Dupilumab treatment improves linear growth and bone biomarkers in children with atopic dermatitis: Post hoc analysis of a phase 3 randomized, placebo-controlled clinical trial and an open-label extension study
Abstract
BACKGROUND: Moderate and severe atopic dermatitis (AD) may affect bone growth and mineral density in children.
OBJECTIVE: To investigate stature, height gain, and biomarker of mineralization bone alkaline phosphatase (BALP) level over time in children with AD treated with dupilumab.
METHODS: Children aged 6 to 11 years with severe AD received dupilumab or placebo in a phase 3 trial for 16 weeks, followed by dupilumab in an open-label trial to week 52. Endpoints included baseline height percentile distribution, proportion of patients achieving ≥5-percentile height increase at weeks 16 and 52, and BALP level to week 52.
RESULTS: Children with severe AD were overrepresented in lower height percentiles at baseline. Among dupilumab-treated children below the 40th height percentile at baseline, 31.3% achieved ≥5-percentile height increase (vs 15.5% with placebo, P < .05) at week 16, and 50.7% at week 52. BALP level, while within normal range throughout, was significantly higher with dupilumab vs placebo at week 16, with further increase to week 52. At week 52, patients who transitioned to dupilumab at week 16 attained height and BALP improvements comparable with patients receiving dupilumab throughout.
LIMITATIONS: One-year duration.
CONCLUSION: Dupilumab treatment in children with AD was associated with height and BALP level improvements.
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 52 participants or records.
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