Abstract

Abstract Background/Aims Individuals with systemic lupus erythematosus (SLE) have an increased rate of mortality compared to the general population. We aimed to assess the cause of death and characteristics of these patients in a large national biologics register. Methods Patients receiving biological or standard of care (SoC) treatment recruited to the UK national SLE biologics registry (2010-21) were included. Demographic, clinical and laboratory data were recorded at recruitment. Information relating to date and cause of death were collected from study centres and the UK Office for National Statistics. The relationship between mortality and patient variables was analysed using a Cox proportional hazards model. Results There were 54 deaths in 1,477 patients over 6,162 patient years of follow up. The mortality rate was 5.97 (6.92-11.80) per 1000 person years (py). The cause of death was identifiable in 52 (96.2%) patients and included infection (21, 38.9%), active SLE (10, 18.5%), malignancy (6, 11.1%), cardiovascular disease (6, 11%), thrombosis (3, 5.6%), opiate toxicity (1, 1.9%) and cerebral haemorrhage (1, 1.9%). The characteristics of patients who died are described in Table 1. The median time between BILAG-BR registration and death was 679 (251-1,227) days. The mortality rate was 11.34 (8.54-15.04) per 1,000 py in patients on rituximab, 2.52 (0.36-17.90) per 1,000 py in belimumab and 3.32 (1.25-8.86) per 1,000 py in patients on SOC medicines. Factors independently associated with mortality included age at recruitment (HR 1.07 [1.05-1.09]), previous myocardial infarction (HR 5.35 [2.27-12.59]), diabetes mellitus (HR 3.87 [1.81-8.29]), previous cancer (HR 3.30 [1.59-6.86]) and hypertension (HR 1.81 [1.00-3.27]). In multivariate models adjusted for age, gender and presence of co-morbidities at baseline, risk of death was not significantly different between rituximab and belimumab (HR 0.36 [0.05-2.65) or SOC (HR 0.40 [0.12-1.32]) groups. Conclusion Risk of mortality was not different between treatment groups after accounting for differences in baseline demographics and co-morbidities. Co-morbidities were independently associated with high risk of death for patients with moderate-to-severe SLE; these should be actively assessed and managed to improve mortality outcomes. Disclosure S. Dyball: Grants/research support; MRC. Other; GSK, UCB. M. Rodziewicz: Grants/research support; MRC. Other; UCB. E. Sutton: None. A. Aksoy: None. S. McDonald: None. B. Parker: Honoraria; Fresenius-Kabi, AbbVie. Grants/research support; Genzyme/Sanofi, GSK. Other; Eli Lilly, Roche. I. Bruce: Consultancies; AstraZeneca, Eli Lilly, UCB, ILTOO, Merck Serono, GSK. Grants/research support; UCB, Roche, GSK, Genzyme/Sanofi. Other; AstraZeneca, GSK, UCB.

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