A Review of the Vitiligo Literature to Standardize Expression of Disease Severity
October 2024 | Volume 23 | Issue 10 | 8049 | Copyright © October 2024
Published online September 20, 2024
Yael Renert-Yuval MD MSca, Seemal Desai MDb, Victor Huang MDc, Samantha Walsh MLS MAd, David Rosmarin MDe, Nanette Silverberg MDf
aPediatric Dermatology Unit, Schneider Children's Medical Center of Israel, Petah Tikva, Israel
and Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
bDepartment of Dermatology, The University of Texas Southwestern Medical Center, Dallas, Texas, and Innovative Dermatology, Plano, TX
cDepartment of Dermatology, University of California, Davis, CA
dHunter College Library, New York, NY
eDepartment of Dermatology, Tufts Medical Center, Boston, MA
fDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY
Abstract
Background: The literature on vitiligo is heterogeneous with limited standardization in vitiligo disease severity reporting.
Objectives: The IDEOM Vitiligo Workgroup initiated a project to develop an improved understanding of clinical reporting of vitiligo severity.
Methods: A medical librarian-developed literature review identified 50 clinical trials treating vitiligo topically using topical corticosteroids or topical tacrolimus that included adult and pediatric patients, with 10 or more patients, with grading by SORT criteria.
Results: Grading systems used included body surface area scoring (BSA) clinically or via photography and mapping. Most studies create a grading system of repigmentation including G0- no change, G1- 1-25%, G2- 26-50%, G3- 51-75%, G4- 75-99%, and G5- 100%. Variations include reporting success as thresholds >25% (G2-G5), >50% (G3-G5), and >75% (G4-G5) repigmentation. Vitiligo Area Scoring Index (VASI), Dermatology Life Quality Index (DLQI), patient satisfaction, and the vitiligo noticeability scale are all standardized scoring systems that have been used in clinical studies. Other metrics reported include onset and maintenance of response, treatment burden, side effects, and cost-effectiveness.
Conclusions: BSA total and quartiles of improvement are the most commonly reported metrics in studies with high-level evidence. The addition of categories of no improvement, complete clearance, spontaneous improvement, and worsening appears to enhance information collection. Collection of data using photographs or computer-assisted BSA monitoring enhances data reproducibility. Thresholds of success should include 25%, 50%, 75%, and adding 90% and 100% repigmentation. VASI represents a validated collection method, which can be modified for 50%, 75%, and 90% improvement. Newer metrics including treatment burden and cost effectiveness are emerging metrics under evaluation.
J Drugs Dermatol. 2024;23(10): doi:10.36849/JDD.8049
INTRODUCTION
There is a poor understanding at this time as to best- practice in recording outcomes in vitiligo. This is because there is an extremely heterogeneous set of publications with limited standardization in vitiligo disease severity reporting. Repigmentation is the most commonly reported metric in clinical trials. How best to analyze this is unclear. Additionally, adverse effects, cosmetic acceptability, control of disease spread, and maintenance of repigmentation have been recommended in randomized controlled trials (RCT), with less than 10% of analyzed trials reporting all three metrics. The IDEOM Vitiligo Workgroup initiated a project to develop an improved understanding of clinical reporting of vitiligo extent and response to therapy, with a focus on identifying studies that enrolled both children and adults.
MATERIALS AND METHODS
A medical librarian-developed literature review. Two reviewers identified studies for inclusion. Fifty English-language clinical trials treating vitiligo topically using topical corticosteroids or topical tacrolimus that included adult and pediatric patients, with 10 or more patients including both children and adults. Grading of studies was performed using SORT criteria. Fifty-three were identified, but 4 additional articles were excluded- 1 for a case report, 2 not in the English language, and 1 for lack of availability, and 49 were reviewed in the final analysis.
