52-Week Safety and Disease Control With Ruxolitinib Cream in Children Aged 2 to 11 Years With Atopic Dermatitis: Results From the Phase 3 TRuE-AD3 Study.

Background

Ruxolitinib (selective Janus kinase [JAK]1/JAK2 inhibitor) cream demonstrated efficacy and safety vs vehicle during 8 weeks of continuous use in a phase 3 study of children with atopic dermatitis (AD).

Objective

To evaluate long-term safety (LTS) and disease control with as-needed ruxolitinib cream use in children.

Methods

Children aged 2-11 years with mild-to-moderate AD initially randomized to ruxolitinib cream (0.75% or 1.5%) in the 8-week study continued the same twice-daily (BID) regimen for an additional 44 weeks but only applied cream as needed BID; patients initially on vehicle were rerandomized (1:1) to apply either ruxolitinib cream strength as needed. Safety and disease control were assessed.

Results

No new safety signals emerged among children who applied ruxolitinib cream in the LTS period (N=282). Application site reactions were infrequent (1.1%), and no serious treatment-related adverse events were observed. Among patients initially randomized to ruxolitinib cream (0.75%/1.5%), disease control was maintained to Week 52 (Investigator's Global Assessment score 0/1, 79.5%/72.3%; affected body surface area, 2.0%/1.9%).

Limitations

No vehicle control in LTS period.

Conclusion

Ruxolitinib cream applied as needed over 44 weeks was well tolerated and demonstrated disease control in children aged 2-11 years, consistent with findings in adolescents and adults.