Key clinical point: A dose of 4 mg baricitinib plus topical corticosteroids (TCS) demonstrated superior efficacy compared to placebo+TCS in pediatric patients with moderate-to-severe atopic dermatitis (AD), with the safety profile being consistent with previous studies involving adults with moderate-to-severe AD.
Major finding: At week 16, a significantly higher proportion of patients receiving 4 mg baricitinib+TCS vs placebo+TCS achieved a validated Investigator’s Global Assessment for AD score of 0 or 1 with a ≥2-point improvement (41.7% vs 16.4%; P < .0001); no significant difference was observed between the 2 mg/1 mg baricitinib and placebo groups. No new safety signals were reported.
Study details: This multicenter phase 3 study, BREEZE-AD-PEDS, included 483 pediatric patients aged 2 to <18 years with moderate-to-severe AD and inadequate response to TCS or systemic treatments who were randomly assigned to receive 4 mg baricitinib+TCS, 2 mg baricitinib+TCS, 1 mg baricitinib+TCS, or placebo+TCS.
Disclosures: Baricitinib was developed by Eli Lilly and Company, under license from Incyte Corporation. Some authors reported various ties, including employment and stock ownership, with Eli Lilly or others.
Source: Torrelo A et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in pediatric patients with moderate-to-severe atopic dermatitis with inadequate response to topical corticosteroids: Results from a phase 3, randomized, double-blind, placebo-controlled study (BREEZE-AD PEDS). Br J Dermatol. 2023 (Mar 31). Doi: 10.1093/bjd/ljad096