Ruxolitinib cream improves sleep disturbances, itch in children with atopic dermatitis
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Key takeaways:
- Ruxolitinib-treated patients achieved greater differences from baseline in itch intensity vs. vehicle.
- More ruxolitinib-treated patients reported a 6-point or higher improvement in sleep disturbance vs. vehicle.
SAN DIEGO — Ruxolitinib cream improved quality of life outcomes, including sleep and itch, in children aged 2 to 11 years with atopic dermatitis, according to a poster presented at the American Academy of Dermatology Annual Meeting.
As Healio previously reported, ruxolitinib cream, a topically administered selective Janus kinase 1 and 2 inhibitor, has proven to be an effective treatment for reducing inflammation and itch in children aged 2 to 11 years with atopic dermatitis, according to results from TRuE-AD3, a randomized, double-blind, vehicle-controlled phase 3 study.
To elucidate the change in patient/parent-reported outcomes (PROs), including sleep-related outcomes, during ruxolitinib-treatment, researchers further analyzed the results from TruE-AD3.
“Improvements in sleep disturbance are particularly important due to an association with mental health comorbidities in AD,” Eric L. Simpson, MD, MCR, Frances J. Storrs Medical Dermatology Professor at Oregon Health & Science University, and colleagues wrote.
A total of 330 patients (median age, 6 years; mean affected body surface area, 10.5%) were randomly assigned to receive vehicle (n = 65), 0.75% ruxolitinib (n = 134) or 1.5% ruxolitinib (n = 131) for 8 weeks. Baseline PROs were similar across treatment groups.
By week 8, a significantly higher proportion of patients treated with 1.5% ruxolitinib (55.4%) and 0.75% ruxolitinib (41%) achieved clear or almost clear skin vs. vehicle (14.6%), as measured by the Patient-Oriented Eczema Measure scale.
Patients treated with 1.5% ruxolitinib experienced the greatest itch relief vs. vehicle (least squares mean [LSM], –2.1 vs. –0.9; P < .0001) by week 8. The 0.75% ruxolitinib group also showed a significant improvement in itch vs. placebo (LSM, –1.9 vs. –0.9; P < .0001) at the same time point.
According to the Patient-Reported Outcomes Measurement Information System, 14.5% and 25.4% of patients treated with 1.5% and 0.75% ruxolitinib, respectively, reported a 6-point or higher improvement in their sleep disturbance vs. 10.7% of vehicle-treated patients.
“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 AD,” the authors concluded.
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Simpson EL, 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). Presented at: American Academy of Dermatology Annual Meeting; March 8-13, 2024; San Diego.
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