Ruxolitinib Cream Could Provide Relief in Children Impacted by Atopic Dermatitis

New findings from a phase 3 study that assessed ruxolitinib cream (Opzelura, Incyte) demonstrate that the cream could provide relief for atopic dermatitis (AD), a condition that impacts the quality of life among children. AD is a chronic, heterogenous, highly pruritic, relapsing inflammatory skin condition that impacts 10% of children.

Researchers conducted a randomized, double-blind, vehicle-controlled phase 3 study, named TRuE-AD3 (NCT04921969). The study included 330 children aged 2 to 11 years old with mild to moderate AD that persisted for longer than 3 months. The researchers aimed to evaluate patient/parent-reported outcomes (PROs) and sleep-related outcomes among children treated with ruxolitinib cream.

The researchers divided the children into 3 groups to either receive vehicle (N=65), 0.75% ruxolitinib cream (N=134) or 1.5% ruxolitinib cream (N=131) twice daily. The study extended for 8 weeks as the children participated in continuous treatment.

The study authors noted that baseline demographics, clinical characteristics, and baseline PROs were comparable among each treatment group (median [range] age, 6 [2–11] years; mean [SD] affected BSA, 10.5% [5.40%]; 76.4% of patients had a baseline Investigator’s Global Assessment [IGA] score of 3), according to study authors.

The results found at week 8 that adjusted mean improvements in patient-oriented eczema measure and itch numerical rating scale, total scores from baseline among the 1.5% ruxolitinib cream group, compared to vehicle were drastic. The total PRO score change was also significant from baseline to week 8. A greater than 6-point improvement from basline in PRO measured information system sleep disturbance or sleep-related impairment was also reported.

“More patients achieved a clinically important improvement (≥6-point) in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance or Sleep-Related Impairment from baseline with ruxolitinib cream than with vehicle,” said the study authors.

Futhermore, the PRO results displayed in children were consistent with phase 3 results among adolescents and adults.

The findings suggest that ruxolitinib cream could be a well-tolerated and effective treatment through week 8 among children aged 2 to 11, that experience mild to moderate AD— aiding itch, pain, and sleep disturbance.

Reference

Effect of Ruxolitinib Cream on Patient-Reported Outcomes (PROs) in Children Aged 2-<12 Years With Atopic Dermatitis (AD): Results From a Randomized, Double-Blind, Vehicle-Controlled Phase 3 Study (TRuE-AD3). Accessed March 8, 2024.