Efficacy and safety of telitacicept in adults with systemic lupus erythematosus: a systematic review and stratified meta-analysis
Abstract
Background Telitacicept is a TACI-Fc fusion protein that targets both B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL). Evidence in adults with systemic lupus erythematosus (SLE) includes placebo-controlled randomized trials, other comparative studies, and single-arm cohorts. Objectives To assess the efficacy and safety of telitacicept in adults with SLE and to synthesize placebo-controlled randomized trials, other comparative studies, and single-arm treatment cohorts separately by study design. Methods We searched electronic databases, screened references, and conducted hand searches, and cross-checked international trial registries. Eligible studies enrolled adults with SLE, including lupus nephritis (LN) subgroups. Comparative binary outcomes were pooled as risk ratios (RRs), continuous outcomes as mean differences (MDs), and single-arm outcomes as logit-transformed proportions. Random-effects models were used, and evidence certainty was assessed using GRADE. Results Thirty-nine reports, all from China, were included, and 22 contributed to quantitative synthesis. In two placebo-controlled randomized trials, telitacicept 160 mg plus standard therapy increased SLE Responder Index-4 (SRI-4) response at 48–52 weeks (RR = 2.04, 95% CI 1.66–2.50; I2 = 0.0%) and slightly increased any adverse events (RR = 1.09, 95% CI 1.02–1.17). No clear difference was observed for serious adverse events (RR = 0.68, 95% CI 0.35–1.30). Observational comparative findings in adult LN and single-arm cohort proportions were assessed separately. GRADE rated SRI-4 response and any adverse event as moderate certainty, serious adverse events as low certainty, and all other outcomes as very low certainty. Conclusion In the Chinese populations studied, telitacicept 160 mg plus standard therapy probably improves SRI-4 response at 48–52 weeks in adults with active SLE and may slightly increase any adverse events. Evidence for other outcomes is uncertain and does not establish comparative efficacy or long-term safety. Systematic Review Registration https://www.crd.york.ac.uk/PROSPERO/view/CRD420261464193, PROSPERO CRD420261464193.