Abstract
The arrival of biologics and small-molecule therapies (eg Janus kinase inhibitors) changed atopic dermatitis treatment, but older systemic treatments continue to be prescribed. To provide real-world effectiveness, safety, and adherence data for dupilumab, cyclosporine, and methotrexate. PEDIatric STudy in Atopic Dermatitis (NCT03687359) is a real-world, prospective, observational, 10-year study of children (<12years) with inadequately controlled moderate-to-severe atopic dermatitis. We report 2-year interim results. Median treatment durations were 8.1, 13.0, and 10.7months 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; ≥6years); itching/scratching (-3.6∗ vs -1.4∗ and -0.2; <6years); 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%). No randomization, placebo, or specified dosages. Dupilumab was associated with numerically greater outcomes and higher adherence than cyclosporine or methotrexate.
Published Version
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