Treatment with dupilumab improved disease severity and patient-reported outcomes (PROs) in paediatric patients aged <12 years with moderate-to-severe atopic dermatitis (AD), according to a 4-year interim analysis of the PEDISTAD* trial presented at PAS 2025.

This ongoing, phase IV, real-world PEDISTAD trial evaluated children aged <12 years with moderate-to-severe AD who are not adequately controlled by topical prescription therapies or for whom such therapies are not medically advisable.

Participants were given dupilumab (n=254), methotrexate (n=136), or cyclosporine (n=145), with mean treatment durations of 27.3, 28.1, and 19.5 months, respectively.

Eczema Area and Severity Index (EASI) total score and percentage-affected body surface area (BSA) score were used to assess the severity of the disease at the start of treatment and the last observation.

In this 4-year analysis, patients who received dupilumab had a greater improvement in mean EASI score (from 19.3 at the start of therapy to 5.2 at the last observation; p<0.0001) than those who received methotrexate (from 17.1 to 8.5; p<0.0001) or cyclosporine (from 19.1 to 13.3; p<0.0001). [Zhang A, et al, PAS2025]

Similarly, a greater improvement in mean total BSA score from initiating therapy to last observation was observed with dupilumab (from 38.1 to 14.5; p<0.0001) compared with methotrexate (from 34.6 to 18.7; p<0.0001) and cyclosporine (from 40.6 to 27.9; p<0.0001).

Moreover, only 14.9 percent of patients in the dupilumab group discontinued treatment compared with 45.9 percent in the methotrexate group and 63.7 percent in the cyclosporine group.

In terms of safety, adverse events (AEs) occurred at a lower rate in the dupilumab arm than the methotrexate or cyclosporine arms (29.8 vs 32.1 [methotrexate] and 48.9 [cyclosporine] exposure-adjusted event rate [EAER] per 100 patient-years).

Fewer serious AEs were also observed with dupilumab compared with methotrexate or cyclosporine (1.19 vs 1.74 and 2.62 EAER per 100 patient-years, respectively).

“Safety was consistent with the known safety profile of dupilumab,” said study author Dr Annie Zhang from Sanofi Cambridge, Massachusetts, US.

Patient-reported outcomes

Another study was presented by Zhang that evaluated the effect of systemic therapies, including dupilumab, methotrexate, and cyclosporine, on Patient-Oriented Eczema Measure (POEM), Children's Dermatology Life Quality Index (CDLQI), Peak Pruritus Numeric Rating scale (PP-NRS), Worst Itch-NRS (WI-NRS), and Dermatitis Family Impact (DFI).

“Understanding the PROs … of paediatric patients with AD receiving systemic therapies is important for the continued management of AD in children,” Zhang noted.

Across all PROs, patients treated with dupilumab achieved greater improvements in POEM, CDLQI, PP-NRS (day and night), WI-NRS, and DFI compared with methotrexate or cyclosporine.

Overall, in this real-world registry cohort, patients aged <12 years treated with dupilumab had greater improvements in AD signs, and lower discontinuation rate and EAER compared with those treated with methotrexate or cyclosporine, Zhang concluded.

*PEDISTAD: Pediatric Study in Atopic Dermatitis