Comparative Efficacy and Safety of Telitacicept versus Belimumab in Systemic Lupus Erythematosus: A Systematic Review and Meta-Analysis.

This study was designed to assess the comparative efficacy and safety of telitacicept and belimumab in adult patients diagnosed with systemic lupus erythematosus (SLE). We systematically searched MEDLINE, Embase, and Web of Science from database inception through March 2026 to identify retrospective observational studies comparing telitacicept and belimumab in adult patients with SLE. A meta-analysis was conducted to pool efficacy data, reporting odds ratios (ORs) and 95% confidence intervals (CIs) for treatment response. The study protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO; Registration No. CRD420261420984). Out of 215 records screened, 5 studies (676 patients; 340 receiving telitacicept and 336 receiving belimumab) met the inclusion criteria following full-text assessment. Telitacicept was associated with significantly improved rates of lupus low disease activity state (LLDAS) at 24 weeks (OR = 1.87, 95% CI = 1.03-3.39, p = 0.041; 2 studies, I2 = 0%, p = 0.92) and complete renal response at 24 weeks (OR = 2.38, 95% CI = 1.10-5.15, p = 0.027; 2 studies, I2 = 0%, p = 0.88) compared to belimumab, utilizing fixed-effects models due to absence of heterogeneity. The Systemic Lupus Erythematosus Responder Index-4 (SRI-4) response at 24 weeks (OR = 2.02, 95% CI = 1.04-3.91, p = 0.038; 1 study) and complete renal response at 52 weeks (OR = 2.67, 95% CI = 1.17-6.09, p = 0.019; 1 study) were also significantly greater with telitacicept. Prednisone tapering to ≤7.5 mg/day at 24 weeks approached statistical significance (OR = 1.56, 95% CI = 1.00-2.43, p = 0.049; 1 study). Analysis of safety endpoints showed no statistically significant differences between groups for overall adverse events (OR = 1.21, 95% CI = 0.96-1.53, p = 0.088; 3 studies, I2 = 0%, p = 0.95), or serious adverse events (OR = 0.68, 95% CI = 0.43-1.08, p = 0.072; 2 studies, I2 = 0%, p = 0.89). Telitacicept suggests greater efficacy over belimumab in achieving LLDAS, SRI-4 response, complete renal response, and reduction in prednisone dosage in patients with SLE, without notable differences in rates of adverse events, serious adverse events, or infections.