Ruxolitinib Cream Improves Itch, Sleep, Skin Pain in Children with Atopic Dermatitis

Eric L. Simpson, MD, MCR

Ruxolitinib cream is associated with greater benefit of patient-reported outcomes including itch, skin pain and sleep quality versus vehicle cream in pediatric patients with atopic dermatitis, according to a new analysis of the phase 3 TRuE-AD3 trial.

In data presented in a poster during the American Academy of Dermatology (AAD) 2024 Annual Meeting in San Diego, CA, this weekend, a team of US-based investigators reported that a twice-daily dose of the topical selective JAK1 / JAK2 inhibitor provided significant benefit for patient-reported outcomes (PROs) regarding itch, sleep disturbance, skin pain, and overall quality of life, among children aged 2 – 11 old originally treated in the TRuE-AD3 trial through 8 weeks.

Presented by Eric L. Simpson, MD, MCR, of the Oregon Health & Science University, the additional analysis from the Incyte-sponsored trial showed pediatric patients with eczema experienced improved symptoms similarly to adolescent and adult patients treated with ruxolitinib cream in TRuE-AD1 and TRuE-AD2.

Investigators conducted the trial to evaluate PRO changes among the pediatric participants of TRuE-AD3, the pivotal phase 3 trial that which showed improved anti-inflammatory and antipruritic response in children aged 2 – 11 years old with atopic dermatitis. Patients were randomized 2:2:1 to either 0.75% ruxolitinib cream (n = 134) or 1.5% ruxolitinib cream (n = 131) twice daily, or the vehicle arm (n = 65). Continuous treatment ran through 8 weeks; patients initially started on ruxolitinib were maintained on their regimen while patients receiving vehicle were randomized 1:1 to either treatment arm through 52 week.

As Simpson and colleagues noted, atopic dermatitis is commonly associated with a high quality-of-life burden on affected children. Their analysis of TRuE-AD3 included 8 measures of PROs:

• Patient Oriented Eczema Measure (POEM), in children aged 2 – 5 and 6 - 11
• Dermatology Life Quality Index (DLQ), in children aged 2 – 3
• Children’s Dermatology Life Quality Index (CDLQI), aged 4 – 11
• EuroQoL-5-dimension (EQ-5D Y VAS), in children aged 4 – 7 and 8 – 11
• Skin Pain Numerical Rating Scale (NRS), in children aged 6 – 11
• Itch NRS, in children aged 6 – 11
• PROMIS Sleep Disturbance, in children aged 5 – 7 and 8 – 11
• PROMIS Sleep-Related Impairment, in children aged 5 – 7 and 8 – 11

The analysis included the 330 patients initiated on either of the ruxolitinib cream regimens or vehicle. Median participant age was 6 years old; mean affected Body Surface Area (BSA) was 10.5% at baseline, and three-fourths (76.4%) of patients had a baseline IGA score of 3. Investigators additionally observed similar mean PRO scores across the 3 treatment arms at baseline.

At 8 weeks, the team reported significant adjusted mean improvements for POEM and Itch NRS scores from baseline among children treated with 1.5% ruxolitinib cream versus vehicle (-11.1 vs -5.5 [P <.0001] and -4.0 vs -2.6 [P <.05], respectively), indicating a significant improvement in patient-reported itch.

They additionally observed a greater rate of patients receiving 0.75% or 1.5% ruxlotinib cream reporting clinically-relevant improvement (≥6 points) in PROMIS Sleep Disturbance from baseline (25.0% and 16.2%, respectively) versus vehicle 9.5%) at week 8.

Simpson colleagues concluded that pediatric patients with mild to moderate atopic dermatitis reported improved quality of life and disease-specific symptoms including itch, skin and sleep disturbance with either dose of ruxolitinib cream versus placebo over 8 weeks.

“Improvements in sleep disturbance are particularly important due to an association with mental health comorbidities in (atopic dermatitis),” they wrote. “The current data add to previous results from this study that showed ruxolitinib cream to be effective and well tolerated through Week 8 in patients aged 2 to 11 years with mild to moderate (atopic dermatitis.”

References

1. ^{Simpson EL, Eichenfield LF, Paller AS, Zaengelin AL, et al. Effect of Ruxolitinib Cream on Patient-Reported Outcomes (PROs) in Children Aged 2–11 Years With Atopic Dermatitis (AD): Results From a Randomized, Double-Blind, Vehicle-Controlled Phase 3 Study (TRuE-AD3). Paper presented at: American Academy of Dermatology (AAD) 2024 Annual Meeting. March 8 – 12, 2024. San Diego, CA.}
2. ^{Smith T. Lawrence Eichenfield, MD: Phase 3 Trial Data on Ruxolitinib for Atopic Dermatitis. HCPLive. Published December 6, 2022. https://www.hcplive.com/view/lawrence-eichenfield-phase-3-trial-data-ruxolitinib-atopic-dermatitis}