RUXOLITINIB cream improved moderate atopic dermatitis and rapidly reduced itch after other topical treatments had failed.
Ruxolitinib Cream Improves Atopic Dermatitis Outcomes
Adults with moderate atopic dermatitis experienced significantly greater improvements in disease severity and skin clearance with 1.5% ruxolitinib cream than with vehicle cream in the randomized, double-blind TRuE-AD4 trial.
The Phase 3b study enrolled 241 adults whose atopic dermatitis had responded inadequately to, was not tolerated with, or was contraindicated for both topical corticosteroids and topical calcineurin inhibitors during the previous 12 months. These participants would typically be considered for escalation to systemic therapy.
Participants had an Investigator’s Global Assessment score of 3, an Eczema Area and Severity Index score above 7, itch scores of at least 4, and 10% to 20% affected body surface area. They were randomized 2:1 to apply ruxolitinib cream or vehicle twice daily for 8 weeks.
At Week 8, 70.0% of participants using ruxolitinib cream achieved at least a 75% improvement in Eczema Area and Severity Index score, compared with 18.5% using vehicle. Investigator’s Global Assessment treatment success was achieved by 61.3% and 13.6%, respectively. Both differences were statistically significant.
Itch Relief Begins Within Minutes
Ruxolitinib cream also provided rapid relief from one of the most burdensome symptoms of atopic dermatitis. A clinically meaningful reduction in current itch was observed as early as 15 minutes after the first application.
By Day 2, 29.8% of participants receiving ruxolitinib cream had achieved at least a 4-point reduction in itch, compared with 13.7% in the vehicle group. This response increased throughout treatment, reaching 62.5% versus 19.8% at Week 8.
Improvements in affected body surface area, sleep disturbance, daily functioning, and dermatology-related quality of life were evident from Week 2 and continued through Week 8. Nearly all participants using ruxolitinib cream experienced some improvement in Eczema Area and Severity Index score by the end of treatment.
Topical Option Before Systemic Therapy
Treatment-emergent adverse events occurred at similar rates with ruxolitinib cream and vehicle, at 35.0% and 35.8%, respectively. Application site acne was the most frequent adverse event associated with ruxolitinib cream, affecting 3.8% of participants.
No serious adverse events were considered treatment related. Researchers also observed no major cardiovascular events, malignancies, serious infections, or thromboses among participants receiving ruxolitinib cream during the 8-week controlled period.
The findings suggest that ruxolitinib cream may provide an effective, well-tolerated topical option for adults with moderate atopic dermatitis before treatment is escalated to systemic therapy. However, the analysis was limited to 8 weeks and compared treatment with vehicle rather than an active therapy.
Reference
Carrascosa JM et al. Ruxolitinib cream in adults with moderate atopic dermatitis after failure of other topicals: A randomized trial. J Eur Acad Dermatol Venereol. 2026. doi:10.1111/jdv.70595.
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