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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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Phase III Study: Other Endpoints

Pruritus

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Infant Study: Exploratory efficacy Endpoints

ISGA clear or almost clear

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Safety Data

Phase III Study Adverse Reactions*

Pivotal trial & 48-week extension study
Adverse Reactions

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Infant Safety Study**

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  • Prescribing Information
  • Patient Information
  • Patient Site
  • EUCRISA Safety Data

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

    Safety outcomes in patients aged 3 to <24 months

    ​​​​​​​Open-label, single-arm, 28-day study designed to evaluate the safety of EUCRISA (n=137)2

    MOST FREQUENTLY REPORTED TREATMENT-RELATED ADVERSE EVENTS IN ≥2.5% OF PATIENTS

    *Application site erythema was also reported in 2.2% (n=3) of patients
    ​​​​​​​
    • The most frequently reported (>5%) all-cause TEAEs were pyrexia (9.5%), upper respiratory tract infection (7.3%), diarrhea (7.3%), dermatitis atopic (6.6%), dermatitis diaper (6.6%), and cough (5.1%)2
    • Discontinuation rate due to TEAEs was 2.9% (n=4) for EUCRISA (all remained in the study)2
      • One patient experienced a serious TEAE of febrile convulsion (not related to treatment)2,3
    Limitations
    • Outcomes were reported by a caregiver or investigator2

    AE=adverse events, TEAE=treatment-emergent adverse event

    *Application site erythema was also reported in 2.2% (n=3) of patients
    ​​​​​​​
    • The most frequently reported (>5%) all-cause TEAEs were pyrexia (9.5%), upper respiratory tract infection (7.3%), diarrhea (7.3%), dermatitis atopic (6.6%), dermatitis diaper (6.6%), and cough (5.1%)2
    • Discontinuation rate due to TEAEs was 2.9% (n=4) for EUCRISA (all remained in the study)2
      • One patient experienced a serious TEAE of febrile convulsion (not related to treatment)2,3

    Limitations

    • Outcomes were reported by a caregiver or investigator2


    ​​​​​​​AE=adverse events, TEAE=treatment-emergent adverse event

    No new safety issues of concern were identified by clinical laboratory findings - ECG, height, weight, or vital signs

    EUCRISA was studied in patients aged 3 to <24 months
    See Infant Safety Study Design

    Hear JP with mild-to-moderate AD explain what EUCRISA means to him and babies like him

    Not an actual patient

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

    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.
    3. 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.
    4. Eichenfield LF, Call RS, Forsha DW, et al. Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis. J Am Acad Dermatol. 2017;77(4):641-649.e5.

    Pivotal Trial Primary Safety Endpoint

    Find out more about EUCRISA's adverse event profile at day 29 from the pivotal studies

    Learn more

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

    Rescue Therapy Endpoint

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

    Learn more

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

    Infant Safety Study Design

    Learn more about Infant Safety Study design and baseline demographics

    Learn more

    ** 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

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

    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.

    Download Copay cards

    ** 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

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    Order Samples

    Register or sign in to check availability and request samples.

    Order now

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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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