Pandya Amit G, Amoloja Theresa, Bibeau Kristen, DiBenedetti Dana, Kosa Katherine, Butler Kathleen, Kornacki Deanna, Ezzedine Khaled
Palo Alto Foundation Medical Group, Suunyvale, CA, USA.
Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Dermatol Ther (Heidelb). 2024 Sep;14(9):2467-2478. doi: 10.1007/s13555-024-01241-w. Epub 2024 Aug 5.
Vitiligo is an autoimmune disease, causing skin depigmentation. Individuals with vitiligo incur substantial psychosocial burden and have expressed frustration with their treatments. Here, we describe the burden of vitiligo and opinions on what constitutes meaningful change among participants of two qualitative interview studies.
Qualitative interviews were conducted with a subgroup of adolescent and adult participants with vitiligo from two pivotal phase 3 clinical trials of ruxolitinib cream (Study 1) and a real-world panel (Study 2). Participants were asked about their disease burden, treatment goals, importance of facial/body improvement (treatment satisfaction: scale range 0-10), and meaningfulness of change (yes/no).
A total of 36 participants from Study 1 and 23 from Study 2 were interviewed. In Study 1, the highest degree of impact was on reduced self-esteem (facial lesions, 62.5%; body lesions, 55.6%), social inhibition (facial lesions, 65.6%; body lesions, 61.1%), and sun sensitivity (facial lesions, 31.3%; body lesions, 55.6%). Most participants (83.3%) reported that facial improvement was equally (36.1%) or more important (47.2%) than body improvement, with mean treatment satisfaction of 8.1 and 6.9, respectively. Meaningful change was reported by 83.3% and 92.9% of participants with 50-74% and ≥ 75% improvement per the facial Vitiligo Area Scoring Index, respectively, and by 82.6% of participants with ≥ 25% improvement per the total Vitiligo Area Scoring Index per Study 1 outcomes at Week 24. In Study 2, most (82.6%) participants felt that the noticeability of their vitiligo affected their behavior. Nearly all (87.0%) said that an ideal treatment would repigment or return natural color to their facial skin; 56.5% considered ≥ 50% facial repigmentation to be the smallest meaningful improvement.
Participants from both qualitative interviews expressed substantial psychosocial burden. Repigmentation in both facial and body vitiligo were important, with meaningful change determined to be ≥ 50% facial repigmentation and ≥ 25% body repigmentation.
白癜风是一种自身免疫性疾病，会导致皮肤色素脱失。白癜风患者承受着巨大的心理社会负担，并且对他们的治疗表达了不满。在此，我们描述了白癜风的负担以及两项定性访谈研究参与者对于有意义变化的看法。
对来自芦可替尼乳膏两项关键3期临床试验（研究1）的青少年和成年白癜风患者亚组以及一个真实世界小组（研究2）进行了定性访谈。询问参与者他们的疾病负担、治疗目标、面部/身体改善的重要性（治疗满意度：量表范围0 - 10）以及变化的意义（是/否）。
研究1共访谈了36名参与者，研究2共访谈了23名参与者。在研究1中，影响程度最高的是自尊降低（面部皮损，62.5%；身体皮损，55.6%）、社交抑制（面部皮损，65.6%；身体皮损，61.1%）以及对阳光敏感（面部皮损，31.3%；身体皮损，55.6%）。大多数参与者（83.3%）报告称面部改善同等重要（36.1%）或比身体改善更重要（47.2%），面部和身体的平均治疗满意度分别为8.1和6.9。根据面部白癜风面积评分指数，分别有83.3%和92.9%的参与者在改善50 - 74%和≥75%时报告有有意义的变化，根据研究1第24周的结果，白癜风面积评分指数总体改善≥25%的参与者中有82.6%报告有有意义的变化。在研究2中，大多数（82.6%）参与者认为他们白癜风的明显程度影响了他们的行为。几乎所有（87.0%）参与者表示理想的治疗会使他们面部皮肤重新色素沉着或恢复自然颜色；56.5%的参与者认为面部色素沉着≥50%是最小的有意义改善。
两项定性访谈的参与者均表达了巨大的心理社会负担。面部和身体白癜风的色素沉着都很重要，有意义的变化被确定为面部色素沉着≥50%和身体色素沉着≥25%。
