Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. (21st September 2022)

• Record Type: Journal Article
• Authors: Blauvelt, Andrew; Kircik, Leon; Papp, Kim A.; Simpson, Eric L.; Silverberg, Jonathan I.; Kim, Brian S.; Kwatra, Shawn G.; Kuligowski, Michael E.; Venturanza, May E.; Wei, Shaoceng; Szepietowski, Jacek C.
• Is Part Of: Journal of the European Academy of Dermatology and Venereology. Volume 37:Number 1(2023)
• Page Start: 137
• Page End: 146
• Publication Date: 2022-09-21
• Subjects: Dermatology -- Periodicals; Sexually transmitted diseases -- Periodicals; 616.5
• DOI: 10.1111/jdv.18571
• Languages: English
• ISSNs: 0926-9959

Abstract

Abstract: Background: Ruxolitinib cream is a topical formulation of ruxolitinib, a Janus kinase (JAK) 1/JAK2 inhibitor. Objectives: To report timing and magnitude of effect of ruxolitinib cream on itch in patients with atopic dermatitis (AD), a highly pruritic inflammatory skin disease. Methods: Two phase 3 trials (TRuE‐AD1 [NCT03745638]/TRuE‐AD2 [NCT03745651]) enrolled patients aged ≥12 years with AD for ≥2 years, Investigator's Global Assessment score of 2 or 3, and 3%–20% affected body surface area. Patients (total N = 1249; median age, 32 years) were randomised (2:2:1) to twice daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream or vehicle cream for 8 weeks of double‐blinded treatment. Worst itch was measured using the numerical rating scale (NRS). Results: Significantly more patients who applied ruxolitinib cream (either strength) achieved a ≥2‐point itch reduction (NRS2) within approximately 12 h versus vehicle (0.75%/1.5% ruxolitinib cream, 16.3%/13.1%; vehicle, 6.9%; both P < 0.05), with further improvements through Week 8 (58.3%/65.1% vs 29.4%; both P < 0.0001). A ≥4‐point itch reduction (NRS4) was achieved by significantly more patients who applied 0.75%/1.5% ruxolitinib cream versus vehicle by Day 2 (8.9%/11.2% vs 2.1%; P < 0.005); higher rates were observed at Week 8 (41.5%/51.5% vs 15.8%; P < 0.0001). Median time for the 0.75%/1.5% ruxolitinib cream groups to achieve NRS4 from baseline was 15.0/13.0 days; this endpoint was not reached by the vehicle group. Conclusions: Ruxolitinib cream demonstrated rapid improvement in itch in patients with mild to moderate AD that was sustained for 8 weeks. Significantly more patients applying ruxolitinib cream achieved itch NRS2 within approximately 12 h and itch NRS4 by Day 2 versus vehicle.