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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 successPhase 3 Study: Other EndpointsPruritusQuality of Life AssessmentsInfant Study: Exploratory EndpointsISGA Clear or Almost Clear%BSA, EASI & POEM52-Week TrialSafety 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 Trial52-Week TrialReal PatientsReal Patient Case ReportsHand 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 - Digit70-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 - Leg72-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 safety data for the 4-week pivotal trials1,2*

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PIVOTAL TRIALS ADVERSE REACTIONS IN ≥1% PATIENTS
  EUCRISA (n=1012) Vehicle (n=499)
APPLICATION SITE PAIN1
Refers to skin sensations such as burning or stinging 		4% (n=45) 1% (n=6)
  • Application site pain resolved within 1 day for 77.6% of patients reporting it3
  • Discontinuation rates due to adverse events were 1.2% for both EUCRISA and vehicle in a pooled analysis3
EUCRISA safety data for patients enrolled in the Open-Label Safety Extension Study1,4

See Open-Label Safety Extension Study Design

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TREATMENT-RELATED ADVERSE EVENTS OCCURRING IN ≥1% OF PATIENTS IN THE OPEN LABEL SAFETY EXTENSION STUDY
EUCRISA (n=517)  
APPLICATION SITE PAIN2
Refers to skin sensations such as burning or stinging		 2% (n=12)
APPLICATION SITE INFECTION2 1% (n=6)
ATOPIC DERMATITIS2 3% (n=16)
  • In the Open-Label Safety Extension Study:
    • There were no reports of application site cutaneous adverse reactions of atrophy or telangiectasia4†‡
    • Discontinuation rate due to adverse events was 1.7% for EUCRISA3
    • Seven treatment-emergent SAEs occurred in the Open-Label Safety Extension Study, but none were considered related to treatment4
SAE=serious adverse event.
Patients enrolled in the Open-Label Safety Extension Study were enrolled following the pivotal trial and were followed for 48 weeks. The total period followed was 52 weeks.
This pooled data reflects information from Trial 1 and Trial 2 of the pivotal trials where patients enrolled were 2 years and older.As per verbatim terms coded using the Medical Dictionary for Regulatory Activities (MedDRA) by System Organ Class/Preferred Term.One treatment-emergent adverse event of skin striae at application site was reported (possibly related to study drug).
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.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.
Safety Data Rescue Therapy Endpoint

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

Learn moreLoading Exploratory Pruritus Endpoint

Find out more about the time to relief in pruritus as found as a Phase 3 study's exploratory endpoint

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Copay Cards Eligibility required. No membership fees. This is not health insurance. Individual savings limited to $970 per tube or $3,880 in maximum total savings per calender year. Only for use with commercial insurance. If you are enrolled in a state or federally funded prescription insurance program, you may not use the copay card. Terms and Conditions apply.

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

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Savings & Support Program

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

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*Limits, terms, and conditions apply.

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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.

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