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First experience of topical SDZ ASM 981 in children with atopic dermatitis
1Department of Paediatric Dermatology, Great Ormond Street Hospital for Children, London WC1 3JH, UK.
Insights
Topical SDZ ASM 981 cream showed low systemic exposure in children aged 1-4 years with atopic dermatitis. This study assessed the safety and efficacy of SDZ ASM 981 in pediatric patients.
Area of Science:
- Dermatology
- Pharmacology
- Pediatrics
Background:
- SDZ ASM 981 is a topical anti-inflammatory agent targeting cytokine release.
- It is under development for atopic dermatitis treatment.
Purpose of the Study:
- To evaluate systemic exposure of SDZ ASM 981 in young children with atopic dermatitis.
- To assess the safety and efficacy of topical SDZ ASM 981 in a pediatric population.
Main Methods:
- 1% SDZ ASM 981 cream applied twice daily for 3 weeks to children aged 1-4 years.
- Blood concentrations measured via radioimmunoassay on days 4, 22, and 1 week post-treatment.
- Efficacy assessed using the Eczema Area Severity Index (EASI).
Main Results:
- Low systemic SDZ ASM 981 levels (<0.5 ng/mL in 63% of samples) observed, with a maximum of 1.8 ng/mL.
- No drug accumulation detected between day 4 and day 22.
- EASI scores improved by 8-89% in most patients, though two experienced uncontrolled flares.
Conclusions:
- Topical 1% SDZ ASM 981 cream resulted in consistently low blood concentrations in pediatric patients.
- Low systemic exposure was noted even with extensive body surface area (BSA) treatment (up to 69%).
Background:
SDZ ASM 981 is a selective inhibitor of inflammatory cytokine release under development for the topical treatment of atopic dermatitis.
Objectives:
This first paediatric study was designed to measure the systemic exposure to SDZ ASM 981 in young children with atopic dermatitis treated on extensive skin areas.
Methods:
Children 1-4 years of age referred to a tertiary care centre for their atopic dermatitis were treated twice daily for 3 weeks with 1% SDZ ASM 981 cream. SDZ ASM 981 blood concentrations were measured on day 4 and 22 (last day) of treatment, and 1 week after the last application, using a radioimmunoassay with a limit of quantification of 0.5 ng mL(-1). Efficacy was assessed by the Eczema Area Severity Index (EASI).
Results:
The 10 patients included had 23-69% of their body surface area (BSA) affected at baseline. Of the 63 SDZ ASM 981 blood concentrations measured, 63% were < 0.5 ng mL(-1); the maximum value observed was 1.8 ng mL-1. No accumulation was evidenced between days 4 and 22. The first two patients experienced a flare of atopic dermatitis that was not controlled by the study medication. In the other patients, the EASI improved by 8-89% at 3 weeks of treatment.
Conclusions:
In these children 1-4 years of age, blood concentrations of SDZ ASM 981 during topical treatment with the 1% cream were consistently low even in the children with the most extensive areas treated (up to 69% of their BSA).