Background Systemic lupus erythematosus (SLE) is an autoimmune disease with a broad spectrum of clinical manifestations. Increased morbidity and mortality were observed despite early and aggressive treatment. A changing pattern of mortality has been observed recently.
Objectives To summarize the incidence rate (IR) of all-cause and specified causes of mortality in SLE in clinical trials (CT).
Methods A systematic review was performed by searching the Medline, Embase and Cochrane databases. The search strategy identified all synonyms of disease and was limited to CTs. Data from randomized CTs and open-label studies were combined to assess the IR of all-cause and specified causes of mortality using a random effects model.
Results The search identified 2168 articles. After selection, 140 studies met the inclusion criteria (13,409 patients and 18,028.71 patients-year of exposure) and were included in the analysis. A total of 283 SLE patients died. IR of all-cause of mortality was 1.73 per 100 patients-year. IRs of specific causes are showed in the table. Stratified analysis showed higher IR for patients treated with higher dose of glucocorticoids (≥1 mg/kg/day of prednisone) [IR was 3.13 (2.15–4.28) vs 1.22 (0.92–1.55)] and for studies with lower percentage of women (less than 91%) [IR was 2.10 (1.49–2.81) vs 1.32 (0.99–1.70)]. Differences in the IR in trials reflect a bias by indication.
Conclusions Most frequent causes of death are still infections and cardiovascular disease. High doses of glucocorticoids were associated with higher rates of mortality.
Disclosure of Interest None declared