Risk of Safety Events in Vitiligo Patients: A Retrospective Real-World Data Study in the US

Vitiligo is a chronic autoimmune depigmenting disease characterized by loss of pigment in the skin, hair, or both. As treatment options evolve, particularly with the emergence of oral Janus kinase inhibitors and dual Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma family kinase inhibitor, it is essential to assess population-level safety events in patients with vitiligo. This retrospective cohort study examined patients aged ≥ 12 years with vitiligo in the United States, comparing them with age-, sex-, and race-matched controls to evaluate patient demographics, baseline comorbidities, medication histories, vitiligo prevalence and incidence across demographic groups, and incidence rates of safety events following vitiligo diagnosis. This study used records dated 1 January 2016 to 30 September 2023 from the Optum Market Clarity United States Electronic Health Record database. This study included 15 047 patients with vitiligo and 75 231 matched controls. In both cohorts, the median age was 51 years and 56.3% of patients were female. Compared with controls, patients with vitiligo had a higher baseline proportion of autoimmune and inflammatory diseases (e.g., autoimmune thyroiditis, psoriasis, alopecia areata, and atopic dermatitis), infections, malignancies, hypothyroidism, allergic rhinitis, and hearing loss; they were also more likely to have used treatments for dermatologic conditions and immunosuppressive medications. Post diagnosis, higher incidence rates of autoimmune and inflammatory conditions (e.g., alopecia areata, systemic sclerosis, pernicious anemia, autoimmune thyroiditis, and psoriasis), infections, hearing-related events, and skin cancer were observed in the vitiligo cohort compared with the non-vitiligo cohort. Furthermore, vitiligo incidence and prevalence rates were numerically higher in Asian and Hispanic populations than in other racial and ethnic groups. However, the observed results should be interpreted with caution considering the limitations of the dataset. These findings provide valuable insight into the epidemiology of and safety considerations for patients with vitiligo in the United States, informing future clinical and therapeutic strategies.