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Therapy for severe childhood eczema will ‘revolutionise clinical practice worldwide’

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Eczema

A biologic therapy for very young children with a moderate to severe form of a eczema has been shown to be safe and effective in an international trial.

The study of dupilumab in poorly controlled eczema is the first large-scale randomised double-blind trial of a monoclonal antibody for any skin disease in patients aged six months to six years.

In the study, published in The Lancet, showed the drug greatly improved the severity of the condition, reducing skin itch and pain within two weeks.

The patients’ sleep also significantly improved, as did their quality of life and that of their parents.

Doctors expect that the international study will ensure this treatment is approved for British children soon, following its adoption in the US in June this year.

University of Manchester principle investigator and academic paediatrician, Dr Peter Arkwright, said:

“Young children and infants who have moderate-to-severe eczema have a substantially reduced quality of life.

“It’s also incredibly stressful for their families, particularly as children’s sleep is so disturbed.

“The fact that infants and young children with moderate-to-severe eczema are inadequately controlled with creams means they have a high unmet medical need.

“We’re so delighted that dupilumab has provided clinically meaningful improvement, with an acceptable safety profile.”

The patients in the trial were enrolled from 31 hospitals, clinics, and academic institutions in Europe and North America from June 2020, to February 2021.

A total of 162 patient were enrolled on the trial, with 83 patients given a subcutaneous injection of dupilumab, and 79 a placebo every 4 weeks as well as continuing standard therapy with low-potency steroid cream for 16 weeks.

Independent assessors scored the level of inflammation and found:

More than a quarter (28 per cent) of patients receiving dupilumab achieved a global skin score of 0 or 1, indicating clear or almost clear skin at week 16.

More than half (53 per cent) of the patients experienced a 75 per cent improvement from the baseline in Eczema Area and Severity Index (EASI) at week 16.

Conjunctivitis was slightly more frequent with dupilumab than placebo (5 per cent vs 0 per cent). However none of the recorded dupilumab-related adverse events were serious or led to treatment discontinuation.

Dr Arkwright said:

“These pivotal trial results strongly support the global approval of dupilumab in infants and children with eczema. It will revolutionise clinical practice worldwide.”

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