Ruxolitinib 1.5 percent cream is the first topical repigmentation treatment approved by the US FDA, European Medicines Agency and in Hong Kong, as well as several other countries, for use in patients ≥12 years of age with nonsegmental vitiligo with facial involvement. Professor Henry Lim of the Department of Dermatology, Henry Ford Health, Detroit, Michigan, US, and Professor Yanhua Liang of the Department of Dermatology, Cosmetology and Venereology, Shenzhen Hospital of Southern Medical University, Shenzhen, China, shared their experience of treating vitiligo with ruxolinitib at the Global Chinese Dermatology Summit held recently in Hong Kong.
Vitiligo, a chronic autoimmune disorder characterized by skin depigmentation due to loss of melanocyte function, significantly afÂfects patients’ psychosocial and overall quality of life (QoL). Lesion concealment has been reported as the most common coping strategy. [Am J Clin Dermatol 2021;22:757-774]
“Topical treatment remains the first-line therapy for vitiligo patients,” said Lim. Traditionally, topical corticosteroids, tacrolimus ointment and pimecrolimus cream have been used to control disÂease progression. Monobenzone, which permanently depigments normal skin surrounding vitiliginous lesions, was the only US FDA–approved topical treatment for vitiligo prior to the approval of ruxoliÂtinib. [www.accessdata.fda.gov/drugÂsatfda_docs/label/2003/08173slr015_ benoquin_lbl.pdf]
Ruxolitinib, a Janus kinase (JAK) 1 and 2 inhibitor, reduces inflammatory mediators such as interleukin-15 and chemokines, limiting CD8+ activity, thereby enabling melanocyte recovery and facilitating endogenous repigmentaÂtion. [Lancet 2020;396:110-120]
Skin repigmentation with ruxolitinib cream: Durable effect
TRuE-V1 and TRuE-V2 studies
Two pivotal phase III, double-blind, vehicle-controlled trials of ruxolitinib cream (TRuE-V1, n=330; TRuE-V2, n=334) in paÂtients ≥12 years of age with nonsegmental vitiligo demonstrated statistically superior repigmentation with ruxolitinib 1.5 percent cream BID vs vehicle cream. The primaÂry endpoint of ≥75 percent improvement from baseline in facial Vitiligo Area Scoring Index (F-VASI75) at week 24 was achieved by significantly more patients in the ruxoliÂtinib vs vehicle cream group in both studies (about 30 vs 10 percent), with continued improvement through week 52. [N Engl J Med 2022;387:1445-1455]
In patients who crossed over at week 24 from vehicle cream to ruxolitinib cream, efficacy at week 52 was consisÂtent with week 24 data from patients who applied ruxolitinib cream from day 1. Ruxolitinib cream was well tolerated, and application site reactions were mild or moderate, with acne and pruritus at application site being the most common adverse events (AEs).
TRuE-V LTE study
Among patients who achieved near-complete facial repigmentation (ie, F-VASI90) in TRuE-V1/TRuE-V2 and continued treatment (n=58) in the roll-over TRuE-V long-term extension (LTE) study, about three in five maintained F-VASI75, and one in two maintained F-VASI90 at week 104. (Figure 1) In the treatment-withdrawal arm (n=58) of the LTE study, repigmentation loss (<F-VASI90) occurred in half of the patients within 1 year of treatment withdrawal, with 44 percent losing repigmentation within 7 months. [RosÂmarin D, et al, EADV 2024, poster P2984]
“Many patients maintained F-VASI75 response even after stopping treatment. Nevertheless, continued application of ruxolitinib cream was associated with reduced risk of losing response vs treatÂment withdrawal,” noted Lim. “Consistent with real-world experience, worsening of vitiligo would happen within 4–6 months of stopping treatment. Thus, continuing treatment, if possible, would be ideal.”
“Of patients who relapsed [<F-VASI75] after treatment withdrawal and restarted treatment, 75 percent regained F-VASI75 and approximately 70 percent regained F-VASI90,” Lim added.
In the cohort of patients who entered the LTE study with <F-VASI90 (n=342), those with limited or no response at week 24 who continued ruxolitinib cream appliÂcation for 80 more weeks generally had increased repigmentation. (Figure 1) “It is definitely worthwhile for patients to continÂue using the medication for a longer period of time,” suggested Lim.
“From my clinical experience, even betÂter repigmentation can be seen by combinÂing narrow-band ultraviolet-B phototherapy with ruxolitinib cream,” shared Lim.
Ruxolitinib cream in Chinese patients
“From our clinical experience thus far, treatment with ruxolitinib has been very efÂfective in Chinese patients, especially those with facial involvement, such as in the case shared – the first patient who was treated with ruxolitinib at our centre,” reported LiÂang. (Case report)
“Ruxolitinib cream was also found to be effective and well-tolerated in treatÂing nonsegmental vitiligo in Chinese paÂtients, according to our recently published single-arm, single-centre, observational study,” he added. [J Am Acad Dermatol 2025;93:475-477]
Results consistent with multinational studies
Inclusion criteria and baseline charÂacteristics of participants in the Chinese study (n=111) were similar to those of the TRuE-V studies. At 24 weeks, F-VASI75 rate was 49.5 percent (vs about 30 percent in the TRuE-V studies), while F-VASI90 rate was 17.1 percent (vs about 16 percent).
Similar to TRuE-V’s findings, ruxolitnib cream was well tolerated, with the most common AEs being application-site pruriÂtus (33.3 percent) and acne (31.5 percent). However, higher incidence of upper respiÂratory tract infections (22.5 vs 1–2 percent) and application-site exfoliation (18.9 vs about 1 percent) was observed in the ChiÂnese study vs TRuE-V.
Supportive therapy – an integral part of vitiligo management
“Healing is not just about [medical] therapy – it starts with trust,” said Liang. “Hence, the Vitiligo House was set up at our hospital to provide a conducive environment where patients can feel safe and able to share their concerns with doctors, and where docÂtors can provide counselling as a start to cogÂnitive behavioural therapy [supportive therapy] along the vitiligo treatment journey.” (Figure 3)
“At Vitiligo House, information on vitiligo and different ways of management are readily accessible to patients. We also periodically organize patient education sessions and activities, for example during World Vitiligo Day,” shared Liang.
“Vitiligo is psychologically debilitating. Having a support group is very important,” concurred Lim. “We started one in Michigan around 2007, where patients meet regularÂly to support each other and have become a community. Patients also gained greater understanding of vitiligo and advances in its treatment.”
In Hong Kong, the Hong Kong Vitiligo Support Group similarly provides support and information for vitiligo patients. [https://hkvsg.org/]
This article is supported by the industry.
LUM/HKG/DOC-178/2026/rev.01
