Infectious complications of Belimumab with standard care in systemic lupus erythematosus

Objectives: We aimed to evaluate the risk of infectious complications of Belimumab with standard care in systemic lupus erythematosus (SLE). Methods: We searched PubMed, Web of Science, EMBASE, and Cochrane databases for studies on SLE and Belimumab and evaluated the study quality using the Cochrane Collaboration tool (ROB 2). A random-effect model was employed to analyze the results. To evaluate publication bias, Egger's tests were used. We also performed subgroup analysis based on the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and British Isles Lupus Assessment Group(BILAG). The study protocol has been registered in PROSPERO (CRD42023421255). Results: Eight studies involving 8545 patients were included, of which four studies had a high attrition bias. The present study suggested that the risks of infectious complications including infection (RR=1.02, 95 %CI=(0.97,1.08), I2=7.7 %) or serious infections (RR=0.94, 95 %CI=(0.77,1.15), I2=0 %), nasopharyngitis(RR=1.02, 95 %CI=(0.79,1.33), I2=36 %), upper respiratory tract infection(RR=0.97, 95 %CI=(0.83,1.14), I2=20.6 %), urinary tract infection(RR=1.09, 95 %CI=(0.91,1.32), I2=0 %), herpes zoster (RR=0.75, 95 %CI=(0.54,1.05), I2=0 %)and influenza(RR=0.98, 95 %CI=(0.69,1.39), I2=0 %) were not significantly increased in patients who received Belimumab with standard care, except for bronchitis (RR=1.51, 95 %CI=(0.98,2.33), I2=23.7 %). Additionally, the subgroup analysis of SLEDAI and the proportion of patients with BILAG 1A/2B did not show any significant impact on infectious complications. Conclusion: Meta-analysis results demonstrated that intravenous (IV) Belimumab(≤10 mg/kg), along with standard care, did not significantly increase the risk of infectious complications in SLE patients having mild-to-moderate disease activity, except for bronchitis. Baseline disease activity and organ damage did not impact the risk of infectious complications.