Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

卷:85

Article

Papp, Kim¹  Szepietowski, Jacek C.²  Kircik, Leon³  Toth, Darryl⁴  Eichenfield, Lawrence F.^5,6  Leung, Donald Y. M.⁷  Forman, Seth B.⁸  Venturanza, May E.⁹  Sun, Kang⁹  Kuligowski, Michael E.⁹  Simpson, Eric L.¹⁰ 

[1] K Papp Clin Res & Prob Med Res, 135 Union St E, Waterloo, ON N2J 1C4, Canada

[2] Wroclaw Med Univ, Dept Dermatol Venereol & Allergol, Wroclaw, Poland

[3] Icahn Sch Med Mt Sinai, New York, NY 10029 USA

[4] XLR8 Med Res & Prob Med Res, Windsor, ON, Canada

[5] Univ Calif San Diego, Dept Dermatol, San Diego, CA 92103 USA

[6] Univ Calif San Diego, Dept Pediat, San Diego, CA 92103 USA

[7] Natl Jewish Hlth, Div Pediat Allergy & Clin Immunol, Dept Pediat, Denver, CO USA

[8] ForCare Clin Res, Tampa, FL USA

[9] Incyte Corp, Wilmington, DE USA

[10] Oregon Hlth & Sci Univ, Portland, OR 97201 USA

关键词: atopic dermatitis;    itch;    JAK inhibitor;    Janus kinase;    ruxolitinib;    topical;   

DOI  :  10.1016/j.jaad.2021.04.085

来源: Elsevier

【 摘 要 】

Background: Ruxolitinib (RUX) cream demonstrated potent anti-inflammatory and antipruritic efficacy in a phase 2 study in adults with atopic dermatitis (AD). Objective: To evaluate 8-week efficacy and safety in 2 phase 3 studies of RUX cream in patients with AD. Methods: Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (NCT03745638) and Study 2 (NCT03745651) enrolled patients aged >= 12 years with AD for >= 2 years, an Investigator's Global Assessment score of 2/3, and 3%-20% affected body surface area. Patients were randomized 2:2:1 to twice-daily 0.75% RUX cream, 1.5% RUX cream, or vehicle cream for 8 continuous weeks. The primary endpoint was Investigator's Global Assessment treatment success at week 8 (Investigator's Global Assessment score of 0/1 and >= 2-grade improvement from baseline). Results: In the Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 and 2, 631 and 618 patients were randomized (631/577 analyzed for efficacy). Significantly more patients achieved Investigator's Global Assessment treatment success with 0.75% RUX cream (50.0%/39.0%) and 1.5% RUX cream (53.8%/51.3%) versus vehicle (15.1%/7.6%; P < .0001) at week 8. Significant itch reductions versus vehicle were reported within 12 hours of first application of 1.5% RUX (P < .05). Application site reactions were infrequent (<1%) and lower with RUX versus vehicle; none were clinically significant. Limitations: Longer-term safety data are not yet available. Conclusions: RUX cream showed anti-inflammatory and prompt antipruritic effects with superior efficacy versus vehicle and was well tolerated.

【 授权许可】

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