Evidence map›Paper›PMID 40156697›Full record

ArticleDermatology and therapy2025

Efficacy and Safety of Ruxolitinib Cream in Vitiligo by Patient Characteristic Subgroups: Descriptive Pooled Analysis From Two Phase 3 Studies.

Julien Seneschal, Albert Wolkerstorfer, Seemal R Desai, Pearl Grimes, Khaled Ezzedine, Amit G Pandya, Deanna Kornacki, Shaoceng Wei, Thierry Passeron, David Rosmarin

2 registry-linked trialsAbstract read
In one paragraph

Article in Dermatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04052425 phase3completednot on this map

Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo

TypeinterventionalSponsorIncyte CorporationRan2019 to 2021Enrolled330ConditionsNon-segmental VitiligoArmsRuxolitinib cream, Vehicle
NCT04057573 phase3completednot on this map

Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo

TypeinterventionalSponsorIncyte CorporationRan2019 to 2021Enrolled344ConditionsNon-segmental VitiligoArmsRuxolitinib cream, Vehicle
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Julien SeneschalCHU de Bordeaux, Dermatology and Pediatric Dermatology, National Reference Center for Rare 25 Skin Disorders, Hôpital Saint-André, UMR 5164, 33000, Bordeaux, France. julien.seneschal@chu-bordeaux.fr.ORCID http://orcid.org/0000-0003-1139-0908
Albert WolkerstorferAmsterdam University Medical Center, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0003-1421-1493
Seemal R DesaiUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.ORCID http://orcid.org/0000-0002-3022-5169
Pearl GrimesVitiligo & Pigmentation Institute of Southern California, Los Angeles, CA, USA.ORCID http://orcid.org/0000-0001-6663-2471
Khaled EzzedineHenri Mondor University Hospital and Université Paris-Est Créteil Val de Marne, Paris, France.ORCID http://orcid.org/0000-0002-5468-4589
Amit G PandyaUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.ORCID http://orcid.org/0000-0002-3916-2651
Deanna KornackiIncyte Corporation, Wilmington, DE, USA.ORCID http://orcid.org/0000-0001-6286-2069
Shaoceng WeiIncyte Corporation, Wilmington, DE, USA.ORCID http://orcid.org/0000-0002-9972-8231
Thierry PasseronCentre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France.ORCID http://orcid.org/0000-0002-0797-6570
David RosmarinIndiana University School of Medicine, Indianapolis, IN, USA.ORCID http://orcid.org/0000-0003-2786-0708

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTwo phase 3 trials (TRuE-V1 and TRuE-V2) demonstrated that a topical formulation of the Janus kinase (JAK) 1/JAK2 inhibitor ruxolitinib significantly improved repigmentation versus vehicle cream in adolescent and adult patients with vitiligo. This post hoc analysis of pooled TRuE-V1/TRuE-V2 data evaluated efficacy and safety by baseline demographics and clinical characteristics.

methodsPatients aged ≥ 12 years with nonsegmental vitiligo were randomized to vehicle cream or 1.5% ruxolitinib cream twice daily for 24 weeks, after which all patients could apply ruxolitinib cream through Week 52. Efficacy was evaluated using achievement of ≥ 75% improvement from baseline in facial Vitiligo Area Scoring Index [F-VASI75] at Week 52. Safety assessments included the frequency of treatment-emergent adverse events (AEs) and treatment-related AEs.

resultsThe TRuE-V studies enrolled 674 patients. Week 52 F-VASI75 was achieved by 50.3% (176/350) of patients who applied ruxolitinib cream throughout and 28.2% (46/163) who crossed over from vehicle to ruxolitinib cream after Week 24. F-VASI75 responses were observed across subgroups regardless of patient age, sex, Fitzpatrick skin type, affected facial body surface area, disease duration, disease stability, and prior treatment status. Treatment-emergent AEs occurred in 52.1% (332/637) of patients, and treatment-related AEs occurred in 13.7% (87/637); rates were generally similar across demographic subgroups.

conclusionsAdolescent and adult patients with vitiligo who applied ruxolitinib cream could achieve clinically meaningful repigmentation per F-VASI75 response at 1 year, regardless of their baseline demographics or clinical characteristics. Ruxolitinib cream was well tolerated, with a similar incidence of treatment-emergent and treatment-related AEs across subgroups.

trial registrationNCT04052425/NCT04057573.

Indexed as

JAK inhibitorJanus kinaseRepigmentationRuxolitinib creamTopicalVitiligo

Identifiers

PMID40156697
PMCPMC12033138

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.