Crisaborole Pfizer

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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 EfficacySteroid-Free Crisaborole Pfizer has proven efficacy in patients ≥ 2 years

See all endpoints for Efficacy

In studies of patients aged 2 and up, significantly more Crisaborole Pfizer patients achieved success in ISGA at Day 29, the primary efficacy endpoint1,3

Success in ISGA, a stringent metric, is defined as Clear (0) or Almost Clear (1) AND at least a 2-grade improvement from baseline1 in patients 2 years and older

TRIAL 1

TRIAL 2

ISGA=Investigator’s Static Global Assessment
This study reflects information from the pivotal trial where patients enrolled were 2 years and older.
What is vehicle?

The Emollient-rich Vehicle control used in clinical studies is the same petrolatum-based, proprietary, nonmedicated ointment formulation in Crisaborole Pfizer only without the active ingredient crisaborole. Ointments contain emollients which can help lock in moisture and soften the skin5.

Utilizing a vehicle arm is a standard way to test the effect of a topical product. Comparing Crisaborole Pfizer to the vehicle provided evidence of the effect of the active ingredient, crisaborole, in pivotal trials.

About ISGA

ISGA Scale2

Not an actual patient. For illustrative purposes only.
*Patients with clinical diagnosis of an ISGA of 4, 1, or 0 at baseline were excluded from enrollment.1,2
ISGA=Investigator's Static Global Assessment. The ISGA is primarily used in clinical trials and rarely used in clinical practice.1,3

Crisaborole Pfizer was studied across a spectrum of patients

See study designLoadingCrisaborole Pfizer was studied as monotherapy in both treatment-naïve and treatment-experienced patients in the pivotal studies of patients aged 2 and up3†

Actual patient treated with Crisaborole Pfizer in clinical trials, who achieved success in ISGA, the primary efficacy endpoint.*
All patients may not respond to treatment with Crisaborole Pfizer. Individual results may vary.

Tab Number 1

Tab Number 2

Tab Number 3

Tab Number 4

  BEFORE: Day 1 (ISGA 3)

  Day 8 (ISGA 2)

  BEFORE: Day 1 (ISGA 3)

  Day 15 (ISGA 2)

  BEFORE: Day 1 (ISGA 3)

   Day 22 (ISGA 2)

  BEFORE: Day 1 (ISGA 3)

   AFTER: Day 29 (ISGA 1)

Success in ISGA, a stringent metric, is defined as Clear (0) or Almost Clear (1) AND at least a 2-grade improvement from baseline at Day 29.1
This study reflects information from the pivotal trial where patients enrolled were 2 years and older.Prior AD treatment was utilized in 418 (41.0%) of Crisaborole Pfizer patients and 230 (45.5%) of Emollient-Rich Vehicle patients. Prior AD treatment was not utilized in 598 (59.0%) of Crisaborole Pfizer patients and 276 (54.5%) of Emollient-Rich Vehicle patients.

Prior AD therapy defined as any prior use of systemic or topical corticosteroids or topical calcineurin inhibitors for the treatment of AD within 90 days before starting the study.

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ReferencesCrisaborole Pfizer Full Prescribing Information. April 2020.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.Data on File. Pfizer Inc., New York, NY.Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AV. Translating the science of quality of life into practice: what do Dermatology Life Quality Index scores mean? J Invest Dermatol. 2005;125(4):659-664.Waters A, Sandhu D, Beattie P, Ezughah F, Lewis-Jones S. Severity stratification of Children's Dermatology Life Quality Index (CDLQI) scores. Br J Dermatol. 2010;163(suppl 1):121.Lewis-Jones S. Quality of life and childhood atopic dermatitis: the misery of living with childhood eczema. Int J Clin Pract. 2006;60(8):984-992.Finlay AY, Khan GK. Dermatology Life Quality Index (DLQl)-a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210-216.Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AV. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015;230(1):27-33.Schünemann HJ, Guyatt GH. Commentary goodbye M(C)ID! Hello MID, where do you come from? Health Serv Res. 2005;40(2):593-597.Langley RG, Paller AS, Hebert AA, et al. Patient-reported outcomes in pediatric patients with psoriasis undergoing etanercept treatment: 12-week results from a phase Ill randomized controlled trial. J Am Acad Dermatol. 2011;64(1):64-70.Lewis-Jones MS, Finlay AV. The children's dermatology life quality index (CDLQI): initial validation and practical use. Br J Dermatol. 1995;19(3):210-216.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.
 Proportion of patients with ISGA Clear or Almost Clear

Find out more about the proportion of patients aged 2 years and older who achieved ISGA clear or almost clear at day 29 from the Phase III trial's secondary endpoint

 Learn more Loading 3 to <24 Month Study Data

Learn more about 28-day, open-label, single-arm, safety study in 3 to <24 month old patients12

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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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