Newtone Technologies, Research and Development, Lyon, France.
Université Côte d'Azur, CHU Nice, Department of Dermatology, Nice, France.
Br J Dermatol. 2023 Dec 20;190(1):62-69. doi: 10.1093/bjd/ljad304.
Facial repigmentation is the primary outcome measure for most vitiligo trials. The Facial Vitiligo Area Scoring Index (F-VASI) score is often chosen as the primary outcome measure to assess the efficacy of treatments for facial vitiligo. Although useful, this scoring system remains subjective and has several limitations.
To assess the agreement and reliability of an algorithmic method to measure the percentage depigmentation of vitiligo on the face.
We developed a dedicated algorithm called Vitil-IA® to assess depigmentation on standardized facial ultraviolet (UV) pictures. We then conducted a cross-sectional study using the framework of the ERASE trial (NCT04843059) in 22 consecutive patients attending a tertiary care centre for vitiligo. Depigmentation was analysed before any treatment and, for 7 of them, after 3 and 6 months of narrowband UVB treatment combined with 16 mg methylprednisolone, both used twice weekly. Interoperator and interacquisition repeatability measures were assessed for the algorithm. The results of the algorithmic measurement were then compared with the F-VASI and the percentage of depigmented skin scores assessed by 13 raters, including 7 experts in the grading of vitiligo lesions.
Thirty-one sets of pictures were analysed with the algorithmic method. Internal validation showed excellent reproducibility, with a variation of < 3%. The percentage of depigmentation assessed by the system showed high agreement with the percentage of depigmentation assessed by raters [mean error (ME) -11.94 and mean absolute error (MAE) 12.71 for the nonexpert group; ME 0.43 and MAE 5.57 for the expert group]. The intraclass correlation coefficient (ICC) for F-VASI was 0.45 [95% confidence interval (CI) 0.29-0.62] and 0.52 (95% CI 0.37-0.68) for nonexperts and experts, respectively. When the results were analysed separately for homogeneous and heterogeneous depigmentation, the ICC for homogeneous depigmentation was 0.47 (95% CI 0.31-0.77) and 0.85 (95% CI 0.72-0.94) for nonexperts and experts, respectively. When grading heterogeneous depigmentation, the ICC was 0.19 (95% CI 0.05-0.43) and 0.38 (95% CI 0.20-0.62) for nonexperts and experts, respectively.
We demonstrated that the Vitil-IA algorithm provides a reliable assessment of facial involvement in vitiligo. The study underlines the limitations of the F-VASI score when performed by nonexperts for homogeneous vitiligo depigmentation, and in all raters when depigmentation is heterogeneous.
面部复色是大多数白癜风临床试验的主要观察指标。面部白癜风面积评分指数(F-VASI)评分常被选为评估面部白癜风治疗效果的主要观察指标。尽管该评分系统很有用,但仍具有主观性,且存在多种局限性。
评估一种算法测量面部白癜风脱色百分比的一致性和可靠性。
我们开发了一种名为 Vitil-IA®的专用算法,用于评估标准化面部紫外线(UV)照片中的脱色程度。然后,我们在一项名为 ERASE 的试验(NCT04843059)的框架下,对 22 名连续就诊于三级白癜风治疗中心的患者进行了一项横断面研究。在任何治疗之前,以及其中 7 名患者接受窄谱 UVB 联合 16mg 甲基强的松龙治疗 3 个月和 6 个月后,对脱色情况进行了分析,两种药物均每周使用两次。评估了算法的操作员间和采集间的可重复性指标。然后将算法测量的结果与 F-VASI 和 13 名评估者(包括 7 名白癜风病变分级专家)评估的脱色皮肤百分比进行比较。
用算法方法分析了 31 组照片。内部验证显示出极好的可重复性,变异度<3%。系统评估的脱色百分比与评估者评估的脱色百分比高度一致[非专家组平均误差(ME)-11.94%和平均绝对误差(MAE)12.71%;专家组 ME 0.43%和 MAE 5.57%]。F-VASI 的组内相关系数(ICC)为 0.45(95%置信区间[CI]0.29-0.62),非专家的 ICC 为 0.52(95%CI 0.37-0.68),专家的 ICC 为 0.52(95%CI 0.37-0.68)。当分别对均匀和不均匀脱色进行分析时,均匀脱色的 ICC 为 0.47(95%CI 0.31-0.77),非专家的 ICC 为 0.85(95%CI 0.72-0.94),专家的 ICC 为 0.85(95%CI 0.72-0.94)。在对不均匀脱色进行分级时,非专家的 ICC 为 0.19(95%CI 0.05-0.43),专家的 ICC 为 0.38(95%CI 0.20-0.62)。
我们证明了 Vitil-IA 算法可以可靠地评估白癜风患者的面部受累情况。该研究强调了 F-VASI 评分在非专家评估均匀性白癜风脱色时的局限性,以及在所有评估者评估不均匀性脱色时的局限性。