Development of a Conceptual Disease Model of the Patient Experience of Systemic Lupus Erythematosus

OBJECTIVES: To develop a conceptual disease model (CDM) of the symptoms and impacts of systemic lupus erythematosus (SLE).

METHODS: A targeted literature review (TLR) was conducted in Embase and Medline to identify English-language full-text publications (published 2018–2023) detailing patient-reported symptoms and their impacts on daily functioning and health-related quality of life among adults with SLE. Data on patient characteristics, and symptoms and impacts of SLE were extracted from selected publications. A CDM of SLE symptoms and impacts was developed based on the concepts extracted from the TLR. Thematic analysis was used to group health concepts by common themes into dimensions capturing symptoms and impacts. Impacts were categorized as ‘proximal’ if they were directly related to SLE and ‘distal’ if they occurred because of a proximal impact.

RESULTS: From 49 publications selected for data extraction, 82 symptoms and 41 impacts of SLE were identified. The most frequently reported symptoms (in ≥10 publications) were fatigue, joint pain, muscle pain, rash, and bodily pain. The most frequently reported impacts (in ≥10 publications) were physical functioning, emotional health, intimate relationships, and cognitive impact. The CDM grouped the 82 symptoms into 14 dimensions (pain and discomfort, weakness, energy-related, skin-related, hair-related, joint-related, kidney problems, hematologic abnormalities, inflammation, flu-like, bladder-related, mouth/taste-related, smell, and other symptoms), 13 impacts proximal to SLE into three dimensions (physical, daily activities, and psychological/emotional impacts) and 28 impacts distal to SLE into seven dimensions (appearance, social functioning, relationship, cognitive, economic, sleep, and independence).

CONCLUSIONS: A CDM of the patient experience of SLE that includes 14 symptom dimensions, three proximal impact dimensions, and seven distal impact dimensions was developed. This CDM is being used to evaluate the suitability of patient-reported outcomes for supporting, in combination with clinical outcomes, the approval of new SLE therapies, as per FDA guidance on patient-focused drug development.