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

Objective: This study was designed to assess the comparative efficacy and safety of telitacicept and belimumab in adult patients diagnosed with systemic lupus erythematosus (SLE). Methods: 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). Results: Out of 215 records screened, five 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). Conclusion: 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.