Ruxolitinib cream monotherapy demonstrates rapid improvement in the extent and signs of mild to moderate atopic dermatitis across head and neck and other anatomic regions in adolescents and adults: pooled results from 2 phase 3 studies

Abstract

Purpose: Ruxolitinib (selective Janus kinase [JAK] 1 and JAK2 inhibitor) cream demonstrated efficacy and safety in patients with atopic dermatitis (AD) in the phase 3 TRuE-AD studies. In TRuE-AD1/TRuE-AD2 (NCT03745638/NCT03745651), adults and adolescents with mild to moderate AD were randomized to apply twice-daily ruxolitinib cream or vehicle for eight weeks. Here, we evaluated the efficacy and tolerability of ruxolitinib cream by anatomic region, focusing on head/neck (HN) lesions that are typically difficult to manage and disproportionately affect quality of life (QoL).

Materials and methods: Eczema Area and Severity Index (EASI) responses in anatomic regions were evaluated in the pooled population (N = 1208) and among patients with baseline HN involvement (n = 663). Itch, Investigator’s Global Assessment (IGA), QoL, and application site tolerability were also assessed.

Results: By Week 2 (earliest assessment), ruxolitinib cream application resulted in significant improvements across all EASI anatomic region subscores and AD signs versus vehicle, with further improvements through Week 8. Significantly more patients with HN involvement who applied ruxolitinib cream versus vehicle achieved clinically meaningful improvements in itch, IGA, and QoL. Application site reactions with ruxolitinib cream were infrequent (<3%), including in patients with HN involvement.

Conclusions: These results support the use of ruxolitinib cream for AD treatment across all anatomic regions, including HN.

Graphical abstract

Keywords:

• Atopic dermatitis
• head and neck
• JAK inhibitor
• ruxolitinib cream

Acknowledgments

The authors thank the patients, investigators, and investigational sites whose participation made the study possible.

Disclosure statement

ELS is an investigator for AbbVie, Eli Lilly, Galderma, Kyowa Hakko Kirin, LEO Pharma, Merck, Pfizer, and Regeneron and is a consultant with honorarium for AbbVie, Eli Lilly, Forte, Galderma, Incyte Corporation, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi-Genzyme, and Valeant. RB has served as an advisory board member, consultant, speaker and/or investigator and received honoraria and/or grants from AbbVie, Arcutis, Arena Pharma, Aristea, Asana BioSciences, Bellus Health, Bluefin Biomedicine, Boehringer Ingelheim, CARA, Dermavant, Eli Lilly, EMD Serono, Evidera, Galderma, GlaxoSmithKline, Incyte Corporation, Inmagene Bio, Kiniksa, Kyowa Kirin, LEO Pharma, Novan, Pfizer, Ralexar, RAPT Therapeutics, Regeneron, Respivant, Sanofi-Genzyme, Sienna, Target RWE, and Vyne Therapeutics and is an employee and shareholder of Innovaderm Research. ZCCF has served as a consultant for the Asthma and Allergy Foundation of America, the National Eczema Association, AbbVie, Beiersdorf, Incyte Corporation, and Pfizer; has received research grants from Eli Lilly, LEO Pharma, Regeneron, Sanofi, Tioga, and Vanda for work related to atopic dermatitis and Menlo Therapeutics for work related to prurigo nodularis; and has received honoraria for continuing medical education work in atopic dermatitis sponsored by education grants from Pfizer and Regeneron/Sanofi. HK, DS, and HR are employees and shareholders of Incyte Corporation. LFSG has served as an investigator, advisor, and/or speaker for AbbVie, Arcutis, Bristol Myers Squibb, Dermavant, Eli Lilly, Incyte Corporation, Ortho Derm, Pfizer, Regeneron, and Sanofi.

Data availability statement

Incyte Corporation (Wilmington, DE, USA) is committed to data sharing that advances science and medicine while protecting patient privacy. Qualified external scientific researchers may request anonymized datasets owned by Incyte for the purpose of conducting legitimate scientific research. Researchers may request anonymized datasets from any interventional study (except phase 1 studies) for which the product and indication have been approved on or after 1 January 2020 in at least one major market (e.g., US, EU, JPN). Data will be available for request after the primary publication or two years after the study has ended. Information on Incyte’s clinical trial data sharing policy and instructions for submitting clinical trial data requests are available at: https://www.incyte.com/Portals/0/Assets/Compliance%20and%20Transparency/clinical-trial-data-sharing.pdf?ver=2020-05-21-132838-960.

Additional information

Funding

Medical writing support was provided by Valerie Kinchen, PhD, of The Curry Rockefeller Group, LLC (Tarrytown, NY), and was funded by Incyte Corporation (Wilmington, DE).