POS0739 DEVELOPMENT OF A CONCEPTUAL MODEL TO UNDERSTAND DISEASE BURDEN IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS AND LONG-TERM ORGAN DAMAGE
Authors: L. Broderick, W. H. Chen, R. Levy, A. Foster, C. Umanzor, D. Chauhan
Journal: Annals of the Rheumatic Diseases (2021)

Background: Systemic lupus erythematosus (SLE) is a chronic, multisystem, autoimmune disease resulting in increased morbidity and mortality and reduced health-related quality of life (HRQoL). Patients with SLE are at risk of developing irreversible long-term organ damage (LTOD) caused by both disease activity and cumulative medication toxicities. Data regarding the overall disease burden and impact of LTOD in patients with SLE are limited. Objectives: The primary objective of this qualitative study was to develop a conceptual model to describe the burden experienced by patients with SLE and LTOD. Methods: This study (GSK Study 209754) was conducted in three phases. First, a targeted literature review was performed to aid the development of an initial draft conceptual model. Key opinion leaders (KOLs) with experience in SLE and LTOD were then interviewed to assess the clarity, language, comprehensibility, and potential use of the conceptual model, and to help shape the patient interview materials. Finally, one-on-one interviews were performed with patients with SLE and LTOD in any of the 12 organ areas (defined by the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index [SDI]), to gather patient perspectives on the common symptoms, functional impacts, treatment experiences, and HRQoL factors associated with LTOD. Data from the interviews were coded and analysed using NVivo software to identify patterns in responses concerning the key concepts of the overall patient burden of LTOD, and used to identify concepts to include in the model. Results: The literature review produced the preliminary conceptual model of LTOD. Results of the KOL interviews (n=5 clinicians and n=1 patient advocate) indicated that the preliminary conceptual model broadly captured the patient experience of LTOD. KOLs emphasised the difference between SLE activity (flares) and LTOD; the conceptual model was subsequently updated in accordance with these recommendations. Interviews conducted with patients with confirmed single (n=9) and multiple LTOD (n=31) indicated that the burden of LTOD associated with SLE was more severe, debilitating, and life threatening than that caused by SLE flares. Almost all patients (39/40) reported aspects of their lives that were more severely affected since their LTOD diagnosis. All 40 patients reported LTOD-related physical impacts, which often affected patients’ ability to perform everyday tasks. The most frequent physical impacts reported were a loss of vitality (39/40), long-term complications (e.g. unstable blood pressure, extreme pain, poor mobility, inflammation, dialysis, infection; 36/40), and severe fatigue (29/40). Cognitive impairments that became more pronounced after their LTOD diagnosis were reported by 27/40 of patients. Typically characterised as “brain fog”, these impairments were described as slower cognitive processing, forgetfulness, confusion, and aphasia. Economic impacts associated with LTOD included patients’ inability to work (31/40), costs of care (33/40), and non-medical-related costs (17/30). Psychosocial impacts reported by patients with LTOD affected their emotional state (39/40), ability to socialise (40/40) and relationships (30/40). Additionally, 30/40 patients reported symptoms as more severe since their LTOD diagnosis, including pain (14/40), fatigue (9/40), and oedema (8/40). Patients’ treatment goals were largely aligned with their experienced impacts of LTOD, including managing the disease and symptoms (25/40), limiting further organ damage (15/40), and improving HRQoL (11/40). Conclusion: The findings from this research clearly indicate that the patient burden of LTOD far surpasses that of SLE without LTOD. These data were incorporated and refined into a conceptual model that fully represents the patient experience of LTOD. The model will help researchers, clinicians, and patients to better understand the impact of SLE-related LTOD progression. Funding: GSK Acknowledgements: Medical writing assistance was provided by Casmira Brazaitis, PhD, Fishawack Indicia Ltd., UK, part of Fishawack Health, and was funded by GSK. Disclosure of Interests: Lynne Broderick Consultant of: GSK, Wen-Hung Chen Shareholder of: GSK, Employee of: GSK, Roger Levy Shareholder of: GSK, Employee of: GSK, April Foster Consultant of: GSK, Cindy Umanzor Consultant of: GSK, Deven Chauhan Shareholder of: GSK, Employee of: GSK