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

被引:13
作者
Blauvelt, Andrew [1 ]
Kircik, Leon [2 ]
Papp, Kim A. [3 ]
Simpson, Eric L. [4 ]
Silverberg, Jonathan, I [5 ]
Kim, Brian S. [2 ]
Kwatra, Shawn G. [6 ]
Kuligowski, Michael E. [7 ]
Venturanza, May E. [7 ]
Wei, Shaoceng [7 ]
Szepietowski, Jacek C. [8 ]
机构
[1] Oregon Med Res Ctr, 9495 SW Locust St,Suite G, Portland, OR 97223 USA
[2] Icahn Sch Med Mt Sinai, New York, NY 10029 USA
[3] K Papp Clin Res & Prob Med Res, Waterloo, ON, Canada
[4] Oregon Hlth & Sci Univ, Portland, OR 97201 USA
[5] George Washington Univ, Washington, DC USA
[6] Johns Hopkins Univ, Sch Med, Baltimore, MD USA
[7] Incyte Corp, Wilmington, DE USA
[8] Wroclaw Med Univ, Dept Dermatol Venereol & Allergol, Wroclaw, Poland
关键词
CRISABOROLE OINTMENT; RATING-SCALE; DOUBLE-BLIND; MODERATE; ADULTS; ITCH; ADOLESCENTS; MANAGEMENT; INHIBITOR; PHASE-3;
D O I
10.1111/jdv.18571
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
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.
引用
收藏
页码:137 / 146
页数:10
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