Efficacy and safety of telitacicept combined with standard of care in patients with proliferative lupus nephritis: a real-world retrospective study.

Abstract

Objective: This study aimed to assess the efficacy and safety of telitacicept combined with standard of care (SoC) as induction therapy for proliferative lupus nephritis (LN) patients in a real-world setting.

Methods: A total of 112 patients with biopsy-proven International Society of Nephrology/Renal Pathology Society Class III/IV (with or without Class V) LN were retrospectively enrolled. Subjects were divided into two groups: the telitacicept group (n=56) receiving telitacicept plus SoC and the control group (n=56) receiving SoC alone. The primary endpoints were the rates of complete renal response (CR) and partial renal response (PR) at week 24, while the secondary endpoints included CR and PR rates, serological profiles, disease activity markers, glucocorticoid tapering and safety assessments at weeks 12 and 52. To minimise selection bias and confounding factors, propensity score-based inverse probability of treatment weighting (IPTW) was employed. The adequacy of the covariates after IPTW was evaluated via standardised mean differences.

Results: Baseline characteristics were comparable between the two groups. The telitacicept group demonstrated significant improvements in disease activity markers, including serum albumin, 24-hour urinary protein and urinary leucocyte and erythrocyte counts. At week 24, the telitacicept group achieved significantly higher CR rate (67.9% vs 39.3%, p=0.004) and PR rate (83.9% vs 67.9%, p=0.023) compared with the control group. Glucocorticoid dosages, systemic lupus erythematosus disease activity index 2000, British Isles Lupus Assessment Group and Physician's Global Assessment scores were significantly reduced in the telitacicept group. Furthermore, multivariate Cox regression analysis identified telitacicept treatment as an independent predictor for achieving CR (HR=4.43; 95% CI, 2.25 to 8.73; p<0.001).

Conclusions: This real-world study demonstrates that telitacicept combined with SoC significantly improves renal response rates during the induction phase of proliferative LN while reducing glucocorticoid exposure. Consequently, telitacicept may represent a promising and effective therapeutic option for the management of proliferative LN.