Efficacy, Safety, and Long-Term Disease Control of Ruxolitinib Cream Among Adolescents with Atopic Dermatitis

A recent study published in the American Journal of Clinical Dermatology has shed light on the efficacy and safety of ruxolitinib cream among adolescents grappling with atopic dermatitis (AD). The research aimed to not only ascertain short-term benefits but also assess long-term disease control during a period of up to 52 weeks.

Conducted across 2 phase 3 trials, namely TRuE-AD1 and TRuE-AD2, the study focused on describing the safety and efficacy of 1.5% ruxolitinib cream compared to a vehicle among adolescents aged 12–17 years.

Participants, aged 12 years and older, with a history of AD for at least 2 years, an Investigator’s Global Assessment score of 2 or 3, and affected body surface area ranging from 3% to 20% at baseline, were enrolled. They were randomly assigned to receive either ruxolitinib cream or a vehicle for an initial 8-week period, followed by a long-term safety period with as-needed use.

The findings revealed a significant improvement in efficacy measures at week 8 among those treated with 1.5% ruxolitinib cream compared to the vehicle group. Notably, a higher proportion of patients on ruxolitinib cream achieved treatment success, as indicated by an Investigator’s Global Assessment score of 0 or 1 with at least a two-grade improvement from baseline, along with substantial improvements in the Eczema Area and Severity Index and itch numerical rating scale.

Furthermore, the study demonstrated promising long-term disease control with ruxolitinib cream, as evidenced by sustained or increased clearance rates and low affected body surface area over the 52-week period. Importantly, the treatment was well-tolerated, with minimal adverse events reported, including a low incidence of application site reactions.

“Meaningful anti-inflammatory and antipruritic effects were demonstrated with 1.5% ruxolitinib cream in the subset of adolescent patients with AD, comparable with those observed in the overall study population; long-term, as-needed use maintained disease control and was well tolerated,” concluded the study authors.

Reference:

Eichenfield LF, Simpson EL, Papp K, et al. Efficacy, safety, and long-term disease control of ruxolitinib cream among adolescents with atopic dermatitis: pooled results from two randomized phase 3 studies. Am J Clin Dermatol. Published online May 2, 2024. doi: 10.1007/s40257-024-00855-2.