Effects of ruxolitinib cream on pruritus and quality of life in atopic dermatitis: Results from a phase 2, randomized, dose-ranging, vehicle- and active-controlled study

J Am Acad Dermatol. 2020 Jun;82(6):1305-1313. doi: 10.1016/j.jaad.2020.02.009. Epub 2020 Feb 11.

Abstract

Background: Atopic dermatitis (AD), a chronic, highly pruritic skin disorder, impairs quality of life (QoL). Janus kinase inhibitors suppress inflammatory and pruritus-associated cytokine signaling in AD.

Objective: To report the effects of ruxolitinib (RUX) cream on itch and QoL in AD.

Methods: A total of 307 adult patients with an Investigator's Global Assessment (score of 2 or 3) and 3% to 20% affected body surface area were randomly assigned for 8 weeks to receive double-blind treatment with RUX (1.5% twice daily, 1.5% once daily, 0.5% once daily, or 0.15% once daily), vehicle twice daily, or triamcinolone cream (0.1% twice daily for 4 weeks then vehicle for 4 weeks). Itch was measured by using the numerical rating scale, and patient QoL was assessed with Skindex-16.

Results: Improvements in itch numerical rating scale and Skindex-16 were observed with RUX cream. Overall, 42.5% of patients who applied 1.5% RUX twice daily experienced minimal clinically important difference in itch within 36 hours of treatment (vehicle, 13.6%; P < .01); near-maximal improvement was observed by week 4. Itch reduction was associated with improved QoL burden (Pearson correlation, 0.67; P < .001). Significant improvements in Skindex-16 overall scores were noted at week 2.

Limitations: Facial AD lesions were not treated.

Conclusion: RUX cream provides a clinically meaningful reduction in itch and QoL burden.

Keywords: JAK inhibitor; Janus kinase; Skindex-16; atopic dermatitis; burden of disease; itch; pruritus; quality of life; ruxolitinib.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-Inflammatory Agents / therapeutic use
  • Dermatitis, Atopic / complications
  • Dermatitis, Atopic / drug therapy*
  • Double-Blind Method
  • Female
  • Humans
  • Janus Kinase Inhibitors / administration & dosage
  • Janus Kinase Inhibitors / therapeutic use*
  • Male
  • Middle Aged
  • Minimal Clinically Important Difference
  • Pruritus / drug therapy*
  • Pruritus / etiology
  • Pyrazoles / administration & dosage
  • Pyrazoles / therapeutic use*
  • Quality of Life*
  • Severity of Illness Index
  • Skin Cream / therapeutic use
  • Triamcinolone / therapeutic use
  • Young Adult

Substances

  • Anti-Inflammatory Agents
  • INCB018424
  • Janus Kinase Inhibitors
  • Pyrazoles
  • Triamcinolone