Long-Term Safety and Efficacy of Dupilumab Treatment in Children Aged 6 Months to 5 Years with Severe Atopic Dermatitis - PubMed
19 hours ago
- #pediatric safety
- #atopic dermatitis
- #dupilumab
- Dupilumab treatment in children aged 6 months to 5 years with severe atopic dermatitis shows long-term safety and efficacy over up to 2 years.
- The study involved 121 patients, with 88% experiencing treatment-emergent adverse events, mostly mild/moderate and not treatment-related.
- Common adverse events included upper respiratory tract infections, nasopharyngitis, and cough; conjunctivitis occurred in 19% of patients but was mild/moderate and resolved.
- One drug-related event (severe urticaria) led to treatment discontinuation, but it was not serious and resolved over time.
- Serious adverse events occurred in 14% of patients, with one drug-related pinworm infection; none led to treatment discontinuation.
- By week 104, 96% achieved EASI-75, 27% achieved IGA 0/1 (clear/almost clear skin), and 92% achieved IGA ≤ 2.
- Quality of life improved significantly, with 89% of patients aged ≥4 years showing clinically meaningful improvement in CDLQI and 100% of infants showing improvement in IDQoL.
- Patients who received placebo in the parent study showed rapid efficacy improvements comparable to those on dupilumab by week 4 of the extension study.
- Long-term safety profile was consistent with short-term data, with no new safety signals detected.
- The study supports dupilumab as a beneficial treatment for infants and young children with severe atopic dermatitis, with a low risk of side effects.