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]

NCT06572384

/ Recruiting临床3期

A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Belimumab Administered Subcutaneously in Adults With Interstitial Lung Disease (ILD) Associated With Connective Tissue Disease (CTD)

Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions. The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or improvement of lung function and improve symptoms associated with ILD with an acceptable safety profile.

开始日期2024-09-11

申办/合作机构

GSK Plc

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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1,309

项与贝利尤单抗相关的文献（医药）

2025-08-01·SEMINARS IN ARTHRITIS AND RHEUMATISM

Infectious complications of Belimumab with standard care in systemic lupus erythematosus: a systematic review and meta-analysis

Review

作者: Wei, James Cheng-Chung ; Fan, Yongsheng ; Chi, Gerald ; Ma, Chenhang ; Wang, Xinchang ; Xia, Shujun ; Wang, Weijie ; Zhao, Yu

OBJECTIVES:

We aimed to evaluate the risk of infectious complications of Belimumab with standard care in systemic lupus erythematosus (SLE).

METHODS:

We searched PubMed, Web of Science, EMBASE, and Cochrane databases for studies on SLE and Belimumab and evaluated the study quality using the Cochrane Collaboration tool (ROB 2). A random-effect model was employed to analyze the results. To evaluate publication bias, Egger's tests were used. We also performed subgroup analysis based on the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and British Isles Lupus Assessment Group(BILAG). The study protocol has been registered in PROSPERO (CRD42023421255).

RESULTS:

Eight studies involving 8545 patients were included, of which four studies had a high attrition bias. The present study suggested that the risks of infectious complications including infection (RR=1.02, 95 %CI=(0.97,1.08), I²=7.7 %) or serious infections (RR=0.94, 95 %CI=(0.77,1.15), I²=0 %), nasopharyngitis(RR=1.02, 95 %CI=(0.79,1.33), I²=36 %), upper respiratory tract infection(RR=0.97, 95 %CI=(0.83,1.14), I²=20.6 %), urinary tract infection(RR=1.09, 95 %CI=(0.91,1.32), I²=0 %), herpes zoster (RR=0.75, 95 %CI=(0.54,1.05), I²=0 %)and influenza(RR=0.98, 95 %CI=(0.69,1.39), I²=0 %) were not significantly increased in patients who received Belimumab with standard care, except for bronchitis (RR=1.51, 95 %CI=(0.98,2.33), I²=23.7 %). Additionally, the subgroup analysis of SLEDAI and the proportion of patients with BILAG 1A/2B did not show any significant impact on infectious complications.

CONCLUSION:

Meta-analysis results demonstrated that intravenous (IV) Belimumab(≤10 mg/kg), along with standard care, did not significantly increase the risk of infectious complications in SLE patients having mild-to-moderate disease activity, except for bronchitis. Baseline disease activity and organ damage did not impact the risk of infectious complications.

2025-07-01·JOINT BONE SPINE

Comparative efficacy and safety of anifrolumab for belimumab-experienced and biologic-naïve patients with systemic lupus erythematosus: Results from the Kyushu Collagen Disease Network for Systemic Lupus Erythematosus (KCDN-SLE) registry

Letter

作者: Maekawa, Makiko ; Ueda, Naoyasu ; Tanaka, Atsushi ; Ayano, Masahiro ; Kushimoto, Kazuo ; Mishima, Koji ; Tsuru, Tomomi ; Doi, Goro ; Akashi, Koichi ; Akahoshi, Mitsuteru ; Ota, Shun-Ichiro ; Nakayama, Tsuyoshi ; Niiro, Hiroaki ; Horiuchi, Takahiko

2025-07-01·AUTOIMMUNITY REVIEWS

Dual B-cell targeting in systemic lupus erythematosus: The role of combined and sequential therapy with rituximab and belimumab

Review

作者: Frade-Sosa, Beatriz ; Gómez-Puerta, José A ; Arnaud, Laurent ; Sarmiento-Monroy, Juan C ; Bruce, Ian N

Systemic lupus erythematosus (SLE) is a complex autoimmune disease characterized by immune dysregulation and autoantibody production. Despite advances in treatment, achieving sustained disease control remains challenging. Rituximab (RTX) and belimumab (BELI) are two B-cell-targeting biologics with complementary mechanisms of action, leading to increasing interest in their combination as a therapeutic strategy for refractory SLE. RTX depletes CD20+ B cells, whereas BELI inhibits B-lymphocyte stimulator (BLyS), reducing the survival of autoreactive B cells. Sequential therapy with these agents may mitigate B-cell repopulation and improve disease control. Recent studies, including SynBioSe and BEAT-LUPUS, suggest that RTX-BELI therapy can reduce autoantibody levels, neutrophil extracellular trap formation, and disease activity, with many patients achieving a lupus low disease activity state (LLDAS). However, the BLISS-BELIEVE and CALIBRATE trials did not demonstrate superiority over monotherapy, highlighting the need to refine patient selection. Combination therapy may be particularly beneficial in lupus nephritis, where BELI delays autoreactive B-cell reconstitution following RTX, potentially prolonging remission. While RTX-BELI therapy is generally well-tolerated, some studies report increased infections, necessitating careful patient monitoring. Lessons from other immune-mediated diseases, including inflammatory bowel disease and rheumatoid arthritis, underscore the potential benefits and risks of dual biologic therapy. Further research, including the ongoing SynBioSe-2 trial, is needed to clarify the optimal use, sequencing, and safety profile of RTX-BELI in SLE. Identifying biomarkers predictive of response may enable personalized treatment approaches, ultimately improving long-term outcomes for patients with refractory SLE.

199

项与贝利尤单抗相关的新闻（医药）

2025-05-26

·汇聚南药

红斑狼疮「潜在大药」亮相

红斑狼疮的靶向治疗药物种类丰富，包括生物制剂和小分子药物等，其中生物制药有3款药获批上市，而尚无用于治疗红斑狼疮的小分子靶向药物获批上市。近期，德国默克宣布其潜在用于治疗皮肤型红斑狼疮（CLE）和系统性红斑狼疮（SLE）的“first-in-class”口服小分子TLR7/8抑制剂enpatoran的一项2期WILLOW研究取得积极结果。此次2期临床的成功，使得红斑狼疮的靶向小分子药物研发更进一步。红斑狼疮靶向治疗生物制剂生物制剂是红斑狼疮靶向治疗的重要组成部分，主要通过靶向特定的细胞因子或免疫细胞来调节免疫反应，包括B细胞激活因子（BAFF/BLyS）、增殖诱导配体（APRIL）、CD20、CD22、T细胞相关靶点CTLA4、CD40L和IL6R等（图1）。图1 红斑狼疮靶向治疗常见的靶点图片来源：参考文献1目前已获批用于治疗红斑狼疮的靶向治疗生物制剂有贝利尤单抗、阿尼鲁单抗和泰它西普。1.贝利尤单抗贝利尤单抗是由GSK和Human Genome Sciences（HGS）共同研发的一种靶向BAFF/BLyS的全人源IgG1λ单克隆抗体，于2011年3月首次在美国获批上市，用于治疗活动性、自身抗体阳性的成人系统性红斑狼疮（SLE）患者，是首个专门用于治疗红斑狼疮的生物制剂。随后2019年12月和2023年2月分别获批用于治疗活动性狼疮肾炎（LN）的成人患者和潜在治疗系统性硬化症（SSc）。贝利尤单抗的获批基于多项关键临床试验，包括BLISS-52和BLISS-76试验以及BLISS-LN试验等，其中BLISS-52和BLISS-76试验结果显示，贝利尤单抗联合标准治疗显著提高了患者的SRI-4反应率（图2）。图2 贝利尤单抗的部分临床试验结果图片来源：参考文献2贝利尤单抗自上市以来销售额呈逐年上升趋势，2022年销售额达11.46亿英镑（约14.9亿美元），2022年销售额达13.49亿英镑（约17.54亿美元），2024年销售额约14.90亿英镑（约19.37亿美元），根据Verified Market Reports的数据，贝利尤单抗的销售额预计到2033年将增至32亿美元，年复合增长率为6.9%。2.阿尼鲁单抗阿尼鲁单抗是由阿斯利康研发的靶向Ⅰ型干扰素受体1（IFNAR1）的人单克隆抗体，于2021年8月获得美国FDA批准，用于治疗正在接受标准疗法的中度至重度SLE成年患者。此次获批是基于两项TULIP 3期试验和MUSE 2期试验。在这些试验中，与安慰剂相比，更多接受阿尼鲁单抗治疗的患者经历了包括皮肤和关节在内的器官系统整体疾病活动度的降低，并且口服皮质类固醇（OCS）的使用持续减少。阿尼鲁单抗目前也在中国开展SLE临床III期试验。3.泰它西普泰它西普是由荣昌生物自主研发的靶向BAFF/BlyS和APRIL两种关键的B细胞存活因子的新型融合蛋白，于2021年3月在中国获得有条件批准，用于治疗活动性SLE患者，有研究显示抗磷脂抗体阳性SLE患者中显示有效，有望进一步拓宽其适应人群。2024年7月，NMPA接受了泰它西普用于治疗类风湿关节炎（RA）的新临床适应症申请，除此之外，泰它西普还在开展重症肌无力（MG）、IgA肾病和原发性干燥综合征（pSS）等适应症。2025年4月8日，荣昌生物在2025年美国神经病学学会（AAN）年会上公布了3期评估泰它西普在全身性重症肌无力（gMG）患者中的疗效和安全性临床试验（NCT05737160）的结果。研究结果显示：在泰它西普240 mg组的参与者中，98.1%的患者在第24周时体重肌无力日常生活活动（MG-ADL）评分降低≥3分，87%的患者定量重症肌无力（QMG）评分降低≥5分。在迄今为止报道的3期研究中，泰利西普在所有gMG药物中具有最高的MG-ADL反应率，它将提供一种重要的新治疗选择gMG。除了上市获批的用于治疗红斑狼疮的生物制剂外，还有很多在研的生物制剂，包括奥滨尤妥珠单抗、达匹罗珠单抗和利替非利单抗等。1.奥滨尤妥珠单抗奥滨尤妥珠单抗是由罗氏研发的是一种II型抗CD20单克隆抗体，于2016年2月首次在FDA获批上市，用于治疗复发或难治性滤泡性淋巴瘤（FL），除此之外，奥滨尤妥珠单抗在治疗狼疮性肾炎和系统性红斑狼疮方面显示出显著的临床益处，特别是在对传统治疗耐药的患者中。FDA已同意审查罗氏提交的奥滨尤妥珠单抗用于治疗狼疮性肾炎的申请，该请求基于3期REGENCY试验（NCT04221477）的数据以补充生物制品许可申请（sBLA）的形式提交。FDA现在预计在10月之前做出关于奥滨尤妥珠单抗批准用于狼疮性肾炎的最终决定。今年2月，3期REGENCY试验的详细分析发表在《新英格兰医学杂志》上。该研究表明，完全肾反应（CRR）的主要终点有统计学意义和临床意义的改善，显示46.4%的奥滨尤妥珠单抗联合标准疗法治疗的患者达到76周时的CRR，而单独接受标准治疗的患者只有33.1%达到。与此同时，补体水平也有临床意义的改善，抗dsDNA、疾病活动和炎症标志物也有所减少（图3）。图3 3期REGENCY试验结果图片来源：参考文献62.达匹罗珠单抗达匹罗珠单抗是由优时比和渤健联合开发的一种人源化聚乙二醇化抗CD40L Fab片段，目前正在进行3期临床试验，用于治疗中度至重度SLE。去年9月，优时比和渤健宣布达皮罗珠单抗的3期PHOENYCS GO研究的积极顶线结果：与安慰剂相比，达皮罗珠单抗组的BICLA反应率显著高于安慰剂组（49.5%vs.34.6%），中度至重度疾病活动得到更大的改善。在测量疾病活动和发作的关键次要终点中观察到临床改善。基于PHOENYCS GO研究的成功结果，优时比和渤健于今年启动第二项3期临床试验PHOENYCS FLY。3.利替非利单抗利替非利单抗是由渤健研发的一种人源化IgG1单克隆抗体，可以靶向血液树突状细胞抗原2（BDCA2），通过抑制BDCA2减少包括I型干扰素（IFN-I）在内的炎性细胞因子的产生，从而调节红斑狼疮的病理机制。此前，利替非利单抗的Ⅱ期LILAC研究结果显示其显著降低皮肤疾病活动度的效果，与安慰剂组相比，能够有效缓解CLE患者的皮肤症状。目前，利替非利单抗正在进行TOPAZ-1和TOPAZ-2两项Ⅲ期临床试验，预计今年会出临床结果。红斑狼疮靶向治疗小分子药物除了生物制剂之外，小分子靶向药物也是红斑狼疮一大类主要治疗药物，治疗的靶点包括JAK、BTK、TLR7/8和蛋白酶体等，包括JAK抑制剂托法替布、巴瑞替尼、乌帕替尼和BTK抑制剂芬布替尼、奥布替尼等。1.托法替布托法替布是由辉瑞开发的一种泛JAK抑制剂，对JAK1/3作用更强，于2012年11月首次获批上市，目前已获批用于治疗多种免疫介导的疾病，包括类风湿关节炎、银屑病关节炎、溃疡性结肠炎、多关节型幼年特发性关节炎和强直性脊柱炎等。托法替布在SLE的一项Ib/IIa期、双盲、随机对照试验取得积极结果：托法替布在无意外严重不良事件（SAE）、疾病恶化或血栓栓塞的研究中耐受性良好。托法替布治疗后血脂谱、动脉硬度、I型IFN基因特征和循环中性粒细胞胞外陷阱得到改善。STAT4风险等位基因患者的实验室参数改善更稳健，这与SLE更严重的临床表型相关。2.乌帕替尼乌帕替尼是由艾伯维研发的一种选择性口服JAK1抑制剂，于2019年8月首次获得FDA，用于治疗多种自身免疫性疾病，包括类风湿性关节炎、银屑病关节炎、特应性皮炎等。去年10月，乌帕替尼单药或者与艾尔布替尼联用（ABBV-599高剂量）显示SLE疾病活动度显著改善并减少发作，并且在48周内耐受性良好。去年12月，ACR Convergence 2024会议上艾伯维公布结果显示，ABBV-599联合治疗组和乌帕替尼单药治疗组的患者疾病活动性降低，并且这种降低在试验的后半部分得以维持，长达104周。在研的靶向TLR 7/8抑制剂TLR7（Toll样受体7）和TLR8是模式识别受体，在自身免疫性疾病（如红斑狼疮）和某些炎症性疾病中，TLR7/8的过度激活可能导致炎症反应失控。因此，开发TLR7/8抑制剂成为治疗红斑狼疮的重要策略，这些抑制剂通过阻断TLR7/8的信号传导，减少炎症反应，降低疾病活动度。目前尚无用于治疗红斑狼疮的靶向TLR7/8抑制剂获批上市，在研的药物有Enpatoran和E6742等。1.EnpatoranEnpatoran是由Merck研发的一种潜在的皮肤型红斑狼疮（CLE）和SLE的同类首创口服疗法，可以选择性地阻断TLR7/8的激活，对其他内体TLR，即TLR3和TLR9没有影响。临床前PK研究表明Enpatoran具有高口服生物利用度，小鼠、大鼠和狗的生物利用度分别为100%、87%和84%。Enpatoran在体外测定中可以有效抑制人TLR7（hTLR7）、小鼠TLR7（m TLR7）和hTLR8，但不抑制mTLR8（图4）。图4 Enpatoran体外抑制结果图片来源：InvivoGen网站近期，Merck宣布了enpatoran的一项2期WILLOW研究（NCT05162586）队列A的积极数据，表明CLE和SLE伴活动性狼疮皮疹患者第16周时疾病活动度具有临床意义的降低，Enpatoran耐受性良好，未发现新的安全性信号。2.E6742E6742是由卫材株式会社（Eisai Co.,Ltd.）研发的一种选择性靶向TLR7/8双拮抗剂，通过抑制TLR7和TLR8的激活，减少促炎细胞因子和自身抗体的产生，用于治疗SLE。E6742的一些临床1/2期试验取得积极结果：E6742具有良好的安全性，耐受性良好，并且能够抑制干扰素基因标志（IGS）反应，在第12周时，E6742 100 mg组BICLA反应率为37.5%（3/8患者），200 mg组为57.1%（4/7患者），而安慰剂组为33.3%（3/9患者）（图5）。这些结果为E6742治疗SLE提供了首个临床证据，并支持进行更大规模、更长期的临床试验。图5 E6742的临床结果图片来源：参考文献12结语红斑狼疮是一种常见的慢性、反复发作的自身免疫性疾病，市场规模也在逐年扩大。目前已有靶向的生物制剂获批上市，尚无靶向的小分子抑制剂获批上市，与生物制剂相比，小分子抑制剂具有可口服等优点。然而用于治疗红斑狼疮的靶向小分子抑制剂研发并不顺利，有多款药物折戟在临床，包括JAK抑制剂Solcitinib、BTK抑制剂Evobrutinib、TLR7/8抑制剂MHV370等，近期，Merck的选择性口服TLR7/8抑制剂2期临床成功给该类药物的研发重拾了信心。参考文献1.Dominik Samotij and Adam Reich,Biologics in the Treatment of Lupus Erythematosus:A Critical Literature Review,Biomed Res Int.2019 Jul 18;2019:81423682.Roger A Levy et.al,10 Years of belimumab experience:What have we learnt?,Lupus.2021 Jul 8;30(11):1705–1721.3.BelimouMab市场规模，竞争市场和预测20324.Saphnelo(anifrolumab)approved in the US for moderate to severe systemic lupus erythematosus5.RemeGen’s Telitacicept Shows Best-in-Class Efficacy in Phase 3 Trial for Generalized Myasthenia Gravis6.R.A.Furie et.al,Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis,The New England Journal of Medicine 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临床3期上市批准ASH会议临床2期siRNA

2025-05-21

·国际糖尿病idiabetes

第2版中国狼疮肾炎诊治和管理指南（2025版）重磅发布，20条推荐意见+24条实践建议尽收眼底

点击“蓝字”关注我们编者按时隔6年，《中国狼疮肾炎诊治和管理指南（2025版）》在2019年第1版中国狼疮肾炎（LN）指南的基础做了如下更新：重点更新了狼疮肾炎的诱导和维持治疗、特殊类型和难治性狼疮肾炎的治疗，增加了狼疮肾炎患者管理及并发症的评估和治疗，共20条推荐意见和24条实践建议，以期为临床医师在治疗决策和疾病管理方面提供指导和参考。一、LN的筛查和评估推荐意见1：所有系统性红斑狼疮（SLE）患者应定期筛查尿液指标[包括尿试纸条法、尿沉渣检查、尿白蛋白/肌酐比值（ACR）、尿蛋白/肌酐比值（uPCR）]及血清肌酐（Scr）和估算肾小球滤过率（eGFR），以早期识别肾脏是否受累；有明确肾脏损伤时推荐肾活检病理检查。（1C）推荐意见2：LN病理类型推荐2018年修订的国际肾脏病学会/肾脏病理学会（ISN/RPS）分型标准（1C）；建议增加狼疮足细胞病和血栓性微血管病两个病理类型，并关注肾小球新月体、足细胞、肾小管-间质和肾血管等特殊病变（2C）。二、LN治疗原则和目标推荐意见3：LN患者免疫抑制治疗方案的选择应根据患者的个体特征、肾脏损伤指标、肾外器官损伤及其严重程度、合并症、药物相关并发症、药物可及性、免疫抑制治疗的反应性、药物基因组学等情况进行个体化选择（1C）。推荐意见4：LN的治疗应遵循从诱导到维持长期、连续治疗的原则；诱导治疗的目标是尽快获得肾脏缓解，力求达到完全肾脏缓解（CRR），并争取实现组织学缓解；获得缓解后应继续维持治疗以保持肾脏持续缓解，预防LN复发，并减少药物相关不良反应（1C）。推荐意见5：治疗期间需要评估SLE的活动性和器官损害，以低疾病活动度（LLDAS）和（或）缓解为最佳目标（1C）。实践建议1：LN需要多学科协作、个体化管理，包括患者教育和医患共同决策，同时考虑患者个人和社会经济成本。三、激素和羟氯喹（HCQ）的应用推荐意见6：激素的使用根据肾脏及肾外器官损伤的类型、活动度、严重程度及合并症等综合评估制定。增生性LN的初始治疗通常在使用推荐疗程甲泼尼龙静脉冲击（250~500 mg/d，连续 1~3 d）后序贯口服低剂量激素方案（2C）。治疗后如患者肾脏和肾外器官损伤指标持续改善，激素应逐渐减量，并在24周时减至5 mg/d以下（2C）；完全肾脏缓解持续12个月以上，在MMF和HCQ或生物制剂维持治疗下可尝试停用激素（2B）。推荐意见7：除非存在禁忌，推荐所有LN患者接受HCQ治疗，最大剂量不超过5 mg/kg/d，同时综合考虑疾病复发和视网膜毒性风险进行个体化用药（1B）；HCQ治疗前及治疗期间定期进行眼科检查，如果出现视网膜病变或视野缺损，即停用HCQ（1C）。四、不同类型LN的免疫抑制治疗1Ⅰ型/Ⅱ型LN实践建议2：Ⅰ型LN建议以SLE肾外表现指导激素和免疫抑制治疗。实践建议3：Ⅱ型LN：表现为非肾病性蛋白尿时，建议以SLE肾外表现指导激素和免疫抑制治疗；表现为肾病综合征或肾病性蛋白尿时，需考虑狼疮足细胞病，并参照狼疮足细胞病治疗（参见特殊类型LN治疗）。2Ⅲ/Ⅳ型（伴或不伴Ⅴ型）LN的诱导治疗推荐意见8：活动性Ⅲ/Ⅳ型（伴或不伴Ⅴ型）LN的诱导治疗推荐选择以下一种免疫抑制方案：（1）激素联合吗替麦考酚酯（MMF）（1B）；（2）激素联合MMF和 Tac（多靶点方案）（1B）；（3）激素联合静脉注射环磷酰胺（IV-CYC）（1B）；（4）激素联合MMF或 IV-CYC和贝利尤单抗（BEL）（1B）。实践建议4：对表现为肾病综合征且肾功能受损不严重（SCr≤3 mg/dl）的患者优先选择多靶点方案。实践建议5：对存在肾功能衰竭进展高风险的患者建议选择IV-CYC，或MMF治疗实践建议6：对免疫学高度活动的Ⅲ/Ⅳ型（伴或不伴Ⅴ型）患者，建议选择MMF联合BEL作为初始诱导方案。实践建议7：对有生育计划的患者，诱导治疗避免使用影响生育能力的免疫抑制剂。3Ⅲ/Ⅳ型，伴或不伴Ⅴ型LN的维持治疗推荐意见9：Ⅲ型/Ⅳ型（伴或不伴Ⅴ型）LN诱导治疗获得肾脏缓解后推荐MMF维持（1B）。推荐意见10：采用MMF联合Tac（多靶点方案），或MMF联合BEL诱导获得缓解者，应继续原方案维持；使用IV-CYC联合BEL方案诱导获得缓解后使用 MMF联合BEL方案维持治疗（1B）。实践建议8：若无法使用MMF，可选择硫唑嘌呤（AZA）、Tac或来氟米特（LFM）维持。图1. 活动性Ⅲ/Ⅳ型（伴或不伴Ⅴ型）狼疮肾炎的诱导治疗流程图4Ⅴ型LN的治疗实践建议9：根据患者基线尿蛋白水平制定Ⅴ型LN患者分层诱导治疗方案：（1）蛋白尿<1.0 g/24 h：建议根据SLE肾外表现，使用激素、HCQ和一般性肾脏保护措施［如肾素血管紧张素醛固酮系统抑制剂（RAASi）、控制血压］，动态观察尿蛋白变化；如治疗过程中肾损伤加重（如尿蛋白增加，或肾功能减退），应启用免疫抑制治疗；（2）蛋白尿 1.0~3.5 g/24 h：建议使用激素联合一种其他免疫抑制剂（MMF、调神经磷酸酶抑制剂[CNIs]、IV-CYC）；（3）蛋白尿>3.5 g/24 h 或表现为肾病综合征：建议优先选择激素联合MMF和Tac（多靶点方案），或初始治疗采用激素联合一种其他免疫抑制剂（如CNIs、MMF、或 IV-CYC）；如治疗反应不理想可切换为多靶点方案，或联合利妥昔单抗（RTX）。实践建议10：Ⅴ型LN可采用MMF、CNIs、MMF+CNIs或AZA维持。五、特殊类型LN的治疗实践建议11：狼疮足细胞病的诱导治疗可考虑单用激素，或激素联合MMF或 Tac；维持方案采用低剂量激素联合MMF或Tac，反复复发者建议联合RTX。推荐意见11：LN伴血栓性微血管病（TMA）提示肾脏预后不良，应根据TMA的病因采用大剂量激素联合血浆置换、RTX，或补体抑制剂（1C）。图2. 狼疮肾炎伴血栓性微血管病的诊疗路径六、LN伴狼疮危象的治疗实践建议12：狼疮危象指SLE活动导致器官功能衰竭或危及生命的疾病状态，需要早期识别，多学科协作紧急处理。推荐意见12：LN伴狼疮危象时，应使用大剂量激素静脉冲击联合IV-CYC、静脉注射免疫球蛋白（IVIG）、血浆置换（PE）/免疫吸附等治疗，并加强器官功能支持和积极对症治疗；难治性病例考虑联合RTX（1C）。七、治疗反应评估及难治性LN的治疗1治疗反应的评估实践建议13：在启动诱导治疗后每个月对LN患者的治疗反应进行评估，达到肾脏缓解后根据患者的个体情况每3~4个月进行一次评估。推荐意见13：对治疗反应不理想的LN患者应分析其可能的原因；对难治性 LN，可选择MMF联合Tac（多靶点方案）、激素联合Tac、CD20单抗等治疗方案（2B）。实践建议14：对难治性LN患者，可考虑细胞治疗（包括CAR-T、间充质干细胞、自体造血干细胞）、靶向浆细胞（如CD38单抗）等治疗，并积极参加新药临床试验。八、LN复发的评估和治疗推荐意见14：LN复发是指肾脏损伤活动性增加并需要加强免疫抑制治疗的一种疾病状态。建议综合考虑患者的基线特征、治疗应答与用药情况，以及生物标志物等多个因素评估LN的复发风险（1B）。实践建议15：LN复发时可以再次使用原初始治疗方案，或推荐的其他一线疗法。对反复复发者，建议使用标准治疗方案联合BEL或其他生物制剂（如RTX）。表1. LN复发的危险因素九、免疫抑制治疗时间实践建议16：LN诱导缓解后应持续治疗至少3年；同时满足以下条件时可考虑逐步停用免疫抑制药物：（1）处于肾脏缓解期（肾功能稳定，uPCR<0.5 g/g）；（2）肾外SLE活动持续静止至少 12 个月；（3）短期内无妊娠计划。对既往有LN复发或者存在复发高风险的患者需要延长维持治疗时间，谨慎停药。十、LN相关CKD（LN-CKD）的管理和治疗实践建议17：在LN患者的全病程中应加强LN-CKD的评估和管理，干预LN-CKD进展的非免疫因素，降低CKD进展和心血管疾病的发生风险。推荐意见15：对LN-CKD患者，建议使用RAASi、钠-葡萄糖协同转运蛋白-2抑制剂（SGLT2i）等（单独或联合使用）抑制CKD进展，保护心肾功能（2B）。图3. 狼疮肾炎的免疫抑制和非免疫抑制治疗路径十一、LN妊娠期的管理推荐意见16：对育龄期女性LN患者，在肾脏缓解至少6个月（尿蛋白定量≤0.5 g/24 h、eGFR≥60 ml/min/1.73 m² )且无疾病活动和其他重要脏器损害并停用妊娠期禁用的药物至足够安全的时间方可考虑妊娠（2C）。推荐意见17：妊娠期可使用的免疫抑制药物包括糖皮质激素、AZA、Tac 和环孢素（CsA）（2D）；若无禁忌或不耐受，推荐妊娠期全程服用HCQ（1C）。推荐意见18：建议LN患者妊娠期使用低剂量阿司匹林预防子痫前期（2C）；对有产科APS的患者推荐低剂量阿司匹林联合肝素预防不良妊娠结局（1B）。实践建议18：妊娠期LN复发者，根据复发严重程度采用不同剂量的非含氟类糖皮质激素治疗，必要时联合其他孕期可用的免疫抑制剂。表2. 妊娠期狼疮肾炎复发和子痫前期的实验室指标比较十二、终末期LN的管理实践建议19：终末期LN（LN-ESKD）患者仍有可能出现肾外狼疮活动，需定期随访，根据临床表现、疾病活动评分及血清学标志物等评估狼疮活动性。实践建议20：尚无确切证据表明一种透析方式优于另一种透析方式，建议根据 LN-ESKD 患者的个体情况选择透析模式。实践建议21：LN-ESKD 患者接受肾移植较其他肾脏替代治疗的长期预后更好，如无禁忌证，建议所有 LN-ESKD 患者列入肾移植候选名单，并在肾外活动停止3~6个月后尽早进行肾移植；如无疾病活动，可进行抢先肾移植。推荐意见19：LN-ESKD 患者移植前应检测抗磷脂抗体谱（aPLs，包括抗心磷脂抗体、抗β2-糖蛋白-1抗体、狼疮抗凝物、抗磷脂酰丝氨酸/凝血酶原抗体等）并评估抗磷脂抗体综合征（APS）。建议使用维生素 K拮抗剂预防APS或aPLs阳性患者移植肾血管血栓形成，并根据肾移植后初期血栓形成/出血风险进行调整（2B）。十三、LN并发症的管理实践建议22：LN患者面临感染高风险，应通过感染筛查［如乙型肝炎病毒（HBV）、结核分枝杆菌感染等］、感染风险评估和疫苗接种（如带状疱疹病毒疫苗、人乳头瘤病毒疫苗、流感病毒疫苗、肺炎球菌疫苗）等措施预防感染；对肺孢子菌肺炎感染高危患者，建议预防性使用甲氧苄啶磺胺甲噁唑。实践建议23：对LN合并 HBV 感染患者，应根据HBV感染状态和免疫抑制方案评估HBV再激活风险，并制定防治策略，包括监测、早期干预治疗或预防性抗病毒。实践建议24：对于LN合并结核患者，若为结核潜伏感染（LTBI），在免疫抑制治疗前或同时进行预防性抗结核治疗（2C）；若结核为活动期，应进行正规抗结核治疗，并根据患者的个体情况兼顾两种疾病的特点再决定激素或免疫抑制剂治疗的时机，同时咨询感染专科医师。推荐意见20：在使用激素治疗期间应补充维生素D和钙剂，定期骨骼健康管理，检查 X线、MRI或同位素骨密度等，尽早发现股骨头坏死、骨质疏松等骨骼并发症（1B）；可使用双膦酸盐或地舒单抗治疗激素相关骨质疏松（2C）推荐意见21：建议定期筛查肿瘤（1B）；对女性患者（已婚或有性生活史）每年进行 1~2 次宫颈细胞学检查，以筛查宫颈癌（2B）。中国狼疮肾炎诊治和管理指南工作组, 国家肾脏疾病临床医学研究中心. 中国狼疮肾炎诊治和管理指南（2025 版）[J]. 中华医学杂志 , 2025, 105(22): 11-47. DOI: 10.3760/cma. j.cn112137-20250327-00748.声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《肾医线》编辑部）

临床研究临床结果

2025-05-08

·PRNewswire

LUPKYNIS Strengthens Market Position as Demand for Lupus Nephritis Treatment Grows | DelveInsight

As a novel calcineurin inhibitor with proven efficacy in improving renal outcomes, LUPKYNIS addresses a high unmet medical need. With increasing awareness, supportive guidelines, and potential global expansion, it is well-positioned for steady market growth. LAS VEGAS, May 8, 2025 /PRNewswire/ -- DelveInsight's " LUPKYNIS Market Size, Forecast, and Market Insight Report" highlights the details around LUPKYNIS, the first oral lupus nephritis-specific treatment, which has expanded the therapeutic arsenal. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of LUPKYNIS. The report also highlights the historical and forecasted sales from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Aurinia Pharmaceuticals/Otsuka Pharmaceutical's LUPKYNIS (voclosporin) Overview LUPKYNIS (voclosporin) is an oral immunosuppressant classified as a calcineurin inhibitor (CNI), shown to improve both short- and long-term outcomes in adult patients with active lupus nephritis when used alongside standard immunosuppressive therapies. By targeting calcineurin, LUPKYNIS helps suppress cytokine activity, inhibits interleukin-2 (IL-2) production, and reduces T-cell driven immune responses. Although the exact mechanism by which voclosporin inhibits calcineurin is not fully understood, it is known that lymphocyte activation increases intracellular calcium, which binds to calcineurin's regulatory site. This activates the calmodulin-binding catalytic subunit, leading to dephosphorylation and activation of the transcription factor NFATc (nuclear factor of activated T-cells, cytoplasmic). The drug's immunosuppressive effect results in decreased lymphocyte proliferation, reduced cytokine production, and lower expression of T-cell activation markers. The recommended initial dose of LUPKYNIS is 23.7 mg twice daily. It should be used in conjunction with mycophenolate mofetil (MMF) and corticosteroids. Learn more about LUPKYNIS projected market size for lupus nephritis @ LUPKYNIS Market Potential Lupus nephritis is a serious and potentially life-threatening complication of systemic lupus erythematosus (SLE), affecting 40–60% of those diagnosed with the disease. It is typically characterized by symptoms such as hematuria (blood in the urine) and proteinuria (protein in the urine). This condition is more prevalent in women, particularly between the ages of 20 and 40. In 2023, the United States recorded the highest number of lupus nephritis cases among the 7MM, with approximately 211K cases, a figure projected to grow by 2034. Treatment strategies for lupus nephritis depend on the kidney biopsy classification of the disease. Standard therapy often includes corticosteroids in combination with immunosuppressive drugs like cyclophosphamide, mycophenolate mofetil, azathioprine, and calcineurin inhibitors. Rituximab, a monoclonal antibody, is widely used, especially for patients with relapsing or treatment-resistant LN, due to its ability to reduce reliance on steroids. Currently, there are only two FDA-approved medications for lupus nephritis: BENLYSTA (belimumab), available as an intravenous or subcutaneous formulation, and LUPKYNIS (voclosporin), a novel oral calcineurin inhibitor. Leading pharmaceutical companies such as Novartis, AstraZeneca, Roche, and Kezar Life Sciences, among others, are actively developing innovative therapies that could redefine the treatment paradigm for lupus nephritis. The treatment landscape is rapidly evolving, shifting away from broad immunosuppression toward more precise, targeted approaches. Recent drug approvals and a strong pipeline of candidates highlight both advancements and the ongoing challenges in creating treatments that are effective, safe, and long-lasting. Emerging therapies ranging from anti-CD20 antibodies and complement inhibitors to interferon-blocking agents and CAR-T cell therapies hold promise but must address key issues such as safety, sustained efficacy, and accessibility. As our understanding of the disease's underlying mechanisms continues to grow, the future of lupus nephritis treatment is expected to become increasingly personalized, offering renewed hope to patients battling this complex disorder. Discover more about the lupus nephritis market in detail @ Lupus Nephritis Market Report Emerging Competitors of LUPKYNIS The developing pipeline for lupus nephritis treatments shows a growing variety of approaches. Multiple candidates, both in early and late stages of development, are underway, including ianalumab (VAY736) (Novartis), GAZYVA (obinutuzumab) (Roche), SAPHNELO (anifrolumab) (AstraZeneca), FABHALTA (iptacopan) (Novartis), ULTOMIRIS (ravulizumab) (AstraZeneca), as well as advanced cellular therapies like CABA-201 (Cabaletta Bio) and YTB323 (Novartis). In March 2025, the FDA accepted a supplemental Biologics License Application based on data from the Phase III REGENCY trial, where obinutuzumab demonstrated a 46.4% Complete Renal Response (CRR), compared to 33.1% for placebo. Unlike previous anti-CD20 therapies such as rituximab, it provides enhanced B-cell depletion and is the first in its class to show efficacy in a randomized Phase III lupus nephritis trial. If approved, it will become the first CD20-targeted treatment specifically indicated for lupus nephritis, with anticipated sales of USD 400 million by 2034. To know more about the number of competing drugs in development, visit @ LUPKYNIS Market Positioning Compared to Other Drugs Key Milestones of LUPKYNIS In September 2024, Japan's Ministry of Health approved it for Lupus Nephritis treatment alongside mycophenolate mofetil. In September 2022, the European Commission approved LUPKYNIS for active Class III, IV, or V Lupus Nephritis. In January 2021, Aurinia Pharmaceuticals received US FDA approval for LUPKYNIS to treat adult lupus nephritis patients in combination with immunosuppressive therapy. Discover how LUPKYNIS is shaping the lupus nephritis treatment landscape @ LUPKYNIS Lupus LUPKYNIS Market Dynamics LUPKYNIS, developed by Aurinia Pharmaceuticals, is the first FDA-approved oral therapy specifically indicated for active lupus nephritis, a serious manifestation of systemic lupus erythematosus. Approved in January 2021 in the US, LUPKYNIS entered a previously underserved market where treatment was largely dependent on off-label use of immunosuppressants like mycophenolate mofetil and corticosteroids. The drug represents a significant advancement in lupus nephritis care, offering both improved efficacy and a better safety profile compared to existing options, especially in reducing proteinuria and preserving kidney function. The market dynamics for LUPKYNIS are shaped by several key factors. On the positive side, there is a strong unmet medical need, a growing prevalence of lupus nephritis, and increasing physician awareness about early diagnosis and intervention. Moreover, LUPKYNIS benefits from a relatively high pricing strategy, supported by its novel mechanism and disease-modifying potential. Aurinia has also built a dedicated commercial infrastructure and patient support programs to drive uptake and adherence. However, LUPKYNIS faces competitive and reimbursement challenges. One of the main competitors is BENLYSTA (belimumab) from GSK, which gained FDA approval for lupus nephritis in December 2020, just a month before LUPKYNIS. Benlysta has the advantage of brand recognition and a longer track record in treating systemic lupus. Additionally, payers have shown some hesitancy in approving LUPKYNIS due to its cost, requiring extensive prior authorizations and documentation of clinical need. Patient compliance also remains an issue, given the need for frequent monitoring of kidney function and drug levels. Looking ahead, the market potential for LUPKYNIS will depend on its ability to expand its label, demonstrate long-term real-world effectiveness, and potentially enter international markets. Aurinia is also exploring lifecycle management strategies, including combination therapies and expanded indications. Partnerships or acquisitions could further boost market access and penetration. Overall, while LUPKYNIS is a pioneering therapy with strong clinical value, its commercial success will be defined by navigating payer landscapes, physician adoption, and sustained differentiation from competing therapies. Dive deeper to get more insight into LUPKYNIS's strengths & weaknesses relative to competitors @ LUPKYNIS Market Drug Report Table of Contents Related Reports Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including Hoffmann-La Roche, Chugai Pharmaceutical, Novartis Pharmaceuticals, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Hoffmann-La Roche, Qilu Pharmaceutical, Vera Therapeutics, Kyverna Therapeutics, Cabaletta Bio, Takeda, Nkarta Therapeutics, Annexon, Century Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, Inflection Biosciences, among others. Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床3期临床结果免疫疗法

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 (Ireland) Ltd.	2011-07-13
狼疮性肾炎	冰岛	GlaxoSmithKline (Ireland) Ltd.	2011-07-13
狼疮性肾炎	列支敦士登	GlaxoSmithKline (Ireland) Ltd.	2011-07-13
狼疮性肾炎	挪威	GlaxoSmithKline (Ireland) 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	美国	GSK Plc	2024-12-12
支气管疾病	临床3期	阿根廷	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
结缔组织病	临床3期	巴西	GSK Plc	2024-09-11
结缔组织病	临床3期	加拿大	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


EULAR2024	N/A	系统性红斑狼疮 BAFF cytokine	1,137	Belimumab	醖鏇選醖鬱獵糧壓觸齋(憲獵壓網醖醖製襯構窪) = 築願獵艱顧淵鹽選簾淵壓淵醖膚構壓觸築憲鏇 (艱獵鏇築製遞積顧膚製 ) 更多	积极	2024-06-05
				Belimumab (Standard of Care)	醖鏇選醖鬱獵糧壓觸齋(憲獵壓網醖醖製襯構窪) = 餘鹹選願築鹹壓遞簾選壓淵醖膚構壓觸築憲鏇 (艱獵鏇築製遞積顧膚製 ) 更多
EULAR2024	N/A	红斑狼疮	-	Belimumab	築積繭鏇蓋鏇窪製壓醖(淵築製鑰觸艱艱範鏇鬱) = 鑰廠願齋鹽夢遞遞鹹範醖壓蓋淵鑰構憲鑰顧壓 (構齋齋壓鬱餘網築齋遞 )	积极	2024-06-05
EULAR2024	N/A	怀孕	17	Belimumab	願繭選構選遞衊製鑰範(鹹襯獵鑰遞膚廠築鹽衊) = 夢衊遞襯製鏇積糧鑰鏇淵構願襯觸膚衊範獵觸 (獵顧繭構餘鬱艱築夢網 ) 更多	积极	2024-06-05
				Non-Belimumab	簾築鑰壓繭廠齋構齋鹹(鑰膚醖繭膚襯觸廠範簾) = 觸蓋淵範網繭鑰顧憲夢遞壓鹹鑰願鏇選艱願廠 (製製窪鹽憲夢襯壓鹹艱 ) 更多
EULAR2024	临床3期	系统性红斑狼疮 baseline SLE disease duration \| baseline Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score \| baseline immunosuppressant (IS) use	3,086	Belimumab	網積夢獵衊顧觸範衊積(膚衊蓋繭獵蓋構範蓋淵): OR = 1.7 (95% CI, 1.46 ~ 1.98), P-Value = <0.0001	积极	2024-06-05
				Placebo
EULAR2024	N/A	系统性红斑狼疮	-	Belimumab	糧遞鹽觸築網淵夢願鏇(糧獵願網憲獵獵餘餘積): HR = 0.72 (95% CI, 0.62 ~ 0.83), P-Value = <0.0001 更多	-	2024-06-05
				Placebo
EULAR2024	N/A	系统性红斑狼疮维持 anti-ds DNA \| RNP \| Sm ... 更多	69	Belimumab (BE)	觸範齋襯壓鬱網製餘鑰(遞鑰觸構製構淵艱積淵) = 襯積膚繭築觸艱鬱夢鏇憲鑰蓋網鹽鏇選製鑰糧 (顧壓壓範鏇積鹹願觸網 ) 更多	积极	2024-06-05
EULAR2024	N/A	狼疮性肾炎 \| 系统性红斑狼疮	106	Subcutaneous Belimumab	憲壓簾憲蓋範獵夢製遞(願憲鑰鬱鏇鑰襯鏇蓋顧) = PSL reduction ≥5 mg was achievable in active disease and positive C1q-binding immune complex 鏇鏇壓蓋鹽簾範積壓窪 (願糧鏇鹽壓襯鬱糧顧遞 ) 更多	积极	2024-06-05
EULAR2024	N/A	红斑狼疮	-	Belimumab	膚簾衊廠齋廠糧淵鬱艱(積齋選顧膚窪積繭齋簾) = 鏇廠衊廠襯鏇艱膚膚鏇齋淵築蓋糧構選鑰衊願 (襯淵餘網選憲鑰淵鬱獵, 6.3)	-	2024-06-05
				Control (no belimumab exposure)	膚簾衊廠齋廠糧淵鬱艱(積齋選顧膚窪積繭齋簾) = 鹹膚顧範範鑰鏇鹽淵衊齋淵築蓋糧構選鑰衊願 (襯淵餘網選憲鑰淵鬱獵, 6.5)
EULAR2024	N/A	-	54	Belimumab	觸餘鹹窪構醖鹹願襯廠(範範範壓鏇衊膚構憲壓) = 憲遞壓齋衊願積糧築淵願餘選廠範壓簾壓淵膚 (願蓋醖遞觸蓋壓艱簾鏇 ) 更多	积极	2024-06-05
NCT04179032 (CTgov)	临床2期	系统性红斑狼疮	25	Belimumab	餘醖廠廠範憲蓋製願獵(鏇夢築製膚積觸鹽齋築) = 壓鏇憲醖簾夢醖鬱壓網糧繭衊艱艱窪艱顧選選 (遞鹹鏇齋簾夢鏇遞糧衊, 壓簾醖鏇齋膚醖積觸餘 ~ 廠齋簾餘顧膚遞獵淵鏇) 更多	-	2024-03-26