) 

    21 (18.1)

    1 (4.8)

    22 (16.1)

    21 (18.1)

    1 (4.8)

    22 (16.1)

    Prior Medication Use, n (%)

    TCS

    63 (54.3)

    9 (49.2)

     72 (52.6)

    TCI

    2 (1.7)

    0

    2 (1.5)

    TCS

    63 (54.3)

    9 (49.2)

    72 (52.6)

    TCI

    2 (1.7)

    0

    2 (1.5)

    %BSA=percentage of treatable body surface area; EASI=Eczema Area and Severity Index; ISGA=Investigator's Static Global Assessment; PK=pharmacokinetics; POEM=Patient-Oriented Eczema Measure; SD=standard deviation; TCI=topical calcinerin inhibitor; TCS=topical corticosteroid.
    aProtocol deviation.
    bIncludes conditions, such as asthma, food allergies, and allergic/seasonal rhinitis.
    References
    1. EUCRISA® (crisaborole) Full Prescribing Information. April 2020.
    2. Schlessinger J, Shepard JS, Gower R, et al. Safety, effectiveness, and pharmacokinetics of crisaborole in infants aged 3 to <24 months with mild-to-moderate atopic dermatitis: a phase IV open-label study (CrisADe CARE 1). Am J Clin Dermatol. 2020. 21:275-284.

    If babies could talk, what would they tell you?

    Hear JP with mild-to-moderate AD explain what EUCRISA means to him and other babies like him
    ​​​​​​​
    Not an actual patient

    Watch JP's story

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    Phase III Study Safety Data

    Find out more about EUCRISA's adverse event profile in patients 2 years and older from the pivotal studies

    Learn more

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    Rescue Therapy Endpoint

    Read about rescue therapy in the 48 week Open-Label Safety Extension study

    Learn more

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    Proportion of patients with ISGA Clear or Almost Clear

    Find out more about the proportion of patients aged 2 years and older who achieved ISGA clear or almost clear at day 29 from the Phase III trial's secondary endpoint

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    Exploratory Pruritus Endpoint

    Find out more about the time to relief in pruritus as found in the Phase III study's exploratory endpoint

    Learn more

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    Learn how the first and only nonsteroidal topical PDE4 inhibitor works within the skin1

    The specific mechanism(s) of action of crisaborole in atopic dermatitis is not well defined. PDE4=phosphodiesterase 4

    Learn more

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    *Eligible patients pay as little as $10​​​​​​

    Terms and Conditions apply​​​​​​

    ​​​​* Patients enrolled in state or federally funded prescription insurance programs are not eligible to use this card. Savings up to $970 per tube. Annual savings up to $3,880. This card will be accepted only at participating pharmacies. This card is not health insurance.

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    Savings & Support Program

    A savings and support program for your patients to help them with their access to EUCRISA

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    Contraindications

    EUCRISA is contraindicated in patients with known hypersensitivity to crisaborole or any component of the formulation.

    Warnings and Precautions

    Hypersensitivity reactions, including contact urticaria, have occurred in patients treated with EUCRISA and should be suspected in the event of severe pruritus, swelling, and erythema at the application site or at a distant site. Discontinue EUCRISA immediately and initiate appropriate therapy if signs and symptoms of hypersensitivity occur.

    Adverse Reactions

    The most common treatment-related adverse reaction occurring in clinical trials was application site pain, such as burning or stinging.

    Please see Full Prescribing Information and Patient Information

    EUCRISA is indicated for topical treatment of mild-to-moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.

    INDICATION

    EUCRISA (crisaborole) is indicated for topical treatment of mild‑to‑moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.

    EUCRISA is for topical use only and is not for ophthalmic, oral, or intravaginal use. For more information, please view the full prescribing information here.

    Please see full Prescribing Information.

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