To estimate the prevalence and comorbidity patterns of mental health disorders (MHDs) in persons with vitiligo and compare relative risks (RRs) with dermatological diseases (atopic dermatitis and psoriasis) and non-vitiligo comparator cohorts using claims data.

Retrospective matched cohort study using nationwide statutory health insurance claims data.

German statutory health insurance claims (DAK-Gesundheit), 2016–2020.

A 40% anonymised sample of insured persons (N=2 885 984). In 2020, persons with vitiligo (International Statistical Classification of Diseases, Tenth Revision, German Modification L80) were compared with cohorts with atopic dermatitis (L20), psoriasis (L40) and persons without vitiligo. Cohorts were propensity score matched (1:3) by age and sex.

Prevalence of MHDs and RRs across comparator cohorts.

Internal plausibility of expert-informed claims-based MHD case definitions using diagnosis-only versus diagnosis-plus-care criteria.

In 2020, 4 631 persons were diagnosed with vitiligo. Affective disorders and neurotic, stress-related and somatoform disorders showed the highest prevalence, with depressive episodes ranging from 8.9% to 19.2% and somatoform disorders from 5.3% to 17.9% across definitions. In matched comparisons with atopic dermatitis, only a few and inconsistent differences were observed. In contrast, more pronounced and consistent differences were identified in comparisons with psoriasis. Emotional disorders in childhood showed higher risks under the most sensitive case definition (RR=2.29, 95% CI 1.14 to 4.61), whereas hyperkinetic disorders showed consistent effects across all definitions (RR range=1.58–1.93). Compared with persons without vitiligo, risks were higher for social phobia (RR range=2.10–2.81) and anxiety disorders (RR range=1.64–1.93).

Persons with vitiligo show a substantial burden of affective and stress-related MHDs. The mental health comorbidity profile was largely comparable to that of atopic dermatitis, whereas more pronounced differences were observed in comparisons with psoriasis. Claims-based prevalence estimates were sensitive to case definition, highlighting the importance of transparent operationalisation.

Atopic dermatitis (AD) is a chronic, relapsing, heterogeneous skin disease affecting 2%–7% of adults, with roughly 30% having moderate-to-severe disease. AD symptoms, like intense itching and skin pain, carry a substantial disease burden that negatively impacts patients’ quality of life (QoL) and psychosocial well-being. Lebrikizumab is a novel, high-affinity monoclonal antibody that selectively binds to and neutralises interleukin-13 with high potency. Three clinical trials with lebrikizumab (ADvocate 1 and 2; ADhere) demonstrated significant clinical benefit in patients with AD, while the 3-year long-term extension study of lebrikizumab (ADjoin) further demonstrated long-term efficacy and safety in patients with AD. The ADTrust study will evaluate patient well-being, their relationship with their skin, long-term effectiveness, and safety of lebrikizumab, treatment satisfaction, and long-term effect of lebrikizumab treatment on different aspects of patients’ lives, including itch, pain, sleep, fatigue, work impairment and overall QoL among adult patients with moderate-to-severe AD in a real-world setting.

This non-interventional, prospective, observational, real-world evidence study will involve approximately 150 sites across Europe and approximately 1200 adults with moderate-to-severe AD treated with lebrikizumab for 2 years. The primary endpoint is patient well-being assessed by the 5-item WHO Well-Being Index (WHO-5) questionnaire. Key secondary endpoints include clinical effectiveness (Eczema Area and Severity Index and Investigator’s Global Assessment Scale), disease symptomatology and control (Patient-Oriented Eczema Measure, 24-hour peak pruritus, skin pain, fatigue and sleep quality Numerical Rating Scale, and safety and tolerability. Other validated endpoints will evaluate physician-reported and patient-reported QoL and treatment satisfaction (Dermatology Life Quality Index, Treatment Satisfaction Questionnaire-9), patients’ work productivity and impairment (Work Productivity and Activity Impairment (WPAI)-AD) and disease control (AD Control Tool). Novel experimental endpoints will also be evaluated with the aim to assess patients’ relationship with their skin (SkinLove questionnaire), disease control (intensity and frequency of flares) and an Effectiveness Diary^+© (a brief monthly survey on a voluntary basis with the aim to assess the long-term impact of lebrikizumab on three fundamental aspects of the patients’ life: the well-being (WHO-5), the itch intensity (24 hours peak pruritus) and the frequency and intensity of flares). Statistical analyses will be descriptive and explorative and based on observed cases. Missing data imputation may be used to handle missing data for primary endpoints and secondary effectiveness endpoints.

This study will be conducted according to the protocol, which has ethics committee approval (Hamburg Ethic Committee in Germany: 2024-101358-BO-ff), and all applicable laws and regulatory requirements for each participating country. The results will be disseminated through scientific publications and congress presentations.

NCT06815380 (Pre-results).