O2 Serious infection, including severe COVID19, seems not to be a major clinical problem in patients with systemic lupus erythematosus treated with Belimumab, according the data from a large multicenter cohort

ObjectivesBelimumab (BLM) had been shown to be consistently effective in patients with systemic lupus erythematosus (SLE) and is increasingly being used. Although it comes a biologic agent with a good safety profile, limited data are available regarding serious infection in real world, particularly concerning to COVID19.We aimed to assess the incidence of serious infection and COVID19 in patients with SLE, undergoing treatment with BLM and explore associated factors.MethodsMulticentre retrospective and longitudinal study of SLE patients treated with BLM, in Spanish rheumatology services. We collected activity status (AM-SLEDAI), organ damage (SLICC/ACR/DI) (SDI), treatments, outcomes and adverse effects, with special focus on serious infectious events. The data were collected at baseline, 6, 12 months and at the last available visit. A bivariate analysis of factors associated with serious infection was performed (Chi2 or Fisher’s test).ResultsA total of 324 patients with SLE (ACR-97 or SLICC-12 criteria) were included; 91% women; mean age (± SD): 42.4 (±12.9) years. Median follow-up: 3.2 years (1.4–5.9). Median time on BLM treatment: 2.7 (±2.4) years; 106 patients (32.7%) discontinued BLM, 22 (6.8%) due to adverse effects, of which 4/22 (18.2%) suffered serious infections, none of them opportunistic.A total of 51/324 patients (15.7%) had > 1 serious infection (up to 53 serious infections recorded.). Incidence density: 7.9 per 100 patient-years (for the first year); 94 out of 297 patients (31%) suffered from COVID19, of whom only 4 were severe, remarkably none of them being under treatment with BLM at the time of SARS-CoV2 infection. There were no deaths due to infection. Serious infection was associated with damage (median SDI (1 (0–2) vs 0 (0–1) (p = 0.023;95%CI: 0.10–1.33) and use of glucocorticoids (GC) (p=0.035; OR 2.25, 95%CI:1.04–5.17)Conclusions1° Incidence rate of serious infection in SLE patients treated with BLM does not differ from that reported in the clinical assays and only a few patients stopping BLM due to infection.2° Organ damage and the use of glucocorticoids were both associated with serious infection.3° Remarkably, no patient presented severe COVID19 or died as a result of an infection.