OVERVIEW

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 1016, vehicle 506)1,2

  • The study included treatment-naïve and treatment-experienced patients following an appropriate washout period3

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

What is vehicle?


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
  • Additional 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)

    Investigator's Static Global Assessment: The ISGA is a 5-point scale from Clear (0) to Severe (4). Clear (0) is defined as minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting. Almost Clear (1) is defined as trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting.1,2

    *Success in ISGA, a stringent metric, is defined as Clear (O) 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=lnvestigator's Static Global Assessment; BSA=body surface area; TCS=topical corticosteroids; TCl=topical calcineurin inhibitors.


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.

ABOUT
ISGA

ISGA Scale2

Not an actual patient. For illustrative purposes only.
*Patients with clinical diagnosis of an ISGA of 4, 1, or 0 at baseline were excluded from enrollment.1,2
The ISGA is primarily used in clinical trials and rarely used in clinical practice.4


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.

BASELINE
CHARACTERISTICS

EUCRISA was studied across a spectrum of patients

EUCRISA baseline characteristics in pivotal trials3

BASELINE PATIENT CHARACTERISTICS3

TRIAL 1 AND TRIAL 2 POOLEDa Crisaborole, 2% (N=1016) Vehicle (N=506)

aTrial 1 and Trial 2 pooled data.
bIncludes American Indian, Alaska Native, Native Hawaiian, Pacific Islander, or Other.
SD=standard deviation.


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.