New long-term extension data from the TRuE-V studies show that the effect of treatment was sustained for more than 1 year in one-third of patients with vitiligo who withdrew from active treatment subsequent to achieving a nearly complete re-pigmentation. Moreover, re-acquiring response after about 15 weeks was possible for 68.8% of those that restarted on ruxolitinib after a relapse.
The FDA approval of ruxolitinib cream for vitiligo treatment was based on the results of the phase 3 TRuE-V1 (NCT04052425) and the TRuE-V2 (NCT04057573) trials . According to Prof. John Harris (UMass Chan Medical School, MA, USA), this can be seen as a milestone in vitiligo therapy, but it is also interesting to see the long-term results .
In 1 cohort of the long-term extension study (NCT04530344) of TRuE-V1 and the TRuE-V2 trials, 116 patients who had achieved a re-pigmentation of at least 90% in the face area were re-randomised to either continue twice-daily ruxolitinib cream 1.5% or withdraw from active treatment by switching to a vehicle. Prof. Harris’ maintenance analysis aimed to investigate the time span to relapse of vitiligo and the duration of maintenance.
At baseline (i.e. week 52 of TRuE-V1 and TRuE-V2), participants with a facial vitiligo area scoring index (F-VASI) ≥90 had a median age of 42.0 years, more than half were women, and 31.9%, 30.2%, and 25.0% had the Fitzpatrick skin types 2, 3, and 4, respectively. Stable disease was present in 70.7%, while the rest had progressive vitiligo.
One year after withdrawal, 39.3% of the participants still had an F-VASI ≥75 response, while 28.6% experienced a relapse defined as F-VASI ≤75. The relapses happened within the first 4 months in half of the cases. Interestingly, 21.4% of the participants in the withdrawal arm and 61.8% who continued on ruxolitinib cream had a sustained F-VASI ≥90 response over 1 year, with a median duration of F-VASI ≥90 response of 195.0 days on vehicle only. Re-starting active treatment in case of relapse in the withdrawal group, resulted in 75% of participants achieving a F-VASI ≥75 scoreover a median period of 12 weeks. An F-VASI ≥90 response was regained in 68.8% of the participants after a median of 15 weeks.
In general, ruxolitinib cream was well tolerated with only mild and moderate treatment-related adverse events. No incidence of application-site acne or pruritus was reported.
“There is a population that really maintains response. If patients lose pigment, put them back on [ruxolitinib] and they will regain it in most cases,” Prof. Harris concluded.
- Rosmarin D, et al. N Engl J Med 2022;387(16):1445–1455.
- Harris JE. Relapse and maintenance of clinical response in the randomised withdrawal arm of the TRuE-V long-term extension phase 3 study of ruxolitinib cream in vitiligo. S025, AAD 2023 Annual Meeting, 17–21 March, New Orleans, USA.
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Table of Contents: AAD 2023
Letter from the Editor
AAD 2023 Highlights Podcast
Psoriasis: New Developments
Switching to risankizumab successful in IL-17 inhibitor non-responders
Novel, selective TYK2 inhibitor shows promise for psoriasis
Hidradenitis Suppurativa: What You Need to Know
Izokibep shows remarkably high grades of clinical response in HS
Bimekizumab could be the new up-and-comer for HS treatment
Pearls of the Posters
Biologics in psoriasis: can they prevent joint involvement?
JAK inhibitor deuruxolitinib shows encouraging hair re-growth in alopecia areata
Biomarkers predicting response of different CSU treatments in children
New Developments in Dermatology
Delgocitinib shows promise as topical therapy for chronic hand eczema
Vitiligo patients maintain re-pigmentation after ruxolitinib cream withdrawal
Nemolizumab decreases lesions and itch in prurigo nodularis
Lichen planus: a future indication for baricitinib?
Atopic Dermatitis: State of the Art
As-needed ruxolitinib shows successful long-term symptom control in AD
Dupilumab: a viable option for atopic hand and foot eczema
Topical roflumilast beneficial in atopic dermatitis
IL-22 receptor blocker reduces itch and skin lesions in AD
IL-4/IL-13 blockade leads to rapid itch reduction in adolescents