P75: Exploratory quality of life and treatment satisfaction in two phase III studies of ruxolitinib cream in vitiligo

David Rosmarin,¹ Thierry Passeron,^2,3 Amit G. Pandya,^4,5 Pearl Grimes,⁶ John E. Harris,⁷ Seemal R. Desai,^5,8 Mark Lebwohl,⁹ Mireille Ruer-Mulard,¹⁰ Julien Seneschal,¹¹ Albert Wolkerstorfer,¹² Deanna Kornacki,¹³ Kang Sun,¹³ Kathleen Butler¹³ and Khaled Ezzedine¹⁴

¹Tufts Medical Center, Boston, MA, USA; ²Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France; ³INSERM U1065, C3M, Université Côte d’Azur, Nice, France; ⁴Palo Alto Foundation Medical Group, Mountain View, CA, USA; ⁵University of Texas Southwestern Medical Center, Dallas, TX, USA; ⁶The Vitiligo & Pigmentation Institute of Southern California, Los Angeles, CA, USA; ⁷University of Massachusetts Medical School, Worcester, MA, USA; ⁸Innovative Dermatology, Plano, TX, USA; ⁹Icahn School of Medicine at Mount Sinai, New York, NY, USA; ¹⁰Office of Mireille Ruer-Mulard, MD, Martiques, France; ¹¹Department of Dermatology and Pediatric Dermatology, National Reference Center for Rare Skin Disorders, Hôpital Saint-André, Université de Bordeaux, INSERM, BMGIC, U1035, F-33000, Bordeaux, France; ¹²Amsterdam University Medical Center, Amsterdam, the Netherlands; ¹³Incyte Corporation, Wilmington, NC, USA; and ¹⁴Henri Mondor University Hospital and Université Paris-Est Créteil Val de Marne, Paris, France

Ruxolitinib [Janus kinase (JAK) 1/JAK2 inhibitor] cream demonstrated clinically meaningful repigmentation and was well tolerated in two phase III studies in adolescents and adults with vitiligo (TRuE-V1 and TRuE-V2). This analysis assessed quality of life (QoL) and treatment satisfaction in patients from TRuE-V1/TRuE-V2. Patients aged ≥ 12 years old with nonsegmental vitiligo (depigmentation ≤ 10% total body surface area) were randomized 2 : 1 to twice-daily ruxolitinib 1.5% cream or vehicle. After 24 weeks, all patients could apply ruxolitinib cream through to week 52. QoL was assessed using the World Health Organization-Five Well-Being Index (WHO-5), Vitiligo-specific QoL instrument (VitiQoL) and the Hospital Anxiety and Depression Scale (HADS). Higher scores indicate worse QoL or anxiety/depression. Treatment satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM); higher scores indicate greater satisfaction. TRuE-V1/TRuE-V2 included 330/331 patients (ruxolitinib, n = 221/222; vehicle, n = 109/109) in the intent-to-treat population. Mean age was 40.2 (38.7) years and 21.5%/33.8% had Fitzpatrick skin phototypes IV–VI. No clear pattern of change from baseline was observed at week 24 for WHO-5, VitiQoL or HADS in patients who applied ruxolitinib cream vs. vehicle (Table). For patients who continued to apply ruxolitinib cream, VitiQoL scores were further decreased at week 52 (mean change from baseline −9.39/−7.13) vs. week 24 (−6.34/−6.07), indicating a possible trend of improved QoL with additional treatment over time. At week 24, mean scores were significantly higher for ruxolitinib cream vs. vehicle for TSQM overall satisfaction (66.28/61.03 vs. 51.79/49.06; P < 0.001) and effectiveness scores (59.03/53.49 vs. 42.22/39.74; P < 0.001). In summary, ruxolitinib cream was associated with improved treatment satisfaction vs. vehicle. Effects on QoL assessed by WHO-5, VitiQoL and HADS were not apparent at week 24, although a possible trend of improved QoL with additional treatment through week 52 was observed for some QoL assessments.

Funding sources: Incyte Corporation.