Li Zheng, Xiaotong Gu, Chumeng Yang, Weina Zhang, Changhai Fu, Yan Wang, Xiaoyong Fang
Current observational evidence suggests that telitacicept has a favorable safety profile and may offer clinical benefit in IgAN, particularly as a well-tolerated therapeutic option. Although superiority in efficacy outcomes was not statistically confirmed, the overall direction of effect tended to favor telitacicept in several analyses. Larger high-quality prospective studies are needed to further clarify its therapeutic value.
BACKGROUND: Telitacicept, a dual BAFF/APRIL inhibitor, is a potential targeted therapy for IgA nephropathy (IgAN), but its real-world efficacy and safety remain unclear.
METHODS: We systematically searched PubMed, Embase, Cochrane Central, ClinicalTrials.gov, CNKI, Wanfang, VIP, and SinoMed from inception to 2 March 2026 for observational studies of telitacicept in biopsy-confirmed IgAN. Eligible studies compared telitacicept monotherapy or telitacicept-based combination therapy with other immunosuppressive treatments. Outcomes included complete remission (CR), changes in 24-h urinary protein (Δ24hUPQ), estimated glomerular filtration rate (ΔeGFR), serum creatinine (ΔScr), albumin (ΔAlb), and adverse drug reactions (ADRs). Odds ratios (ORs) and mean differences (MDs) were pooled.
RESULTS: Eight observational studies involving 459 patients were included. Compared with other immunosuppressive therapies, telitacicept monotherapy showed no statistically significant differences in CR, Δ24hUPQ, ΔeGFR, ΔScr, and ΔAlb. Similarly, telitacicept-based combination therapy did not show statistically significant differences in CR, Δ24hUPQ, ΔeGFR, ΔScr, and ΔAlb. In terms of safety, telitacicept monotherapy was associated with a significantly lower incidence of ADRs than control treatments (OR 0.37, 95% CI 0.20-0.67). The certainty of evidence ranged from moderate to very low across outcomes.
CONCLUSIONS: Current observational evidence suggests that telitacicept has a favorable safety profile and may offer clinical benefit in IgAN, particularly as a well-tolerated therapeutic option. Although superiority in efficacy outcomes was not statistically confirmed, the overall direction of effect tended to favor telitacicept in several analyses. Larger high-quality prospective studies are needed to further clarify its therapeutic value.
SYSTEMATIC REVIEW REGISTRATION: The study was registered in the PROSPERO database (CRD420261296245), https://www.crd.york.ac.uk/PROSPERO/recorddashboard.