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HomeEfficacy

Phase 3 Study Primary Endpoints

Success in ISGA: Clear or almost clearStudy Design

Phase 3 Study Secondary and Other Endpoints

ISGA clear or almost clearTime to ISGA success
Phase 3 Study: Other EndpointsPruritusQuality of life assessmentsInfant Study: Exploratory EndpointsISGA clear or almost clear%BSA, EASI & POEM52-Week Trial
Safety DataSafety DataPhase 3 Study Adverse Reactions*Pivotal trial & 48-week extension study Adverse ReactionsOpen-Label Safety Extension Study*Open-Label Safety Extension Study Rescue Therapy EndpointStudy designInfant Safety Study**Adverse ReactionsStudy design and Demographics52-Week TrialReal PatientsReal patient case reportsReal patient case studiesNana's experience with EucrisaBraxton's testimonialHand and fingerFace and neckOtherHand and finger5-yr-old Caucasian female - hands8-yr-old Caucasian female - hands15-yr-old Caucasian male - hand55-yr-old Caucasian female - hand64-yr-old Caucasian female - thumb70-yr-old Caucasian male - thumbFace and neck15-yr-old Caucasian male - chin18-yr-old Hispanic female - face and neck75-yr-old Caucasian male - faceOther39-yr-old Asian male - arm44-yr-old African American female - legs72-yr-old Caucasian female - legDosingSavings & SupportSavings & SupportEventsMaterialsVideosCopay CardsCost and Coverage
Prescribing InformationPatient Information Indication Patient Site
Safety DataSafety profile established in 5 studies, including pivotal and open-label safety extension studies, and an open-label infant safety studyEUCRISA study design for Open-Label Safety Extension study1,2 OPEN-LABEL SAFETY EXTENSION STUDY2,4

Eligible patients who completed Pivotal Trial 1 and Pivotal Trial 2 were enrolled in the open-label safety extension study.2

517 patients were cycled on or off therapy in 4-week intervals per study protocol for 48 weeks. Adverse events, serious adverse events, clinical laboratory results, local tolerability, vital signs and physical examinations were evaluated.

The open-label extension study did not evaluate the efficacy in EUCRISA

Open-Label Safety Extension (AD-303)4

Participants in Trials 1 and 2 were given the option of participating in a long-term, open-label, single-arm safety study for 48 weeks; patients from both the EUCRISA and Emollient-rich Vehicle arms of the pivotal trials were eligible to participate

Open-Label Safety Extension Primary Endpoints

  • Adverse events and serious adverse events
  • Changes in disease severity, including the concomitant use of TCS or TCI rescue medications3
Patients could use non-medicated emollients as needed in an off-treatment period.246 patients were discontinued in the open-label safety extension study. Reasons for discontinuation were: sponsor closure of the study (109), withdrawal by parent or guardian (63), lost to follow-up (36), withdrawal by patient (23), adverse event (9), other (6), death (0).4ISGA=Investigator’s Static Global Assessment; TCS=topical corticosteroid; TCI=topical calcineurin inhibitor.

OPEN-LABEL SAFETY EXTENSION STUDY2,4

Eligible patients who completed Pivotal Trial 1 and Pivotal Trial 2 were enrolled in the open-label safety extension study.2
517 patients were cycled on or off therapy in 4-week intervals per study protocol for 48 weeks. Adverse events, serious adverse events, clinical laboratory results, local tolerability, vital signs and physical examinations were evaluated.
The open-label extension study did not evaluate the efficacy of EUCRISA

Open-Label Safety Extension (AD-303)4
Participants in Trials 1 and 2 were given the option of participating in a long-term, open-label, single-arm safety study for 48 weeks; patients from both the EUCRISA and Emollient-rich Vehicle arms of the pivotal trials were eligible to participate

Open-Label Safety Extension Primary Endpoints

  • Adverse events and serious adverse events
  • Changes in disease severity, including the concomitant use of TCS or TCI rescue medications3

* Patients could use non-medicated emollients as needed in an off-treatment period.
246 patients were discontinued in the open-label safety extension study. Reasons for discontinuation were: sponsor closure of the study (109), withdrawal by parent or guardian (63), lost to follow-up (36), withdrawal by patient (23), adverse event (9), other (6), death (0).4

ISGA=Investigator’s Static Global Assessment; TCS=topical corticosteroid; TCI=topical calcineurin inhibitor.

Trial 1 and Trial 2.This study reflects information from the pivotal trials where patients enrolled were 2 years and older.ReferencesEUCRISA® (crisaborole) Full Prescribing Information. April 2023.Data on File. Pfizer Inc., New York, NY.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.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.
Safety Data 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

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Not an actual patient

Rescue Therapy Endpoint

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

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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

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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

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Copay Cards

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

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 Loading
Savings & Support Program

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

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PP-EUC-USA-0032
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.

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.
Important Safety Information

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

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