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
Amy S. Paller, Marjolein de Bruin‐Weller, Danielle Marcoux, Eulàlia Baselga, Vânia Oliveira Carvalho, Ledit Ardusso, Suzanne G.M.A. Pasmans, Mirna Toledo‐Bahena, Cory Rubin, Joel C. Joyce, Lara Wine Lee, Bryan Adams, Rajan Gupta, Marius Ardeleanu, Annie Zhang
Abstract
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 (night-time: -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.