REVEAL-UK: “Real world Evidence in Vitiligo Employing dAtabase anaLyses in UK”
This study aims to investigate the burden of disease of Vitiligo in both adolescent and adult vitiligo patients to determine the incidence and prevalence of Vitiligo in the UK and evaluate the patient journey following vitiligo diagnosis. Vitiligo is a long-term, depigmenting skin disorder which leads to development of white patches on the skin. This study will describe the most common diseases occurring at the same time as Vitiligo and characterize the healthcare resources used by vitiligo patients and patterns of treatments given. This is a historical study using primary and secondary care data from linked CPRD Aurum and HES databases in the UK (England). Study period is from 1st January 2010 to 31st December 2021.
Patients with vitiligo in the UK will benefit from the potential information which will contribute to epidemiology evidence and inform the scientific community to support diagnosis, treatment, and prognosis in this patient population.
The planned study is a longitudinal, retrospective cohort study of patients with vitiligo determined from the Clinical Practice Research Datalink (CPRD). CPRD data will be used to determine clinical and demographic characteristics of patients, medication usage, primary care consultations and specialist referrals. Data from Hospital Episode Statistics will be used to determine clinical characteristics, healthcare resource use, vitiligo-related procedures, and the number of specialist dermatology contacts. Index of Multiple Deprivation data will be used as part of the demographic characterisation of patients. The study will be descriptive with no formal statistical comparisons.
The first primary objective is to calculate annual vitiligo incidence rates and point prevalence for the period 2010-2021. The second primary objective will describe the clinical and demographic characteristics of a cohort of incident vitiligo patients, and this will be presented as summary statistics. There will be a particular focus on mental health comorbidities which will form part of primary objective three. The third primary objective will additionally present rates of healthcare resource use, dermatology referrals and dermatology specialist contacts, as well as an analysis of time from diagnosis to first, second and third vitiligo-related treatment using Kaplan-Meier graphs. Secondary objectives will include presentation of longitudinal vitiligo-related treatment patterns using Sankey diagrams. In addition to the analysis of the incident cohort, annual rates of healthcare resource use (primary objective three) and the proportion of patients receiving pre-defined categories of treatment for vitiligo and mental health comorbidities (secondary objective two) will be presented by calendar year for patents with prevalent vitiligo.
The results from this study will help to understand the incidence and prevalence of vitiligo in the UK and understand the comorbidity burden of patients with vitiligo. They will also help to understand the extent of healthcare resource utilisation by vitiligo patients and the treatments they receive.
Primary outcomes: annual incidence and prevalence rates; demographic and clinical characteristics (year of diagnosis, age; sex; socio-economic status (SES), ethnicity, comorbidities);. burden of disease (healthcare resource utilisation, occurrence of mental health outcomes, time to treatment, number of specialist and hospital referrals);
Secondary outcomes: longitudinal and annual treatment patterns (using Sankey and Kaplan Meier plots); sub-group analyses (by age, ethnic group, SES and sex)
Sarah Jenner - Chief Investigator - IQVIA Ltd ( UK )
Laura Girardat-Rotar - Corresponding Applicant - IQVIA AG (Switzerland)
Adrián Pérez - Collaborator - IQVIA ( IMS Health ) France
Anne Broe - Collaborator - IQVIA Ltd ( UK )
Christopher Lee - Collaborator - IQVIA Ltd ( UK )
Clare Flach - Collaborator - IQVIA Ltd ( UK )
Shala Mhlanga - Collaborator - IQVIA AG (Switzerland)
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;Patient Level Index of Multiple Deprivation