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.