Evaluating the Efficacy of Crisaborole Using the Atopic Dermatitis Severity Index and Percentage of Affected Body Surface Area

Abstract

Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis. This post hoc analysis pools results from 2 phase 3 studies (ClinicalTrials.gov, NCT02118766 [AD-301]; NCT02118792 [AD-302]) to evaluate crisaborole efficacy in patients ≥ 2 years with mild-to-moderate atopic dermatitis (per Investigator's Static Global Assessment) using the Atopic Dermatitis Severity Index (ADSI) and percentage of treatable body surface area (%BSA). Patients were randomly assigned 2:1 to receive crisaborole (n = 1,016) or vehicle (n = 506) twice daily for 28 days. ADSI scores were the sum of pruritus, erythema, exudation, excoriation, and lichenification severity scores, each graded on a 4-point scale from none (0) to severe (3). Respective mean changes in ADSI score and %BSA at day 29 were (crisaborole vs. vehicle) -3.52 versus -2.42 (p < 0.0001) and -7.43 versus -4.44 (p < 0.0001). Crisaborole was effective in treating mild-to-moderate atopic dermatitis based on ADSI and %BSA.

Keywords: Investigator’s Static Global Assessment; atopic dermatitis; atopic dermatitis severity index; crisaborole.

Conflict of interest statement

Conflicts of interest: JIS served as a consultant and/or advisory board member for and received honoraria from AbbVie, AnaptysBio, Asana, Arena, Boehringer-Ingelheim, Dermavant, Eli Lilly, Galderma, GlaxoSmithKline, Glenmark, Kiniksa, LEO, Menlo, Novartis, Pfizer, Regeneron-Sanofi, and Realm; served as a speaker for Regeneron-Sanofi; and received research grants from GlaxoSmithKline. WCP, HT, RAG, and MAZ are employees and stockholders of Pfizer Inc. AMT is a former employee and stockholder of Pfizer Inc.

Data sharing statement: Upon request, and subject to certain criteria, conditions and exceptions (see https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.

Figures

Fig. 1

Atopic Dermatitis Severity Index (ADSI) score calculation and severity bands.aAdditional detail regarding grading of signs/symptoms can be found in Paller AS, et al (6).

Fig. 2

Baseline atopic dermatitis (AD) severity by outcomes measure (pooled AD-301 and AD-302).aSeverity bands for Atopic Dermatitis Severity Index (ADSI): clear/ almost clear (0–< 2), mild (2–< 6), moderate (6–< 9), severe (9–15) (18), bSeverity bands for percentage of treatable body surface area (%BSA): clear (0), mild (> 0–< 16), moderate (16–< 40), severe (40–100) (18). ISGA: Investigator’s Static Global Assessment; SD: standard deviation.

Fig. 3

Mean change in Atopic Dermatitis Severity Index (ADSI) score from baseline over time (pooled AD-301 and AD-302).

Fig. 4

Proportion of patients with Atopic Dermatitis Severity Index (ADSI) score of clear/almost clear at day 29 by baseline ADSIa(A) and baseline percentage of treatable body surface area (%BSA)b(B) (pooled AD-301 and AD-302).aADSI scores were stratified according to following severity bands: clear/almost clear (0–< 2), mild (2–< 6), moderate (6–< 9), and severe (9–15) (18). Analysis was conducted among patients with baseline ADSI > 1. b%BSA was stratified according to the following severity bands: clear (0), mild (> 0–< 16), moderate (16–< 40), and severe (40–100) (18).

Fig. 5

Change from baseline in Atopic Dermatitis Severity Index (ADSI) score at day 29 by baseline lichenification (pooled AD-301 and AD-302).

Fig. 6

Proportion of patients with (A) success in Investigator’s Static Global Assessment (ISGA)aand (B) ISGA clear or almost clear at day 29 by baseline Atopic Dermatitis Severity Index (ADSI) severityb(pooled AD-301 and AD-302).aISGA success was defined as achieving score of clear (0) or almost clear (1) with a 2-grade or more improvement from baseline. bADSI scores were stratified according to following severity bands: clear/almost clear (0–< 2), mild (2–< 6), moderate (6–< 9), and severe (9–15) (18).

Fig. 7

Proportion of patients with (A) success in Investigator’s Static Global Assessment (ISGA)aand (B) ISGA clear or almost clear at day 29 by baseline percentage of treatable body surface area (%BSA) severityb. aISGA success was defined as achieving score of clear (0) or almost clear (1) with a 2-grade or more improvement from baseline, b%BSA was stratified according to the following severity bands: clear (0), mild (> 0–< 16), moderate (16–< 40), and severe (40–100) (18).