- Design
- Multicentre prospective registry cohort (BioDay), up to 3 years
- Population
- 309 children (6 months to 16 years) with moderate-to-severe atopic dermatitis on dupilumab
- Primary outcome
- Effectiveness, safety and drug survival
- Effect
- 3-year drug survival 80%; mean EASI 3.4 and itch 3.6; ocular surface disease in 37%
A Dutch multicentre registry followed 309 children with moderate-to-severe atopic dermatitis started on dupilumab, for up to three years. Most maintained good control: mean Eczema Area and Severity Index stayed low at 3.4 (95% CI 2.4 to 4.5) and mean itch score at 3.6 (3.1 to 4.1) at three years, with a three-year drug survival of 80%.
Safety matched expectations rather than raising new flags. The most frequent adverse event was dupilumab-associated ocular surface disease, in 37% of children. One in six stopped treatment, mostly for ineffectiveness, adverse events or administration problems, with most discontinuations in the first 18 months. The youngest children, aged 6 months to 5 years, consistently reported more itch and more quality-of-life impairment and more often stopped because of administration difficulties.
The practical value is in counselling. This supports dupilumab as a durable option in children, while flagging ocular surface disease to watch for and the extra support the youngest and their families need.
- Prospective registry of 309 children with moderate-to-severe atopic dermatitis, up to 3 years.
- Control was maintained: mean Eczema Area and Severity Index 3.4 and itch score 3.6 at 3 years; drug survival 80%.
- Dupilumab-associated ocular surface disease was the commonest adverse event, in 37%.
- One in six discontinued, mostly within 18 months, for ineffectiveness, adverse events or administration problems.
- Children under 5 reported more itch and quality-of-life impairment and needed more administration support.
Why it matters
It extends dupilumab's evidence from trials into years of real-world paediatric use and names where the practical problems concentrate.
Don't overread it
This was an observational registry without a control group, so it describes long-term outcomes rather than proving superiority over other treatments.
The statistics, in plain English
Low mean severity and itch scores with 80 percent still on treatment at three years indicate durable real-world control; as a registry cohort without a comparator, it describes outcomes rather than proving effect size against an alternative.
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