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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 safety data for the 4-week pivotal trials*,1,2
PIVOTAL TRIALS ADVERSE REACTIONS IN ≥1% PATIENTS
  Crisaborole Pfizer (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 Crisaborole Pfizer and vehicle in a pooled analysis3

*This pooled data reflects information from Trial 1 and Trial 2 of the pivotal trials where patients enrolled were 2 years and older

Crisaborole Pfizer safety data for patients enrolled in the Open-Label Safety Extension study1,4

See Open-Label Safety Extension study design

TREATMENT-RELATED ADVERSE EVENTS OCCURRING IN ≥1% OF PATIENTS IN THE OPEN LABEL SAFETY EXTENSION STUDY
Crisaborole Pfizer (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 Crisaborole Pfizer3
    • 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 olderAs 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).
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ReferencesCrisaborole Pfizer 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.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. 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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