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

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

卷:145

Article

Kim, Brian S.¹  Howell, Michael D.²  Sun, Kang²  Papp, Kim³  Nasir, Adnan⁴  Kuligowski, Michael E.² 

[1] Washington Univ, Sch Med, St Louis, MO 63130 USA

[2] Incyte Corp, Wilmington, DE USA

[3] K Papp Clin Res & Prob Med Res, Waterloo, ON, Canada

[4] Wake Res Associates LLC, Raleigh, NC USA

关键词: Atopic dermatitis;    CCL17;    IgE;    itch;    JAK inhibitor;    Janus kinase;    ruxolitinib;    topical;   

DOI  :  10.1016/j.jaci.2019.08.042

来源: Elsevier

【 摘 要 】

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.

【 授权许可】

Free