TRuE-AD3: Ruxolitinib cream effective in children with AD

Ruxolitinib cream, a topically administered selective Janus kinase 1/2 inhibitor, appears to be effective for mild-to-moderate atopic dermatitis (AD) in children aged 2–11 years, according to the TRuE-AD3 trial presented at AAAAI 2024.

“Ruxolitinib cream 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, as shown in two phase III clinical studies (TRuE-AD1/TRuE-AD2),” said Dr Weily Soong from AllerVie Health, Birmingham in Alabama, US.

In the current phase III, double-blind TRuE-AD3 study, 330 children aged 2–6 and 7–11 years with mild-to-moderate AD for ≥3 months. They were randomized in 2:2:1 ratio to receive ruxolitinib cream 0.75% (n=134) or 1.5% (n=131) or a vehicle cream (n=65) twice daily for 8 weeks of continuous treatment. The patients on ruxolitinib continued to use it for 44 weeks, while those who were initially given the vehicle were switched to 0.75% or 1.5% ruxolitinib cream.

At week 8, significantly more patients aged 2–6 years treated with ruxolitinib cream 1.5% achieved IGA*-treatment success than those treated with the vehicle cream (60.6 percent vs 15.2 percent; p<0.0001), as well as those aged 7–11 years (52.3 percent vs 6.3 percent; p<0.0001).

A significantly higher percentage of patients who received ruxolitinib cream 1.5% also achieved a 75-percent improvement in EASI** (EASI75) score from baseline to week 8 in both age groups (2–6 years: 74.2 percent vs 18.2 percent and 7–11 years: 60 percent vs 12.5 percent; p<0.0001 for both groups) vs those who received the vehicle cream.

Additionally, EASI95 was observed in 43.9 percent (p<0.01) and 43.1 percent (p<0.001) of ruxolitinib cream 1.5% recipients in both the younger and older cohorts, respectively, compared with 15.2 percent and 6.3 percent of vehicle recipients.

The effects observed in the ruxolitinib cream 0.75% cohort were similar to those observed in the ruxolitinib cream 1.5% cohort.

In terms of safety, a few application site reactions were reported with ruxolitinib, but no serious adverse events or deaths have been reported.

“In children with mild-to-moderate AD, [both strengths of] ruxolitinib cream were similarly well tolerated in [both age groups] … There were no serious infections, MACE, malignancies, or thromboses observed,” said Soong.

“The efficacy and safety of ruxolitinib cream in both paediatric age groups in TRuE-AD3 were similar to those reported for adults and adolescents in the TRuE-AD1 and TRuE-AD2 studies,” he noted.