Study Design | Crisaborole Pfizer | Safety Info | Rwanda

Overview

About ISGA

Baseline Characteristics

Crisaborole Pfizer was studied across a spectrum of patients

Crisaborole Pfizer was studied in two multicenter, randomized, double-blind, vehicle-controlled trials treating 1522 patients 2 years and older with mild-to-moderate atopic dermatitis (Crisaborole Pfizer n=1016, vehicle n=506)^1,2I

The study included treatment-naïve and treatment-experienced patients following an appropriate washout period²

SELECT ENROLLMENT CRITERIA^1,2

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 Crisaborole Pfizer.²

BASELINE CHARACTERISTICS OF PATIENTS, POOLED DATA

^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.²

What is vehicle?

The Emollient-rich Vehicle control used in clinical studies is the same petrolatum-based, proprietary, nonmedicated ointment formulation in Crisaborole Pfizer 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 Crisaborole Pfizer 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) Assessments²
  - Change from baseline in mean dermatology-related QoL scores: Children’s Dermatology Life Quality Index (CDLQI) and Dermatology Life Quality Index (DLQI)
- Exploratory pruritus endpoints
  - Time to improvement in Pruritus: Severity of Pruritus Score (SPS)
  - Proportion 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=lnvestigator's Static Global Assessment; BSA=body surface area; TCS=topical corticosteroids; TCl=topical calcineurin inhibitors.

References

Crisaborole Pfizer Full Prescribing Information. April 2020.

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.

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.

ISGA Scale²

Tab Number 1

Tab Number 2

Tab Number 3

Tab Number 4

Tab Number 5

ISGA Grade 4

Severe*:
Deep or bright red erythema, with severe induration/papulation and with oozing/crusting

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

ISGA Grade 3

Moderate:
Pink-red erythema, with moderate induration/papulation and no oozing/crusting

ISGA Grade 2

Mild:
Faint pink erythema, with mild induration/papulation, no oozing/crusting

ISGA Grade 1

Almost clear:
Trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting

ISGA Grade 0

Clear:
Minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting

References

Crisaborole Pfizer Full Prescribing Information. April 2020.

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 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.

Crisaborole Pfizer was studied across a spectrum of patients

Crisaborole Pfizer baseline characteristics in pivotal trials²

TRIAL 1 AND TRIAL 2 POOLED^a

Crisaborole, 2%
(n=1016)

Vehicle (n=506)

Age (years)

Mean (SD)	12.3 (12.16)	12.1 (11.65)
Median	9.0	9.0
Min to max	2 to 79	2 to 79
2-11 years	627 (61.7%)	315 (62.3%)
2-6 years	335 (33.0%)	171 (33.8%)
7-11 years	292 (28.7%)	144 (28.5%)
12-17 years	247 (24.3%)	124 (24.5%)
>18 years	142 (14.0%)	67 (13.2%)

Sex

Male	450 (44.3%)	225 (44.5%)
Female	566 (55.7%)	281 (55.5%)

Ethnicity

Not Hispanic or Latino	816 (80.3%)	405 (80.0%)
Hispanic or Latino	200 (19.7%)	101 (20%)

Race

White	617 (60.7%)	306 (60.5%)
Black or African American	285 (28.1%)	139 (27.5%)
Asian	52 (5.1%)	27 (5.3%)
Other^b	44 (4.3%)	21 (4.2%)
Native Hawaiian or Pacific Islander	7 (0.7%)	8 (1.6%)
American Indian or Alaska Native	11 (1.1%)	5 (1.0%)

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

References

Crisaborole Pfizer Full Prescribing Information. April 2020.