A greater percentage of patients with atopic dermatitis who used ruxolitinib (RUX) cream achieved an itch-free state within about 36 hours and sustained it throughout 8 weeks compared with those who used vehicle, according to findings from a study published in the Journal of the American Academy of Dermatology.
Researchers assessed achievement of an itch-free state in patients with atopic dermatitis using pooled data from the phase 3 TRuE-AD1 and TRuE-AD2 studies, in which ruxolitinib cream showed anti-inflammatory and antipruritic activity and was well tolerated.
An itch-free state was defined as having a baseline itch numerical rating scale (NRS) score of greater than 1 and achieving a score of 0 or 1; reporting no itch days in the preceding week on the Patient-Oriented Eczema Measure question 1 (POEM Q1) in patients with 1 or more days of itch in the previous week at baseline; and achieving a SCORing Atopic Dermatitis itch score of 0 or 1 (SCORAD itch 0/1) in patients with a baseline score of greater than 1.
All 1208 patients who had baseline itch were included in the analysis, except for 41 individuals from 1 study site owing to quality issues. On day 1, the 1.5% RUX group had 403 participants, the 0.75% RUX group had 399 participants, and the vehicle group had 200 participants, respectively. At week 8, the 1.5% RUX group had 370 participants, the 0.75% RUX group had 342 participants, and the vehicle group had 153 participants, respectively.
Groups that used RUX cream had higher percentages who achieved an itch-free state vs those who used vehicle. The difference in itch NRS 0/1 compared with vehicle was statistically significant on day 2, about 36 hours after the initial application (1.5% RUX cream, 19%; 0.75 RUX cream, 15.4%; vehicle, 4.6%, respectively) and remained significant through week 8 (1.5% RUX, 49.5%; 0.75% RUX, 43.9%; vehicle, 18.3%, respectively).
The median time to achieve itch NRS 0/1 was 14.0 and 9.0 days for the RUX 0.75% and 1.5% groups, respectively, and was not estimable for those who used vehicle.
According to multivariable proportional hazards regression analysis, age (<18 years [n = 198] vs ≥18 years [n = 877]) was the only factor that was significantly associated with a faster itch response (median time to NRS 0/1: <18 years; 11.0 [95% CI, 8.0, 13.0] days; ≥18 years, 17.0 [95% CI, 14.0, 21.0] days; hazard ratio, 0.754 [95% CI, 0.630, 0.902]; P =.002) of the factors that were assessed (sex, race, geographic region, body surface area, Eczema Area and Severity Index score, and Investigator Global Assessment score).
A higher percentage of patients who used RUX cream vs vehicle reported no days of itch according to POEM Q1, itch NRS 0/1 or POEM Q1, or SCORAD itch 0/1 for weeks 2 through 8.
“Achievement of an itch-free state is critical for improving patients’ quality of life and burden of illness, as itch can profoundly affect sleep, work productivity, and overall health,” stated the investigators. “These results demonstrate that RUX cream addresses an unmet need by rapidly improving itch, a chronic and burdensome symptom, in adults and adolescents with AD.”
Disclosure: These studies were funded by Incyte Corporation. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Blauvelt A, Szepietowski JC, Papp K, et al. Itch-free state in patients with atopic dermatitis treated with ruxolitinib cream: pooled analysis from 2 randomized phase 3 studies. J Am Acad Dermatol. Published online September 13, 2022. doi:10.1016/j.jaad.2022.09.010