As-needed ruxolitinib in children with AD: Disease control stable through 52 weeks

As-needed application of ruxolitinib cream, a topically administered selective Janus kinase 1/2 inhibitor, resulted in long-term safety and disease control in children aged 2–11 years with mild-to-moderate atopic dermatitis (AD), according to updated results of the phase III TRuE-AD3 trial presented at EADV 2024.

“Both strengths of ruxolitinib cream were well tolerated throughout the entire 52-week study period, with no meaningful differences between strengths,” said Dr Amy Paller from the University of California San Diego in La Jolla, California, US.

In the long-term safety (LTS) period (treat as needed: weeks 8–52), 288 children (mean age 7 years, 52.8 percent female) with moderate-to-severe AD were evaluated. Patients who were originally randomized to ruxolitinib cream 0.75% (n=119) or 1.5% (n=114) continued on their regimen, whereas those receiving the vehicle cream were rerandomized 1:1 to ruxolitinib cream 0.75% (n=25) or 1.5% (n=24) twice daily as-needed for recurrences of lesions for a maximum of 3 days until clearance. [EADV 2024, abstract 8082]

Safety

During the LTS period, there was a low incidence of treatment-related treatment-emergent adverse events (TEAEs; 6.0 percent), with only 1.1 percent of application site reactions reported.

The most common TEAEs were upper respiratory tract infection (13.4 percent [0.75%] and 16.2 percent [1.5%]), nasopharyngitis (5.2 percent and 13.1 percent, respectively), and COVID-19 (9 percent and 6.9 percent).

No cases of folliculitis or herpes zoster were observed and so were MACE, malignancies, or thromboses.

Disease control

A higher percentage of ruxolitinib recipients achieved an Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) than the vehicle recipients (50 percent [0.75%] and 72.4 percent [1.5%] vs 24.5 percent) at week 8, which further improved with as-needed ruxolitinib cream through week 52 (79.5 percent [0.75%] and 72.3 percent [1.5%]).

Among children who switched from the vehicle to as-needed ruxolitinib cream, 78.9 percent (0.75%) and 72.2 percent (1.5%) achieved clear or almost clear skin, respectively, at week 52.

Of note, “patients spent nearly half of the LTS period off treatment due to lesion clearance,” said Paller.

Moreover, both cohorts demonstrated a low mean affected body surface area during the 44-week as-needed treatment period, with 1.5 percent (0.75%) and 1.6 percent (1.5%) in the vehicle-ruxolitinib cohort and 2 percent and 1.9 percent, respectively, in the continuous ruxolitinib cohort.

“Overall, in patients aged 2–11 years with mild-to-moderate AD, ruxolitinib cream for up to 1 year was well tolerated … with effective long-term disease control from as early as 2 weeks,” said Paller.

“Safety and efficacy results in children aged 2–11 years were similar to phase III results in adolescents and adults and maximum-use studies in children, adolescents, and adults,” she added.