The purpose of this study is to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.

开始日期2025-09-01

申办/合作机构

NYU Langone Health

NCT06716606

/ Recruiting临床3期

An Open Label Study to Investigate the Long-term Safety and Efficacy of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

This is an open label extension (OLE) study of an ongoing randomized controlled clinical study 218224 (Parent Study). The OLE study will describe how well tolerated belimumab will be long term, and whether it might continue to slow progression of lung function decline, slow overall disease progression and improve quality of life.

开始日期2024-12-12

申办/合作机构

GSK Plc

[+1]

NCT06381453

/ Recruiting临床2期IIT

Belimumab in the Management of Autoimmune Hepatitis: a Multi-centre, Open-label Trial of Add-on Belimumab Therapy to Standard of Care

Background: Autoimmune hepatitis (AIH) is a rare chronic and lifelong liver disease. Untreated, disease progresses to end-stage cirrhosis and the focus of therapy is with immunosuppression. Current therapies are limited, not targeted, and associated with side effects that patients report reduce quality of life. AIH is believed to arise as a consequence of genetic & environmental risks. Disease is characterised by impaired immunoregulation, that favours a chronic and relapsing hepatitis. As well as recognising an important role for cytotoxic T cells and regulatory T cells, it has become apparent that in AIH, as well as other related autoimmune conditions, that B-cells are important. AIH is characterised by a plasma cell rich interface hepatitis and elevated IgG concentrations. Furthermore B-cell lineages interact with regulatory T-cells. Off-label use of Rituximab, an anti-CD20 agent, has been described for patients with AIH. A number of other ways of effectively targeting B-cells in the treatment of related autoimmune diseases have also been developed, but there have been limited studies in people living with autoimmune hepatitis. Belimumab is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator. It is approved in the Canada to treat systemic lupus erythematosus and lupus nephritis. It has not been studied before in AIH, but off-label reports are published. In an open-label clinical trial of people living with autoimmune hepatitis, the investigator will now formally study the effect of adding Belimumab to existing standard of care, with the goal being to evaluate treatment efficacy, the ability to reduce the burden of existing therapies whilst still controlling AIH disease, and to describe the tolerability & safety of Belimumab in people with AIH. Study Design: Open label, multi-centre, Canadian clinical trial. Patient population: Patients with autoimmune hepatitis, excluding patients with decompensated liver disease, who either have active disease despite standard of care (Group A), or who are maintained with disease remission using standard of care therapy (Group B). 48 patients will be recruited. Intervention: Weekly sub-cutaneous Belimumab. Duration: 72 weeks with interim analysis after 24 patients have been treated for 24 weeks; target recruitment 48 patients. Evaluation: Safety, Serum liver tests, quality of life, exploratory immunologic biomarkers, optional liver biopsy or fine needle liver aspirate. Primary end-point: Group A: 50% or more of subjects have an ALT<2x ULN & corticosteroids at a dose of

开始日期2024-12-11

申办/合作机构

University Health Network

[+1]

100 项与贝利尤单抗相关的临床结果

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100 项与贝利尤单抗相关的转化医学

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100 项与贝利尤单抗相关的专利（医药）

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1,297

项与贝利尤单抗相关的文献（医药）

2025-12-01·JOURNAL OF MEDICAL ECONOMICS

Comparison of utilization and total medicare fee-for-service expenditures for subcutaneous versus intravenous versions of a select group of therapies.

Article

作者: Sarocco, Phillip ; Kardel, Peter ; Maynard, Jason ; Sheetz, Caitlin

INTRODUCTION:

Comparisons of subcutaneous (SC) and intravenous (IV) delivery of biotherapeutics in Europe have revealed differences in cost, convenience, and preference. In the US, claims-based studies comparing SC and IV delivery have been limited. This study compared resource utilization and expenditures between cohorts of patients receiving the same drug by the SC or IV route of administration (ROA) across several indications.

METHODS:

Medicare Fee-For-Service claims were compared between cohorts of patients who received SC- or IV-delivered abatacept, belimumab, daratumumab, infliximab, tocilizumab, trastuzumab/pertuzumab, or vedolizumab. For each drug, utilization rates and healthcare expenditures per service site were compared between ROAs. Observed differences in baseline characteristics were accounted for using Inverse Probability Treatment Weighting models that balanced pre-index differences between ROAs per drug. Each ROA comparison per drug and service site was weighted and conducted independently.

RESULTS:

Across seven drugs, a total sample size of 158,632 (72,820 IV; 85,812 SC) was analyzed. For most comparisons, high-spend sites were utilized at a higher rate for IV administration. In particular, all comparisons revealed more frequent hospital outpatient department utilization for the IV ROA. For five of the seven drugs, SC treatment was associated with lower mean total Medicare expenditures, with savings of up to $56,000 per patient annually. Although three SC treatments had higher medication index spend, the total spend for these drugs across sites was significantly lower for SC delivery.

LIMITATIONS:

Limitations of this study include differences in billing between the SC and IV ROAs, potential treatment selection bias, and the assumption of equivalent efficacy.

CONCLUSIONS:

To our knowledge, this study was the first and largest US Medicare claims analysis, comparing patients receiving SC or IV versions of the same therapeutic across multiple drugs and indications. Findings demonstrated that SC delivery may facilitate reduced resource utilization and expenditures across drugs and disease indications.

2025-12-01·IMMUNOLOGIC RESEARCH

Effects of belimumab on peripheral blood Breg cells and cytokines in childhood systemic lupus erythematosus

Article

作者: Qiu, Shan ; Peng, Qianqian ; Zhang, Ruifeng ; Chen, Na ; Yuan, Tingting ; Lu, Qian ; Zhong, Zhaowen ; Lv, Juan

To evaluate the therapeutic effectiveness of belimumab (BLM) in childhood systemic lupus erythematosus (cSLE) by analyzing peripheral blood Breg cell subsets and related cytokines at multiple time points post-treatment, compared with conventional therapy. From January 2023 to August 2023, 36 cSLE patients receiving BLM plus standard therapy (BLM group) and 35 receiving standard therapy alone (conventional group) were enrolled. Thirty age- and sex-matched healthy children were included as controls. Flow cytometry was used to detect absolute counts and ratios of peripheral Breg cell subsets at baseline, 6 weeks, 6 months, and 1 year. Serum cytokine levels (IL-2, IL-10, IL-21, IL-35, and IFN-γ) were measured by ELISA. After 6 weeks, IL-2, IL-21, and IFN-γ levels decreased significantly in both groups (P > 0.05 between groups); however, after 6 months and 1 year, these cytokines remained lower in the BLM group (all P < 0.05). IL-10 and IL-35 levels increased in both groups from week 6, with a milder increase in the BLM group (all P < 0.05). CD3⁻CD19⁺ B cells declined in both groups, with significant intergroup differences (P < 0.001). The BLM group showed a higher proportion of CD27⁺CD24⁺ B cells at week 6 compared to the conventional group (P < 0.05), but this reversed at 1 year (P < 0.05). CD38⁺CD24⁺ B cells were significantly higher in the BLM group at 6 months and 1 year (P < 0.001), while the conventional group showed no significant change after 6 weeks (P > 0.05). At baseline, the relative proportion of CD38⁺CD19⁺ B cells was higher in the BLM group than in the conventional treatment group (all P < 0.05). With ongoing treatment, both groups showed a decreasing trend in B cell proportions, with statistically significant differences observed within each group (all P < 0.05). Moreover, the decline in the BLM group was more pronounced compared to the conventional group at corresponding time points (all P < 0.05). Belimumab may exert immunomodulatory effects in childhood systemic lupus erythematosus by influencing peripheral Breg cell subsets and cytokine profiles. Compared with conventional therapy, it appears to provide more sustained regulation of certain immune parameters over time. These findings suggest its potential as a complementary therapeutic option targeting B cell dysregulation in cSLE, although further studies are needed to confirm these observations and clarify the underlying mechanisms.

2025-11-01·LUPUS

Efficacy and safety of Belimumab, Rituximab and Voclosporin in the treatment of lupus nephritis based on registered clinical trials: A systematic review and network meta-analysis

Review

作者: Li, Feigao ; Li, Menghao ; Liu, Xizhe ; Zhang, Xinhui ; Liu, Xiuju

Objective:

To systematically compare the clinical effectiveness and safety of Belimumab, Rituximab and Voclosporin in the treatment of lupus nephritis based on network meta-analysis method.

Methods:

Systematic search of registered clinical trials in four major databases (Pubmed, Embase, Web of Science, The Cochrane Register of Clinical Trials) and ClinicalTrials.gov. According to the inclusion and exclusion criteria of the protocol, Screening of registered randomized controlled clinical trials of Belimumab, Rituximab and Voclosporin in the treatment of lupus nephritis.

Results:

This study included a total of five registered randomized controlled clinical trials involving 1212 subjects. In terms of complete renal remission, Voclosporin −1 year, High-Voclosporin-1 year, Voclosporin-2 years and Belimumab-2 years were all significantly better than placebo; At the same time, the effect of Voclosporin-1 year on complete renal remission rate was significantly better than that of Rituximab-1 year [OR = 3.2, 95% CI (1.41,7.24)]. In terms of safety, placebo was significantly better than High-Voclosporin-1 year [OR = 0.23, 95% CI (0.07,0.82)], and the difference was statistically significant; There was no significant difference in the incidence of serious adverse events.

Conclusion:

Voclosporin and Belimumab showed significant clinical efficacy in the treatment of lupus nephritis, and the safety was not statistically different from placebo. Voclosporin had significantly better clinical efficacy than Rituximab during 1-year treatment period. Increasing the dose of Voclosporin did not significantly improve the efficacy, but it will increase the safety risk of adverse events.

299

项与贝利尤单抗相关的新闻（医药）

21 小时之前

·丁香园风湿时间

系统性红斑狼疮：11 种新疗法最新进展！

系统性红斑狼疮（SLE）是一种以自身免疫反应为核心机制的系统性炎症性疾病，可累及多器官。由于疾病的复杂性及异质性，其治疗一直面临「疗效有限与毒性累积」的两难困境。长期以来，糖皮质激素（GCs）及广谱免疫抑制剂如环磷酰胺、吗替麦考酚酯（MMF）、硫唑嘌呤（AZA）构成治疗主轴，但感染、骨质疏松及心血管事件等长期副作用成为主要死因之一 [1]。 03 年 EULAR 指南明确提出 []： ● GCs 应仅用于短期诱导或过渡性治疗； ● 尽早联合免疫调节剂（HCQ、MMF、CNI 等）； ● 强调实现低疾病活动状态（LLDAS）或缓解（DORIS）为核心目标。因此，SLE 治疗正从「免疫抑制」向「免疫精准调控」转变。Tanaka 教授在 05 年综述中指出：未来 SLE 治疗的方向是在最小化激素基础上，通过靶向免疫通路实现免疫重建与无药缓解（drug-free remission）[3]。发病机制与机制驱动治疗 SLE 是一种由遗传易感性、环境因素、免疫紊乱和表观遗传调控共同驱动的多因素疾病。其核心病理机制是免疫耐受的破坏，导致机体对自身抗原产生持续免疫反应。 01 自身免疫反应的激活：从 T 细胞到 B 细胞在 SLE 中，自身抗原的持续暴露导致自身反应性 T 细胞的激活及调节性 T 细胞（Treg）功能障碍。滤泡辅助性 T 细胞（Tfh）在生发中心中对 B 细胞进行活化和分化信号传递，促使其在 IL-1 等细胞因子刺激下发生类别转换，最终分化为自身抗体产生的浆细胞。这些自身抗体与自身抗原结合形成免疫复合物，沉积于组织后激活补体系统，引发组织损伤和慢性炎症。 B 细胞除产生抗体外，还分泌 IL-6、TNF 等细胞因子，加剧炎症反应。全基因组关联研究（GWAS）发现，多数 SLE 易感基因在 B 细胞中高表达 [4]，进一步强调了 B 细胞在 SLE 体液免疫与自身免疫中的核心作用。 0 先天免疫激活：树突细胞与 TLR 信号 GWAS 同样发现了多个与先天免疫信号和细胞内通路相关的易感基因，包括 IRF5、IRAK1、TLR7 等，它们在浆细胞样树突细胞（pDC）中高表达。pDC 在 SLE 患者中异常活跃，能识别核酸-抗体复合物并通过 Toll 样受体（TLRs）通路产生大量 I 型干扰素（IFN-I）。 DNA-抗 dsDNA 抗体复合物被树突细胞的 Fc 受体摄取后，通过 TLR7/9-MyD88-IRF7 轴触发 IFN-α 等细胞因子释放。这一过程不仅激活树突细胞自身，还促进 B 细胞、T 细胞的增殖与分化，形成恶性循环。值得注意的是，TLR7 基因突变（Y64 H）可导致单基因型儿童狼疮。小鼠研究证实该突变导致 TLR7-MyD88 信号过度激活，引起 CD11c⁺ 衰老样 B 细胞积聚与自身抗体持续产生，提示 TLR7 是 SLE 发病的关键分子枢纽 [5]。 03 干扰素信号与 BAFF 通路的「桥梁作用」 SLE 患者常存在 I 型干扰素基因特征（IFN signature）过度表达，同时血清中可检测到 IFN-α 和 BAFF（B-cell activating factor）水平升高 [6]。IFN-I 不仅增强抗原呈递能力，还可刺激 BAFF 分泌，促进 B 细胞分化与自身抗体生成。因此，IFN-BAFF 轴成为连接先天与适应性免疫反应的核心通路。 B 细胞靶向治疗的持续进化 B 细胞在 SLE 发病中扮演核心角色，不仅产生自身抗体，还通过抗原呈递和细胞因子分泌维持炎症反应。因此，B 细胞相关靶点（CD0、CD40L、BAFF 等）成为近年来药物研发的重点。 01 抗 CD0 抗体：Obinutuzumab Obinutuzumab 为新一代 II 型抗 CD0 抗体，具有更强的抗体依赖细胞毒活性（ADCC）和吞噬活性，可更彻底清除 B 细胞。在 III 期 REGENCY 研究中，活动性狼疮性肾炎（LN）患者接受 Obinutuzumab 联合标准方案（MMF+GCs）治疗 1 个月后，完全肾缓解率 46.4%，显著高于安慰剂组的 33.1%（P = 0.0）[7]。不良反应以轻中度感染为主，无新的安全信号。该结果证实，强化 B 细胞清除可显著改善肾脏结局。 0 抗 CD40L 抗体：Dapirolizumab pegol CD40-CD40L 通路是 T 细胞与 B 细胞间关键的共刺激信号。早期全 IgG 型抗 CD40L 抗体因血栓风险而终止开发，而 Dapirolizumab pegol 通过去 Fc 结构避免了该风险。 IIb 期研究虽未达主要终点，但在免疫学指标（dsDNA、补体水平）及 SLEDAI 下降方面表现出趋势性改善，安全性良好 [8]。目前 III 期 PHOENYCS 试验正在进行中，预期将进一步验证其在非肾性 SLE 中的疗效。 BAFF/APRIL 通路：B 细胞「生存信号」的双重封锁 BAFF 与 APRIL（A proliferation-inducing ligand）是维持 B 细胞分化、存活及免疫球蛋白产生的核心因子。在 SLE 患者中，两者水平普遍升高，且与疾病活动密切相关。 01 Ianalumab 靶向 BAFF 受体（BAFF-R）的单克隆抗体，既能阻断 BAFF 信号，又可通过 ADCC 机制清除 B 细胞。在干燥综合征 IIb 期试验中显著改善 ESSDAI 评分，目前 SIRIUS-SLE 及 SIRIUS-LN 两项 III 期研究正在进行 [9]。该药物的独特机制有望在不完全清除 B 细胞的情况下，实现免疫稳态恢复。 0 Telitacicept Telitacicept 是一种重组融合蛋白，与 TACI（BAFF/APRIL 的受体之一）和人 IgG-Fc 结合，从而抑制 BAFF 和 APRIL 信号。在中国开展的随机、对照 IIb 期研究中，49 例中重度活动性 SLE 患者被随机分配至安慰剂或每周一次的 Telitacicept（80/160/40 mg），主要终点为第 48 周 SRI-4。Telitacicept 各剂量组的 SRI-4 应答率（71.0%、68.3%、75.8%）均显著高于安慰剂组（33.9%）；各组不良事件发生率相似 [10]。目前全球 III 期 REMESLE 研究正在进行。树突细胞与 I 型干扰素通路的新靶点 IFN-I 在 SLE 发病中的中心地位已得到充分证实。Anifrolumab 作为抗 IFNAR1 抗体的成功上市，为后续上游靶点开发奠定了基础。 01 Litifilimab Litifilimab 是一种靶向浆细胞样树突细胞（pDC）特异分子 BDCA 的单克隆抗体，可抑制 IFN-α 的产生，从而降低免疫系统的过度激活。在一项 IIb 期 LILAC 研究中，Litifilimab 相较安慰剂显著改善关节活动度（总活动关节数下降 15.0 vs 11.6，P = 0.04）及皮肤病变指标，且耐受性良好 [11]。常见不良事件包括带状疱疹及唇疱疹感染。目前 III 期 TOPAZ 研究正在进行，以进一步验证其在 SLE 中的疗效与安全性。与 Anifrolumab 相比，Litifilimab 作用于更上游的 pDC-IFN 轴，理论上可减少广谱干扰素阻断所致的副作用。小分子药物 01 Voclosporin 新一代口服钙调神经磷酸酶抑制剂（CNI），为环孢素 A 结构类似物，药代稳定、肾毒性较低。在 AURORA Ⅲ 期研究中，Voclosporin + MMF 方案在活动性狼疮性肾炎中显著提高完全肾缓解率（41% vs 3%），并允许显著减量糖皮质激素 1。长期随访（AURORA-）证实疗效持续、安全性良好。适用于活动性 LN，但应避免用于 eGFR＜30 mL/min/1.73 m² 的患者。 Voclosporin 以低激素剂量实现显著肾缓解，是当前狼疮性肾炎治疗的新标准之一。 0 Upadacitinib 选择性 JAK1 抑制剂，已在类风湿关节炎等免疫性疾病中获批。在一项 II 期 SLE 研究中，341 例中重度 SLE 患者被随机分配接受 Upadacitinib 单用或与 BTK 抑制剂 Elsubrutinib 联合。在第 4 周，主要终点（SRI-4 应答且泼尼松 ≤ 10 mg/d）达标率为 54.8%（Upa 30 mg + Els 60 mg）vs 37.3%（安慰剂），差异显著。联合组复发更少、首次复发延迟，无新增安全信号 [13]。目前 III 期 SELECT-SLE 研究正在进行。 03 Deucravacitinib（Tyk 抑制剂）通过抑制 Tyk「假激酶结构域」，实现高选择性，避免传统 JAK 抑制剂的不良反应（如感染风险、血脂异常）。II 期 PAISLEY 研究显示：SRI-4 应答率 58% vs 34%（P < 0.001），且长期耐受良好 [14]。III 期 POETYK SLE 正在开展。 Deucravacitinib 通过精准抑制 Tyk 通路改善多系统 SLE 活动，疗效确切、安全性可控，是 JAK 家族中最具前景的新成员。 04 Cenerimod Cenerimod 是一种选择性口服 S1P1 受体调节剂，可通过阻断 S1P 信号通路抑制淋巴细胞从二级淋巴器官外流，从而减少外周循环中的活化淋巴细胞。作为与 Fingolimod 类似的新型免疫调控药物，它在系统性红斑狼疮中显示出良好的耐受性和潜在疗效 [15]，目前 Ⅲ 期研究正在进行。Cenerimod 代表了 S1P 通路调控在 SLE 中的新方向，为小分子免疫调节药物的重要成员。免疫重建疗法：从药物控制到「治愈」探索 01 CAR-T 疗法 CAR-T（嵌合抗原受体 T 细胞）疗法是一种创新性细胞免疫治疗，通过改造患者自身 T 细胞，使其识别并清除 B 细胞。常见靶点为 CD19 或 BCMA。其在血液肿瘤中的成功经验被延伸至自身免疫病，包括 SLE。 01 年，Schett 等首次报道难治性 SLE 患者接受 CD19-CAR-T 治疗后实现快速、持久的缓解，B 细胞暂时清除、尿蛋白消失、血清学指标恢复正常，且副作用轻微 [16]。随后多例研究显示，患者均在 3 个月内达到 DORIS 缓解，B 细胞约在 3~4 个月后重新出现，提示该疗法可重建免疫稳态。在 I/II 期 CASTLE 研究中，4 例患者（其中 SLE 10 例、IIM 5 例、SSc 9 例）接受自体 CD19-CAR-T 治疗后均取得临床改善，并能停用免疫抑制剂。主要不良反应为轻中度细胞因子释放综合征（CRS），未见严重神经毒性或局部免疫反应。 CAR-T 疗法为难治性 SLE 提供了「免疫系统重启」的新思路，虽仍面临安全性与成本挑战，但其治愈潜力备受关注。 0 T 细胞双特异抗体（TCE） TCE 是一种能同时结合 T 细胞与 B 细胞靶点的双特异抗体，通过桥接 T 细胞与靶 B 细胞，诱导 T 细胞介导的 B 细胞裂解 [17]。该机制已在难治性 B 细胞淋巴瘤中验证有效，代表药物包括： ● CD19-TCE：blinatumomab ● CD0-TCE：mosunetuzumab、epcoritamab、glofitamab 这类药物通过同时结合 B 细胞表面抗原（CD19/CD0）与 T 细胞上的 CD3，绕过传统 MHC 限制，直接形成免疫突触，从而激活 T 细胞杀伤 B 细胞。目前已观察到 CD8⁺T 细胞介导的靶细胞裂解效应，相关 SLE 临床试验正在规划中。表 1. SLE 新药与疗法进展迈向低激素、精准与免疫重建的新时代 03 年 EULAR 指南标志着 SLE 治疗理念的重大转变 —— 从依赖激素控制向「免疫精准调控与缓解维持」过渡。目前，多种新型生物制剂与小分子药物正重塑 SLE 治疗格局： 1 B 细胞通路靶向药物如 Belimumab、Ianalumab、Obinutuzumab、Dapirolizumab pegol； I 型干扰素及树突细胞靶向药物如 Anifrolumab、Litifilimab； 3 信号通路抑制剂如 Upadacitinib（JAK）、Deucravacitinib（Tyk）； 4 以及细胞重建疗法如 CAR-T 和 TCE。这些新策略共同推动 SLE 从传统免疫抑制走向低激素甚至免疫重塑的「药物性缓解」阶段。随着病理机制的深入理解和多靶点药物的出现，SLE 治疗正处于从「广谱免疫抑制」到「免疫平衡重建」的转型阶段：靶点更加多样（如 BAFF、IFN-I、Tyk、S1P 等通路），安全性不断优化（如 Fc 修饰、选择性免疫抑制），免疫重建理念逐渐成型（CAR-T/TCE 探索长期缓解）。未来研究将聚焦于不同亚型的精准用药、长期安全性与可及性评估。总体来看，SLE 治疗正迈向「低激素化、个体化与免疫重建」的新时代。 ✩ 本文仅供医疗卫生等专业人士参考投稿邮箱：huanghaihua@dxy.cn 策划：黄海花参考资料： [1] . Ugarte-Gil MF, Mak A, Leong J, et al. Impact of glucocorticoids on the incidence of lupus-related major organ damage: a systematic literature review and meta-regression analysis of longitudinal observational studies. Lupus Sci Med 01; 8(1). [] . Fanouriakis A, Kostopoulou M, Andersen J, et al. EULAR recommendations for the management of systemic lupus erythematosus: 03 update. Ann Rheum Dis 04; 83(1): 15-9. [3] . Tanaka Y. Novel therapies in treatments of SLE. Best Pract Res Clin Rheumatol 05: 10101. [4] . Liu Z, Davidson A. Taming lupus-a new understanding of pathogenesis is leading to clinical advances. Nat Med 01; 18(6): 871-8. [5] . Brown GJ, Cañete PF, Wang H, et al. TLR7 gain-of-function genetic variation causes human lupus. Nature 0; 605(7909): 349-56. [6] . Tanaka Y. State-of-the-art treatment of systemic lupus erythematosus. Int J Rheum Dis 00; 3(4): 465-71. [7] . Furie RA, Rovin BH, Garg JP, et al. Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. N Engl J Med 05; 39(15): 1471-83. [8] . Furie RA, Bruce IN, Dörner T, et al. Phase , randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate-to-severe active systemic lupus erythematosus. Rheumatology (Oxford) 01; 60(11): 5397-407. [9] . Dörner T, Bowman SJ, Fox R, et al. Safety and Efficacy of Ianalumab in Patients With Sjögren's Disease: 5-Week Results From a Randomized, Placebo-Controlled, Phase b Dose-Ranging Study. Arthritis Rheumatol 05; 77(5): 560-70. [10] . Wu D, Li J, Xu D, et al. Telitacicept in patients with active systemic lupus erythematosus: results of a phase b, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis 04; 83(4): 475-87. [11] . Furie RA, van Vollenhoven RF, Kalunian K, et al. Trial of Anti-BDCA Antibody Litifilimab for Systemic Lupus Erythematosus. N Engl J Med 0; 387(10): 894-904. [1] . Rovin BH, Teng YKO, Ginzler EM, et al. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet 01; 397(1089): 070-80. [13] . Merrill JT, Tanaka Y, D'Cruz D, et al. Efficacy and Safety of Upadacitinib or Elsubrutinib Alone or in Combination for Patients With Systemic Lupus Erythematosus: A Phase Randomized Controlled Trial. Arthritis Rheumatol 04; 76(10): 1518-9. [14] . Morand E, Pike M, Merrill JT, et al. Deucravacitinib, a Tyrosine Kinase Inhibitor, in Systemic Lupus Erythematosus: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol 03; 75(): 4-5. [15] . Askanase AD, D'Cruz D, Kalunian K, et al. Cenerimod, a sphingosine-1-phosphate receptor modulator, versus placebo in patients with moderate-to-severe systemic lupus erythematosus (CARE): an international, double-blind, randomised, placebo-controlled, phase trial. Lancet Rheumatol 05; 7(1): e1-e3. [16] . Mougiakakos D, Krönke G, Völkl S, et al. CD19-Targeted CAR T Cells in Refractory Systemic Lupus Erythematosus. N Engl J Med 01; 385(6): 567-9. [17] . Reed DR, Lum LG. Looking ahead to CD3, T-cell engager bispecific antibodies for hematological malignancies. Expert Opin Biol Ther 04; 4(8): 761-7.

2025-11-20

·豫见风湿

儿童系统性红斑狼疮：为什么更严重？十年研究带来哪些新发现

系统性红斑狼疮（SLE）不仅发生在成年人，约 15–20% 患者在儿童或青少年期发病，称为儿童发病型狼疮（cSLE）。相比成人，儿童发病往往更急、累及器官更多，如肾脏、中枢神经系统、肌骨系统，同时需要更高强度的激素和免疫抑制治疗，因此长期损伤和生活质量影响更明显。儿童为何“更凶险”？研究发现，儿童狼疮不仅是“提前出现的成人狼疮”，而是具有独特免疫异常。其免疫系统仍在发育，更容易出现自身免疫耐受破坏，表现为：I型干扰素显著升高 → 免疫系统长时间处于高激活状态清除凋亡细胞能力差 → 自身抗原暴露更多器官损伤出现更早 → 肾炎和神经系统受累更常见因此，许多患者在十几岁就面临肾功能下降、认知受损甚至早发心血管风险。遗传与表观遗传的新认识近十年基因组和表观遗传研究发现儿童狼疮往往遗传驱动更强：单基因缺陷（特别是补体相关） → 可导致极早发病、严重表型多基因风险叠加，在女性及特定族群更突出表观遗传变化（如DNA甲基化、miRNA）可能是青春期发病的重要“开关” 这意味着儿童狼疮发病机制不仅不同，还可能需要更早的遗传筛查和干预策略。技术推动机制突破单细胞测序、空间转录组、免疫组库等技术揭示了：独特的 T、B细胞活化谱肾炎灶内细胞通讯网络与神经系统受累相关的炎症信号这为未来根据免疫亚型精准分层提供基础。新型生物标志物传统尿蛋白并不能满足早期监测需求，新研究提出：领域潜在标志物价值肾炎尿蛋白组、脂质组提前预测复发心血管风险炎症相关脂质动脉硬化早筛中枢神经系统神经炎症分子鉴别精神症状来源未来有望实现“更早识别、更早干预”。治疗进入靶向时代儿童狼疮逐步引入生物制剂和精准用药，如贝利木单抗、B细胞靶向疗法、JAK/IFN阻断剂。但仍存在：主要依赖成人试验数据儿科药物批准有限生物制剂可及性不均未来方向是建立儿科专属指南与临床试验体系，并减少激素依赖，提高长期生活质量。

2025-11-19

·中国临床试验注册中心

他克莫司联合泰它西普治疗 PLA2R 相关性膜性肾病的疗效和安全性研究

注册号： Registration number： ChiCTR2500112773 最近更新日期： Date of Last Refreshed on： 2025-11-19 14:34:37 注册时间： Date of Registration： 2025-11-19 00:00:00 注册号状态：预注册Registration Status： Prospective registration注册题目：他克莫司联合泰它西普治疗 PLA2R 相关性膜性肾病的疗效和安全性研究Public title： Efficacy and Safety of Tacrolimus and Telitacicept in PLA2R-Associated Membranous Nephropathy注册题目简写：English Acronym：研究课题的正式科学名称：他克莫司联合泰它西普治疗 PLA2R 相关性膜性肾病的有效性和安全性的多中心、开放标签、随机对照临床试验Scientific title： A Multicenter, Open-Label, Randomized Controlled Trial of Tacrolimus Combined with Telitacicept for Efficacy and Safety in PLA2R-Associated Membranous Nephropathy研究课题代号(代码)： Study subject ID：在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：申请注册联系人：姜明伟研究负责人：孙世仁 Applicant： Mingwei Jiang Study leader： Shiren Sun 申请注册联系人电话： Applicant telephone： +86 176 9567 0709 研究负责人电话： Study leader's telephone： +86 29 8966 1609申请注册联系人传真： Applicant Fax：研究负责人传真： Study leader's fax：申请注册联系人电子邮件： Applicant E-mail： 794480087@qq.com 研究负责人电子邮件： Study leader's E-mail： sunsrsun@163.com申请单位网址(自愿提供)： Applicant website(voluntary supply)：研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：申请注册联系人通讯地址：中国陕西省西安市新城区长乐西路街道127号研究负责人通讯地址：中国陕西省西安市新城区长乐西路街道127号Applicant address： No.127 Chang le West Road, Xincheng District, Xi’an, Shaanxi Province, China Study leader's address： No.127 Chang le West Road, Xincheng District, Xi’an, Shaanxi Province, China申请注册联系人邮政编码： Applicant postcode： 710032 研究负责人邮政编码： Study leader's postcode： 710032申请人所在单位：空军军医大学第一附属医院Applicant's institution： The First Affiliated Hospital of the Air Force Medical University研究负责人所在单位：空军军医大学第一附属医院Affiliation of the Leader： The First Affiliated Hospital of the Air Force Medical University是否获伦理委员会批准：是Approved by ethic committee： Yes伦理委员会批件文号： Approved No. of ethic committee： KY20252391-F-1号伦理委员会批件附件： Approved file of Ethical Committee：查看附件View批准本研究的伦理委员会名称：空军军医大学第一附属医院医学伦理委员会Name of the ethic committee： The Ethics Committee of the First Affiliated Hospital of the Air Force Medical University伦理委员会批准日期： Date of approved by ethic committee： 2025-11-06 00:00:00伦理委员会联系人：程梁华Contact Name of the ethic committee： Lianghua Cheng伦理委员会联系地址：中国陕西省西安市新城区长乐西路街道127号Contact Address of the ethic committee： No.127 Chang le West Road, Xincheng District, Xi’an, Shaanxi Province, China伦理委员会联系人电话： Contact phone of the ethic committee： +86 29 8477 1794 伦理委员会联系人邮箱： Contact email of the ethic committee： XJYYLLWYH@163.com研究实施负责（组长）单位：空军军医大学第一附属医院Primary sponsor： The First Affiliated Hospital of the Air Force Medical University研究实施负责（组长）单位地址：中国陕西省西安市新城区长乐西路127号Primary sponsor's address： No.127 Chang le West Road, Xincheng District, Xi’an, Shaanxi Province, China试验主办单位(项目批准或申办者)： Secondary sponsor：国家：中国省(直辖市)：陕西市(区县)： Country： China Province： Shaanxi City：单位(医院)：空军军医大学第一附属医院具体地址：陕西省西安市新城区长乐西路127号 Institution hospital： The First Affiliated Hospital of the Air Force Medical University Address： No.127 Chang le West Road, Xincheng District, Xi’an, Shaanxi Province经费或物资来源：自选课题（自筹）Source(s) of funding： Self selected topic (self funded)研究疾病：原发性膜性肾病 Target disease： primary membranous nephropathy研究疾病代码：Target disease code：研究类型：干预性研究Study type： Interventional study研究所处阶段：上市后药物 Study phase： 4研究设计：随机平行对照 Study design： Parallel 研究目的：评估他克莫司联合泰它西普治疗PLA2R相关性膜性肾病患者的有效性和安全性 Objectives of Study： The objective of this study is to evaluate the efficacy and safety of the combination therapy of tacrolimus and telitacicept for the treatment of PLA2R-associated membranous nephropathy药物成份或治疗方案详述： Description for medicine or protocol of treatment in detail：纳入标准： 1.入组时年龄18-80岁；2.经肾活检确诊为原发性膜性肾病的患者；3.PLA2R抗体阳性；4. 24小时尿蛋白＞3.5g/24h且血清白蛋白＜30g/L；5.以CKD-EPI公式估算的肾小球滤过率≥60mL/min/1.73m²；6.受试者同意在整个研究期间与其伴侣采取有效的避孕措施；7.自愿签署知情同意书。Inclusion criteria 1. Aged 18 to 80 years at enrollment; 2. Patients diagnosed with primary membranous nephropathy by renal biopsy; 3. Positive for anti-PLA2R antibody; 4. 24-hour urinary protein>3.5g/24h and serum albumin<30g/L; 5. eGFR>=60mL/min/1.73m^2 calculated by the CKD-EPI formula; 6. Subjects agree to use effective contraceptive measures with their partners throughout the study period; 7. Voluntarily sign the informed consent form.排除标准： 1.继发性膜性肾病（由自身免疫性或感染性疾病、药物、肿瘤等引起）；2.已知对研究药物的活性成分或任何所列赋形剂存在过敏或超敏反应的患者；3.筛选期开始前24周内发生心肌梗死、急性冠脉综合征、卒中、癫痫发作或血栓栓塞事件（如深静脉血栓形成或肺栓塞）的患者；4.筛选前24周内行大手术（含关节手术），或入组后24周内计划行手术；5.HIV感染、梅毒、活动性结核、未治疗的潜伏期结核者；6.筛选期有未得到控制的活动性感染（单纯尿路感染、细菌性咽炎除外）者；7.活动性乙型肝炎或丙型肝炎病毒感染者；8.筛选期有活动性肝病（定义为：ALT/AST/胆红素水平超过正常上限的3倍）或严重肝脏疾病（如肝硬化）的患者；9.筛选期内eGFR快速下降（＞15mL/min/1.73m²）的患者；10.实验室检查结果存在严重异常者（如血红蛋白<70g/L、血小板计数<50,000/mm³、中性粒细胞计数<1,000/mm³等）；11.接受过肾移植或其他器官移植者；12.既往存在恶性肿瘤病史的患者，但除外：确定已治愈或已缓解≥5年的肿瘤、已根治性切除的皮肤基底细胞或鳞状细胞癌或任何部位的原位癌；13.过去12周内使用B细胞靶向药物（如利妥昔单抗、奥托珠单抗、贝利尤单抗、阿仑单抗、硼替佐米、CD38单抗）或其他生物制剂；14.过去12周内曾使用全身性糖皮质激素或免疫抑制剂，包括但不限于：环磷酰胺、硫唑嘌呤、麦考酚酯、来氟米特、他克莫司、环孢素、雷公藤等；15.筛选前28天内使用过任何试验药物，或在试验药物的5个半衰期（以较长者为准）；16.筛选前24周内接种活疫苗者；17.受试者在过去24周内有酒精或药物滥用史；18.怀孕或哺乳期或试验完成6个月内有生育计划者；19.研究者判断存在其他不适合参加本次临床试验的原因。Exclusion criteria： 1. Secondary membranous nephropathy(caused by autoimmune diseases, infectious diseases, drugs, tumors, etc.);2. Patients with known allergy or hypersensitivity to the active ingredients of the study drugs or any listed excipients;3. Patients who had myocardial infarction, acute coronary syndrome, stroke, seizure, or thromboembolic events within 24 weeks prior to the start of the screening period;4. Patients who underwent major surgery(including joint surgery) within 24 weeks prior to screening, or plan to undergo surgery within 24 weeks after enrollment;5. Patients with HIV infection, syphilis, active tuberculosis, or untreated latent tuberculosis;6. Patients with uncontrolled active infection at screening(excluding uncomplicated urinary tract infection and bacterial pharyngitis);7. Patients with active HBV or HCV infection;8. Patients with active liver disease(defined as: ALT/AST/bilirubin levels exceeding 3 times the upper limit of normal) or severe liver disease(e.g., cirrhosis) at screening;9. Patients with a rapid decline in eGFR(>15mL/min/1.73m^2) during the screening period;10. Patients with severe abnormalities in laboratory test results (e.g., hemoglobin<70g/L, platelet count<50,000/mm^3, neutrophil count<1,000/mm^3, etc.);11. Patients who have undergone kidney transplantation or other organ transplantation;12. Patients with a history of malignant tumors, except for: tumors confirmed to be cured or in remission for >=5 years, skin basal cell or squamous cell carcinoma that has been radically resected, or carcinoma in situ at any site;13. Patients who have used B-cell targeted drugs(e.g., rituximab, ocrelizumab, belimumab, alemtuzumab, bortezomib, CD38 monoclonal antibody) or other biological agents within the past 12 weeks;14. Patients who have used systemic glucocorticoids or immunosuppressants within the past 12 weeks, including but not limited to: cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, tripterygium wilfordii, etc.;15. Patients who have used any investigational drug within 28 days prior to screening, or within 5 half-lives of the investigational drug(whichever is longer);16. Patients who have received live vaccines within 24 weeks prior to screening;17. Patients with a history of alcohol or drug abuse within the past 24 weeks;18. Patients who are pregnant, lactating, or have plans for childbearing within 6 months after the completion of the trial;19. Patients deemed by the investigator to have other reasons unsuitable for participating in this clinical trial.研究实施时间： Study execute time：从 From 2025-11-06 00:00:00至 To 2027-06-30 00:00:00 征募观察对象时间： Recruiting time：从 From 2025-11-26 00:00:00 至 To 2026-08-31 00:00:00干预措施： Interventions：组别：试验组样本量： 60 Group： Test Group Sample size：干预措施：他克莫司+泰它西普干预措施代码： Intervention： Tacrolimus+Telitacicept Intervention code：组别：对照组样本量： 60 Group： Control Group Sample size：干预措施：他克莫司干预措施代码： Intervention： Tacrolimus Intervention code：研究实施地点： Countries of recruitment and research settings：国家：中国省(直辖市)：陕西省市(区县)： Country： China Province： Shaanxi City：单位(医院)：空军军医大学第二附属医院单位级别：三级甲等 Institution hospital： The Second Affiliated Hospital of the Air Force Medical University Level of the institution： Tertiary A 国家：中国省(直辖市)：陕西省市(区县)： Country： China Province： Shaanxi City：单位(医院)：陕西省中医医院单位级别：三级甲等 Institution hospital： Shaanxi Provincial Hospital of Traditional Chinese Medicine Level of the institution： Tertiary A 国家：中国省(直辖市)：陕西省市(区县)： Country： China Province： Shaanxi City：单位(医院)：西安交通大学第二附属医院单位级别：三级甲等 Institution hospital： The Second Affiliated Hospital of Xi'an Jiaotong University Level of the institution： Tertiary A 国家：中国省(直辖市)：甘肃省市(区县)： Country： China Province： Gansu City：单位(医院)：兰州大学第二医院单位级别：三级甲等 Institution hospital： The Second Hospital & Clinical Medical School, Lanzhou University Level of the institution： Tertiary A 国家：中国省(直辖市)：宁夏回族自治区市(区县)： Country： China Province： Ningxia Hui Autonomous Region City：单位(医院)：宁夏医科大学总医院单位级别：三级甲等 Institution hospital： The General Hospital of Ningxia Medical University Level of the institution： Tertiary A 国家：中国省(直辖市)：宁夏回族自治区市(区县)： Country： China Province： Ningxia Hui Autonomous Region City：单位(医院)：宁夏回族自治区人民医院单位级别：三级甲等 Institution hospital： Ningxia Hui Autonomous Region People's Hospital Level of the institution： Tertiary A 国家：中国省(直辖市)：河北省市(区县)： Country： China Province： Hebei City：单位(医院)：中国人民解放军白求恩国际和平医院单位级别：三级甲等 Institution hospital： Bethune International Peace Hospital of the People's Liberation Army of China Level of the institution： Tertiary A 国家：中国省(直辖市)：陕西省市(区县)： Country： China Province： Shaanxi City：单位(医院)：陕西省人民医院单位级别：三级甲等 Institution hospital： Shaanxi Provincial People's Hospital Level of the institution： Tertiary A 国家：中国省(直辖市)：陕西省市(区县)： Country： China Province： Shaanxi City：单位(医院)：咸阳市中心医院单位级别：三级甲等 Institution hospital： Xianyang Central Hospital Level of the institution： Tertiary A 国家：中国省(直辖市)：陕西省市(区县)： Country： China Province： Shaanxi City：单位(医院)：咸阳市第一人民医院单位级别：三级甲等 Institution hospital： Xianyang First People's Hospital Level of the institution： Tertiary A测量指标： Outcomes：指标中文名：达到完全缓解患者的比例指标类型：主要指标 Outcome： Complete remission rate Type： Primary indicator 测量时间点：治疗24周时测量方法： Measure time point of outcome： At week 24 of treatment Measure method：指标中文名：达到临床缓解（包括完全缓解+部分缓解）患者的比例指标类型：次要指标 Outcome： Clinical remission rate (including complete remission + partial remission) Type： Secondary indicator 测量时间点：治疗12和24周时测量方法： Measure time point of outcome： At weeks 12 and 24 of treatment Measure method：指标中文名：免疫学缓解率（PLA2R抗体转阴患者的比例）指标类型：次要指标 Outcome： Immunological remission rate (the proportion of patients with seronegative conversion of PLA2R antibody) Type： Secondary indicator 测量时间点：治疗12和24周时测量方法： Measure time point of outcome： At weeks 12 and 24 of treatment Measure method：指标中文名： PLA2R抗体水平较基线的变化指标类型：次要指标 Outcome： Change in anti-PLA2R antibody level from baseline Type： Secondary indicator 测量时间点：治疗12和24周时测量方法： Measure time point of outcome： At weeks 12 and 24 of treatment Measure method：指标中文名： 24小时尿蛋白与基线的比值指标类型：次要指标 Outcome： Ratio of 24-hour urine protein to baseline Type： Secondary indicator 测量时间点：治疗4、8、12、18、24周时测量方法： Measure time point of outcome： at weeks 4, 8, 12, 18 and 24 of treatment Measure method：指标中文名： eGFR相对于基线的变化情况指标类型：次要指标 Outcome： Change in eGFR from baseline Type： Secondary indicator 测量时间点：治疗12和24周时测量方法： Measure time point of outcome： At weeks 12 and 24 of treatment Measure method：指标中文名：血清白蛋白相对于基线的变化指标类型：次要指标 Outcome： Change in serum albumin from baseline Type： Secondary indicator 测量时间点：治疗12和24周时测量方法： Measure time point of outcome： At weeks 12 and 24 of treatment Measure method：指标中文名：治疗过程中不良事件或严重不良事件的发生率和严重程度指标类型：次要指标 Outcome： Incidence rate and severity grade of adverse events or serious adverse events during treatment Type： Secondary indicator 测量时间点：测量方法： Measure time point of outcome： Measure method：采集人体标本： Collecting sample(s) from participants：标本中文名：血液组织： Sample Name： Blood Tissue：人体标本去向使用后销毁说明 Fate of sample： Destruction after use Note：标本中文名：尿液组织： Sample Name： Urine Tissue：人体标本去向使用后销毁说明 Fate of sample： Destruction after use Note：征募研究对象情况： Recruiting status：尚未开始 Not yet recruiting 年龄范围： Participant age：最小 Min age 18 岁 years 最大 Max age 80 岁 years性别：男女均可 Gender： Both随机方法（请说明由何人用什么方法产生随机序列）：申办方采用中央随机系统生成Randomization Procedure (please state who generates the random number sequence and by what method)： The applicant uses a central randomization system.是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: 公开/Public盲法：开放标签Blinding： Open-label study试验完成后的统计结果（上传文件）：点击下载Calculated Results after the Study Completed(upload file)： download是否共享原始数据： IPD sharing 否No共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：无The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)： None数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：病例记录表和电子采集和管理系统Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture： Case Record Form and Electronic Data Capture数据与安全监察委员会： Data and Safety Monitoring Committee：有/Yes注册人： Name of Registration： 2025-11-19 14:34:24

临床1期

100 项与贝利尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03068	贝利尤单抗	L04AA26	DB08879

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
狼疮性肾炎	欧盟	GlaxoSmithKline Trading Services Ltd.	2011-07-13
狼疮性肾炎	冰岛	GlaxoSmithKline Trading Services Ltd.	2011-07-13
狼疮性肾炎	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2011-07-13
狼疮性肾炎	挪威	GlaxoSmithKline Trading Services Ltd.	2011-07-13
系统性红斑狼疮	美国	GlaxoSmithKline LLC	2011-03-09

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
支气管疾病	临床3期	中国	GSK Plc	2024-12-12
支气管疾病	临床3期	日本	GSK Plc	2024-12-12
支气管疾病	临床3期	阿根廷	GSK Plc	2024-12-12
支气管疾病	临床3期	韩国	GSK Plc	2024-12-12
结缔组织病	临床3期	美国	GSK Plc	2024-09-11
结缔组织病	临床3期	中国	GSK Plc	2024-09-11
结缔组织病	临床3期	日本	GSK Plc	2024-09-11
结缔组织病	临床3期	阿根廷	GSK Plc	2024-09-11
结缔组织病	临床3期	澳大利亚	GSK Plc	2024-09-11
结缔组织病	临床3期	比利时	GSK Plc	2024-09-11

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05917288 (CTgov)	临床1期	系统性红斑狼疮	16	Belimumab (Belimumab 200 mg/mL Every Week)	壓艱壓選鏇製鏇網簾鹽(製壓繭鏇淵窪築網鏇鬱) = 餘觸壓餘齋廠鹹鹹鏇鹽構構積鏇顧壓襯繭遞觸 (鑰製衊蓋壓艱襯壓積襯, 27.50) 更多	-	2025-11-14
				Belimumab (Belimumab 200 mg/mL Every 10 Days)	遞鏇積膚鬱糧鬱製觸醖(糧衊鬱廠憲遞積糧壓醖) = 觸製糧鹽膚憲獵選膚網鹹簾蓋獵選築遞艱範繭 (顧鹽壓襯廠鬱壓顧廠憲, 17.44) 更多
NCT04515719 (Ann Rheum Dis) 人工标引	临床4期	系统性红斑狼疮	231	BelimumabBelimumab 120 mg + SOC	遞繭齋簾簾顧鹹網簾範(襯獵蓋襯範網選窪醖夢) = 壓選簾鬱遞壓蓋願淵鹽衊夢願築鏇窪鏇觸蓋壓 (淵糧範簾夢積餘積糧鏇 ) 达到更多	积极	2025-11-06
				Placebo (saline) + SOC	遞繭齋簾簾顧鹹網簾範(襯獵蓋襯範網選窪醖夢) = 鏇鏇壓廠鹽鑰夢醖觸齋衊夢願築鏇窪鏇觸蓋壓 (淵糧範簾夢積餘積糧鏇 ) 达到更多
NCT04515719 (ACR2025) 人工标引	临床4期	系统性红斑狼疮	231	BelimumabBelimumab 120mg + Standard of Care	廠製鏇襯憲選願觸窪積(網網網製窪蓋醖餘齋鬱) = 鏇鏇顧鹽範淵糧築遞蓋壓積鏇蓋夢鬱獵製蓋獵 (鹽選簾鬱蓋鬱餘鏇餘憲 ) 达到更多	积极	2025-10-24
				Placebo + Standard of Care	廠製鏇襯憲選願觸窪積(網網網製窪蓋醖餘齋鬱) = 鑰艱鬱願壓範網顧選築壓積鏇蓋夢鬱獵製蓋獵 (鹽選簾鬱蓋鬱餘鏇餘憲 ) 达到更多
RELIABLE (ACR2025)	N/A	系统性红斑狼疮	400	Belimumab	鹽艱蓋餘廠憲蓋壓廠獵(膚鏇網衊製網遞選築築) = 醖鏇製夢網鏇範構顧餘鹹鬱構繭窪繭憲顧繭選 (鹹艱廠鏇窪繭淵繭窪夢 ) 更多	积极	2025-10-24
ACR2025	N/A	系统性红斑狼疮	2,841	Belimumab	夢夢夢憲襯糧膚觸鑰蓋(選選鹽觸壓繭製蓋鹹鬱): HR = 0.45 (95.0% CI, 0.26 ~ 0.8)	积极	2025-10-24
				Azathioprine
NCT00424476 (BLISS-52, ACR2025)	临床3期	系统性红斑狼疮	910	Belimumab+Antimalarials+Glucocorticoids	願獵襯遞網獵餘窪壓淵(餘獵選襯顧艱網築網膚) = 遞獵衊壓醖網鹹夢鹹顧構製窪鹹鬱淵繭醖廠鬱 (醖糧積蓋淵膚遞遞餘鹽 ) 更多	积极	2025-10-24
				Immunosuppressants+Antimalarials+Glucocorticoids	願獵襯遞網獵餘窪壓淵(餘獵選襯顧艱網築網膚) = 選選選構壓齋膚簾範築構製窪鹹鬱淵繭醖廠鬱 (醖糧積蓋淵膚遞遞餘鹽 ) 更多
NCT00410384 (ACR2025)	临床3期	系统性红斑狼疮	2,386	Belimumab	蓋製蓋膚觸襯選獵膚蓋(構憲築製齋顧築壓蓋選) = 遞繭膚齋衊蓋窪夢鏇壓蓋願鹹壓廠鏇選鬱築範 (獵醖鑰製觸夢積鹹願艱 ) 更多	积极	2025-10-24
				Placebo	構製衊衊獵膚築簾繭網(壓齋壓獵積齋廠鏇齋鹽) = 鹹鹽獵齋廠繭醖廠觸鬱鹽憲製膚夢艱築蓋網醖 (選鏇鑰廠壓構蓋艱獵鏇 ) 更多
ACR2025	N/A	狼疮性肾炎	2,052	Mycophenolate mofetil (MMF)	艱窪網範繭窪襯範廠鏇(願淵憲夢齋範憲鬱顧蓋) = 築襯選網遞顧窪鑰構遞窪夢繭艱廠鹹襯遞憲醖 (築壓鏇夢積鬱選積蓋憲 )	积极	2025-10-24
				Azathioprine (AZA)	艱窪網範繭窪襯範廠鏇(願淵憲夢齋範憲鬱顧蓋) = 餘廠糧艱鏇淵鏇蓋廠鹽窪夢繭艱廠鹹襯遞憲醖 (築壓鏇夢積鬱選積蓋憲 )
JULES (ACR2025)	N/A	系统性红斑狼疮	67	Belimumab	願壓顧鏇夢築簾鏇鏇願(網顧齋窪襯遞製衊淵壓) = 選製餘網齋遞壓衊淵遞襯遞蓋鹽醖鹹艱淵齋糧 (蓋範築窪簾獵餘觸簾窪 ) 更多	积极	2025-10-24
NCT01639339 (BLISS-LN, ACR2025)	临床3期	狼疮性肾炎	271	Belimumab	淵鬱範繭膚繭觸夢積獵(艱夢選夢鏇鏇餘淵淵觸) = 築艱繭簾選遞構觸選積築醖蓋製鬱齋獵淵壓鏇 (廠顧鏇窪醖築醖膚淵餘 )	积极	2025-10-24
				Placebo	淵鬱範繭膚繭觸夢積獵(艱夢選夢鏇鏇餘淵淵觸) = 鑰獵選鬱觸廠網遞鹹築築醖蓋製鬱齋獵淵壓鏇 (廠顧鏇窪醖築醖膚淵餘 )