Off-label Studies on the Use of Ruxolitinib in Dermatology

Abstract

Purpose: Ruxolitinib (Jakafi) is a Janus kinase 1 and 2 small molecule inhibitor that the Food and Drug Administration approved for myelofibrosis and polycythemia vera. It has been expanded to off-label treatment for a variety of dermatologic conditions, with several clinical trials ongoing. A review of available studies and cases of off-label uses was performed to guide clinicians seeking evidence on the efficacy of this Janus kinase inhibitor for dermatologic disorders.Materials and Methods: PubMed/MEDLINE, EMBASE, Scopus, and ClinicalTrials.gov databases were searched with the term "ruxolitinib," and results were manually reviewed to identify published data on off-label uses of ruxolitinib. Studies included are structured by quality of evidence available.Results: Ruxolitinib may have utility in the treatment of atopic dermatitis, psoriasis, and vitiligo, with data from open-label and randomized trials supporting efficacy of topical formulations. Evidence of utility for alopecia areata is mixed and differs depending on topical versus oral form. Evidence for numerous other conditions is available through case reports and case series.Conclusions: There is growing evidence supporting potential off-label use of oral and topical ruxolitinib for a wide range of skin conditions. There are several ongoing investigations of ruxolitinib use in dermatology that will undoubtedly better define its efficacy and appropriate use in dermatology.

Topical ruxolitinib: A new treatment for vitiligo

“…The recommended dose of ruxolitinib cream for the treatment of vitiligo is a thin layer spread twice daily on affected areas covering up to 10% of the body surface area. The formulation has also been previously approved for the topical short‐term and non‐continuous chronic treatment of mild to moderate atopic dermatitis, and some new evidence suggests that it may be effective in treating cutaneous lichen planus and psoriasis 35,36 …”

“…The formulation has also been previously approved for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis, and some new evidence suggests that it may be effective in treating cutaneous lichen planus and psoriasis. 35,36 There were no approved treatments for vitiligo in the United States until the FDA approved the use of 1.5% ruxolitinib cream in June 2022. In Europe the management of vitiligo is based on the most recent guidelines of the Vitiligo European Task Force 37 and the British Association of Dermatologists.…”

Off-Label Use: Ruxolitinib im Einsatz bei entzündlichen Hauterkrankungen

“…Ruxolitinib wurde für die Durchführung von Studien zusätzlich zur oralen Form auch in topischen Formulierungen verfügbar gemacht (zumeist als 0,5%- bis 1,5%-Ruxolitinib-Creme). Beschriebene Nebenwirkungen der topischen Formulierung sind Hautrötung, Exfoliationen, Follikulitiden und Juckreiz bei 14% bis 20% der Patienten [3].…”

Off-Label-Use: Ruxolitinib im Einsatz bei entzündlichen Hauterkrankungen

“…Ruxolitinib wurde für die Durchführung von Studien zusätzlich zur oralen Form auch in topischen Formulierungen verfügbar gemacht (zumeist als 0,5% bis 1,5% Ruxolitinib Creme). Beschriebene Nebenwirkungen der topischen Formulierung sind Hautrötung, Exfoliationen, Follikulitiden und Juckreiz bei 14% bis 20% der Patienten [3]. Das Ziel der vorgestellten Übersichtsarbeit ist die Zusammenfassung der bisher in der Literatur veröffentlichten Studien sowie Berichten zu Off-Label-Anwendungen von Ruxolitinib in dermatologischen Indikationen.…”