TOPLINE

A topical Janus kinase (JAK) inhibitor, ruxolitinib, 1.5%, cream was associated with greater improvement in skin lesions and itch than vehicle cream in adults with cutaneous lichen planus (LP), with Investigator’s Global Assessment (IGA) treatment success maintained through week 32.

METHODOLOGY

• Researchers conducted a phase 2 randomized, double-blind, vehicle-controlled trial involving 64 adults with predominantly cutaneous LP at 19 sites in the United States and Canada. The median age was 57 years; 72% were women; 63% were White, 28% were Black.
• Patients received either ruxolitinib, 1.5%, cream or vehicle cream twice daily for 16 weeks. After the double-blind period, eligible patients received ruxolitinib cream for another 16 weeks in an open-label phase, applying it twice daily when symptoms required treatment.
• Participants had an IGA score of 3 or 4, an itch Numerical Rating Scale (NRS) score of at least 4, and disease affecting no more than 20% of the body surface area. Hypertrophic LP was present in 48% of the participants.
• The primary outcome was IGA treatment success at week 16, defined as clear or almost-clear skin with at least a 2-grade improvement from baseline. Secondary outcomes included changes in itch and skin pain.

TAKEAWAY

• At week 16, IGA treatment success occurred in 50.0% of patients receiving ruxolitinib cream vs 21.9% receiving vehicle (response rate difference, 29.4%; P = .01).
• A 4-point or greater improvement in Itch NRS score occurred in 48.4% of patients receiving ruxolitinib cream vs 16.1% receiving vehicle at week 16 (response rate difference, 33.5%; P = .004).
• Skin pain scores decreased by 3.0 points with ruxolitinib cream vs 1.3 points with vehicle at week 16 (mean treatment difference, −1.8; 95% CI, −3.2 to −0.4), with improvement observed as early as week 2.
• Among patients initially assigned to ruxolitinib cream who continued into the open-label phase, IGA treatment success was 53.3% at week 16 and 60.0% at week 32 with as-needed treatment. No serious adverse events or adverse events leading to discontinuation were reported with ruxolitinib cream; one case of squamous cell carcinoma was reported outside the treatment area and was considered unrelated to treatment.

IN PRACTICE

"In this randomized clinical trial of treatment with a topical JAK inhibitor in cutaneous LP, use of ruxolitinib, 1.5%, cream twice daily significantly reduced clinical signs (lesions) of LP and itch," the authors wrote. "Therefore," they added, "ruxolitinib cream represents a promising potential treatment for cutaneous LP."

SOURCE

The study was led by Aaron R. Mangold, MD, Mayo Clinic, Scottsdale, Arizona. It was published online on September 23 in JAMA Dermatology.

LIMITATIONS

Interpretation was limited by the small study population and the lack of formal validation for the modified IGA. Diagnosis was not biopsy-confirmed in about one third of participants, while the high proportion of patients with hypertrophic disease could limit the applicability of the findings to other LP variants.

DISCLOSURES

The study was sponsored by Incyte Corporation. Mangold and several authors reported receiving grants, personal fees, royalties, and research support from Incyte and other pharmaceutical companies, and reported holding patents. One author reported being an employee and holding stock in Incyte. Full disclosures are available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.