Background: The arrival of biologics and small-molecule therapies (e.g. Janus kinase inhibitors) changed atopic dermatitis (AD) 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: PEDISTAD (NCT03687359) is a real-world, prospective, observational, 10-year study of children (<12 years) with inadequately controlled moderate-to-severe AD. 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.
Keywords: atopic dermatitis; cyclosporine; dupilumab; methotrexate; moderate-to-severe; pediatric; real-world; systemic.
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