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Treatment of Atopic Dermatitis With Ruxolitinib Cream (JAK1/JAK2 Inhibitor) or Triamcinolone Cream

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Published:1st Feb 2020

Author: Kim BS, Howell MD, Sun K, Papp K, Nasir A, Kuligowski ME; INCB 18424-206 Study Investigators.

Source: Journal of Allergy and Clinical Immunology

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Ref.:J Allergy Clin Immunol. 2020 Feb;145(2):572-582.

DOI:10.1016/j.jaci.2019.08.042

Treatment of Atopic Dermatitis With Ruxolitinib Cream (JAK1/JAK2 Inhibitor) or Triamcinolone Cream

Background: Atopic dermatitis (AD) is a highly pruritic chronic inflammatory skin disorder. Ruxolitinib, a selective inhibitor of Janus kinase (JAK)-1 and JAK2, potently suppresses cytokine signaling involved in AD pathogenesis.

Objective: 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 (IGA) score of 2 or 3 (mild or moderate), and 3%?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 endpoint was the comparison between 1.5% RUX cream BID and vehicle in mean percentage change from baseline in Eczema Area and Severity Index (EASI) at Week 4.

Results: All RUX regimens demonstrated therapeutic benefit at Week 4; 1.5% BID provided the greatest improvement in EASI (71.6% vs 15.5%; P<0.0001) and IGA responses (38.0% vs 7.7%; P<0.001) 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<0.0001) 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.

Conclusion: RUX cream provided rapid and sustained improvements in AD symptoms and was well tolerated.

Clinical Implications: Ruxolitinib cream significantly reduced signs of atopic dermatitis (AD) throughout the study and rapidly decreased itch. These data support possible addition of ruxolitinib cream to the topical armamentarium for AD.

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