Ruxolitinib cream efficacious, safe in pediatric patients with atopic dermatitis
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Key takeaways:
- Pediatric patients treated with ruxolitinib 0.75% or 1.5% cream had significant improvement vs. those treated with vehicle.
- IGA and EASI results were higher in the 1.5% treatment group of both age groups.
WASHINGTON — Ruxolitinib was efficacious and well tolerated in pediatric patients with mild to moderate atopic dermatitis, according to a poster presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting.
“Atopic dermatitis (AD), a chronic, heterogeneous, highly pruritic, relapsing inflammatory skin disease, typically begins in childhood and affects approximately 10% of children,” Weily Soong, MD, chief research innovation officer at AllerVie Health, and colleagues wrote. “Ruxolitinib cream, a topically administered selective Janus kinase (JAK) 1/JAK2 inhibitor, is an effective nonsteroidal monotherapy initially used twice daily continuously to reduce signs and symptoms of AD and as needed for longer-term disease control in adults and adolescents with mild to moderate AD.”
The double-blind, vehicle-controlled phase 3 TRuE-AD3 trial included patients with AD aged 2 to 6 years (n = 167) and aged 7 to 11 years (n = 163) who were randomly assigned 2:2:1 to receive 0.75% ruxolitinib cream, 1.5% ruxolitinib cream or vehicle twice daily for 8 weeks.
For the following 44 weeks, patients in both treatment groups were instructed to remain on their regimen, whereas patients in the vehicle cohort were rerandomized 1:1 to the two treatment groups.
After 8 weeks of treatment, 35.3% of patients aged 2 to 6 years in the 0.75% group and 60.6% of those in the 1.5% treatment group achieved IGA success, compared with 15.2% of those in the placebo group. Of those aged 7 to 11 years, 37.9% and 52.3% achieved IGA treatment success, respectively, compared with 6.3% of the placebo group.
EASI 75 was achieved by 48.5% of the 3- to 6-year-olds and 54.5% of the 7- to 11-year-olds in the 0.75% treatment cohorts, 74.2% and 60% of the 1.5% treatment cohorts and 18.2% and 12.5% of the placebo groups.
Patient-reported itch also decreased significantly in all treatment groups.
EASI 90 was achieved by 32.4% and 36.4% of the respective 0.75% treatment groups, 43.9% and 43.1% of the 1.5% groups and 15.2% and 6.3% of the placebo groups.
Both ruxolitinib strengths were well tolerated at both age ranges with no serious adverse events reported.
“In children with mild to moderate AD, ruxolitinib cream was similarly well tolerated in younger (2 to 6 years) and older (7 to 11 years) pediatric patients, and no serious infections, MACE, malignancies, or thromboses were observed,” the authors wrote.
Reference:
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Soong W, et al. Poster 001. Presented at: AAAAI Annual Meeting; Feb. 23-26, 2023; Washington, D.C.
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