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2024-12-04

申办/合作机构

GSK Plc

[+1]

CTR20243677 / Recruiting临床3期

一项在结缔组织病（CTD）相关间质性肺疾病（ILD）成人患者中评价贝利尤单抗皮下给药的有效性和安全性的III期、随机、双盲、安慰剂对照、平行组研究

主要目的：评价贝利尤单抗+标准治疗与安慰剂+标准治疗相比在减缓CTD-ILD受试者肺容量下降方面的有效性。关键次要目的：评价贝利尤单抗+标准治疗与安慰剂+标准治疗相比在减缓CTD-ILD受试者肺容量下降%预测值方面的有效性。评价贝利尤单抗+标准治疗与安慰剂+标准治疗相比在减缓CTD-ILD受试者ILD进展方面的有效性。评价贝利尤单抗+标准治疗与安慰剂+标准治疗相比对CTD-ILD受试者疲劳的作用。评价贝利尤单抗+标准治疗与安慰剂+标准治疗相比在减轻CTD-ILD受试者症状严重程度方面的作用

开始日期2024-11-18

申办/合作机构

GlaxoSmithKline (Ireland) Ltd.

[+2]

NCT06576271 / Recruiting临床1期

A Phase 1, First-time-in-human, Three-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK4527363 in Healthy Participants (Part A), Participants With Active Systemic Lupus Erythematosus (Part B), and Healthy Participants of Chinese and Japanese Descent (Part C)

This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of GSK4527363 in healthy participants (Part A), participants with active SLE (Part B), and healthy participants of Chinese and Japanese descent (Part C).

开始日期2024-09-02

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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1,163

项与贝利尤单抗相关的文献（医药）

2025-04-01·IMMUNOLOGY LETTERS

Early decrease of T-bet+ B cells during subcutaneous belimumab predicts response to therapy in systemic lupus erythematosus patients

Article

作者: Sciannamea, Maddalena ; Basile, Umberto ; Stefanini, Lucia ; Olivieri, Giulio ; La Gualana, Francesca ; Picciariello, Licia ; Conti, Fabrizio ; Casato, Milvia ; Gragnani, Laura ; Visentini, Marcella ; Basili, Stefania ; Petriti, Begi ; Ceccarelli, Fulvia ; Spinelli, Francesca Romana ; Natalucci, Francesco

Systemic lupus erythematosus (SLE) is characterized by B cell dysregulation and expansion of atypical B cells that may correlate with disease manifestations and activity. This study investigated the impact of subcutaneous (sc) Belimumab (BLM) on the peripheral B cell compartment and on the functional properties of CD21^low, T-bet⁺ and CD11c⁺ atypical B cells, in 21 active SLE patients over a 12-month period. At baseline, active SLE patients displayed reduced unswitched IgM memory B cells and expansion of atypical B cells, compared to healthy donors and to SLE patients in remission. sc BLM therapy promptly restored B cell homeostasis with a reduction of T-bet⁺ B cells, observed early in patients responsive to therapy. These findings highlight the pathogenic role of T-bet⁺ B cells in SLE disease and suggest their potential utility as biomarker of clinical response.

2025-01-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Type I interferon-stimulated genes predict clinical response to belimumab in systemic lupus erythematosus

Article

作者: Mo, Lingfei ; Zhu, Li ; Luo, Jing ; Wang, Yanhua ; He, Lan ; Hu, Nan ; Du, Xinru ; Ju, Bomiao ; Liu, Xinyi ; Tian, Juan ; Li, Hanchao ; Li, Qian ; Zhang, Jing

The type I interferon (IFN-I) response is crucial in systemic lupus erythematosus (SLE). The mRNA level of interferon-stimulated genes (ISGs) is widely used for evaluating the activity of IFN in SLE. However, the character of ISGs in belimumab-treated SLE patients has not be reported. In this study, we enrolled 53 SLE patients undergoing belimumab treatment and assessed their clinical responses at 3, 6, and 12 months. The expression levels of 25 ISGs in Peripheral blood mononuclear cells (PBMCs) were quantified at baseline and at 3 months using quantitative real-time PCR. Using Least absolute shrinkage and selection operator (LASSO)-logistic regression, five genes (CXCL10, EPSTI1, HECR6, IFI27, IFIH1) were identified to predict belimumab efficacy. The IFN signature score, a multivariate logistic regression model based on the change rates of these genes, positively predicted the SLE responder index (SRI) at 12 months, with an area under curve of 0.940 in receiver operating characteristic and favorable outcomes in decision curve analysis. Patients with an IFN signature score ≥0 had higher SRI response rates, better clinical markers (including SLE disease activity index 2000 scores, anti-dsDNA, IgG levels, daily doses of prednisone, and higher complement C3 and C4 levels), and faster B cell decline than those with scores <0. In conclusion, after 3 months of belimumab treatment, the expression levels of IFN-I-inducible genes varied, and the IFN signature score reliably forecasted the SRI response at 6 and 12 months.

2024-12-31·RENAL FAILURE

Effectiveness and safety of B cell-targeting biologics in the treatment of lupus nephritis: a systematic review and network meta‑analysis

Review

作者: Yang, Si-Qi ; Wang, Yao-Guang ; Zhao, Xi ; Li, Man

OBJECTIVES:

To evaluate the effectiveness and safety of different B cell-targeting biological agents combining with standard of care in patients with lupus nephritis (LN).

METHODS:

Comprehensive literature searches were conducted using PubMed, Embase, Web of Science, and Central in the Cochran Library, spanning from inception to May 20th, 2024. Randomized control trials (RCTs) comparing rituximab (RTX), belimumab, ocrelizumab, obinutuzumab, and anifrolumab in LN were selected. The primary outcomes of interest were related to complete renal remission (CRR), and partial renal remission (PRR). Additionally, we delved into safety outcomes, examining the occurrence of serious adverse events (SAEs), infections, and the discontinuation rates due to adverse events.

RESULTS:

A total of 6 RCTs with 1150 patients applying various B cell-targeting biological agents were included. Notably, ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that obinutuzumab (SUCRA 85.2%) has the highest potential superiority in improving CRR, followed by belimumab, ocrelizumab. Regarding the improvement in PRR, obinutuzumab (SUCRA 83.0%) has the highest potential superiority. In terms of safety, with a focus on SAEs, infections, and the discontinuation rates due to adverse events, the results were: SUCRA-based ranking indicated that RTX (SUCRA 74.1%) had the highest probability of postponing SAEs, followed by belimumab and obinutuzumab. Concerning infection reduction, anifrolumab (SUCRA 78.7%) had the highest potential superiority. Safety events monitoring infection occurred better with RTX than with standard therapy (OR = 3.57, 95% CI 1.02, 12.66) and were statistically different. For the discontinuation rates due to adverse events, RTX (SUCRA 88.6%) demonstrated the highest potential superiority.

CONCLUSIONS:

Concerning the effectiveness and safety outcomes, obinutuzumab, belimumab, and RTX plus standard of care may be superior to the current standard therapy as treatments for LN. This study protocol has been registered with PROSPERO, with a registration number of CRD42024548522.

176

项与贝利尤单抗相关的新闻（医药）

2024-12-12

·药精通Bio

自免疾病: 系统性红斑狼疮 (SLE) 的靶向治疗进展

系统性红斑狼疮（SLE，Systemic lupus erythematosus）通常称为狼疮，是一种累及多系统的系统性自身免疫性疾病，具有显著的发病率和死亡率。系统性红斑狼疮患者经常会经历疾病发作和缓解的交替时期。SLE 的表现多种多样，从皮疹和关节炎到贫血和血小板减少，再到浆膜炎、肾炎、癫痫发作和精神病。据估计，大约 90% 的 SLE 患者是女性，大多数病例年龄在 15 至 44 岁之间。SLE 女性怀孕被认为是高风险，与一般人群相比，孕产妇和新生儿的发病率和死亡率较高。近年来，精细免疫表型、全基因组关联研究（GWAS）、单细胞测序、多组学分析和基因编辑的进展显着增强了对SLE发病机制的理解。这些技术突破还推动了针对免疫细胞、共刺激分子、细胞因子和信号转导途径的疗法的开发和临床研究，包括单克隆抗体、小分子药物和嵌合抗原受体（CAR-）T细胞免疫疗法。贝利木单抗（Belimumab）和阿尼鲁单抗（Anifrolumab）等治疗方法的批准为临床医生、研究人员和患者提供了更大的信心和更多的选择来治疗中度至重度系统性红斑狼疮，特别是难治性病例。１.　FDA 已批准 SLE 靶向治疗Belimumab（Benlysta） Belimumab（Benlysta）由 GSK 开发，是第一个 B 淋巴细胞刺激剂（BlyS）的靶向抑制剂。通过与 BlyS 结合，Belimumab 抑制 B 细胞（包括自身反应性 B 细胞）的存活，并减少其分化为负责产生免疫球蛋白的浆细胞，尽管它不直接与 B 细胞结合。贝利木单抗最初于 2011 年 3 月获得 FDA 批准用于治疗 SLE，是首个 SLE 靶向疗法，贝利木单抗于 2020 年 12 月获得扩大批准用于治疗狼疮性肾炎。它通常与羟氯喹（Plaquenil）和吗替麦考酚酯（CellCept）等其他药物联合使用，以增强治疗效果。Anifrolumab（Saphnelo） Saphnelo（anifrolumab）是一种全人源单克隆抗体，可与 I 型 IFN 受体的亚基 1 结合，有效阻断 I 型 IFN 的活性。I 型 IFN，例如 IFN-α、IFN-β 和 IFN-κ，是参与调节 SLE 相关炎症途径的细胞因子。在大多数成年 SLE 患者中观察到 I 型 IFN 信号传导活性增加，并且与疾病严重程度相关。作为“首创新药”I 型 IFN 受体拮抗剂，Saphnelo 代表了 SLE 治疗的重大进步。2021年8月2日，美国FDA批准Saphnelo用于治疗中重度SLE。２.　治疗 SLE 的靶向疗法正在开发中表 1. 治疗系统性红斑狼疮的靶向疗法聚乙二醇化抗体 - Dapirolizumab Dapirolizumab pegol 是一种新型研究中人源化无 Fc聚乙二醇 (PEG) 缀合的抗原结合 (Fab') 片段。它抑制 CD40L 信号传导，已被证明可以减少 B 细胞活化和自身抗体产生，减轻 IFN-I 分泌，并减弱 T 细胞和抗原呈递细胞 (APC) 活化。 2024 年 9 月 24 日，UCB 和 Biogen 联合宣布 III 期 PHOENYCS GO 研究评估 dapirolizumab pegol 治疗 SLE 的效果积极。 PHOENYCS GO 是一项多中心、随机、双盲、安慰剂对照、平行的 III 期试验，旨在评估dapirolizumab联合标准护理 (SOC) 疗法与安慰剂加 SOC 疗法在患有以下疾病的患者中的疗效和安全性，包括中度至重度系统性红斑狼疮，共有 321 名患者参与了该研究。分析显示，dapirolizumab pegol 与 SOC 相结合，达到了其主要终点。BICLA方法评估中，第 48 周时，与安慰剂加 SOC 相比，患者的中度至重度疾病活动度显著改善。BICLA 是一个既定的复合终点，用于通过患者病史、临床检查和实验室测试评估临床疾病活动性。此外，评估疾病活动和耀斑的关键次要终点显示出具有临床意义的改善。 dapirolizumab pegol 的安全性与之前的研究一致，并且与接受免疫调节治疗的 SLE 患者的预期安全结果一致。Litifilimab（利替非利单抗） Litifilimab (BIIB059) 由 Biogen 开发，是一种靶向 BDCA2 的全人源化 IgG1 mAb。通过抑制 BDCA2，它可以减少炎症细胞因子（包括 IFN-I）的产生，在调节 SLE 的病理机制中发挥着至关重要的作用。Litifilimab　是目前最先进的BDCA2靶向疗法，已进入治疗皮肤红斑狼疮（CLE）和SLE的III期临床试验。图 1. Litifilimab 的作用机制在一项涉及 SLE 参与者的 2 期试验中，在 24 周内，与安慰剂相比，litifilimab 与基线相比，肿胀和压痛关节的数量有更大程度的减少。需要更长时间和更大规模的试验来确定Litifilimab治疗 SLE 的安全性和有效性。JAK 抑制剂 - Upadacitinib Upadacitinib 是一种选择性、可逆性 JAK 抑制剂，正在研究用于治疗各种严重的免疫介导的炎症性疾病。在细胞和酶活性测定中，与 JAK2、JAK3 和 TYK2 相比，upadacitinib 对 JAK1 显示出特异的强的抑制作用。该药物已被批准用于治疗成人中度至重度类风湿性关节炎、银屑病关节炎、溃疡性结肠炎和强直性脊柱炎。 2023 年，艾伯维宣布了 upadacitinib 的 2 期临床试验取得积极结果，该试验可作为单一疗法或联合使用（elsubrutinib 60 mg 和 upadacitinib 30 mg），用于治疗继续接受标准狼疮治疗的中度至重度 SLE 成人的疗法。基于这些结果，艾伯维表示将推进upadacitinib进入SLE治疗的3期临床试验。S1P1 调节剂 - Cenerimod Cenerimod 是一种潜在的“FIC”、高选择性 S1P1 受体调节剂。这种每日一次的口服片剂正在开发用于治疗系统性红斑狼疮。2022 年 12 月，Idorsia 启动了 OPUS 项目，该项目由两项多中心、随机、双盲、安慰剂对照 3 期试验组成，旨在评估 cenerimod 与中重度 SLE 成人患者的疗效、安全性和耐受性。Cenerimod 已获得美国 FDA 授予的治疗 SLE 的快速通道资格。在 II 期临床试验中，测试的最高剂量为 4 mg，六个月后，与安慰剂相比，治疗组在主要终点（mSLEDAI-2K 评分）上显示出数值改善。然而，除了 4 mg 剂量（p＝ 0.029）外，其他组中没有观察到显着差异。此外，在第 52 周时，所有试验组的 mSLEDAI-2K 和 SRI-4 评分均未发现显著差异。细胞治疗 - KYV-101 KYV-101 是一种新型全人源抗 CD19 嵌合抗原受体 (CAR) T 细胞疗法，旨在用于 B 细胞驱动的自身免疫性疾病。它专门靶向 CD19，这是一种在 B 细胞表面表达的蛋白质。B 细胞除了与许多类型的恶性肿瘤有关，也与自身免疫性疾病相关。 References: [1] Dapirolizumab Pegol Phase 3 Data Presented at the American College of Rheumatology Shows Significant Reduction in Systemic Lupus Erythematosus Disease Activity .[2] Trial of Anti-BDCA2 Antibody Litifilimab for Systemic Lupus Erythematosus,10.1056/NEJMoa2118025 [3]Phase 2 Study of Upadacitinib (RINVOQ®) Alone or as a Combination Therapy Meets Primary and Key Secondary Endpoints in Patients with Systemic Lupus Erythematosus [4] Encouraging Phase 2 data on cenerimod – Idorsia's S1P1 receptor modulator currently investigated for SLE – presented at ACR 2019 END 免责声明：本文仅作知识交流与分享及科普目的，不涉及商业宣传，不作为相关医疗指导或用药建议。文章如有侵权请联系删除。 OTC2024类器官前沿应用与3D细胞培养论坛圆满落幕，点击图片可查看会后报告，咨询OTC2025类器官论坛请联系：王晨 180 1628 8769

免疫疗法细胞疗法临床研究临床结果

2024-12-10

·空之客

从云顶新耀EVER001公布数据看膜性肾病治疗前景

12月4日，云顶新耀公布了新一代共价可逆的BTK抑制剂EVER001（XNW1011）治疗原发膜性肾病的1b/2a期临床试验阶段性数据。在两个队列中，24-36周的CR+PR比例达到80%以上、ICR达到90%以上，且不良反应多为G1/2、也没有BTK典型的血液毒性等。 https://ir-api.eqs.com/media/document/293b0a39-7df8-4e9c-aad7-90f692260ba5/assets/EVER001%20pMN%20data%20release%20presentation_EN%20vF.pdf?disposition=inline 这既是云顶新耀在肾病领域重要资产的里程碑，也是膜性肾病这一临床需求高度未满足适应症的重要治疗进展，我们不妨借此机会审视一下这个蓝海适应症的空间，以及EVER001此次临床结果处于何等位置。 1 膜性肾病概述膜性肾病（membranous nephropathy，MN）是一种自身免疫性的肾小球疾病，是成人肾病综合征最常见的原因，全球发病率8-10/百万人，其中约75%是原发性膜性肾病（pMN），中国和美欧日分别有约200万和20万患者，已经属于相当大的患者群体（作为对比，中国类风关患者人数也就500万左右）。近年来在MN机制研究方面最大的进展要数确认了磷脂酶A2受体（phospholipase A2 receptor，PLA2R）作为关键自身抗原，其与HLA之间的相互作用有助于MN进展，特别是强调了B细胞在发病机制中的关键作用，这都从组织学和病理学角度加深了对疾病的理解。 doi: 10.1002/mco2.614 目前认为MN有通过B细胞和抗原递呈细胞两种不同的自身免疫途径，MHC II将PLA2R片段递呈给CD4+ T细胞，从而导致B细胞的活化、扩增及anti-PLA2R抗体产生。 MN是一种慢性进行性肾病，通常起病隐匿、早期无症状或仅伴有轻微肢体水肿，多数成年患者的临床症状表现为肾病综合征，包括蛋白尿（>3.5 g/d）、水肿、低血清白蛋白（<30 g/L）和高脂血症，部分伴有并发高血压（与MN的严重程度有关）。经皮肾脏活检是诊断的金标准，此外对PLA2R等自身抗体的血清学监测也是可选的辅助诊断手段。 2 现有治疗方案目前全球还没有获批MN的药物（下述药物的应用都是超适应症），KDIGO等指南的首选建议都还是缓解蛋白尿、水肿和高血压等临床症状的保守支持治疗方案，包括ACEI、ARB、利尿剂、他汀等。对于支持治疗未能缓解或疾病进展风险高的患者，采取免疫抑制剂以及联合治疗，包括传统的环磷酰胺、泼尼松及其他皮质激素，以及新型的免疫抑制剂如钙调磷酸酶抑制剂（环孢素和他克莫司）以及CD20单抗（利妥昔单抗等）。对于这几种目前常用的免疫抑制剂，Rituximab凭借较高的响应率和较好的安全性依从度已经基本上成为首选，钙调磷酸酶抑制剂有一定有效性但复发率偏高，环磷酰胺+激素方案的有效性没问题但存在致癌等风险，总之现有治疗方案都还只是权宜之计，远未满足临床需求。 3 代表产品和在研管线正是由于上述较大的患者群体和有限的治疗方案，为新一代MN的药物开发留下相当广阔的空间，围绕着MN进展过程中的抗原递呈、T细胞和B细胞激活等环节，CD20、CD38、BTK、BAFF、补体等通路靶点都已经在研发当中，我们将近期已经披露临床数据的产品和管线进行对比。 1）BTK抑制剂首先细看一下以EVER001为代表的最具潜力的BTK抑制剂。 BTK抑制剂靶向于B细胞信号通路，主要功能是抑制B细胞的成熟和增殖，并防止其分化为产生自身抗体的浆细胞，且对其他多种免疫具有广泛调节作用，这与CD20单抗B细胞清除疗法不同。 BTK抑制剂此前在自身免疫领域有过一些尝试但还并不算成功。作为新一代BTK抑制剂，EVER001最鲜明的特征是共价可逆以及高选择性，有望在高活性的同时大幅降低脱靶带来的毒性，这也是EVER001的安全性良好、特别是没有出现其他BTK常见毒性的核心原因。 EVER001本次公布的1b/2a期临床研究（NCT05800873），分成两个队列，剂量分别是100mg QD-BID和200mg BID，基线PLA2R自身抗体滴度为85.4RU/mL、血清白蛋白3.1g/dL，与其他研究相比基线并不算严重。在最重要的蛋白尿改善指标上，低剂量组在第36周较基线下降78.3%，在11例受试者中达到2 CR + 7 PR，且此后在随访期内蛋白尿并无反弹；高剂量组在第24周较基线下降73.8%，在7例受试者中达到6 PR。这与其他产品和管线相比，尤其是高剂量组处于明显领先的地位，例如现有一线推荐方案Rituximab在6个月和12个月的CR+PR为35%和60%、都远低于EVER001两个剂量组在28周以后的缓解率水平，即使是二代CD20单抗Obinutuzumab在6个月和12个月的CR+PR提升到了75%和90%、也低于EVER001高剂量组的蛋白尿缓解速度，其他CaN、CD38和BAFF等机制则有效性更低。在降低anti-PLA2R自身抗体指标上，低剂量组在第28周较基线下降90%以上，在11例受试者中ICR高达10例；高剂量组在第24周较基线也下降90%以上，7例受试者全部达到ICR。EVER001对anti-PLA2R的降低速度也有显著优势，特别是ICR在16周就突破50%，与Obinutuzumab的速度相当，而快于Rituximab以及CaN、BAFF等机制药物。对于需要长期用药的自身免疫疾病，安全性的重要性更加凸显，EVER001的TRAE发生率58%且多为1/2级和短暂性的，而Rituximab的AE发生率普遍在70%以上。此外，并没有出现BTK常见的毒性，须知包括Sanofi、Roche、诺诚健华等各家BTK抑制剂在自免领域的应用都受困于毒性问题。综上，从有效性和安全性两个角度来看，EVER001都具有显著的临床优势。 2） CD20单抗与多数用于治疗其他自免疾病的B细胞清除思路类似，CD20单抗可以在关键阶段诱导CD20+ B细胞的死亡，阻止向记忆B细胞和浆细胞的进展，从而减少自身抗体的产生。已经被广泛使用的Rituximab，以其最主要的MENTOR研究为例（NCT01180036），在6个月和12个月的蛋白尿CR+PR比例仅仅为35%和60%，难以令人满意，提升空间较大；它相对环孢素要安全一些，AE发生率71%，但三级以上AE和SAE发生率为17%。 https://www.nejm.org/doi/10.1056/NEJMoa1814427 Roche二代产品Obinutuzumab优于Rituximab，6个月和12个月的蛋白尿CR+PR比例为75%和90%，3级以上不良反应发生率也进一步降低。 doi: 10.1093/ndt/gfae230/7821258 天广实的另一款CD20单抗MIL62也在1/2期临床（NCT05398653），展现出与Obinutuzumab相近的有效性。 3） BAFF单抗 GSK的Belimumab公布了二期REBOOT研究结果（NCT03949855），在联用Rituximab的情况下似乎并没有比Rituximab单药带来多少额外获益，6个月和12个月的蛋白尿CR+PR比例分别为23%和67%。 https://www.asn-online.org/education/kidneyweek/2024/program-abstract.aspx?controlId=4117696 4） CD38单抗 CD38单抗主要作用于浆细胞，，能有效减少自身抗体的产生，特别是对于复发或难治患者。 Biogen（收购HI-Bio后）与天境合作开发的Felzartamab公布了1/2期M-PLACE研究结果（NCT04145440），但有效性显著不如前面几种管线，6个月蛋白尿PR比例13.3%且没有CR。 https://www.kireports.org/article/S2468-0249(24)01794-7 5）其他药物在STARMEN研究中（NCT01955187），钙调磷酸酶抑制剂Tacrolimus+Rituximab与交替使用激素+环磷酰胺对照，6个月和12个月的蛋白尿CR+PR比例分别为44% vs 74%、51% vs 79%，后者有效性更优但毒性略大、特别是有更高的致癌风险。 https://doi.org/10.1016/j.kint.2020.10.014 4 总结与展望综合以上临床结果对比，EVER001展现出的蛋白尿改善和anti-PLA2R自身抗体降低水平，较现有治疗方案以及在研管线确实处于较为明显的优势，在MN这个蓝海适应症上抢得了先机。除了这些已经浮出水面的结果，未来还有补体CFB/D、MASP2、CAR-T等其他机制药物值得期待。在如今自免领域也快卷疯了的背景下，像MN这种患者基数庞大、现有疗法不足、新晋玩家寥寥的适应症，绝对算是一股清流。附录主要膜性肾病药物临床数据

免疫疗法临床1期临床2期

2024-12-03

·PRNewswire

Lupus Nephritis Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 30+ Companies Working in the Domain

The lupus nephritis market is poised for growth, driven by rising disease prevalence, advancements in therapeutics such as biologics and targeted therapies, and increased investment in R&D. Heightened awareness and robust support from governments and key industry players further create a dynamic environment for innovation and better patient outcomes. LAS VEGAS, Dec. 3, 2024 /PRNewswire/ -- DelveInsight's ' Lupus Nephritis Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline lupus nephritis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the lupus nephritis pipeline domain. Key Takeaways from the Lupus Nephritis Pipeline Report DelveInsight's lupus nephritis pipeline report depicts a robust space with 30+ active players working to develop 35+ pipeline therapies for lupus nephritis treatment. Key lupus nephritis companies such as AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others are evaluating new lupus nephritis drugs to improve the treatment landscape. Promising lupus nephritis pipeline therapies such as Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others are under different phases of lupus nephritis clinical trials. In November 2024, Adicet Bio announced that the first LN patient had been dosed in the Phase I clinical trial evaluating ADI-001 in autoimmune diseases. In November 2024, Kyverna Therapeutics announced that it would present updated clinical data from LN patients treated with KYV-101 in ongoing Kyverna-sponsored KYSA-1 and KYSA-3 Phase I/II studies and named patient treatments. In October 2024, Kezar Life Sciences suspended subject enrolment and patient dosing in the Phase II PALIZADE trial of zetomipzomib for active lupus nephritis. In June 2024, Nkarta announced the initiation of Ntrust-I, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening. The company also announced the clearance by the U.S. Food and Drug Administration (FDA) of its second Investigational New Drug (IND) application for NKX019 in autoimmune disease. In June 2024, Adicet Bio announced that the US Food and Drug Administration (FDA) had granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis. In April 2024, Caribou Biosciences announced that it had received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024. In March 2024, Artiva Therapeutics is looking to dose the first patient in a Phase I/II trial assessing its cell therapy AlloNK in lupus nephritis (LN). Request a sample and discover the recent advances in lupus nephritis treatment drugs @ Lupus Nephritis Pipeline Report The lupus nephritis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage lupus nephritis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the lupus nephritis clinical trial landscape. Lupus Nephritis Overview Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE), an autoimmune disease that can affect multiple organ systems. In lupus nephritis, the immune system mistakenly attacks the kidneys, leading to inflammation and damage. The exact cause is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors, including infections and exposure to certain drugs or UV light. Symptoms of lupus nephritis can vary but often include swelling in the legs and feet, high blood pressure, foamy urine, and in severe cases, hematuria. Patients may also experience fatigue, joint pain, and skin rashes, typical of lupus. Diagnosis usually involves a combination of blood tests, urinalysis, and imaging studies. A kidney biopsy may be necessary to evaluate the extent of kidney damage and guide treatment. Treatment for lupus nephritis aims to reduce inflammation and prevent kidney damage. It often involves corticosteroids and immunosuppressive medications such as mycophenolate mofetil or azathioprine. In severe cases, more aggressive treatments, including cyclophosphamide or biologic therapies like belimumab, may be utilized. Regular monitoring of kidney function and overall health is crucial for managing the disease effectively. Find out more about lupus nephritis treatment drugs @ Drugs for Lupus Nephritis Treatment A snapshot of the Lupus Nephritis Pipeline Drugs mentioned in the report: Learn more about the emerging lupus nephritis pipeline therapies @ Lupus Nephritis Clinical Trials Lupus Nephritis Therapeutics Assessment The lupus nephritis pipeline report proffers an integral view of the lupus nephritis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Lupus Nephritis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Interferon alpha-beta receptor antagonists, Cell death inhibitors, Cell death stimulants, Antibody-dependent cell cytotoxicity, B-cell activation factor receptor antagonists, Glucokinase stimulants, Dendritic cell inhibitors, Complement factor D inhibitors, Complement C3 inhibitors, Proteasome inhibitors, Natural killer cell replacements, Immunologic cytotoxicity; T lymphocyte replacements Key Lupus Nephritis Companies: AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others. Key Lupus Nephritis Pipeline Therapies: Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others. Dive deep into rich insights for new drugs for lupus nephritis treatment, visit @ Lupus Nephritis Drugs Table of Contents For further information on the lupus nephritis pipeline therapeutics, reach out @ Lupus Nephritis Treatment Drugs Related Reports Lupus Nephritis Epidemiology Lupus Nephritis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted lupus nephritis epidemiology in the 7MM. 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 NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, CABALETTA BIO, 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 – 2024 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

临床申请

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

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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	2024-12-04
支气管疾病	临床3期	阿根廷	GSK Plc	2024-12-04
支气管疾病	临床3期	比利时	GSK Plc	2024-12-04
支气管疾病	临床3期	巴西	GSK Plc	2024-12-04
支气管疾病	临床3期	丹麦	GSK Plc	2024-12-04
支气管疾病	临床3期	芬兰	GSK Plc	2024-12-04
支气管疾病	临床3期	法国	GSK Plc	2024-12-04
支气管疾病	临床3期	德国	GSK Plc	2024-12-04
支气管疾病	临床3期	希腊	GSK Plc	2024-12-04
支气管疾病	临床3期	以色列	GSK Plc	2024-12-04

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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	系统性红斑狼疮维持 anti-ds DNA \| RNP \| Sm ... 更多	69	Belimumab (BE)	構鬱鏇壓窪壓膚廠網願(艱壓遞遞顧襯鏇膚鑰鬱) = 夢遞窪壓鑰廠膚襯窪願範築蓋衊鏇蓋衊醖夢窪 (簾襯壓鹽衊繭餘鏇壓餘 ) 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	願齋蓋構糧觸餘鬱艱構(構鏇壓鑰網構鏇積顧鬱) = PSL reduction ≥5 mg was achievable in active disease and positive C1q-binding immune complex 艱顧壓蓋窪憲遞鑰鹽鏇 (鹹窪蓋窪餘壓網鑰顧鏇 ) 更多	积极	2024-06-05
EULAR2024	N/A	红斑狼疮	-	Belimumab	製網艱網觸襯構範鹹艱(艱網築繭遞淵醖醖齋夢) = 齋襯糧網淵艱鑰範選範鏇鏇獵醖鏇鏇獵窪繭鹽 (淵廠艱蓋醖遞範鏇糧願, 6.3)	-	2024-06-05
				Control (no belimumab exposure)	製網艱網觸襯構範鹹艱(艱網築繭遞淵醖醖齋夢) = 簾淵網簾蓋襯鏇網鏇鏇鏇鏇獵醖鏇鏇獵窪繭鹽 (淵廠艱蓋醖遞範鏇糧願, 6.5)
EULAR2024	N/A	系统性红斑狼疮 BAFF cytokine	1,137	Belimumab	積選憲齋鏇憲憲夢顧簾(鑰範糧鏇構淵獵觸廠鹹) = 顧觸範鏇廠蓋齋願餘糧淵網襯衊範築蓋糧蓋鹹 (構網遞膚繭糧憲構餘構 ) 更多	积极	2024-06-05
				Belimumab (Standard of Care)	積選憲齋鏇憲憲夢顧簾(鑰範糧鏇構淵獵觸廠鹹) = 網築簾積鬱壓齋願鬱製淵網襯衊範築蓋糧蓋鹹 (構網遞膚繭糧憲構餘構 ) 更多
EULAR2024	N/A	怀孕	17	Belimumab	選築積鹽醖衊網積壓淵(膚鏇遞構蓋構選鹹觸夢) = 顧鬱蓋願製糧鹹鹹鬱廠鹹窪範夢糧願積蓋遞築 (壓鹹築觸蓋餘遞憲鬱繭 ) 更多	积极	2024-06-05
				Non-Belimumab	簾觸廠窪網鬱觸願遞醖(夢襯餘蓋簾積膚鏇齋積) = 壓夢遞願膚淵鏇窪壓壓遞淵構範鹹鏇蓋積網獵 (憲鏇鹹網廠廠獵繭襯範 ) 更多
EULAR2024	N/A	红斑狼疮	-	Belimumab	鏇憲窪醖窪鑰憲齋糧齋(範獵蓋積網製衊夢築蓋) = 膚積廠網淵繭鬱構鹽憲鑰顧壓繭醖遞艱構選範 (鏇蓋壓淵鏇範願網簾鏇 )	积极	2024-06-05
EULAR2024	N/A	系统性红斑狼疮	-	Belimumab	糧衊鹽廠選選膚鏇鑰獵(繭襯願鹽鑰淵醖簾廠窪): HR = 0.72 (95% CI, 0.62 ~ 0.83), P-Value = <0.0001 更多	-	2024-06-05
				Placebo
EULAR2024	N/A	-	54	Belimumab	製艱範鏇網觸鏇鏇廠艱(範淵淵網憲獵鬱鏇窪艱) = 遞窪願夢壓築憲顧鹹鑰鬱糧鏇選廠窪範觸餘衊 (襯網壓顧艱簾齋繭鹽鑰 ) 更多	积极	2024-06-05
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	顧鹽簾顧遞鬱獵蓋艱積(齋淵獵蓋窪夢網窪網製): OR = 1.7 (95% CI, 1.46 ~ 1.98), P-Value = <0.0001	积极	2024-06-05
				Placebo
NCT04179032 (CTgov)	临床2期	系统性红斑狼疮	25	Belimumab	膚製膚築夢遞憲艱餘鏇(衊鏇壓衊鹹觸鹽憲艱觸) = 淵願艱願鹽齋衊襯鬱夢壓膚網觸鑰積繭憲鏇蓋 (壓廠鹽艱鏇鑰構積鹽壓, 餘膚糧構鏇夢製壓蓋築 ~ 願獵製夢鏇鏇餘顧鬱衊) 更多	-	2024-03-26