• Prescribing Information
  • Patient Information
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  • Phase III Study Primary Endpoint*
    Phase III Study Secondary Endpoints*
    Phase III Study: Other Endpoints*
    Infant Study: Exploratory Endpoint**

    *Phase III pivotal studies and open-label safety extension study investigated in patients 2 years and older

    **Infant study investigated patients aged 3 to <24 months

    *Phase III pivotal studies and open-label safety extension study investigated in patients 2 years and older

    **Infant study investigated patients aged 3 to <24 months

    EUCRISA Efficacy

    Steroid-Free EUCRISA has proven efficacy in patients ≥ 2 years

    Pooled data from the pivotal trials of patients aged 2 and up: an exploratory post hoc analysis with 28 days of treatment11

    Median time to improvement in pruritus3

    POOLED

    INDIVIDUAL

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    • Improvement was defined as a daily mean Severity of Pruritus Scale (SPS) score of ≤1 with at least a 1-point improvement from baseline3,9
    • At baseline, pruritus was moderate in 46% (n=352) and 44% (n=162) of EUCRISA and Emollient-rich Vehicle patients, respectively3,†
    • Improvement was defined as a daily mean Severity of Pruritus Scale (SPS) score of ≤1 with at least a 1-point improvement from baseline3,9
    • At baseline, pruritus was moderate in 46% (n=352) and 44% (n=162) of EUCRISA and Emollient-rich Vehicle patients, respectively3,†
    General Limitations
    • Subjects with fewer than 2 SPS assessments on Day 1 and fewer than 2 SPS assessments on Day 2 (30%) were considered as missing data and were excluded from this analysis
    • The protocol did not specify who should complete the SPS assessment. This resulted in the combination of parent/guardian and patient-reported data

      *Baseline was the mean of at least 2 SPS assessments on Day 1. SPS daily values were the mean of at least 2 SPS assessments on that day9.

     †Proportion of patients and their reported SPS scores at Baseline: Mild: EUCRISA 24% (n=183) and Emollient-rich Vehicle 28% (n=104). Severe: EUCRISA 28% (n=214) and Emollient-rich Vehicle 26% (n=98).

    Comparisons between EUCRISA and Emollient-rich Vehicle cannot be made as the study was not designed for this purpose.

    Post hoc analysis study description3,9

    Pivotal Trial

    • Prespecified endpoints: Time to improvement in pruritus and proportion of patients with improvement in pruritus
    • Endpoints were assessed using the Severity of Pruritus Scale (SPS) which, at that time, had yet to be validated
    • Patients or parents/guardians were asked to record their or their child's itching and/or scratching in the SPS twice a day. SPS data were analyzed using a single SPS observation from each day
    • ​​​​​​​Each observation within a day was analyzed as a discrete observation and used to determine the first improvement after dosing

    Post Hoc

    • SPS was validated through qualitative study and quantitative analysis to establish its validity and reliability as a measure of pruritus in atopic dermatitis
    • Validation analysis determined that an average of ≤2 SPS observations is necessary to provide a reliable measure of pruritus severity
    • A post hoc analysis was conducted using the validated measure
    • ​​​​​​​Baseline was the mean of ≤2 SPS assessments on Day 1

    Severity of pruritus scale3,9

    The SPS is a patient- or parent/guardian-reported outcome using a 4-point scale measuring pruritus over the past 24 hours.

    None: No itching

    Mild: Occasional, slight itching/scratching

    Moderate: Constant or intermittent itching/scratching which is not disturbing sleep

    Severe: Bothersome itching/scratching which is disturbing sleep

    Please note: Sleep disturbance was not measured in this assessment and was only used as a descriptive anchor in the verbal rating scale to indicate higher levels of itch severity.


    Pooled data results from an exploratory post hoc analysis*

    Proportion of patients with improvement in pruritus3

    POOLED

    TRIAL 1

    TRIAL 2

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    General Limitations
    • Subjects with fewer than 2 SPS assessments on Day 1 and had no post-baseline data (26%) were considered missing data and were excluded from the analysis set
    • The protocol did not specify who should complete the SPS assessment. This resulted in the combination of parent/guardian and patient-reported data

      *Baseline was the mean of at least 2 SPS assessments on Day 1. SPS daily values were the mean of at least 2 SPS assessments on that day.

     †Improvement was defined as a weekly mean SPS score of ≤1 with at least a 1-point improvement from baseline.9

      Comparisons between EUCRISA and Emollient-rich Vehicle cannot be made as the study was not designed for this purpose.9

      This study reflects information from the pivotal trial where patients enrolled were 2 years and older.

    References
    1. EUCRISA® (crisaborole) Full Prescribing Information. April 2020.
    2. Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016;75(3):494-503.e4.
    3. Data on File. Pfizer Inc., New York, NY.
    4. Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AV. Translating the science of quality of life into practice: what do Dermatology Life Quality Index scores mean? J Invest Dermatol. 2005;125(4):659-664.
    5. Waters A, Sandhu D, Beattie P, Ezughah F, Lewis-Jones S. Severity stratification of Children's Dermatology Life Quality Index (CDLQI) scores. Br J Dermatol. 2010;163(suppl 1):121.
    6. Lewis-Jones S. Quality of life and childhood atopic dermatitis: the misery of living with childhood eczema. Int J Clin Pract. 2006;60(8):984-992.
    7. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQl)-a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210-216.
    8. Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AV. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015;230(1):27-33.
    9. Schünemann HJ, Guyatt GH. Commentary goodbye M(C)ID! Hello MID, where do you come from? He​​​​​​​alth Serv Res. 2005;40(2):593-597.
    10. Langley RG, Paller AS, Hebert AA, et al. Patient-reported outcomes in pediatric patients with psoriasis undergoing etanercept treatment: 12-week results from a phase Ill randomized controlled trial. J Am Acad Dermatol. 2011;64(1):64-70.
    11. Lewis-Jones MS, Finlay AV. The children's dermatology life quality index (CDLQI): initial validation and practical use. Br J Dermatol. 1995;19(3):210-216.
    12. Eichenfield LF, Tom WL, Berger TJ, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71(1)116-132.
    13. Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70(2):338-351.
    14. 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.

    Pivotal Trial Primary Efficacy Endpoint

    Find out more about the proportion of patients who achieved clear or almost clear at day 29 in the primary endpoint

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    ** This is an optional area where footnotes can live.

    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

    3 to <24 Month Study Data

    Learn more about 28-day, open-label, single-arm, safety study in 3 to <24 month old patients14

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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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    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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    Copay Cards

    *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.