Treatment of atopic dermatitis with ruxolitinib cream (JAK1/JAK2 inhibitor) or triamcinolone cream

INCB 18424-206 Study Investigators

Research output: Contribution to journalArticlepeer-review

67 Scopus citations

Abstract

Background: Atopic dermatitis (AD) is a highly pruritic chronic inflammatory skin disorder. Ruxolitinib, a selective inhibitor of Janus kinase 1 and Janus kinase 2, potently suppresses cytokine signaling involved in AD pathogenesis. Objective: We sought to evaluate the efficacy and safety of ruxolitinib (RUX) cream in adults with AD. Methods: In this phase 2 study (NCT03011892), 307 adult patients with AD, an Investigator's Global Assessment score of 2 or 3 (mild or moderate), and 3% to 20% affected body surface area were equally randomized for 8 weeks of double-blind treatment to RUX (1.5% twice daily [BID], 1.5% once daily [QD], 0.5% QD, 0.15% QD), vehicle, or triamcinolone cream (0.1% BID for 4 weeks, then vehicle for 4 weeks). Subsequently, patients could apply 1.5% RUX BID for 4 additional weeks of open-label treatment. The primary end point was the comparison between 1.5% RUX cream BID and vehicle in mean percentage change from baseline in Eczema Area and Severity Index at week 4. Results: All RUX regimens demonstrated therapeutic benefit at week 4; 1.5% BID provided the greatest improvement in Eczema Area and Severity Index (71.6% vs 15.5%; P <.0001) and Investigator's Global Assessment responses (38.0% vs 7.7%; P <.001) versus vehicle. Rapid reductions in the itch numerical rating scale score occurred within 36 hours (1.5% BID vs vehicle, ‒1.8 vs ‒0.2; P <.0001) and were sustained through 12 weeks. Patients who transitioned to 1.5% RUX BID improved in all measures. RUX was not associated with clinically significant application-site reactions. Conclusions: RUX cream provided rapid and sustained improvements in AD symptoms and was well tolerated.

Original languageEnglish
Pages (from-to)572-582
Number of pages11
JournalJournal of Allergy and Clinical Immunology
Volume145
Issue number2
DOIs
StatePublished - Feb 2020

Keywords

  • Atopic dermatitis
  • CCL17
  • IgE
  • JAK inhibitor
  • Janus kinase
  • itch
  • ruxolitinib
  • topical

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