P4.A003: Dupilumab Improves Family Quality of Life in Infants and Children With Atopic Dermatitis

Background: Atopic Dermatitis (AD) has a significant adverse impact on the quality of life (QoL) of the pediatric patients and their caregiver(s) and family. Data quantifying the extent of this impact for the patient’s family and the effect of treatments in alleviating family impact is limited. This analysis reports the impact of AD on the QoL of the pediatric patient’s caregiver(s) and family and the effect of treatment with dupilumab evaluated by the Dermatitis Family Impact (DFI).

Methods: Patients aged 6 months to 11 years with AD were enrolled in either of two randomized, double blind, placebo-controlled, 16-week, phase 3 studies. In LIBERTY AD PEDS (NCT03345914) 367 patients aged 6 to 11 years received dupilumab 100/200 mg every 2 weeks (q2w; 100 mg: weight < 30kg, 200 mg: ≥30kg), 300 mg every 4 weeks (q4w) or placebo. In LIBERTY AD PRESCHOOL (NCT03346434 part B) 162 patients aged 6 months to 5 years received dupilumab 200/300 mg q4w (200 mg: weight 5 - < 15 kg; 300 mg: 15 - < 30 kg) or placebo. Patients received concomitant topical corticosteroids (TCS) in both studies. Mean changes in Dermatitis Family Impact (DFI; range 0-30; higher scores indicate greater impact) from baseline to Week 16 were assessed.

Results: At baseline, mean total DFI scores were in the range of 13.5-17.7 across both studies, corresponding to moderate alteration in family QoL. At Week 16, DFI scores were significantly improved in patients receiving dupilumab+TCS vs patients receiving placebo+TCS in both studies. In children aged 6 to 11 years, there was an improvement of 73.4% (patients < 30kg) and 75.4% (patients ≥30kg) of DFI in patients receiving dupilumab vs 38.7% and 40.6% in patients receiving TCS and placebo. In patients aged 6 months to 5 years, LS mean change (SE) in DFI scores were -10.5 (0.8)/ -2.7 (0.8) in the dupilumab/placebo groups respectively (P < 0.0001). Most families of patients treated with dupilumab achieved a DFI score corresponding to no or low-impact on QoL. Ocular surface disease was reported in 9.9% of children aged 6 to 11 years and 7.2% of children aged 6 months to 5 years. The safety profile was consistent with the known dupilumab safety profile in adults and adolescents.

Conclusion: Dupilumab treatment in children aged 6 months to 11 years with AD resulted in significant improvement in quality of life of the patient’s caregiver(s) and family.