In maximum-use conditions, 1.5% ruxolitinib cream for the treatment of atopic dermatitis (AD) was well tolerated and had a high level of efficacy. These findings were published in a study in the American Journal of Clinical Dermatology.

This open-label trial recruited adolescents and adults with AD at 6 sites in the United States and 1 site in Canada in 2019. Patients (N=41) aged 12 to 65 years who had AD for 2 or more years and had at least 25% of body surface area (BSA) involvement were eligible for study participation. Safety, tolerability, efficacy, and pharmacokinetics of 1.5% ruxolitinib cream were evaluated through day 28 with an extension period through day 56.

Patients were  median age 17.0 (interquartile range [IQR], 15-36) years, 68.3% were White, median BSA was 31.2% (IQR, 28.6%-44.0%), numerical rating scale (NRS) for itch was mean 5.5 (standard deviation [SD], 1.7) points, 26.8% had previously used antihistamines, 12.2% corticosteroids, and 2.4% methotrexate.


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Treatment-emergent adverse events (TEAE) were reported by 31.7% of patients. Few events were of grade 2 (n=3) or 3 (n=1) severity. Only 2 events were observed in more than 1 patient (aspartate aminotransferase increase [n=2], upper respiratory tract infection [n=2]).

A TEAE leading to treatment discontinuation occurred in 1 patient. Most patients (90.2%) chose to continue therapy through the 28-day extension period.

The daily amount of ruxolitinib cream applied was 21.8 g (SD, 13.1) during the first 28 days and decreased to 9.0 g (SD, 7.5) during the extension period, due to the reduction of active lesions.

The geometric mean concentration of ruxolitinib was 26.5 nM during the first 28 days during which time all baseline lesions were treated. Plasma concentration of ruxolitinib peaked at 4 hours after application on day 1 at 241 nM. The overall median trough plasma concentration was stable during the first 28 days, decreasing during the extension period. Concentrations were lower among patients with less than 40% BSA.

Treatment success was observed among 20% at day 15, 35.9% at day 28, and 56.8% at day 56. Most patients had clear or almost clear skin by day 28 (61.5%), with more than three-quarters (81.1%) achieving clear or almost clear skin during the extension.

Itch NRS decreased by 1.9 points at day one, with 90.5% achieving at least a 4-point NRS improvement by day 56. Similarly, Eczema Area and Severity (EASI) improvement of 75% or greater was achieved by 30.0% at day 15 and 94.6% at day 56.

This study may have been limited by the lack of a control vehicle and the small sample size.

These data suggested to the investigators that in a maximum use scenario, 1.5% ruxolitinib cream was safe and effective for the treatment of AD among adolescents and adults.

Reference

Bissonnette R, Call RS, Raoof T, et al. A Maximum‑Use Trial of Ruxolitinib Cream in Adolescents and Adults with Atopic Dermatitis. Am J Clin Dermatol. Published online April 4, 2022. doi:10.1007/s40257-022-00690-3