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 (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.
Competing Interests: Conflicts of interest Dr Paller has been an investigator, consultant, and/or data and safety monitoring board member for AbbVie, Abeona Therapeutics, Amryt Pharma, Azitra, BioCryst, BMS, Boehringer Ingelheim, Castle Creek Biosciences, Catawba Research, Dermavant, Eli Lilly, Galderma, InMed Pharmaceuticals, Incyte, Janssen, Krystal Biotech, LEO Pharma, Novartis, Regeneron Pharmaceuticals Inc, Sanofi, Seanergy, TWi Biotechnology, and UCB. Dr de Bruin-Weller has been a consultant, advisory board member, and/or speaker for AbbVie, Almirall, Amgen, Eli Lilly, Galderma, Janssen, LEO Pharma, Pfizer, Regeneron Pharmaceuticals Inc, and Sanofi Genzyme. Dr Marcoux has been an investigator for AbbVie, Amgen, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, and Regeneron Pharmaceuticals Inc. They have served as a consultant for AbbVie, Amgen, BMS, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals Inc, Sanofi Genzyme, and UCB, and is or has been a speaker for AbbVie, Amgen, BMS, Novartis, Pfizer, Regeneron Pharmaceuticals Inc, and Sanofi Genzyme. Dr Baselga has been an investigator for AbbVie, Boehringer Ingelheim, Dermira, Eli Lilly, LEO Pharma, Pfizer, and Novartis, and served as a consultant for Almirall, Galderma, Novartis, Pfizer, Pierre-Fabre, Regeneron Pharmaceuticals Inc, and Sanofi Genzyme. Dr Carvalho has been a speaker for Expanscience, Galderma, Johnson & Johnson Consumer Health, Mantecorp Skincare, Megalabs, and Royal Canin. They have been a consultant for Johnson & Johnson and have been an investigator for Sanofi. Dr Ardusso has been a consultant and/or advisory board member, and/or speaker for AstraZeneca, GSK, and Sanofi and has been an investigator for Novartis, Sanofi Genzyme, Amgen, Chiesi, AstraZeneca, Areteria, bellus, and Upstream Bio. Dr Pasmans has been a consultant, advisory board member, and or speaker for LEO Pharma, Pfizer, Regeneron, and Sanofi Genzyme. They have been an advisory board member, and or speaker or investigator for LEO Pharma, Regeneron Pharmaceuticals, Sanofi Genzyme, Novartis, Pierre Fabre, Boerhinger Ingelheim; have received grants from Novartis, Pierre Fabre, Micreos, BAP Medical, D&M B.V., and DeclaCare, Boerhinger Ingelheim, Ministry of Ministry of Health, Welfare and Sport, and ZonMW. Dr Toledo-Bahena has been a speaker for AbbVie, Pfizer, Expanscience, Panalab, Lilly, LEO Pharma, UCB, Faes Pharma, and Pierre Fabre, and has been an investigator for Pfizer, Lilly, Abbvie, and Sanofi. Dr Rubin has been a speaker for AbbVie, Amgen, Bayer, BMS, Castle Creek Biosciences, Celgene, Cutanea, Dermavant, DermTech, Galderma, Genentech, Helsinn, Incyte, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Promius Pharma, Regeneron Pharmaceuticals Inc, Sanofi, Sun Pharma, and UCB; has served as a consultant for AbbVie, Allergan, Amgen, Biofrontera, Castle Creek Biosciences, Celgene, Dermavant, DermTech, Incyte, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Promius, Regeneron Pharmaceuticals Inc, Sanofi, and UCB, and as an investigator for BMS, Cara Therapeutics, Castle Biosciences, DermTech, Janssen, LEO Pharma, and Sanofi. Dr Joyce has been a consultant for Pfizer and Sanofi, a speaker for Sanofi, and served as an investigator for AbbVie, Aclaris Therapeutics, Amgen, AstraZeneca, Bayer, BMS, Eli Lilly, Galderma, Incyte, Janssen, NFlection Therapeutics, Novartis, Pfizer, Sanofi, and UCB. Dr Wine Lee has been an advisory board member for Castle Creek Biosciences, Eli Lilly, Pfizer, Regeneron Pharmaceuticals Inc, and Verrica, has served as a consultant for AbbVie, Amryt Pharma, Kimberly-Clark, Krystal Biotech, Novartis, and Pyramid Biosciences, has been an investigator for AbbVie, Amgen, Amryt Pharma, Arcutis Biotherapeutics, Castle Creek Biosciences, Celgene, Eli Lilly, Galderma, Incyte, Mayne Pharmaceuticals, Novartis, Pfizer, Regeneron Pharmaceuticals Inc, Sanofi, Target Pharma, Trevi Therapeutics, and UCB, and a speaker for Amryt Pharma and Krystal Biotech. Dr Adams is an employee of Sanofi and may hold stock and/or stock options in the company. Dr Gupta is a consultant for Sanofi. Dr Ardeleanu is an employee and shareholder at Regeneron Pharmaceuticals Inc. Dr Zhang is an employee of Sanofi Genzyme and may hold stock and/or stock options in the company.
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