Infant Safety Study

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Phase III Study Primary Endpoint*

Success in ISGA: Clear or almost clear

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 Endpoint**

ISGA clear or almost clear %BSA, EASI & POEM

*Phase III pivotal studies and open-label safety extension study investigated in patients 2 years and older

**Infant study investigated patients aged 3 to <24 months

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

*Phase III pivotal studies and open-label safety extension study investigated in patients 2 years and older

**Infant study investigated patients aged 3 to <24 months

Real-World Patients

Savings & Support

Phase III Study Primary Endpoint*

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 Endpoint**

ISGA clear or almost clear %BSA, EASI & POEM

*Phase III pivotal studies and open-label safety extension study investigated in patients 2 years and older
**Infant study investigated patients aged 3 to <24 months

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

*Phase III pivotal studies and open-label safety extension study investigated in patients 2 years and older
**Infant study investigated patients aged 3 to <24 months

JAKi Experience

JAKi experience

Clinical trial exposure JAKi market experience Mechanism of action

Savings and Support

XELSOURCE^SM patient support Co-Pay Savings Card Patient resources HCP resources

Dosing and Administration

Dosing and administration in RA/PsA

Dosing considerations Dosing adjustments Lab abnormalities Lab monitoring

Dosing and administration in UC

Dosage considerations Dosage adjustments Lab monitoring

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

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References

EUCRISA® (crisaborole) Full Prescribing Information. April 2020.
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.
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.

Pivotal Trial Primary Safety Endpoint

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

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Rescue Therapy Endpoint

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

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Infant Safety Study Design

Learn more about Infant Safety Study design and baseline demographics

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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

Learn more

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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

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Savings & Support Program

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

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Order Samples

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Patient Assistance

PP-CRI-USA-2882

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.