EUCRISA was studied across a spectrum of patients
EUCRISA was studied in two multicenter, randomized, double-blind, vehicle-controlled trials treating 1522 patients with mild-to-moderate atopic dermatitis (EUCRISA n=1016, vehicle n=506)1,2
- The study included treatment-naïve and treatment-experienced patients following an appropriate washout period 3
Key inclusion area:
- 2 years of age or older
- Clinical diagnosis of ISGA Mild (2) or Moderate (3) atopic dermatitis
- Atopic dermatitis involvement ≥ 5% treatable BSA (excluding scalp)
Key exclusion criteria:
- TCS or TCI use within 14 days of study
- Significant active infection
- Any previous use of biologic therapy
- Systemic corticosteroid or immunosuppressant use within 28 days of study
- a5 patients were randomized but did not receive EUCRISA.2
- bIn the pivotal trials, races other than Caucasian included American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or other Pacific Islander, Other.3
The Emollient-rich Vehicle control used in clinical studies is the same petrolatum-based, proprietary, nonmedicated ointment formulation in EUCRISA only without the active ingredient crisaborole. Ointments contain emollients which can help lock in moisture and soften the skin.5
Utilizing a vehicle arm is a standard way to test the effect of a topical product. Comparing EUCRISA to the vehicle provided evidence of the effect of the active ingredient, crisaborole, in pivotal trials.
Clinical trial endpoints
- Primary efficacy endpoint
- Proportion of patients achieving success in ISGA* at Day 29, a stringent metric, defined as Clear (0) or Almost Clear (1) AND at least a 2-grade improvement from baseline2
- Secondary efficacy endpoints
- Time to success in ISGA,*† defined as the proportion of patients achieving an ISGA of Clear (0) or Almost Clear (1) AND at least a 2-grade improvement from baseline2
- Proportion of patients who achieved an ISGA of Clear (0) or Almost Clear (1) at Day 292
- Primary safety assessments
- Adverse events, vital signs, ECGs, and clinical laboratory parameters2
- Other endpoints
- Dermatology-related Quality of Life (QoL) Assessments3
- Change from baseline in mean dermatology-related QoL scores: Children’s Dermatology Life Quality Index (CDLQI) and Dermatology Life Quality Index (DLQI)
- Pruritus related Assessment
- Time to improvement in Pruritus (SPS)
- Portion of patients who achieved improvement in pruritus (SPS)
†Physician evaluation at Days 1 (baseline), 8, 15, 22, 29.2
ISGA=Investigator's Static Global Assessment; BSA=body surface area; TCS=topical corticosteroids; TCl=topical calcineurin inhibitors.
- EUCRISA® (crisaborole) Full Prescribing Information. December 2018.
- 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.
- 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.
- Eichenfield LF, Tom WL, Berger TG, 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.