Dupilumab led in children of every skin colour, and ciclosporin varied most

Design

observational international real-world registry, non-randomised treatment allocation, 4-year results

Population

500 children under 12 with moderate-to-severe atopic dermatitis (314 White, 186 non-White)

Primary outcome

change in eczema area and severity index, itch score and quality of life

Effect

EASI improvement, non-White: dupilumab 13.6, methotrexate 8.2, ciclosporin 9.2 points; White: 14.2, 10.1, 4.5 points

PEDISTAD is an observational international registry of children with moderate-to-severe atopic dermatitis on systemic treatment. This four-year analysis split 500 children under 12 into 314 categorised as White and 186 as non-White, the latter grouping Black or African American, Asian, American Indian or Alaskan Native and multiracial children together.

Eczema area and severity index improved on every drug in both subgroups. Dupilumab gave the largest improvement in both — 13.6 points in non-White and 14.2 in White children. Methotrexate gave 8.2 and 10.1. Ciclosporin was the outlier: 9.2 points in non-White children against 4.5 in White ones. Itch improved significantly with dupilumab in both subgroups, and ciclosporin was the least effective agent for itch in this cohort. Quality-of-life measures improved similarly in both groups with dupilumab, and by more than with either older drug.

The safety figures run the other way from what the subgroup framing might suggest. Exposure-adjusted adverse event rates were higher in White children on every drug — 58.33 events per 100 person-years on ciclosporin against 28.72 in non-White children, with smaller gaps for dupilumab and methotrexate. That is a registry finding in unequal groups, not a demonstration that the drugs are safer in darker skin.

For Indian practice the useful conclusion is the negative one: nothing here suggests dupilumab needs to be used differently or expected to work less well in the children a dermatologist here actually sees. The constraint on dupilumab in India is cost, not response, and this dataset does not address cost at all.

• Expect dupilumab to outperform methotrexate and ciclosporin on severity, itch and quality of life regardless of the child's skin colour
• Do not lower expectations of dupilumab response in children with skin of colour on the basis of immunophenotype differences
• Where ciclosporin is used for cost reasons, counsel that itch response was the weakest of the three drugs here
• Review adverse events actively on ciclosporin — it carried the highest event rate in both subgroups
• Treat the racial grouping as a crude proxy: 'non-White' pooled several very different populations in this analysis

Why it matters

The assumption that biologic response differs by ethnicity shapes who gets offered an expensive drug first.

Don't overread it

This is a registry with non-random treatment allocation — it cannot establish that one drug is better than another, only what happened to children given each.

The statistics, in plain English

These are within-group improvements from an observational registry, not randomised comparisons, so the drugs were given to different children for different reasons — a child started on ciclosporin may differ systematically from one started on dupilumab. No confidence intervals are given for the between-drug differences, so the gap between 14.2 and 10.1 points cannot be tested here. The non-White group is smaller (186 against 314), which makes its estimates less precise, and the adverse event rates are exposure-adjusted counts rather than risks, so they depend on how long each child stayed on each drug.

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