Correlation of Patient-Reported Vitiligo Noticeability Scale With Physician-Assessed Facial Vitiligo Area Scoring Index Responses: Post Hoc Analyses From the True-V Trials of Ruxolitinib Cream in Vitiligo

Speaker(s)

Wolkerstorfer A1, Passeron T2, Rosmarin D3, Sebastian M4, Desai SR5, Alam MS6, Seneschal J7, Butler K8, Bibeau K8, Ren H8, Pandya AG9
1Amsterdam University Medical Center, Amsterdam, North Holland, Netherlands, 2Centre Hospitalier Universitaire de Nice, Université Côte d'Azur and INSERM, C3M, Université Côte d'Azur, Nice, France, 3Indiana University School of Medicine, Indianapolis, IN, USA, 4Hautarztpraxis Mahlow, Blankenfelde-Mahlow, Brandenburg, Germany, 5University of Texas Southwestern Medical Center, Dallas, TX, USA, 6SimcoDerm Medical & Surgical Dermatology Centre, Barrie, ON, Canada, 7Hôpital Saint-André, Bordeaux, Gironde, France, 8Incyte Corporation, Wilmington, DE, USA, 9Palo Alto Foundation Medical Group, Mountain View, CA, USA, and University of Texas Southwestern Medical Center, Dallas, TX, USA

Presentation Documents

Vitiligo is a chronic autoimmune disease that targets melanocytes, resulting in patches of skin depigmentation. A cream formulation of ruxolitinib, a Janus kinase (JAK) JAK1/2 inhibitor, is approved by the US Food and Drug Administration and European Medicines Agency for topical treatment of nonsegmental vitiligo in patients aged ≥12 years. In 2 phase 3 studies of adults and adolescents with vitiligo (TRuE-V1 [NCT04052425]/TRuE-V2 [NCT04057573]), ruxolitinib cream was statistically superior to vehicle at Week 24 in the primary and all key secondary efficacy endpoints.

OBJECTIVES: We present post hoc Vitiligo Noticeability Scale (VNS) and facial Vitiligo Area Scoring Index (F-VASI) correlation data for patients who applied 1.5% ruxolitinib cream twice daily from Day 1 in TRuE-V trials.

METHODS: Pooled data for patients were categorized at Weeks 24 and 52 by VNS response (VNS3/4/5 [slightly less noticeable/a lot less noticeable/no longer noticeable] and VNS4/5) assessed by patients against a baseline facial photograph, and F-VASI responses of ≥50%/≥75%/≥90% improvement from baseline (F-VASI50/F-VASI75/F-VASI90). Tetrachoric (Rtet) and polyserial correlations (for binary and ordinal responses, respectively) with associated P-values were calculated.

RESULTS: At Week 24, VNS3/4/5 and VNS4/5 responses were achieved by 68.5% (270/394) and 22.8% (90/394) of patients, respectively; by Week 52, response rates had increased to 82.9% (290/350) for VNS3/4/5 and 36.3% (127/350) for VNS4/5. The strongest correlations were observed for VNS4/5 and F-VASI75 responses at Week 24 (Rtet, 0.49; P<0.0001), indicating a mild positive association between variables.

CONCLUSIONS: This pooled post hoc analysis of ruxolitinib cream treated patients from the TRuE-V trials found repigmentation quality as reflected by patient-reported VNS was moderately but significantly associated with physician-assessed F-VASI clinical outcomes. These findings suggest that patient-reported VNS response does not necessarily predict physician-reported F-VASI response; therefore, both tools are important to assess outcomes since they measure different constructs of interest.

Code

PCR256

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

No Additional Disease & Conditions/Specialized Treatment Areas, Sensory System Disorders (Ear, Eye, Dental, Skin)