- Design
- Prospective multicentre cohort (BioDay Registry), Netherlands, up to 3 years
- Population
- 309 children aged up to 16 with moderate to severe atopic dermatitis starting dupilumab
- Primary outcome
- EASI and Investigator Global Assessment, safety and drug survival
- Effect
- Mean EASI 3.4 (95% CI 2.4 to 4.5) at 3 years; 3-year drug survival 80.1%; ocular surface disease 36.6%
The BioDay Registry followed 309 children up to age 16 with moderate to severe atopic dermatitis who started dupilumab at seven Dutch hospitals. Mean age was 10.2 years, and 51 were aged six months to five years.
Most kept their disease controlled, with mean EASI of 3.4 (95% CI 2.4 to 4.5) and mean pruritus score of 3.6 (3.1 to 4.1) after three years. Dupilumab-associated ocular surface disease was the commonest adverse event, in 113 children (36.6%). Fifty children (16.2%) stopped the drug, mainly for ineffectiveness (38%), adverse events (30%) or administration problems (22%), most within 18 months. Three-year drug survival was 80.1%.
The youngest children had higher itch scores and worse quality of life and stopped more often because of administration problems. There was no comparison group, so the figures describe what happens on treatment rather than what the drug adds.
- Three-year drug survival was 80.1% in this registry.
- Ocular surface disease affected 36.6%, so ask about red, sore or itchy eyes at review.
- Most stopping happened within 18 months.
- Children aged six months to five years had more itch and quality-of-life impairment.
- Administration problems drove discontinuation in the youngest, so plan injection support.
Why it matters
It gives real-world durability data in a population where trial follow-up was short, and shows the eye is the practical problem.
Don't overread it
A registry with no comparison group and with discontinuers dropping out cannot show how much of the control is due to dupilumab.
The statistics, in plain English
Drug survival is the proportion still on the drug, so it reflects both benefit and tolerability. Without a control group, the low EASI at three years cannot be credited to the drug alone, since children who respond poorly may have stopped and left the analysis.
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