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
SELECT SCREENING CRITERIA1,2

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)
*Success in ISGA, a stringent metric, is defined as Clear (0) or Almost Clear (1) AND at least a 2-grade improvement from baseline.1
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.
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References

  1. EUCRISA® (crisaborole) Full Prescribing Information. December 2018.
  2. 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.
  3. Data on File. Pfizer Inc., New York, NY.
  4. 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.
  5. 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.