Effectiveness and safety of Belimumab and Telitacicept in systemic lupus erythematosus: a real-world, retrospective, observational study.

To examine the effectiveness and safety of two different B cell activating factor/proliferation-inducing ligand inhibitors, telitacicept and belimumab, in treating patients with active systemic lupus erythematosus (SLE). Patients with active SLE who received belimumab (n = 100) or telitacicept (n = 101) from 2019 to 2023 at multiple centers in China were retrospectively collected, and the effectiveness and safety of telitacicept and belimumab was evaluated. The subgroups of lupus nephritis and hematologic abnormalities were analyzed to explore if there were any differences in the efficacy of the two biologics on improving kidney and blood systems. Propensity score-based inverse probability of treatment weighting (IPTW) was used to reduce selection bias. No significant between-group differences in patient characteristics were observed after adjustment by IPTW. The proportion of SLE Responder Index 4 at 24 weeks was significantly higher in the telitacicept group (p = 0.031), but no significant difference was observed in 52 weeks follow-up data. More significant improvements were observed in telitacicept group for C4 and a larger decrease was observed in telitacicept group for IgA and IgM levels at 4 weeks. A better improvement of hemoglobin in anemia patients from the telitacicept group at 24 weeks was observed. There were no significant differences in kidney effectiveness and treatment-related adverse events differences between the two groups. Patients receiving telitacicept showed a higher SRI-4 rate compared to those receiving belimumab at 24 weeks. Due to the real-world nature of this study and the limitation of IPTW application, further extensive investigations in larger cohorts and head-to-head clinical trials are required to validate these findings. Key Points • The telitacicept group displayed a higher SRI-4 rate at 24 weeks and a more substantial improvement in serological indices at 4 weeks. • No differences were observed in the effectiveness in lupus nephritis patients between belimumab and telitacicept groups. • A better improvement of hemoglobin in anemia patients at 24 weeks was observed in telitacicept group.

Jin HZ ，Cai ML ，Wang X ，Li Z ，Ma B ，Niu L ，Wang P ，Pan HF ，Li SD ，Bao W ，Wang GS ，Li XM ，Xie C ，Chen Z ... -  《-》

Belimumab versus telitacicept in sequential treatment after rituximab for refractory lupus nephritis: a real-world multicentre study.

Both belimumab and telitacicept are recognised blockers for B lymphocyte activation, both of which have been approved as add-on therapies for SLE in China. The aim of this study is to compare the efficacy of rituximab (RTX) followed by belimumab or telitacicept in a real-world cohort. A total of 49 refractory lupus nephritis patients were enrolled from four independent centres, subsequently categorised into two treatment groups: belimumab group (n=35) and telitacicept group (n=14) based on their treatment following RTX. The outcomes of renal response rates were evaluated. In this study cohort, 63.3% presented with anti-dsDNA antibody positivity and 79.6% exhibited hypocomplementemia, with a mean Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score of 13±6, estimated glomerular filtration rate (eGFR) of 76.2 (30.2, 113.7) mL/min and urinary protein creatinine ratio (uPCR) of 2.45 (0.77, 5.19) g/g. There was no significant differences between groups. After a follow-up duration of 26±12 months, renal objective remission rate was 80.0% (28 patients) in belimumab group and 85.7% (12 patients) in telitacicept group (difference, 5.7 percentage points, 95% CI, -25.8 to 26.8, p=1.000). Renal complete response was 54.3% (19 patients) in belimumab group and 78.6% (11 patients) in telitacicept group (difference, 24.3 percentage points, 95% CI, 9.7 to 47.8, p=0.194). The anti-dsDNA antibody, complement, eGFR, uPCR and SLEDAI-2K Score were improved in both groups with a significant reduction in prednisone dose. Major adverse effects included immunoglobulin deficiency, respiratory tract infection and urinary tract infection. No death occurred. The sequential treatment of belimumab or telitacicept following RTX may represent a promising therapeutic approach in the management of refractory lupus nephritis. Further investigation is necessary to establish optimal protocols and long-term benefits.

Chen Y ，Lei X ，Xu J ，Chen X ，Pan H ，Zhang Q ，Wang J ，Ren P ，Lan L ，Shi N ，Chen L ，Wang Y ，Chen J ，Jin L ，Yang Y ，Xue J ，Han F ... -  《Lupus Science & Medicine》

Belimumab in early systemic lupus erythematosus: A propensity score matching analysis.

This study aimed to evaluate the clinical efficacy of belimumab in patients with early systemic lupus erythematosus (SLE), defined as having a disease duration of less than 6 months. We retrospectively identified patients with SLE in the early stage who received belimumab and standard of care (belimumab group) or standard of care alone (control group) since September 2020. Propensity score matching (PSM) was used to reduce potential bias. The primary endpoint was lupus low disease activity status (LLDAS) at weeks 12 and 24. The secondary endpoints were remission and the proportion of glucocorticoid dose tapering to 7.5 mg/day. The efficacy of belimumab in patients with lupus nephritis was also assessed. Out of 111 eligible patients, 16 patients in the belimumab group and 31 patients in the control group were identified by 1:2 PSM. At week 24, a significantly higher proportion of individuals achieved low disease activity state (LLDAS) in the belimumab group compared to the control group (56.3% vs. 19.4%, OR = 5.357, 95% CI = 1.417 to 20.260, p = 0.013). Furthermore, more patients in the belimumab group were reduced to low-dose glucocorticoid ( ≤ 7.5 mg/day) at week 24 (75.0% vs. 35.5%, OR = 5.182, 95%CI = 1.339 to 20.058, p = 0.017). Significant improvements in Patient Global Assessment scores were observed at Week 12 and 24 for those treated with belimumab compared to controls. In a subgroup analysis evaluating the efficacy of belimumab in patients with lupus nephritis, 42.9% of the seven individuals treated with belimumab achieved a complete renal response (CRR) by Week 24, and no instances of disease relapse were observed. In SLE patients with a disease duration of less than 6 months, belimumab treatment can promote LLDAS achievement and reduce glucocorticoid dose, leading to a better prognosis. Introducing belimumab in the early stage of SLE may be a beneficial decision.

Lu C ，He N ，Dou L ，Yu H ，Li M ，Leng X ，Zeng X ... -  《Immunity Inflammation and Disease》

The efficacy of rituximab plus belimumab or telitacicept in refractory lupus nephritis.

Chen Y ，Shi N ，Lei X ，Ren P ，Lan L ，Chen L ，Wang Y ，Xu Y ，Lin Y ，Chen J ，Han F ... -  《-》

Erratum: Eyestalk Ablation to Increase Ovarian Maturation in Mud Crabs.

《Jove-Journal of Visualized Experiments》