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》

Efficacy of initial combination with belimumab in newly diagnosed childhood-onset lupus nephritis: a single-centre historical control study.

To explore the efficacy of initial treatment of newly diagnosed childhood-onset lupus nephritis (cLN) with combination of belimumab and either cyclophosphamide, mycophenolate mofetil, tacrolimus or multitargeted therapy. A historical control study was conducted on children aged 5-17 years with newly diagnosed cLN. All patients recruited met the 2012 Systemic Lupus International Collaborating Clinics and/or 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for SLE, and the 2003 International Society of Nephrology/Renal Pathology Society histopathological criteria for LN. The primary endpoint was primary efficacy renal response (PERR) at 12 months, and secondary endpoints included complete renal response (CRR), lupus low disease activity state (LLDAS) and remission (Definitions of Remission in Systemic Lupus Erythematosus (DORIS)) at 12 months, changes of SLE Disease Activity Index (SLEDAI) and dose of glucocorticoid (GC). A total of 101 patients were included with 38 patients in the belimumab group and 63 patients in the standard immunotherapy group. There were no statistically significant differences between the two groups at baseline. At 12 months, compared with the standard immunotherapy group, more patients in the belimumab group had a higher PERR (97.1% vs 80.0%, χ2=3.965, p=0.046), CRR (94.1% vs 76.6%, χ2=4.679, p=0.031), LLDAS (75.0% vs 18.6%, χ2=27.84, p<0.001) and DORIS (34.4% vs 11.9%, χ2=6.626, p=0.01). The belimumab group had faster and greater reductions in SLEDAI and dose of GC (p<0.05), with a significantly higher proportion of patients with dose of GC ≤7.5 mg/day (82.9% vs 30.4%, χ2=19.737, p<0.001). In the standard immunotherapy group, 4 patients (6.3%) experienced a decline in estimated glomerular filtration rate of 30% or more at 12 months, while no patients in the belimumab group experienced worsening of renal function. There were no serious adverse events reported in two groups, and there was no significant difference in the occurrence of infection between the two groups. This study reported for the first time the effectiveness of combined belimumab therapy in a Chinese cohort of patients with cLN. The strategy of initial combination with belimumab helps achieve treatment targets earlier and faster GC tapering. And initial combination therapy in children with cLN with high disease activity may yield more significant benefits.

Gong Y ，Liu S ，Liu H ，Shi Y ，Li Y ，Guan W ，Zeng Q ，Lv Q ，Zhang X ，Wei Q ，Chen J ，Shen Q ，Xu H ，Sun L ... -  《Lupus Science &amp; Medicine》

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 ... -  《-》

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 ... -  《-》

Real-world efficacy of belimumab in systemic lupus erythematosus: a prospective cohort from a single centre in China.

The objective of this study was to explore the efficacy and safety of belimumab among Chinese patients with SLE in a real-world setting. A prospective cohort study was performed, and SLE patients taking belimumab on a background of standard-of-care (SoC) treatment were consecutively enrolled from July 2021 to December 2022. Based on baseline characteristics, the patients were divided into three groups: the newly diagnosed group, the relapsed group and the refractory group. Patients in the newly diagnosed group were newly diagnosed with SLE within 4 weeks of starting belimumab. Patients in the relapse group had experienced a severe flare. Refractory patients were patients with unsatisfactory GC taper and/or disease activity control. Clinical data were collected, and disease assessments were conducted regularly. Newly diagnosed patients with SoC alone and healthy controls (HCs) were also enrolled. A total of 123 SLE patients were included in the analysis, with a median follow-up period of 12 months (range 3-18 months). Thirty-three out of 123 patients were newly diagnosed, 32 had relapsed disease, and 58 had refractory disease. The SLE Responder Index 4 (SRI-4) response was achieved with good tolerance by 55.77% of patients at 3 months, 56.63% at 6 months, 63.24% at 9 months, 63.64% at 12 months and 57.14% at 18 months. Serological parameters (anti-dsDNA and C3/C4), SLEDAI-2K and daily prednisone intake were improved overall and in each group. Of the three groups, the newly diagnosed group had the highest SRI-4 rate as well as the greatest improvement in serological parameters and SLEDAI-2K. Compared with newly diagnosed patients with SoC alone, the cumulative prednisone intake of newly diagnosed patients taking belimumab was significantly decreased. Our data supported the efficacy of belimumab in Chinese SLE patients in a real-life setting. Our study also provided new evidence indicating remarkable achievement of the SRI-4 response during belimumab therapy in newly diagnosed SLE patients.

Zhao Y ，Qi F ，Bai J ，Zhang N ，Yang T ，Sun W ，Li X ，Wei W ... -  《-》