Twice-daily application of ruxolitinib cream monotherapy appears effective and well tolerated in the treatment of mild-to-moderate atopic dermatitis (AD), regardless of age, based on a pooled analysis of three phase III trials presented at AAAAI/WAO 2025.

By week 8, a significantly higher percentage of patients on 1.5% ruxolitinib cream achieved an Investigator's Global Assessment treatment success (IGA-TS*) across all age groups (56.5 percent vs 10.8 percent [children], 50.6 percent vs 14 percent [adolescents], and 53 percent vs 10.9 percent [adults]; p<0.0001 for all) compared with those on the vehicle cream. [AAAAI/WAO 2025, abstract 613]

The benefit of 0.75% ruxolitinib cream over vehicle cream in terms of achieving IGA-TS was similar to that observed with 1.5% ruxolitinib cream (36.6 percent vs 10.8 percent, 47.2 percent vs 14 percent, and 44 percent vs 10.9 percent in children, adolescents, and adults, respectively; p<0.0001 for all).

From baseline to week 8, significantly more 1.5% ruxolitinib cream recipients achieved a ≥75- and ≥90-percent improvement in the Eczema Area and Severity Index (EASI) scores in all age groups (63.1 percent vs 18.8 percent [EASI75] and 43.8 percent vs 7.8 percent [EASI90]; p<0.0001 for both) than vehicle recipients.

Among those aged ≥6 years with an itch Numerical Rating Scale (NRS) score of ≥4 at baseline, more patients treated with 1.5% ruxolitinib cream experienced a greater reduction in NRS score at week 8 vs those on the vehicle cream (49.9 percent vs 18.5 percent; p<0.0001).

“[Pooled results showed that] significantly more patients who applied 1.5% ruxolitinib cream vs vehicle cream in the TRuE-AD studies achieved IGA-TS, EASI75, EASI90, EASI100, itch NRS4, and itch NRS 0/1 at week 2, with maintained or further improvement at weeks 4 and 8,” said the researchers.

“Overall, following 8 weeks of twice-daily ruxolitinib cream monotherapy, the majority of patients aged ≥2 years met key clinically relevant AD endpoints,” they noted.

This pooled analysis involved 330 children (aged 2?11 years) with AD for ≥3 months from TRuE-AD3 study and 236 adolescents (aged 12?17 years) and 972 adults (aged ≥18 years) with AD for ≥2 years from TRuE-AD1 and TRuE-AD2 studies, respectively. They were randomized in a 2:2:1 ratio to apply 0.75% or 1.5% ruxolitinib cream twice daily or a vehicle cream for 8 weeks of continuous treatment.

At baseline, 76.4 percent of children, 74.2 percent of adolescents, and 74.2 percent of adults had an IGA score of 3, with an affected body surface area of 10.5 percent, 10.4 percent, and 9.4 percent, respectively.

In terms of safety, “both strengths of ruxolitinib cream were well tolerated across the age groups, with few application site reactions and no safety findings suggestive of systemic JAK inhibition,” noted the researchers.

“Overall, the consistent efficacy and safety results observed across age groups demonstrate that ruxolitinib cream monotherapy is an effective and well-tolerated treatment option for patients with mild-to-moderate AD,” the researchers concluded.