Belimumab 200mg/1ml solution for injection pre-filled disposable devices

B cell-targeted therapies play an important role in systemic lupus erythematosus (SLE). Belimumab targets B lymphocyte stimulator (BLyS), whereas telitacicept inhibits both BLyS and APRIL. Although both drugs have demonstrated clinical efficacy in SLE, comparative benefits and risks of telitacicept versus belimumab remain unclear. We performed a systematic review and meta-analysis using indirect comparisons to compare their efficacy and safety. We searched 6 database for randomized controlled trials (RCTs) published up to November 1, 2025, without language restriction. Trials evaluating belimumab or telitacicept in adult SLE patients were included. Primary outcomes included SLE Responder Index 4 (SRI4), SRI7 response rates and decreasing SLEDAI score. Secondary outcomes included prednisone dose reduction, anti-dsDNA change, adverse events (AEs) and serious AEs. Data extraction and risk-of-bias assessment were performed independently by two reviewers. Analysis used RR with 95% CI, and heterogeneity was assessed by I2. Sensitivity, subgroup and publication-bias analyses were performed. 11 trials with telitacicept and belimumab involving 4303 participants were included. Compared with the belimumab group, telitacicept significantly increased the SRI4 response rate (relative risk [RR], 2.03, 95%CI, 1.65-2.49, p < 0.0001), SRI7 response rate (RR, 3.61, 95%CI, 1.57-8.29, p = 0.002) and decreased SLEDAI score (RR, 1.67, 95%CI, 1.41-1.97, p < 0.0001). Compared with belimumab, telitacicept exhibited a significant advantage in SRI4 response rate (p for interaction = 0.0002), without a significant difference in adverse events. Certainty of evidence ranged from moderate to high, but heterogeneity was present for some outcomes. Telitacicept improved SRI4 and SRI7 response rates, reducing disease activity and prednisone dosage, without a clear increase in infection risk compared with belimumab. Dual inhibition of BLyS and APRIL by telitacicept may offer an effective option for reducing SLE activity. Further large-scale, long-term head-to-head trials are needed to confirm these findings.

Abstract licence: CC BY

ObjectiveThis study was designed to assess the comparative efficacy and safety of telitacicept and belimumab in adult patients diagnosed with systemic lupus erythematosus (SLE).MethodsWe 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).ResultsOut 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).ConclusionTelitacicept 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.

Abstract licence: CC BY-NC