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HomeEfficacy

Phase 3 Study Primary Endpoints

Success in ISGA: Clear or almost clearStudy Design

Phase 3 Study Secondary and Other Endpoints

ISGA clear or almost clearTime to ISGA successPhase 3 Study: Other EndpointsPruritusQuality of life assessmentsInfant Study: Exploratory EndpointsISGA clear or almost clear%BSA, EASI & POEM52-Week TrialSafety DataSafety DataPhase 3 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 Demographics52-Week TrialReal PatientsReal patient case reportsReal patient case studiesNana's experience with EucrisaBraxton's testimonialHand and fingerFace and neckOtherHand and finger5-yr-old Caucasian female - hands8-yr-old Caucasian female - hands15-yr-old Caucasian male - hand55-yr-old Caucasian female - hand64-yr-old Caucasian female - thumb70-yr-old Caucasian male - thumbFace and neck15-yr-old Caucasian male - chin18-yr-old Hispanic female - face and neck75-yr-old Caucasian male - faceOther39-yr-old Asian male - arm44-yr-old African American female - legs72-yr-old Caucasian female - legDosingSavings & SupportSavings & SupportEventsMaterialsVideosCopay CardsCost and Coverage
Prescribing InformationPatient Information Indication Patient Site
EfficacyIn a post-hoc analysis, median time to improvement* in pruritus was seen in 4 days with EUCRISA3*Baseline was the mean of at least 2 SPS assessments on Day 1. SPS daily values were the mean of at least 2 SPS assessments on that day.3

Pooled data from the pivotal trials of patients aged 2 and up: an exploratory post hoc analysis with 28 days of treatment11

Pooled data from the pivotal trials of patients aged 2 and up: an exploratory post hoc analysis with 28 days of treatment11Median time to improvement in pruritus3

POOLED

INDIVIDUAL

  • Improvement was defined as a daily mean Severity of Pruritus Scale (SPS) score of ≤1 with at least a 1-point improvement from baseline3,9
  • At baseline, pruritus was moderate in 46% (n=352) and 44% (n=162) of EUCRISA and Emollient-rich Vehicle patients, respectively3,†
Comparisons between EUCRISA and Emollient-rich Vehicle cannot be made as the study was not designed for this purpose.
  • Improvement was defined as a daily mean Severity of Pruritus Scale (SPS) score of ≤1 with at least a 1-point improvement from baseline3,9
  • At baseline, pruritus was moderate in 46% (n=352) and 44% (n=162) of EUCRISA and Emollient-rich Vehicle patients, respectively3,†
Comparisons between EUCRISA and Emollient-rich Vehicle cannot be made as the study was not designed for this purpose.

General Limitations

  • Subjects with fewer than 2 SPS assessments on Day 1 and fewer than 2 SPS assessments on Day 2 (30%) were considered as missing data and were excluded from this analysis
  • The protocol did not specify who should complete the SPS assessment. This resulted in the combination of parent/guardian and patient-reported data
Baseline was the mean of at least 2 SPS assessments on Day 1. SPS daily values were the mean of at least 2 SPS assessments on that day.9Proportion of patients and their reported SPS scores at Baseline: Mild: EUCRISA 24% (n=183) and Emollient-rich Vehicle 28% (n=104). Severe: EUCRISA 28% (n=214) and Emollient-rich Vehicle 26% (n=98).

POOLED

TRIAL 1

TRIAL 2

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Post hoc analysis study description3,9

Pivotal Trial

  • Prespecified endpoints: Time to improvement in pruritus and proportion of patients with improvement in pruritus
  • Endpoints were assessed using the Severity of Pruritus Scale (SPS) which, at that time, had yet to be validated
  • Patients or parents/guardians were asked to record their or their child's itching and/or scratching in the SPS twice a day. SPS data were analyzed using a single SPS observation from each day
  • Each observation within a day was analyzed as a discrete observation and used to determine the first improvement after dosing

Post Hoc

  • SPS was validated through qualitative study and quantitative analysis to establish its validity and reliability as a measure of pruritus in atopic dermatitis
  • Validation analysis determined that an average of ≤2 SPS observations is necessary to provide a reliable measure of pruritus severity
  • A post hoc analysis was conducted using the validated measure
  • Baseline was the mean of ≤2 SPS assessments on Day 1
Severity of pruritus scale3,9

The SPS is a patient- or parent/guardian-reported outcome using a 4-point scale measuring pruritus over the past 24 hours.

0. None: No itching
1. Mild: Occasional, slight itching/scratching
2. Moderate: Constant or intermittent itching/scratching which is not disturbing sleep
3. Severe: Bothersome itching/scratching which is disturbing sleep

Please note: Sleep disturbance was not measured in this assessment and was only used as a descriptive anchor in the verbal rating scale to indicate higher levels of itch severity.Pooled data results from an exploratory post hoc analysis*Proportion of patients with improvement† in pruritus3

POOLED

TRIAL 1

TRIAL 2

General Limitations

  • Subjects with fewer than 2 SPS assessments on Day 1 and had no post-baseline data (26%) were considered missing data and were excluded from the analysis set
  • The protocol did not specify who should complete the SPS assessment. This resulted in the combination of parent/guardian and patient-reported data
Baseline was the mean of at least 2 SPS assessments on Day 1. SPS daily values were the mean of at least 2 SPS assessments on that day.Improvement was defined as a weekly mean SPS score of ≤1 with at least a 1-point improvement from baseline.9Comparisons between EUCRISA and Emollient-rich Vehicle cannot be made as the study was not designed for this purpose.9This study reflects information from the pivotal trial where patients enrolled were 2 years and older.
ReferencesEUCRISA® (crisaborole) Full Prescribing Information. April 2023.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.Eichenfield LF, Tom WL, Berger TJ, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71(1)116-132.Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70(2):338-351.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.
Efficacy Pivotal Trial Primary Efficacy Endpoint

Find out more about the proportion of patients who achieved clear or almost clear at day 29 in the primary endpoint

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 3 to <24 Month Study Data

Learn more about 28-day, open-label, single-arm, safety study in 3 to <24 month old patients14

 See data Loading 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

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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

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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.

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.
Important Safety Information

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

Indication EUCRISA is indicated for topical treatment of mild-to-moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.Important Safety Information 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. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut. IndicationEUCRISA (crisaborole) is indicated for topical treatment of mild-to-moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.