EfficacyIn a post hoc analysis, median time to improvement* in pruritus was seen in 4 days with EUCRISA3Pooled 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 pruritus3POOLED
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
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Post hoc analysis study description3,9Pivotal 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 scale3,9The 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 pruritus3POOLED
TRIAL 1
TRIAL 2
Comparisons between EUCRISA and Emollient-rich Vehicle cannot be made as the study was not designed for this purpose.9General 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.9Improvement was defined as a weekly mean SPS score of ≤1 with at least a 1-point improvement from baseline.9This study reflects information from the pivotal trials 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.