Ruxolitinib Shows Clinical Benefit in Children, Adults With Atopic Dermatitis

Eric Simpson, MD

Credit: Oregon Health & Science University

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

REFERENCES
1. Simpson E, Eichenfield L, Papp K, et al. Efficacy and Safety of Ruxolitinib Cream Monotherapy in Patients Aged 2 Years and Older With Mild-to-Moderate Atopic Dermatitis: Results From 3 Large Randomized Phase 3 Studies. Presented at: 2025 AAAAI/WAO Joint Congress, February 28-March 3. Abstract 613.

2. Hui-Beckmann, J, Goleva, E, Bronoff, A, et al. Early Life Cheek Skin Barrier Changes are Associated with Atopic Dermatitis Development. Poster will be presented at the AAAAI 2025 meeting in San Diego from February 28 – March 3.