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Background  Systemic Lupus Erythematosus (SLE) is characterised by fluctuating periods of minimal disease activity and ‘flare’. Flare is an important outcome variable impacting the disease burden associated with SLE. The objective of this study was to obtain population-based utility values for varying severities of flare to measure the impact on health-related quality of life (HRQoL) in Australia, Canada, France, Japan, Spain and the UK.    Methods  Six health states (HS) for varying severities of flare were developed based on literature, patient blogs, and interviews with patients (n = 12), rheumatologists (n = 7) and nurses (n = 2). HS were validated by independent clinical experts (n = 6) and pilot interviews (n = 10, UK). HS were evaluated using the time-trade-off (TTO) method during face-to-face interviews with a minimum representative sample (n = 100) of the general population, per-country. Visual Analog Scale (VAS) scores were obtained to validate TTO scores. TTO scores were converted into utility values.    Results  The highest mean TTO utility scores were observed for the anchor HS (minimal disease activity) across all countries; means ranged from 0.66 in Japan to 0.82 in UK. All flare HS were associated with a disutility compared with the anchor HS (p < 0.001), means ranged across countries: mild flare HS: 0.55–0.71, moderate flare HS: 0.38–0.53, severe renal flare HS: 0.33–0.45, severe central nervous system (CNS) flare HS: 0.30–0.45 and severe generalised flare HS: 0.19–0.33. Mean VAS scores followed the same trend.    Conclusions  These results show increasing severity of flare has a detrimental impact on HRQoL. The severe generalised flare HS received the lowest mean utility score suggesting that the perceived day-to-day impact of a severe generalised flare was greater than a severe CNS or severe renal flare. This is, to the best of our knowledge, the first utility study to assess varying severities of flare in SLE across six different countries.

Elicitation of health state utilities associated with varying severities of flares in Systemic Lupus Erythematosus