Dupilumab shows long-term safety, efficacy in children, adolescents with atopic dermatitis

Key takeaways:

• Dupilumab is the first biologic agent approved to treat atopic dermatitis in patients aged 6 months and older.
• A pooled analysis found dupilumab to be safe and efficacious in pediatric and adolescent patients.

Children and adolescents with atopic dermatitis treated with long-term dupilumab showed positive results and acceptable safety, according to a meta-analysis of multiple studies.

“Moderate to severe AD often demands systemic therapies, such as systemic corticosteroid and immunosuppressive agents, which are limited by the need for continuous laboratory monitoring and side effects,” Yuanyuan Xu, MD, of the department of dermatology at West China Hospital at Sichuan University, and colleagues wrote. “With a deeper understanding of AD pathogenesis, targeted biological agents are now available and provide novel options for AD patients with poor response to topical treatment.”

Researchers conducted a systemic review and meta-analysis of seven clinical trials and 11 observational studies in which patients with AD were treated with dupilumab (Dupixent, Sanofi/Regeneron). They then extracted data from each study — including study type, follow-up duration, treatment regimen and duration, outcome parameters, region and patient characteristics — which were used to achieve conclusions on efficacy and safety.

A total of 1,275 children and adolescents were eligible for analysis.

Pooled percentages included 72.9% (95% CI, 61.6%-81.9%) for EASI 50, 57.4% (95% CI, 48.1%-66.2%) for EASI 75, 31.3% (24%-39.7%) for EASI 90 and 29.7% (23.3%-37%) for EASI 100.

In the observational studies, the pooled rates for EASI 50 and EASI 75 response were 94.6% and 73.4%, respectfully, which the researchers said was significantly higher than the 70.1% and 51.7% in the clinical trials (P = .037).

In a meta-analysis of nine studies, IGA scores of 0/1 — or clear or almost clear — had an overall pooled rate of 35.2% (95% CI, 29.3%-41.5%), with the pooled IGA of 0/1 in investigational studies studies being significantly larger compared with clinical trials (67.6% vs. 25.7%; P < .001).

Adverse events in observational studies and treatment-emergent adverse events in clinical trials were evaluated and analyzed as well. Overall treatment-emergent adverse events had a pooled rate of 7.2% in clinical trials, whereas adverse events in observational studies had an overall pooled rate of 7.6%.

“Dupilumab is an effective and safe treatment choice for pediatric AD patients, with favorable efficacy profile observed from long-term use and an acceptable safety profile. More long-term, high-quality, controlled studies in different regions are needed for further verification,” the authors wrote.