Ruxolitinib Cream for Patients With Facial and/or Neck Atopic Dermatitis

Although topical treatments are standard for atopic dermatitis (AD), facial/neck AD remains challenging to manage effectively. In a presentation showcased at the Revolutionizing Atopic Dermatitis (RAD) June 2024 meeting, a study evaluated the efficacy and safety of 1.5% ruxolitinib cream in treating AD in these regions.

In a phase 2, randomized, double-blind, vehicle-controlled trial (NCT05127421), adolescents and adults aged 12 to 70 years with AD were studied. Eligible participants had AD for at least 6 months, an Investigator’s Global Assessment (IGA) score of 2 or 3, and ≤20% total body surface area affected, with ≥0.5% on the face/neck. They were randomized 2:1 to apply either 1.5% ruxolitinib cream or vehicle cream twice daily for 4 weeks. After this period, all participants could use ruxolitinib cream as needed for an additional 4 weeks. Efficacy was assessed using digital photographs, focusing on the proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (EASI-75) in the head/neck area at week 4. Safety was evaluated based on treatment-emergent adverse events (TEAEs).

Of the 77 patients randomized (54 to ruxolitinib cream and 23 to vehicle), 66 completed the vehicle-controlled period. The median age was 38 years, with 80.5% female and 44.2% Black participants. At baseline, mean overall and head/neck EASI scores were 4.0 and 1.2, respectively. A greater proportion of patients using ruxolitinib cream achieved head/neck EASI-75 at week 4 (37.0% vs 17.4% for vehicle), although this was not statistically significant (P=0.091). Facial/neck IGA treatment success was significantly higher in the ruxolitinib group (41.7% vs 11.1%). Improvements continued through week 8 for those using ruxolitinib from the start.

During the vehicle-controlled period, 11.1% of patients using ruxolitinib reported TEAEs compared to 21.7% in the vehicle group. Application-site reactions were rare, and no serious TEAEs or discontinuations occurred due to TEAEs.

The study concluded that ruxolitinib cream is effective and well-tolerated for treating facial/neck AD, with more patients achieving significant improvement compared to the vehicle.

Reference
Cotliar J, Lai Z, Kuo Y, Nawaz H, et al. Efficacy and safety of 1.5% ruxolitinib cream in patients with facial and/or neck atopic dermatitis: a randomized, double-blind, decentralized phase 2 study. Poster presented at: Revolutionizing Atopic Dermatitis; June 8-10, 2024; Chicago, IL.