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A multicenter study of crisaborole use in pediatric patients with atopic dermatitis in real-world setting in Thailand
Susheera Chatproedprai1, Nootchanard Rujimethapass2, Patawee Na Bangxang3
1Division of Pediatric Dermatology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok.
Insights
Crisaborole showed potential benefits for Thai children with atopic dermatitis (AD), improving symptoms and tolerability. Further controlled studies are needed to confirm these real-world findings in pediatric AD treatment.
Area of Science:
- Dermatology
- Pediatrics
- Pharmacology
Background:
- Crisaborole demonstrates efficacy in atopic dermatitis (AD) treatment.
- Limited data exists on its use in Southeast Asian children.
- Ethnic variations in AD may impact treatment response.
Purpose of the Study:
- Evaluate crisaborole's real-world effectiveness and safety.
- Assess treatment outcomes in Thai children (aged >3 months) with mild-to-moderate AD.
- Examine improvements in clinical signs and pruritus.
Main Methods:
- Prospective observational study in Bangkok, Thailand (July 2023-July 2024).
- Ninety pediatric patients with mild-to-moderate AD applied crisaborole twice daily.
- Outcomes assessed via Investigator's Static Global Assessment (ISGA), pruritus, Atopic Dermatitis Severity Index (ADSI), and Total Signs Score (TSS) at 14 and 28 days.
Main Results:
- ISGA success rates reached 38.1% by day 28.
- Pruritus severity improved in 71.4% of patients by day 28.
- Significant reductions in ADSI and TSS observed; mild, transient adverse events (e.g., redness, burning) reported in 47.2%.
Conclusions:
- Crisaborole treatment was linked to improved clinical outcomes and good tolerability in Thai pediatric AD patients.
- The observational design limits causal inference.
- Controlled trials are recommended to validate these findings.
Background:
Increasing evidence supports the efficacy of crisaborole in atopic dermatitis (AD). Ethnic differences in AD endotypes may influence treatment outcomes, while data in Southeast Asian children remain limited.
Objective:
To evaluate the efficacy and safety of crisaborole in Thai children aged >3 months with mild-to-moderate AD in a real-world multicenter setting.
Methods:
This prospective observational study enrolled pediatric patients with mild-to-moderate AD were recruited from dermatology clinics at three tertiary hospitals in Bangkok between July 2023 and July 2024. Eligible patients applied crisaborole twice daily to all AD lesions. Outcomes included Investigator's Static Global Assessment (ISGA) success and improvements in pruritus and clinical signs at days 14 and 28. Disease severity was assessed using the Atopic Dermatitis Severity Index (ADSI) and Total Signs Score (TSS).
Results:
Ninety Thai participants (median age 5.4 years; 54.4% girls) were enrolled. The intent-to-treat population included 89 and 84 participants at days 14 and 28, respectively. ISGA success rates were 10.1% and 38.1%, while pruritus severity improved in 50.6% and 71.4% of patients at days 14 and 28, respectively. Clinical signs improvement varied by feature and significant reductions in ADSI and TSS from baseline. Treatment-related adverse events occurred in 47.2% of patients, most commonly application-site redness (32.6%), burning/stinging (19.1%), and exudation (5.6%); all were mild and transient.
Conclusions:
Crisaborole treatment was associated with improved clinical outcomes and was generally well tolerated. However, the observational design and lack of a control group preclude causal conclusions regarding efficacy. Controlled studies are needed to confirm these findings.