Efficacy and safety of telitacicept in adults with systemic lupus erythematosus: a systematic review and stratified meta-analysis
In brief
Telitacicept roughly doubled lupus response at one year, with slightly more side effects
In two placebo-controlled trials, adults with active lupus taking telitacicept plus standard therapy were about twice as likely to meet the SRI-4 response measure at 48 to 52 weeks; any adverse events rose slightly, with no clear difference in serious events. All included reports came from China, and evidence on other outcomes and long-term safety remains uncertain.
- Journal
- Frontiers in medicine (Q1)
- Published
- 25 September 2026
- Study design
- Systematic review / meta-analysis of RCTs
- Evidence level
- Level 1, High (CEBM 1a)
- Authors
- Zihua Wang, Huan Li, Jigao Li, Wen Fu, Songwei Li, Fuhai Feng, et al.
- PMID
- 42856831
- DOI
- 10.3389/fmed.2026.1959776
Why clinicians should know about it
- Picked for Rheumatology (paper of the day, 12 October 2026): Improves SRI-4 response, moderate certainty
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.