Significantly more patients given ruxolitinib cream vs vehicle demonstrated rapid improvements in itch that were sustained over time.
Ruxolitinib cream was associated with significantly rapid and sustained reduction in itch among patients with atopic dermatitis (AD), according to study findings published recently in Journal of the European Academy of Dermatology and Venereology.
Cited as the single most burdensome symptom of AD in adults, itch has shown to have a pronounced impact on patients’ quality of life (QOL). Cost-related burdens have also been reported among patients with AD who experience frequent itch, but there remains a prevailing unmet need to rapidly address these symptoms, noted researchers, as currently used topical corticosteroids, as well as calcineurin and phosphodiesterase-4 inhibitors, have anatomic and long-term use restrictions.
One such topical treatment that can be used on all body areas and is generally well tolerated with long-term use is ruxolitinib cream, the only topical formulation of a Janus kinase (JAK) inhibitor approved in the United States. As a selective and potent inhibitor of JAK1 and JAK2, ruxolitinib cream has demonstrated its dual anti-inflammatory and antipruritic effects vs vehicle and its general safety in 2 phase 3 studies (TRuE-AD1 and TRuE-AD2).
Conducting a pooled analysis of the TRuE-AD1 and TRuE-AD2 studies, researchers sought to explore the timing and magnitude of effect of ruxolitinib cream on itch in patients with AD.
Enrolled patients of the 2 large phase 3 studies were 12 years or older and had AD for at least 2 years, with an Investigator’s Global Assessment score of 2 or 3 and 3% to 20% affected body surface area (BSA). A total of 1249 patients were randomized (2:2:1) to twice daily 0.75% ruxolitinib cream (n = 500), 1.5% ruxolitinib cream (n = 499), or vehicle cream (n = 250) for 8 weeks of double-blinded treatment, with worst itch measured via the numerical rating scale (NRS; 0 [no itch] to 10 [worst imaginable itch]).
“Worst itch NRS scores (measured score and change from baseline [daily and at weeks 2, 4, and 8]) and the proportion of patients with a greater than or equal to 4-point improvement (NRS4) in worst itch NRS score (daily and at weeks 2, 4, and 8) was assessed,” explained the study authors.
“The proportion of patients with a greater than or equal to 2-point improvement (NRS2) was assessed post hoc, consistent with the recent suggestion that NRS2 may represent a clinically important difference. The times needed to reach itch NRS2 and itch NRS4, which were both secondary endpoints of the TRuE-AD studies, were also evaluated.”
The study cohort was majority female (61.2%) and most patients were White (68.6%), followed by Black (24.2%), Asian (3.8%), or other races (3.4%). At baseline, 84.2% of patients had an itch NRS score greater than or equal to 2 and 64.4% had an itch NRS score greater than or equal to 4.
Findings showed that significantly more patients who applied ruxolitinib cream (either strength) achieved NRS2 within approximately 12 hours vs vehicle (0.75%/1.5% ruxolitinib cream, 16.3%/13.1%; vehicle, 6.9%; both P < .05), with further improvements reported through week 8 (58.3%/65.1% vs 29.4%; both P < .0001).
Among patients with higher levels of itch at baseline, NRS4 was achieved by significantly more patients who applied 0.75%/1.5% ruxolitinib cream vs vehicle by day 2 (8.9%/11.2% vs 2.1%; P <.005), with higher rates also observed at week 8 (41.5%/51.5% vs 15.8%; P < .0001). Median time for the 0.75%/1.5% ruxolitinib cream groups to achieve NRS4 from baseline was 15.0/13.0 days, whereas this end point was not reached by the vehicle group.
“The timing and magnitude of itch relief associated with ruxolitinib cream treatment suggests that it may provide meaningful improvement in QOL and addresses an unmet need for patients with AD,” concluded researchers.
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