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HomeAboutAboutMechanism of ActionMechanism of ActionEfficacyEfficacyPhase III Study Primary EndpointsSuccess in ISGA: Clear or almost clearStudy DesignPhase III Study Secondary EndpointsISGA clear or almost clearTime to ISGA successPhase III Study: Other EndpointsPruritusQuality of life assessmentsInfant Study: Exploratory efficacy EndpointsISGA clear or almost clear%BSA, EASI & POEMSafetySafetyImportant Safety InformationPhase III 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 DemographicsDosingMedical InformationVisit the Pfizer Medical Information Africa Website for Healthcare ProfessionalsSubmit a medical question to Pfizer

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Crisaborole Pfizer Safety DataSafety profile established in 4 studies, including pivotal and open-label safety extension studies, and an open-label infant safety study

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Crisaborole Pfizer 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 Crisaborole Pfizer

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 Crisaborole Pfizer 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

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    *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.
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ReferencesCrisaborole Pfizer (crisaborole) Full Prescribing Information. April 2020.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.e4Eichenfield 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. 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 in the Phase III study's exploratory endpoint

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Learn how 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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