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Phase 3 Study Primary Endpoints
Phase 3 Study Secondary and Other Endpoints
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
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
* 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.
Hear JP with mild-to-moderate AD explain what EUCRISA means to him and other babies like him
Not an actual patient
Read about rescue therapy in the 48 week Open-Label Safety Extension study
Find out more about the time to relief in pruritus as found in the Phase III study's exploratory endpoint
The specific mechanism(s) of action of crisaborole in atopic dermatitis is not well defined. PDE4=phosphodiesterase 4
*Eligible patients pay as little as $10
A savings and support program for your patients to help them with their access to EUCRISA
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To report an adverse event, please call 1-800-438-1985
Pfizer for Professionals 1-800-505-4426
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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.
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