Topical treatments can provide relief with minimal adverse events (AEs) in patients with atopic dermatitis (AD). Crisaborole ointment 2% is a nonsteroidal phosphodiesterase inhibitor for the treatment of mild-to-moderate AD. The objective was to assess the efficacy and safety of crisaborole ointment in patients with AD who had received prior treatments of corticosteroids [topical corticosteroids (TCS) or systemic corticosteroids)], topical calcineurin inhibitors (TCI) or no prior treatments (treatment-naive). This was a post-hoc analysis of two identically designed, vehicle-controlled, randomized, double-blind, phase III studies of patients aged ≥2 years (ClinicalTrials.gov NCT02118766 and NCT02118792). Patients were assigned crisaborole or vehicle (2: 1) twice daily for 28 days and had a baseline Investigator’s Static Global Assessment (ISGA) score of mild (2) or moderate (3). Patients were divided into three subgroups: treatment-experienced patients who had received prior treatments of corticosteroids (systemic or dermatologic) or TCI; treatment-experienced patients who had received prior treatment with TCS or TCI; and treatment-naive patients who received no prior treatments within 90 days to screening. The primary endpoint was success in ISGA, defined as an ISGA score at day 29 of clear (0) or almost clear (1) with a ≥ 2-grade improvement from baseline. Additional endpoints included a Severity of Pruritus Scale (SPS) at week 4 (weekly average) of none (0) or mild (1) with a ≥ 1-grade improvement from baseline; changes in the Atopic Dermatitis Severity Index (ADSI), Dermatology Life Quality Index (DLQI), Children’s Dermatology Life Quality Index (CDLQI) and Dermatitis Family Impact Questionnaire (DFI) results were also assessed at day 29. AEs, including treatment-emergent AEs and serious AEs, were analysed. A significantly higher proportion of crisaborole-treated patients than vehicle-treated patients achieved success in ISGA in all subgroups [corticosteroids or TCI: 27.9% vs. 15.9% (P = 0.001); TCS or TCI: 27.4% vs. 14.7% (P = 0.001); treatment-naive: 35.0% vs. 26.8% (P = 0.017)]. SPS score 0/1 with a ≥ 1-grade improvement was also achieved by a significantly higher proportion of crisaborole-treated patients than vehicle-treated patients in all subgroups [corticosteroids or TCI: 35.1% vs. 14.9% (P \u3c 0.001); TCS or TCI: 34.5% vs. 13.5% (P \u3c 0.001); treatment-naive: 36.3% vs. 26.0% (P = 0.01)]. Changes in the least squares mean for ADSI, DLQI, CDLQI and DFI results were also significant for crisaborole- vs. vehicle-treated patients in all subgroups except for DLQI, DFI and ADSI (not examined) results for the treatment naive subgroup. Treatment-related AEs were infrequent and mild to moderate in severity. Crisaborole demonstrated a favourable efficacy and safety profile in both treatment-naive and treatment-experienced patients with AD
