Which prescription treatments are FDA-approved for the treatment of pediatric atopic dermatitis (AD)?

Updated: Jun 03, 2020
  • Author: Robert A Schwartz, MD, MPH; Chief Editor: Dirk M Elston, MD  more...
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Answer

Crisaborole topical ointment 2% (Eucrisa) was approved by the US Food and Drug Administration (FDA) in December 2016 for mild-to-moderate atopic dermatitis in adults and children aged 2 years or older. The approval was based on two placebo-controlled trials (n=1522). Patients who received crisaborole achieved greater response with clear or almost clear skin after 28 days compared with vehicle-treated patients (P<.001).<ref>28</ref> In March 2020, the FDA expanded the indication to include infants and children aged 3 months or older. Use in pediatric patients aged 3 months to less than 2 years was supported by data from a 28-day open-label, safety, and pharmacokinetics trial (n=137). [29]

Dupilumab is a monoclonal antibody that inhibits interleukin (IL)–4 and IL-13 signaling by blocking the shared IL-4Ra and originally demonstrated efficacy in phase 2 clinical trials. [30, 31] It was initially approved by the FDA for adults in 2017 who have moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies are not advisable. In 2019, this indication was expanded to include adolescents aged 12 years or older, and in 2020 to include children as young as 6 years. It is a subcutaneous injection administered every 2 weeks.

Approval of dupilumab was based on clinical trials investigating dupilumab as monotherapy (SOLO 1 and SOLO 2) and in concomitant administration with topical corticosteroids (CHRONOS). Results from the SOLO 1 (n=671) and SOLO 2 (n=708) trials showed 36-38% of patients who received dupilumab had scores of 0 or 1 (clear or almost clear) on the Investigator's Global Assessment scale compared with placebo (8-10%) (P< .001). Additionally, improvement from baseline to week 16 of at least 75% on the Eczema Area and Severity Index (EASI) was reported in significantly more patients who received each regimen of dupilumab than in patients who received placebo (P< .001). [32] Approval in adolescents was based on a phase 3 trial showing statistically significant improvement of the EASI-75 in the dupilumab-treated group compared with placebo. [33]

Results from the phase 3 trial (LIBERTY AD PEDS; n = 367) in children aged 6-11 years showed 75% of those taking dupilumab plus topical corticosteroids achieved EASI-75 at 16 weeks compared with 26-28% of children using topical corticosteroids alone (P< .001). [34]


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