- Design
- multicentre prospective cohort study (BioDay Registry), up to 3 years of follow-up
- Population
- 309 children aged 16 or under with moderate to severe atopic dermatitis starting dupilumab at 7 Dutch hospitals
- Primary outcome
- effectiveness by EASI and IGA, safety, and drug survival
- Effect
- 3-year drug survival 80.1%; mean EASI 3.4 (95% CI 2.4 to 4.5); ocular surface disease in 36.6%
The Dutch BioDay registry followed 309 children aged 16 or under with moderate to severe atopic dermatitis who started dupilumab across seven hospitals, with up to three years of follow-up. Median follow-up ranged from 45 weeks in the youngest group to 89.5 weeks in the 12 to 16 year olds.
Disease control held: mean Eczema Area and Severity Index was 3.4 (95% CI 2.4 to 4.5) and mean itch score 3.6 (3.1 to 4.1) at three years. Three-year drug survival was 80.1%. Fifty children (16.2%) stopped, most within the first 18 months, for ineffectiveness (38% of stoppers), adverse events (30%) or administration problems (22%). Dupilumab-associated ocular surface disease was the commonest adverse event at 36.6%. Allergic asthma, allergic rhinitis and being aged 6 to 11 were each associated with lower discontinuation.
The age-specific signal is the part to act on. Children aged 6 months to 5 years consistently reported more itch and worse quality of life than older children throughout, and stopped more often because of the injections themselves. That is a fixable problem: injection technique, topical anaesthesia, who administers it and where, reviewed before concluding the drug has failed. And with ocular surface disease in over a third, ask about the eyes at every visit rather than waiting for a complaint.
- Ask about dry, gritty or red eyes at every review; ocular surface disease affected 36.6%
- In under-fives, review injection technique and setting before calling the drug ineffective
- Expect most discontinuations in the first 18 months - persistence after that is high
- Track itch and quality of life separately in young children; severity scores alone understate their burden
- Consider dose reduction where control is sustained, as this registry did when clinically indicated
Why it matters
Most paediatric dupilumab failures in this cohort were not the biology failing - they were injections, eyes and the first 18 months.
The statistics, in plain English
Drug survival of 80.1% at three years is a composite measure of effectiveness, tolerability and practicality - a patient stays on a drug only if all three hold, which is why it predicts real-world use better than a response rate. Mean EASI of 3.4 with an interval of 2.4 to 4.5 is mild disease on average, but a mean hides the minority doing badly. This is an observational registry with no comparator, so it describes what happened on treatment rather than what treatment achieved.
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