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.

Summary

In 330 children with mild-to-moderate atopic dermatitis, ruxolitinib cream (0.75% and 1.5%) significantly increased IGA treatment success at 8 weeks versus vehicle (36.6%/56.5% vs 10.8%). Itch and quality of life improved, and safety was consistent with adolescent/adult data.

Key Findings

• At week 8, IGA treatment success was 36.6% (0.75%) and 56.5% (1.5%) vs 10.8% with vehicle (P = .0001 and P < .0001).
• Improvements were observed in itch and quality of life measures.
• Safety profile in children was consistent with that in adolescents and adults.

Clinical Implications

Ruxolitinib cream can be considered a nonsteroidal option for children aged 2–11 years with mild-to-moderate atopic dermatitis, though longer-term safety and head-to-head comparisons with topical steroids/calcineurin inhibitors are needed.

Limitations

• Enrollment limited to North America, potentially affecting generalizability
• Short treatment duration (8 weeks) without long-term safety data or active comparator

Future Directions

Head-to-head trials versus topical steroids/calcineurin inhibitors and longer-term safety/maintenance studies in diverse populations.