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Efficacy

Phase III Study Primary Endpoints

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

Study Design

Phase III Study Secondary Endpoints

ISGA clear or almost clear

Time to ISGA success

Phase III Study: Other Endpoints

Pruritus

Quality of life assessments

Infant Study: Exploratory efficacy Endpoints

ISGA clear or almost clear

%BSA, EASI & POEM

Safety Data

Phase III Study Adverse Reactions*

Pivotal trial & 48-week extension study
Adverse Reactions

Open-Label Safety Extension Study*

Open-Label Safety Extension Study Rescue ​​​​​​​Therapy Endpoint

Study design

Infant Safety Study**

Adverse Reactions

Study design and Demographics

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  • Prescribing Information
  • Patient Information
  • Patient Site
    •

    EUCRISA Efficacy

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

    In studies of patients aged 2 and up, significantly more EUCRISA patients achieved success in ISGA at Day 29, the primary efficacy endpoint1,3

    Success in ISGA, a stringent metric, is defined as Clear (0) or Almost Clear (1) AND at least a 2-grade improvement from baseline1 in patients 2 years and older

    TRIAL 1

    TRIAL 2

    View more

    ISGA=Investigator’s Static Global Assessment
    ​​​​​​​This study reflects information from the pivotal trial where patients enrolled were 2 years and older.

    What is vehicle?

    The Emollient-rich Vehicle control used in clinical studies is the same petrolatum-based, proprietary, nonmedicated ointment formulation in EUCRISA only without the active ingredient crisaborole. Ointments contain emollients which can help lock in moisture and soften the skin5.

    Utilizing a vehicle arm is a standard way to test the effect of a topical product. Comparing EUCRISA to the vehicle provided evidence of the effect of the active ingredient, crisaborole, in pivotal trials.

    About ISGA

    ISGA Scale2

    Not an actual patient. For illustrative purposes only.
    *Patients with clinical diagnosis of an ISGA of 4, 1, or 0 at baseline were excluded from enrollment.1,2
    ISGA=Investigator's Static Global Assessment. The ISGA is primarily used in clinical trials and rarely used in clinical practice.1,3

    EUCRISA was studied across a spectrum of patients
    See study design

    EUCRISA was studied as monotherapy in both treatment-naïve and treatment-experienced patients in the pivotal studies of patients aged 2 and up3†

    Actual patient treated with EUCRISA in clinical trials, who achieved success in ISGA, the primary efficacy endpoint.*
    ​​​​​​​All patients may not respond to treatment with EUCRISA. Individual results may vary.


    Day 8

    Day 15

    View more

    BEFORE: Day 1 (ISGA 3)

    Day 8 (ISGA 2)

    Day 15 (ISGA 2)

    Day 22

       Day 22 (ISGA 2)

    Day 29

       AFTER: Day 29 (ISGA 1)

    * Success in ISGA, a stringent metric, is defined as Clear (0) or Almost Clear (1) AND at least a 2-grade improvement from baseline at Day 29.1
    This study reflects information from the pivotal trial where patients enrolled were 2 years and older.
    ​​​​​​​
    † Prior AD treatment was utilized in 418 (41.0%) of EUCRISA patients and 230 (45.5%) of Emollient-Rich Vehicle patients. Prior AD treatment was not utilized in 598 (59.0%) of EUCRISA patients and 276 (54.5%) of Emollient-Rich Vehicle patients.

    Prior AD therapy defined as any prior use of systemic or topical corticosteroids or topical calcineurin inhibitors for the treatment of AD within 90 days before starting the study.

    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? Health 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.

    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

    Learn more

    ** 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

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

    3 to <24 Month Study Data

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

    See data

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

    Savings & Support Program

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

    See resources

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

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

    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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