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Ruxolitinib Shows Clinical Benefit in Children, Adults With Atopic Dermatitis
Data from 3 pooled phase 3 studies in children, adolescents, and adults will be presented at the AAAI/WAO Joint Congress.
Most patients with atopic dermatitis (AD) over 2 years of age clinically benefitted from 8 weeks of twice-daily ruxolitinib cream monotherapy.1
These findings, from 3 randomized phase 3 studies, will be presented at the 2025 American Academy of Allergy, Asthma, and Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress, February 28-March 3, in San Diego, California, by Eric Simpson, MD, Frances J. Storrs, M.D. Medical Dermatology Professor, Dermatology, School of Medicine, Oregon Health & Science University.
“Following 8 weeks of twice-daily ruxolitinib cream monotherapy, the majority of patients aged ≥2 years met key clinically relevant AD endpoints. Efficacy and safety results were consistent across age groups,” Simpson and colleagues wrote.1
Simpson and colleagues evaluated ruxolitinib in children with AD aged 2 to 11 years in the TRuE-AD3 study (NCT04921969), and in adolescents and adults with AD in the TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651) studies. Participants had to have an Investigator’s Global Assessment (IGA) score of 2/3, and a 3%–20% affected body surface area to qualify. They were randomized 2:2:1 to apply twice-daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream for 8 weeks. The studies assessed efficacy as proportions of patients who achieved IGA treatment success (IGA-TS) with a score of 0/1 with at least a 2-grade improvement from baseline, and at least a 75% or 90% improvement from baseline in the Eczema Area and Severity Index (EASI-75/EASI-90) at Week 8.1
Altogether, the analysis includes data from 330 children, 236 adolescents, and 972 adults. The investigators found that at Week 8, significantly more (all P <.01) children, adolescents, and adults who applied 1.5% ruxolitinib cream versus vehicle achieved IGA-TS (56.5% vs 10.8%, 50.6% vs 14.0%, 53.0% vs 10.9%, respectively), EASI-75 (67.2% vs 15.4%, 60.9% vs 34.9%, 62.2% vs 16.4%), and EASI-90 (43.5% vs 10.8%, 39.1% vs 7.0%, 44.9% vs 7.0%). In terms of safety, both strengths of ruxolitinib cream were well tolerated across age groups. There were few application site reactions and no safety findings suggestive of systemic JAK inhibition.1
Other research set to be presented at the AAAAI/WAO Congress, led by Jessica Hui-Beckman, MD, from the National Jewish Health, found that infants who develop AD have skin barrier dysfunction in cheeks with delayed FLG processing, decreased protein-bound ceramides, and increased IL-18.2
Among 18 babies, 8 developed atopic dermatitis. Children who developed atopic dermatitis had significantly increased transepidermal water loss from the birth visit (P < .05). Moreover, FLG breakdown products, such as sis-UCA, were significantly lower at birth (P < .05) and 3 months (P = .0784) for children who later developed atopic dermatitis.2
Additionally, amino acids originating from FLG, such as histidine (P < .05) and glutamine (P < .05 and P < .01) acid, were significantly lower at birth and 3 months, respectively, for children who developed atopic dermatitis. These children also had significantly decreased levels of protein-bound ceramides at 3 months (P < .05). Furthermore, IL-18 was significantly increased at birth and even greater at 3 months (P < .01) for children who developed atopic dermatitis.2
