Outcomes in this new analysis were compared among children aged 6 to 11 years, all of whom had severe atopic dermatitis and were randomized to treatment with dupilumab or placebo for 16 weeks.
Dupilumab has potential to produce improvements in atopic dermatitis severity by 2 weeks after treatment initiation, as measured by signs and symptoms of the disease and its impact on patient quality of life (QOL), according to new findings published recently in American Journal of Clinical Dermatology.1
Outcomes were investigated among 304 pediatric patients with severe AD aged 6 to 11 years randomized 1:1:1 to treatment with either dupilumab plus concomitant topical corticosteroids (TCS) or placebo plus TCS. The 3 treatments regimens were 300-mg dupilumab every 4 weeks plus TCS (n = 122), weight-based treatment with either 100-mg dupilumab (baseline weight < 30 kg) or 200-mg dupilumab (baseline weight > 30 kg) every 2 weeks plus TCS (n = 59), or placebo plus TCS (n = 123).
“In this post hoc analysis, we included patients receiving dupilumab 300 mg every 4 weeks plus TCS (regardless of weight), dupilumab 200 mg every 2 weeks plus TCS (baseline weight ≥ 30 kg), or placebo + TCS,” the authors noted.
Their primary outcome was dupilumab response at week 16 as measured by Investigator’s Global Assessment (IGA) score of 0 (clear skin) or 1 (almost clear skin). Data were from the LIBERTY AD PEDS trial.2
Overall, dupilumab resulted in clinically meaningful improvements in AD signs, symptoms, and QOL from baseline through week 16 compared with placebo:
“This effect was rapid, with significant improvements vs placebo observed as early as week 2,” the authors wrote, “and they were sustained through to the end of the study.”
Among those who saw improvement in only AD signs and symptoms, the results again trended positive vs placebo:
“Greater improvements from baseline to week 16 were seen across all 3 outcome measures with dupilumab compared with placebo,” the study investigators noted, “with similar efficacy across the 2 doses.”
By week 16, both dupilumab groups also had greater reductions in IGA score from baseline > 2 compared with placebo:
The study authors also used the Patient Global Impression of Disease questionnaire (no, mild, medium, severe, very severe symptoms) to measure patient improvement. At week 16, 65.6% and 69.5% of patients in the 300-mg and 200-mg dupilumab cohorts, respectively, said they had no or mild symptoms vs 17.1% of the placebo group (P < .0001). In addition, findings from patient responses to the Patient Global
Impression of Change questionnaire showed those noting their symptoms were “much better” were significantly higher in both dupilumab groups (70.5% and 79.7%, respectively) compared with the placebo group (26.8%; (P < .0001).
The study investigators highlighted that fewer rescue medications were needed in both dupilumab groups vs the placebo group and that “potent TCS were the most commonly used rescue medications.”
Potential limitations on generalizability of these findings include outcomes seen that were not prespecified (not planned by the authors) and some of the subgroups having small patient populations.
1. Dupilumab provides clinically meaningful responses in children aged 6-11 years with severe atopic dermatitis: post hoc analysis results from a phase III trial. Am J Clin Dermatol. Published online June 10, 2023. doi:10.1007/s40257-023-00791-7
2. Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD). NCT03345914. Updated August 13, 2020. Accessed July 18, 2023. https://clinicaltrials.gov/study/NCT03345914