Evaluation of ruxolitinib cream 1.5% as an at-home therapy for repigmentation in non-segmental vitiligo

ABSTRACT

Introduction

Vitiligo is a chronic, autoimmune condition characterized by skin depigmentation caused by inflammatory-mediated melanocyte degradation. Treatment of vitiligo is challenging due to the chronic nature of the condition. Ruxolitinib cream 1.5% was recently approved by the Food and Drug Administration (FDA) as a Janus kinase 1 and 2 inhibitor for use in nonsegmental vitiligo for those 12 years and older.

Areas covered

The purpose of this review is to describe the role of ruxolitinib in treating nonsegmental vitiligo.We searched PubMed using search terms nonsegmental vitiligo, jak inhibitor, and ruxolitinib. Clinicaltrials.gov was used to identify clinical trial data including efficacy, pharmacodynamics, pharmacokinetics, safety, and tolerability.

Expert opinion

In both phase II and phase III (TRuE-V1 and TRuE-V2) trials, ruxolitinib cream 1.5% improved repigmentation with minimal adverse effects. Topical ruxolitinib is a much needed new vitiligo treatment option.  Real life efficacy may not match that seen in clinical trials if the hurdle of poor adherence to topical treatment is not surmounted.

KEYWORDS:

• JAK/STAT inhibitor
• CD8+ cytotoxic T cells
• CXCL9
• CXCL10
• CXCR receptor
• Vitiligo Area Scoring Index (VASI)

Article highlights

• This Expert Review discusses the results of TRuE-V1 and TruE-V2 clinical trials.

• Topical JAK inhibitor, ruxolitinib 1.5% cream, was effective in treating non-segmental vitiligo in Phase II and III clinical trials.

• Poor adherence to topical treatments, a hurdle to the effectiveness of existing topical vitiligo treatment options, may also limit the clinical efficacy of topical ruxolitinib.

• Ruxolitinib topical cream treatment improves vitiligo best when applied to small body surface areas (<10% BSA) or facial involvement.

• Ruxolitinib cream is well-tolerated with minimal associated adverse effects.

• TRuE-V1 and TruE-V2 trials lacked a diverse demographic of study participants.

• There is a need to understand the effectiveness of this cream on larger body surface areas and its long-term efficacy following discontinuation of its use.

Declaration of interest

S Feldman has received research, speaking and/or consulting support from AbbVie, Accordant, Almirall, Alvotech, Amgen, Arcutis, Arena, Argenx, Biocon, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Eli Lilly and Company, Eurofins, Forte, Galderma, Helsinn, Janssen, Leo Pharma, Micreos, Mylan, Novartis, Ono, Ortho Dermatology, Pfizer, Regeneron, Samsung, Sanofi, Sun Pharma, UCB, Verrica, Voluntis, and vTv Therapeutics. He is founder and part owner of Causa Research and holds stock in Sensal Health. McMichael has received research grants, royalties, and/or consulting support from a variety of companies, including Allergan; Almirall; Arcuits; Bioniz; Cassiopea; Concert Pharmaceuticals; Covance; eResearch Technology, Inc; Galderma; Incyte; Informa Healthcare; Johnson & Johnson; Keranetics; Lilly; Merck & Co, Inc; Pfizer; Proctor & Gamble; Revian; Samumed; and UpToDate. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.