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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 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 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- and 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 nonmedicated 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), and death (0).4

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

Patients could use nonmedicated 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), and death (0).4ISGA=Investigator’s Static Global Assessment; TCI=topical calcineurin inhibitor; TCS=topical corticosteroid.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 Rescue Therapy Endpoint

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

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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.

Please see Full Prescribing Information and Patient Information. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut. IndicationEUCRISA (crisaborole) is indicated for topical treatment of mild-to-moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.