摘要：

This retrospective cohort study evaluated the efficacy and safety of telitacicept combined with standard therapy in class III-V lupus nephritis (LN). We enrolled 146 patients with lupus nephritis confirmed by renal biopsy. Among them, 73 patients received treatment with telitacicept in combination with the standard therapy regimen, while the remainder were treated with the standard therapy alone. This analysis included class III/IV ± V or class V LN. Efficacy endpoints included cumulative complete renal response (CRR, 24hUTP < 0.5 g with stable renal function) and partial renal response (PRR, 50 % reduction in 24hUTP from baseline) at 6 months, 1 year, and the end of follow-up. Multivariate regression was used to assess baseline predictors of CRR. Safety was also evaluated. Compared with the control group, telitacicept showed remarkable efficacy in improving disease activity indicators such as serum albumin (ALB), complement levels, and 24-h urinary total protein (24hUTP), with a significant reduction in antibody positivity rates and immunoglobulin levels, alongside an improvement in anemia. By 6 months, the CRR rate in the telitacicept group reached 64.4 % (64.4 % vs 45.2 %, P = 0.020). At 1 year, the cumulative CRR was significantly higher in the telitacicept group compared to the control group (80.8 % vs 61.6 %; P = 0.010). During follow-up, the time to achieve CRR was significantly earlier in the telitacicept group (median 4.0 months, 95 %CI, 2.71-5.29) than in the control group (median 9.0 months, 95 %CI, 5.25-12.75) (LogRank P = 0.006). Moreover, subgroup analyses indicated better efficacy of telitacicept in patients with positive dsDNA antibodies (OR, 1.70, 95 %CI, 1.20-2.40, P for interaction = 0.031). Telitacicept dose reduction did not increase disease activity. Multivariate analysis showed that the use of telitacicept was a favorable factor for achieving CRR, and other predictors included BMI, eGFR, and 24hUTP. Compared with the standard treatment group, the risk of adverse renal outcome events in the telitacicept group was reduced by 53 %. The incidence of adverse events was similar between the two groups. This real-event study confirmed that the addition of telitacicept to standard therapy significantly boosted clinical remission rates and improved prognosis in patients with LN. It was also found that telitacicept may be more likely to achieve CRR in dsDNA antibody-positive patients. At baseline, the use of telitacicept, lower BMI and 24hUTP levels, and higher eGFR levels were associated with a greater likelihood of achieving CRR. In addition, for patients who achieve CRR and SLEDAI score ≤ 6, we advocate dose reduction of telitacicept after 6 months of treatment.

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