A conceptual model of the patient experience of cutaneous lupus erythematosus

BackgroundThere is limited qualitative research on the patient experience of cutaneous lupus erythematosus (CLE), and no fit-for-purpose patient-reported outcome (PRO) instruments are currently available in this population. This study aimed to better characterise the disease experience of CLE, focusing on the most prevalent subtypes, discoid lupus erythematosus (DLE) and sub-acute CLE (SCLE), and to develop a conceptual model depicting the core signs, symptoms, and impacts of the disease.MethodsSemi-structured, concept elicitation interviews were conducted in the United States among 25 patients with CLE (n = 15 DLE; n = 10 SCLE) and three expert clinicians to explore the signs, symptoms, and impacts of CLE. Interviews were audio-recorded and verbatim transcripts were coded and thematically analysed. Concepts reported by ≥ 50% of patients with an average bothersome rating of ≥5/10 were considered salient.ResultsThe most frequently reported signs and symptoms included itch (n = 25/25), skin lesions (n = 24/25), skin sensitivity to light (n = 23/25), skin redness (n = 22/25), skin scaling (n = 20/25), fatigue (n = 21/25), skin crusting, skin pain, joint pain, headaches (n = 19/25, each), and hair loss (n = 18/25). The most frequently reported impacts included limited social functioning (n = 22/25), body image concerns (n = 21/25), affected family/partner relationships (n = 19/25), recreational/leisure activities (n = 18/25), and sleep (n = 16/25). Key signs, symptoms, and impacts reported were generally consistent across SCLE and DLE subtypes, although patients with DLE reported greater scalp involvement and hair loss. The conceptual model summarises the core signs, symptoms, and impacts of CLE, while also highlighting any subtype-specific differences.ConclusionsThis study provides robust patient insights into the signs, symptoms, and impacts of CLE, with skin lesions, itch, skin sensitivity to light, hair loss, and fatigue emerging as most bothersome to patients. Scalp lesions warrant additional consideration due to their potential to cause permanent hair loss and scarring. This conceptual model can be used to identify target concepts for measurement and inform the development and selection of fit-for-purpose PRO instruments.