TRuE AD3: Ruxolitinib Safety and Efficacy Confirmed in Children with Atopic Dermatitis

Ruxolitinib cream (RUX) demonstrated long-term safety and efficacy in children aged 2 to 11 with mild-to-moderate atopic dermatitis (AD), with over 60% of patients achieving clear or nearly clear skin, according to updated data presented recently at the 2024 European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam. 

Conducted as part of the TRuE-AD3 study, the study researchers included 330 children randomized to either 0.75% or 1.5% RUX cream or a vehicle cream twice daily for an initial 8-week period in the analysis. Following this, those assigned to RUX continued treatment as needed for an additional 44 weeks.

Clear or almost clear skin (IGA score of 0/1) was achieved by 50% and 72.4% of patients at week 8 using 0.75% and 1.5% RUX cream, respectively, compared with 24.5% using vehicle. By week 52, these results were further improved or maintained, with over 70% of patients showing increased disease control regardless of whether they started with vehicle or RUX. Affected body surface area (BSA) decreased significantly over time, with BSA values lower than 3% in most patients after 44 weeks of as-needed treatment.

The study also confirmed the cream’s safety, with low incidences of treatment-emergent adverse events (TEAEs). Upper respiratory tract infections and nasopharyngitis were the most commonly reported TEAEs.

“This study evaluated the long-term safety and efficacy of ruxolitinib cream in patients aged 2 to 11 years with mild to moderate AD," co-author Linda Stein Gold, MD, Director of Clinical Research and Division Head of Dermatology at Henry Ford Health System in Detroit, MI, told Practical Dermatology. "We found that treatment for up to 1 year was well tolerated, with a low incidence of application site reactions, and no cases of MACE, malignancy, thrombosis, herpes zoster, or folliculitis. Systemic plasma concentrations were low suggesting systemic JAK inhibition is highly unlikely. Children experienced effective long-term disease control, with >60% of patients achieving clear or almost clear skin and a mean affected BSA of ≤3% for the majority of the 44-week as-needed treatment period.”