INDIVIDUAL ARTICLE: Appraisal of Ruxolitinib 1.5% Cream as a First-Line Topical Therapeutic Agent for Adolescents and Adults With Mild-to-Moderate Atopic Dermatitis

February 2025 | Volume 24 | Issue 2 | s5 | Copyright © February 2025


Published online January 31, 2025

Naiem T. Issa MD PhDa, Pearl Kwong MDb, Christopher G. Bunick MD PhDc, Leon Kircik MDd

aForefront Dermatology, Vienna, VA; Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL; George Washington University School of Medicine and Health Sciences, Washington, DC
bSuncoast Skin Solutions, Inc, Jacksonville, FL; Apex Clinical trials, Jacksonville, FL
cDepartment of Dermatology and Program in Translational Biomedicine, Yale University School of Medicine, New Haven, CT
dIcahn School of Medicine at Mount Sinai, New York, NY; Indiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC Louisville, KY; DermResearch, PLLC Louisville, KY; Skin Sciences, PLLC Louisville, KY

Abstract
Dermatology has entered the long-awaited paradigm shift from steroidal to non-steroidal therapeutics for the topical treatment of atopic dermatitis. Topical Janus kinase (JAK) inhibitors have garnered a strong recommendation for the treatment of adult atopic dermatitis (AD) by the American Academy of Dermatology in the most recent updated guidelines as of 2023. Ruxolitinib 1.5% cream is the only FDA-approved topical JAK inhibitor available in the US and is approved for the short-term and intermittent chronic treatment of mild-to-moderate AD in adolescents and adults aged >= 12 years with up to 20% affected body surface area (BSA). Since approval in 2021, ruxolitinib cream has been shown to be consistently effective across disease severities, age groups, and anatomic sites of special interest (ie, head and neck region, hands). Real-world usage as monotherapy and in combination with other topicals have confirmed its efficacy in practice and further led to reduced usage of topical corticosteroids. Ruxolitinib cream also has the potential to reduce economic costs due to AD-related decline in work productivity. Here, we review the most up-to-date clinical trial and real-world efficacy data that position ruxolitinib 1.5% cream as a first-line AD therapeutic.

J Drugs Dermatol. 2025;24:2(Suppl 2):s5-15.

INTRODUCTION

The topical therapeutic landscape of atopic dermatitis (AD) has entered the "golden age" of drug development. Until now, the landscape was comprised of 3 major mechanistic classes: (1) corticosteroids, calcineurin inhibitors (tacrolimus and pimecrolimus), and phosphodiesterase-4 (PDE-4) inhibitors (crisaborole and, more recently, roflumilast). The current topical pipeline also includes the aryl hydrocarbon receptor (AhR) agonist tapinarof, which is undergoing the regulatory approval process in the United States (US).1

Janus kinase (JAK) proteins are critical transducers of cytokine inflammatory signals intracellularly. In particular, JAK1 and JAK2 are activated by the core AD cytokines interleukin (IL)-4, IL-13, IL-22, IL-31, thymic stromal lymphopoietin (TSLP), among others, to recruit signal transducer and activator of transcription (STAT) proteins that are then phosphorylated. STAT proteins subsequently dimerize and cause DNA transcriptional changes in various immune and non-immune cell types to ultimately cause increased expression of additional pro-inflammatory cytokines. As such, targeting JAK1/2 has been a highly sought-after therapeutic approach for AD, resulting in 2 oral
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