Pruritus | EUCRISA® (crisaborole) ointment 2% HCP Site

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Efficacy

Phase 3 Study: Primary Endpoints

Success in ISGA: Clear or Almost Clear

Study Design

Phase 3 Study: Secondary and Other Endpoints

ISGA Clear or Almost Clear

Time to ISGA success

Phase 3 Study: Other Endpoints

Pruritus

Quality of Life Assessments

Infant Study: Exploratory Endpoints

ISGA Clear or Almost Clear

%BSA, EASI & POEM

52-Week Trial

Safety Data

Phase 3 Study Adverse Reactions*

Pivotal Trial & 48-Week Extension Study Adverse Reactions

Open-Label Safety Extension Study*

Open-Label Safety Extension Study Rescue Therapy Endpoint

Study Design

Infant Safety Study**

Adverse Reactions

Study Design and Demographics

52-Week Trial

Real Patients

Real Patient Case Reports

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Face and Neck

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Prescribing Information

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Indication

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Efficacy

In a post hoc analysis, median time to improvement* in pruritus was seen in 4 days with EUCRISA³

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

Median 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 Baseline^3,9
At Baseline, pruritus was Moderate in 46% (n=352) and 44% (n=162) of EUCRISA and Emollient-rich Vehicle patients, respectively^3,†

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 Baseline^3,9
At Baseline, pruritus was Moderate in 46% (n=352) and 44% (n=162) of EUCRISA and Emollient-rich Vehicle patients, respectively^3,†

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.⁹

Proportion 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 description^3,9

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 scale^3,9

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

Comparisons between EUCRISA and Emollient-rich Vehicle cannot be made as the study was not designed for this purpose.⁹

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.⁹

Improvement was defined as a weekly mean SPS score of ≤1 with at least a 1-point improvement from baseline.⁹

This study reflects information from the pivotal trials where patients enrolled were 2 years and older.

References

EUCRISA® (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

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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 as a Phase 3 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.

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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.