Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis

Authors

Andrew Blauvelt, Oregon Medical Research Center, Portland, Oregon, USA.
Leon Kircik, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Kim A. Papp, K. Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada.
Eric L. Simpson, Oregon Health & Science University, Portland, Oregon, USA.
Jonathan I. Silverberg, George Washington University, Washington, District of Columbia, USA.
Brian S. Kim, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Shawn G. Kwatra, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Michael E. Kuligowski, Incyte Corporation, Wilmington, Delaware, USA.
May E. Venturanza, Incyte Corporation, Wilmington, Delaware, USA.
Shaoceng Wei, Incyte Corporation, Wilmington, Delaware, USA.
Jacek C. Szepietowski, Department of Dermatology, Venereology, and Allergology, Wroclaw Medical University, Wroclaw, Poland.

Document Type

Journal Article

Publication Date

9-6-2022

Journal

Journal of the European Academy of Dermatology and Venereology : JEADV

DOI

10.1111/jdv.18571

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.

APA Citation

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; and Szepietowski, Jacek C., "Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis" (2022). GW Authored Works. Paper 1659.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/1659

Department

Dermatology