Ruxolitinib Cream Effective, Well Tolerated Among Black Patients With Atopic Dermatitis

A high proportion of Black patients with atopic dermatitis (AD) were reported to achieve clear or almost clear skin following treatment with ruxolitinib cream, according to study results presented at the American Academy of Dermatology’s (AAD) annual meeting held March 25 to 29, 2022.

Researchers pooled data from 2 phase 3 studies — TRuE-AD1 (ClinicalTrials.gov Identifier: NCT03745638) and TRuE-AD2 (ClinicalTrials.gov Identifier: NCT03745651) — in which 292 (23.4%) of participants identified as Black or African American and had atopic dermatitis for 2 years or longer. The mean age of this cohort was 34.5 years (range, 12-71 years); 194 were women, and 98 were men.

In both studies, participants were randomly assigned (2:2:1) to one of 2 ruxolitinib regimens (0.75% cream or 1.5% cream) or vehicle cream, each administered twice daily for 8 weeks of double-blind continuous treatment (vehicle-controlled period). Participants who initially received ruxolitinib cream continued treatment for 44 weeks (long-term safety period; as-needed treatment). Participants who initially received the vehicle cream were reassigned randomly (1:1) in a blinded fashion to either 0.75% or 1.5% ruxolitinib cream. A total of 170 (72.3%) patients completed the study.

The investigators reported that skin clearance occurred as early as week 2 in some patients. At the conclusion of the vehicle-controlled period, more patients who applied ruxolitinib cream vs vehicle cream achieved Investigator’s Global Assessment treatment success (IGA-TS), at least a 75% improvement in the Eczema Area and Severity Index (EASI-75), and at least a 4-point improvement in the itch numerical rating scale (itch NRS4).

For patients who continued applying 0.75% or 1.5% ruxolitinib cream from the vehicle-controlled period, 53.8% and 61.9% achieved clear or almost clear skin at week 8, respectively; 70.1% and 70.0% achieved clear or almost clear skin at week 52. For patients who replaced vehicle cream with 0.75% or 1.5% ruxolitinib cream at the beginning of the long-term safety  period, 36.0% and 18.2% achieved clear or almost clear skin at week 8, respectively; 76.5% and 66.7% achieved clear or almost clear skin at week 52.

The investigators also reported that the mean percentage of affected body surface area decreased during the long-term safety period.

The most frequently reported treatment-emergent adverse events were upper respiratory tract infection and hypertension.

“Over the 52-week study period, ruxolitinib cream was well tolerated among Black or African American patients, with a favorable safety profile and a low incidence of application site reactions,” according to the researchers.

Disclosure: Some study author(s) declared affiliations with biotech, pharmaceutical, and/or device companies. This research was supported by Incyte Corporation. Please see the original reference for a full list of disclosures.

Reference

Eichenfield LF, Stein Gold LF, Chiesa Fuxench ZC, Venturanza ME, Brar KK. Safety and efficacy over 8 weeks and disease control over 52 weeks with ruxolitinib cream among Black or African American patients with atopic dermatitis: pooled results from two phase 3 studies. Poster presented at: 2022 American Academy of Dermatology Annual Meeting; March 25-29, 2022; Boston, Massachusetts. Poster 34794.