Ruxolitinib cream was associated with rapid improvement in itch in patients with mild to moderate atopic dermatitis (AD) and was sustained for 8 weeks, according to study findings published in the Journal of the European Academy of Dermatology and Venereology.
Investigators reported their findings regarding the timing and extent of the effect of ruxolitinib cream on itch in patients with AD using pooled data from the phase 3 TRuE-AD1 and TRuE-AD2 studies.
Randomized, double-blinded studies were conducted in 10 countries and included participants aged 12 years and older, with an Investigator Global Assessment (IGA) score of 2 or 3 and 3% to 20% body surface area involvement excluding the scalp.
Patients were randomly assigned 2:2:1 to 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream (all twice a day) for 8 weeks of double-blinded treatment in both studies, respectively. Worst itch was measured with use of the numerical rating scale (NRS), and an electronic diary was completed each evening.
A total of 1249 patients were randomly assigned (vehicle, n=250; 0.75% ruxolitinib cream, n=500; 1.5% ruxolitinib cream, 499), of whom 1208 patients (vehicle, n=244; 0.75% ruxolitinib cream, n=483; 1.5% ruxolitinib cream, n=481) were assessed for efficacy. The overall median age of the participants was 32 (range, 12-85) years, 61.2% were female, and 68.6% were White. At baseline, 84.2% of participants had an itch NRS score of 2 or greater, and 64.4% had an itch NRS score of 4 or greater.
A statistically significant reduction in itch was found within about 12 hours of the first application of ruxolitinib cream (mean change from baseline, -0.4 and -0.5 points for 0.75% and 1.5% ruxolitinib cream, respectively) compared with vehicle (-0.1 points; both P < .02).
Participants’ mean itch NRS score (5.1 at baseline) decreased throughout, with lower scores for the ruxolitinib cream groups occurring at day 56 (0.75% ruxolitinib cream, 2.0; 1.5% ruxolitinib cream, 1.8; vehicle, 3.5). The mean change at week 8 for itch NRS score was -3.1 and -3.3 points for 0.75% and 1.5% ruxolitinib cream, respectively, compared with -1.6 points for vehicle (both P <.0001).
About 80% of patients who used ruxolitinib cream had reduced itch at week 8 compared with baseline, according to the 10-point visual analog scale itch component of SCORing Atopic Dermatitis, compared with 48% patients who used vehicle.
Among patients who had higher baseline levels of itch (NRS score ≥4; n=778 [64.4%]), significantly more patients who applied ruxolitinib cream achieved itch NRS4 (8.9% and 11.2% for 0.75% and 1.5% ruxolitinib cream, respectively) vs vehicle (2.1%; both P < .005) by day 2.
Additional improvement in itch NRS4 was found throughout the vehicle-controlled period, with statistically significant improvement observed compared with vehicle at week 8 (41.5% and 51.5% for 0.75% and 1.5% ruxolitinib cream, respectively; vehicle, 15.8%; both P <.0001).
The median time to reach itch NRS4 for the 0.75% and 1.5% ruxolitinib cream groups was 15.0 and 13.0 days, respectively, and it was not reached by the vehicle group.
A study limitation is that relatively few (3.8%) Asian patients were enrolled compared with other racial groups.
“The timing and magnitude of itch relief associated with ruxolitinib cream treatment suggests that it may provide meaningful improvement in quality of life and addresses an unmet need for patients with atopic dermatitis,” stated the researchers.
Disclosure: This study was funded by Incyte Corporation. Several of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Blauvelt A, Kircik L, Papp K, et al. Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. J Eur Acad Dermatol Venereol. Published online September 6, 2022. doi:10.1111/jdv.18571