Investigating efficacy of PDE-4 inhibitors in reducing topical steroid use for management of pediatric atopic dermatitis: A double-blind randomized control study

Background: Atopic dermatitis (AD) affects up to 20% of children worldwide (1). Approved treatments include phosphodiesterase-4 (PDE-4) inhibitors, topical calcineurin inhibitors (TCI), and topical corticosteroids (TCS), but TCS-related side effects can limit their use (2,3,4). This study investigated efficacy of PDE-4 inhibitors in reducing TCS usage and improving quality of life (QOL) in pediatric AD patients. Patients aged 2-17 with mild or moderate AD were recruited from the Johns Hopkins Pediatric Dermatology Department and blindly randomized to use PDE-4 inhibitor, vehicle, or control ointment. Patients using TCI performed a two-week washout period prior to enrollment. Participants were evaluated at study onset, after 30 days, and after 90 days, through photographs, AD scoring, and pruritus rating (5,6). QOL was surveyed using QOL indices (CDLQI/DLQI) and family impact questionnaires (DFI) (7,8,9). Fourteen patients were enrolled, and preliminary data was collected from ten patients (mean age 7.5 years). Preliminary results demonstrate average decrease in DFI of 4.6 points in PDE-4 inhibitor group compared to 1 point in vehicle/control group. QOL indexes demonstrate average 4.7 point improvement in PDE-4 group compared to 1.5 points in vehicle/control group. AD scoring decreased in vehicle/control groups by 5.26 points, and in PDE-4 inhibitor groups by 1.27 points. Overall, patients using PDE-4 inhibitor used TCS an average 1.3 times weekly vs. 2.1 times in vehicle/control group. Our analyses demonstrate efficacy of PDE-4 inhibitors in decreasing TCS use in pediatric patients. These findings are important in guiding management of AD patients to minimize the potential impact of TCS- related adverse effects.