Demographics and Baseline Disease Characteristics of Early Responders to Crisaborole for Atopic Dermatitis

June 2020 | Volume 19 | Issue 6 | Original Article | 619 | Copyright © June 2020


Published online May 29, 2020

Linda F. Stein Gold MD,a Liza Takiya PharmD,b Chuanbo Zang PhD,c Paul Sanders PhD,d Steven R. Feldman MD PhDe

aDepartment of Dermatology, Henry Ford Health System, Detroit, MI bMedical Affairs, Pfizer Inc., Collegeville, PA cBiostatistics, Pfizer Inc., Collegeville, PA dClinical Development and Operations, Global Product Development, Pfizer R&D UK Ltd., Surrey, United Kingdom eDepartment of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC







In patients achieving ISGA clear or almost clear, patients were more likely to be early (day 8) responders if they were aged <12 years (<12 years vs ≥12 years, OR [95% CI], 1.47 [1.12-1.95]; P=0.0063), were white (white vs non-white, 1.57 [1.19-2.07]; P=0.0015), had mild baseline disease by ISGA (mild vs moderate, 5.63 [4.22-7.50]; P<0.0001), had mild %BSA involvement (mild vs moderate/severe, 1.95 [1.46-2.62]; P<0.0001), had not received prior AD treatment (prior vs no prior, 0.75 [0.57-0.98]; P=0.0338), had disease duration ≤6.45 years (≤6.45 years vs >6.45 years, 1.61 [1.24-2.11]; P=0.0005), or did not concurrently use antihistamines (use vs no use, 0.52 [0.37-0.72]; P=0.0001; Figure 2).

Early SPS responders were more likely to be aged <12 years (<12 years vs ≥12 years, OR [95% CI], 1.93 [1.38-2.70]; P=0.0001) or have moderate baseline disease severity by ISGA (mild vs moderate, 0.72 [0.52-1.00]; P=0.0475; Figure 3). No additional significant differences were observed between remaining subgroups for ISGA or SPS early response definitions.

Early Response as Predictor of Day 29
Response Patients who were early (day 8) ISGA success responders were more likely than those who were not day-8 responders to achieve day-29 ISGA success response (OR [95% CI], 4.32 [2.98-6.26]; P<0.0001; Figure 4A). Similarly, patients who were early (day 8) ISGA clear or almost clear responders were more likely than those who were not day-8 responders to achieve day-29 ISGA clear or almost clear response (5.50 [4.04-7.47]; P<0.0001; Figure 4B). Finally, patients who were early (day 8) SPS responders were more likely than those who were not day-8 responders to achieve SPS response at day 29 (10.71 [7.27-15.79]; P<0.0001; Figure 4C).

DISCUSSION

Based on this post hoc pooled analysis, patients who were aged <12 years versus patients aged ≥12 years were more likely to be early responders to crisaborole treatment according to all 3 early response criteria: ISGA success, ISGA clear or almost clear, and SPS response. In terms of ISGA success and ISGA clear or almost clear criteria, white patients, patients who had not received prior AD treatment, had disease duration ≤6.45 years, and/or did not concurrently use antihistamines were more likely to be early responders. The factors associated with early response were consistent between the 2 definitions of ISGA response, except for disease severity at baseline, which