Background: In children, Immunoglobulin E (IgE) sensitization may play a role in the sequential development of atopic diseases, also known as the atopic march. Previous reports show that dupilumab treatment decreases IgE levels in pediatric and adult patients with moderate-to-severe atopic dermatitis (AD) over 16 and 52 weeks, respectively. This analysis evaluated changes in serum total IgE levels, a biomarker associated with disease burden and atopic comorbidities, during 1.5 years of dupilumab treatment in children aged 6 to 11 years with moderate-to-severe AD.Methods: In LIBERTY PED OLE (NCT02612454), an ongoing open-label extension (OLE), patients aged 6 to 11 years with moderate-to-severe AD received weight-tiered dupilumab based on baseline weight (200 mg every 2 weeks (q2w): 30 kg to <60 kg; 300 mg q2w: ≥60 kg). Serum total IgE (kU/L) was collected at baseline, Weeks 16, 52, and 76. The data presented are descriptive; no statistics were performed.Results: In patients aged 6 to 11 years (n = 383), 146 discontinued from the study and 76 discontinued by Week 76. At this time point, the most reported reasons for discontinuation were patient withdrawal (n = 14), physician decision (n = 5), lack of efficacy (n = 5), and other (n = 38). Thirty-two patients had data at baseline, 36 at Week 16, 32 at Week 52, and 27 at Week 76. At baseline, median (Q1, Q3) total IgE levels (kU/L) were 1441.5 (372, 10,240), which decreased to 782.5 (162.5, 6987) by Week 16 and down to 319.5 (78.6, 2297) by Week 52. At Week 76, median total IgE levels were 381 (63.7, 2192). Median (Q1:Q3) change in total IgE levels from baseline at Weeks 16, 52, and 76 were -684.0 (-2147.0, -54.6), -1569.1 (-8881.5, -184.9), and -1578.7 (-12317.5, -186.1), respectively.Conclusion: Dupilumab treatment normalizes serum total IgE levels over time in pediatric patients aged 6 to 11 years with moderate-to-severe AD compared to normal reference standards (4–6 years: ≤ 307 kU/L; 7–8 years: ≤ 403 kU/L; 9–12 years: ≤ 696 kU/L). Early treatment with dupilumab may improve disease control and potentially contribute to reducing the burden or the risk of development of atopic comorbidities in pediatric patients.
