Efficacy and safety of ruxolitinib cream in children aged 2 to 11 years with atopic dermatitis: Results from TRuE-AD3, a phase 3, randomized double-blind study
- PMID: 40378883
- DOI: 10.1016/j.jaad.2025.05.1385
Efficacy and safety of ruxolitinib cream in children aged 2 to 11 years with atopic dermatitis: Results from TRuE-AD3, a phase 3, randomized double-blind study
Abstract
Background: Ruxolitinib (Janus kinase 1 and Janus kinase 2 inhibitor) cream demonstrated efficacy and safety in adolescents and adults with mild-to-moderate atopic dermatitis (AD).
Objective: To evaluate 8-week efficacy and safety of ruxolitinib cream in children with mild-to-moderate AD.
Methods: This phase 3 study (TRuE-AD3; NCT04921969) enrolled children aged 2-11 years with an Investigator's Global Assessment (IGA) score of 2 or 3 and 3% to 20% affected body surface area. Patients were randomized 2:2:1 to twice-daily ruxolitinib cream (0.75% or 1.5%) or vehicle for 8 weeks. The primary endpoint was the proportion of patients achieving IGA treatment success (IGA-TS; score of 0/1 with ≥2-grade improvement from baseline) at Week 8.
Results: Children (N = 330) were randomized to vehicle (n = 65), 0.75% ruxolitinib cream (n = 134), or 1.5% ruxolitinib cream (n = 131). At Week 8, significantly more patients achieved IGA-TS with 0.75%/1.5% ruxolitinib cream (36.6%/56.5%) versus vehicle (10.8%; P = .0001/P < .0001). Improvements in itch and quality of life were also observed. The safety profile was consistent with that observed in adults and adolescents.
Limitations: Enrollment was limited to patients in North America.
Conclusion: Ruxolitinib cream provided superior improvements versus vehicle in AD signs and symptoms in children with mild-to-moderate AD and was well tolerated.
Keywords: JAK inhibitor; Janus kinase; atopic dermatitis; children; eczema; efficacy; pediatric; phase 3; randomized; ruxolitinib cream; safety; topical.
Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Conflicts of interest Dr Eichenfield has served as a consultant, speaker, advisory board member, or investigator for AbbVie, Amgen, Arcutis, Apogee, Attovia, Bristol Myers Squibb, Castle Biosciences, Dermavant, Eli Lilly, Forte, Galderma, Incyte Corporation, Janssen, Johnson & Johnson, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Target RWE, and UCB. Dr Stein Gold has served as an investigator, advisor, and/or speaker for AbbVie, Arcutis, Bristol Myers Squibb, Dermavant, Eli Lilly, Incyte Corporation, Ortho Derm, Pfizer, Regeneron, and Sanofi. Dr Simpson has served as an investigator for AbbVie, Eli Lilly, Galderma, Kyowa Hakko Kirin, LEO Pharma, Merck, Pfizer, and Regeneron and as a consultant with honoraria for AbbVie, Eli Lilly, Forte, Galderma, Incyte Corporation, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, and Valeant. Dr Zaenglein has served as an investigator for AbbVie, Biofrontera, Dermavant, Incyte Corporation, and Galderma and as a consultant for Dermavant and UCB. Dr Armstrong has served as a research investigator and/or scientific advisor to AbbVie, Bristol Myers Squibb, Dermavant, Dermira, Incyte Corporation, Janssen, LEO Pharma, Lilly, Modmed, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB. Dr Tollefson has served as an investigator for Incyte Corporation and Pfizer. Dr Soong has served as an investigator for AbbVie, Allakos, Amgen, Dermavant, Eli Lilly, Galderma, Incyte Corporation, LEO Pharma, Pfizer, Regeneron, and Sanofi and as a consultant or speaker for AbbVie, Amgen, Dermavant, Eli Lilly, Incyte Corporation, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, and UCB. Dr Wine Lee has received research funding from AbbVie, Amgen, Amryt, Arcutis, Avita, Castle Creek, Celgene, Eli Lilly, Galderma, Incyte Corporation, Janssen, Kiniksa, Krystal Biotech, Mayne Pharmaceuticals, MoonLake, Novartis, Pfizer, Pyramid Bioscience, Regeneron, Sanofi, Target Pharma, Timber Pharmaceuticals, Trevi Therapeutics, and UCB and fees from AbbVie, Amryt, Eli Lilly, Kimberly Clark, Novartis, Pfizer, Regeneron, and Verrica. Dr Devani has served as an advisor, consultant, and/or speaker for AbbVie, Amgen, Arcutis, Bausch Health, Bristol Myers Squibb, Galderma, Incyte Corporation, Janssen, LEO Pharma, Pfizer, Sanofi Genzyme, Sun Pharma, UCB, and Valeant; an investigator for AbbVie, AnaptysBio, Arcutis, Arena, Asana, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Concert, CorEvitas, Dermavant, Dermira, Eli Lilly, Galderma, Incyte Corporation, Janssen, LEO Pharma, Meiji Pharma, Nektar Therapeutics, Nimbus Lakshmi, Novartis, Pfizer, RAPT Therapeutics, Regeneron, Reistone, Sanofi Genzyme, Sun Pharma, Takeda, and UCB; and has received grants from AbbVie, Bausch Health, Janssen, LEO Pharma, Novartis, and Sanofi Genzyme. Dr Forman has received honoraria, clinical research grants, or fees as a consultant, speaker, advisory board member, and/or investigator for AbbVie, Aclaris Therapeutics, Bluefin, Eli Lilly, Incyte Corporation, Innovaderm Research, MoonLake, Novartis, Pfizer, Regeneron, UCB, and XBiotech. Dr Siri has received research grants from AbbVie, Amgen, AnaptysBio, Biorasi, Eli Lilly, Galderma, Incyte Corporation, Kiniksa, LEO Pharma, Novartis, Pfizer, Q32, Regeneron, and UCB and was a speaker or advisor for Arcutis, Dermavant Sciences, Incyte Corporation, Pfizer, Regeneron, and Sanofi. Drs Kallender, Angel, Li, and Chen are employees and shareholders of Incyte Corporation. Dr Paller has served as an investigator or consultant for AbbVie, Abeona, Apogee, Applied Pharma Research, Arcutis, Aslan, BioCryst, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Galderma, Eli Lilly, Incyte Corporation, Janssen, Johnson and Johnson, Krystal Biotech, LEO Pharma, Mitsubishi Tanabe, Nektar, Primus, Procter and Gamble, Regeneron, Sanofi, Seanergy, TWI Biotech, and UCB.
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