Real-world treatment outcomes of systemic treatments for moderate-to-severe atopic dermatitis in children aged less than 12 years: 2-year results from PEDIatric STudy in Atopic Dermatitis

Background: The arrival of biologics and small-molecule therapies (eg Janus kinase inhibitors) changed atopic dermatitis treatment, but older systemic treatments continue to be prescribed. Objective: To provide real-world effectiveness, safety, and adherence data for dupilumab, cyclosporine, and methotrexate. Methods: PEDIatric STudy in Atopic Dermatitis (NCT03687359) is a real-world, prospective, observational, 10-year study of children (<12 years) with inadequately controlled moderate-to-severe atopic dermatitis. We report 2-year interim results. Results: Median treatment durations were 8.1, 13.0, and 10.7 months for dupilumab (n = 144), methotrexate (n = 114), and cyclosporine (n = 121), respectively. Dupilumab had numerically greater within-group improvements than methotrexate and cyclosporine in Eczema Area and Severity Index (-12.4* vs- 5.7* and- 3.3); body surface area affected (-19.9%* vs- 11.8%* and- 8.8%*); itching (nighttime:- 2.1* vs- 0.4 and + 0.1; daytime:- 1.5* vs +0.1 and + 0.2; $ 6 years); itching/scratching (-3.6* vs- 1.4* and- 0.2; < 6 years); and Patient-Oriented Eczema Measure (-7.0* vs- 4.7* and- 1.5) (*P < .05 within-group improvements from baseline). Dupilumab had less discontinuations (8.3% vs 28.9% and 43.0%) and adverse event(s) (18.1% vs 29.8% and 31.4%). Limitations: No randomization, placebo, or specified dosages. Conclusion: Dupilumab was associated with numerically greater outcomes and higher adherence than cyclosporine or methotrexate.