更新于：2023-09-06

Siltuximab

司妥昔单抗

更新于：2023-09-06

概要

概要

基本信息

药物类型

单克隆抗体

别名

Anti-interleukin-6 monoclonal antibody、Chimeric anti-interleukin-6 monoclonal antibody、Siltuximab (USAN/INN)

+ [4]

靶点

IL-6(白细胞介素-6)

作用机制

IL-6抑制剂(白细胞介素-6抑制剂)

治疗领域

肿瘤、免疫系统疾病、血液及淋巴系统疾病+ [4]

在研适应症

Castleman病、多中心Castleman病、精神分裂症+ [3]

非在研适应症

结直肠癌、头颈部肿瘤、轻链 (AL) 淀粉样变性+ [13]

原研机构

EUSA Pharma, Inc.

在研机构

Centocor, Inc.

Janssen Biotech, Inc.

Ergomed Plc

+ [4]

非在研机构

西安杨森制药有限公司A.O. Ospedale Papa Giovanni XXIII

最高研发状态(全球)批准上市

首次获批日期(全球)

美国 (2014-04),

多中心Castleman病

最高研发状态(中国)批准上市

特殊审评孤儿药 (美国)、临床急需境外新药 (中国)

登录后查看首次获批时间轴

序列信息

Sequence Code 87889L

Source: WHOINN

Sequence Code 1215539H

Source: WHOINN

关联

项与司妥昔单抗相关的临床试验

NCT05697510 / Recruiting临床1期IIT

Monocentric Phase 1 Study With Dose-escalation of Siltuximab in Combination With Idarubicin and Cytarabine Chemotherapy in Patients With Acute Myeloblastic Leukaemia (AML) With Poor Prognosis: SILTUXILAM

This is a phase 1 dose escalation study testing the addition of an anti-IL6 (siltuximab) to standard induction chemotherapy for high-risk AML.

开始日期2023-03-16

申办/合作机构

Nantes University Hospital

NCT05684692 / Not yet recruiting临床2期IIT

Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

This is a placebo-controlled, multi-arm phase II platform screening trial designed to test the safety, pain responses, and pharmacodynamic activity of multiple experimental therapies simultaneously in participants with moderate-to-severe pain due to schwannomatosis (SWN).
This Master Study is being conducted as a platform that may allow participants with pain associated with schwannomatosis to receive a novel intervention throughout this study. Embedded within the Master Study are individual drug sub-studies:
Investigational Drug Sub-Study A: Siltuximab
Investigation Drug Sub-Study B: Erenumab-Aooe

开始日期2023-03-01

申办/合作机构

The Massachusetts General Hospital

[+2]

NCT05316116 / Recruiting早期临床1期IIT

A Pilot Study of Siltuximab in Large Granular Lymphocytic Leukemia (LGLL)

The purpose of the study is to evaluate the safety and effectiveness of siltuximab for participants being treated for large granular lymphocytic leukemia (LGLL).

开始日期2023-02-15

申办/合作机构

H. Lee Moffitt Cancer Center & Research Institute, Inc.

[+1]

100 项与司妥昔单抗相关的专利（医药）

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303

项与司妥昔单抗相关的文献（医药）

2023-06-16·Expert review of anti-infective therapy

Tocilizumab for the treatment of COVID-19.

Article

作者: Robert Flisiak ; Marta Flisiak-Jackiewicz ; Piotr Rzymski ; Dorota Zarębska-Michaluk

INTRODUCTION:

Since the beginning of the COVID-19 pandemic, the repurposing of medicines has been pursued to find interventions effective in preventing fatal outcome of the disease. One of these drugs was tocilizumab, an interleukin-6 inhibiting monoclonal antibody, previously used to treat several immune-related disorders.

AREAS COVERED:

In this article, we present the results of the initial observational studies and subsequent randomized clinical trials on the efficacy and safety of tocilizumab in the treatment of COVID-19. Despite conflicting results, possibly due to the heterogeneity of the studied populations, large studies have ultimately proven that preventing IL-6 from attaching to its receptors can effectively reverse the fatal course of the disease. We also discuss the meta-analyses, which mostly supported the validity of tocilizumab therapy. We show how tocilizumab found its place in the most important recommendations on COVID-19 treatment and obtained authorization from the major regulatory authorities.

EXPERT OPINION:

The criteria for optimizing tocilizumab therapy in COVID-19 still need to be established. They are also important considering the existing risks of future zoonotic spillovers and epidemics that may trigger hyperinflammation that could be efficiently blocked. The experience gained with tocilizumab shall be perceived as preparedness for future challenges.

2023-06-12·PharmacoEconomics - open

Cost-Effectiveness Analysis of Siltuximab for Australian Public Investment in the Rare Condition Idiopathic Multicentric Castleman Disease.

Article

作者: Francis Shupo ; Keith R Abrams ; Zanfina Ademi ; Grace Wayi-Wayi ; Natasa Zibelnik ; Matt Kirchmann ; Carolyn Rutherford ; Kelly Makarounas-Kirchmann

OBJECTIVES:

This paper presents an Australian model that formed part of the health technology assessment for public investment in siltuximab for the rare condition of idiopathic Multicentric Castleman Disease (iMCD) in Australia.

METHODS:

Two literature reviews were conducted to identify the appropriate comparator and model structure. Survival gain based on available clinical trial data were modelled using an Excel-based model semi-Markov model including time-varying transition probabilities, an adjustment for trial crossover and long-term data. A 20-year horizon was taken, and an Australian healthcare system perspective was adopted, with both benefits and costs discounted at 5%. The model was informed with an inclusive stakeholder approach that included a review of the model by an independent economist, Australian clinical expert opinion and feedback from the Pharmaceutical Benefits Advisory Committee (PBAC). The price used in the economic evaluation reflects a confidential discounted price, which was agreed to with the PBAC.

RESULTS:

An incremental cost-effectiveness ratio of A$84,935 per quality-adjusted life-year (QALY) gained was estimated. At a willingness-to-pay threshold of A$100,000 per QALY, siltuximab has a 72.1% probability of being cost-effective compared with placebo and best supportive care. Sensitivity analyses results were most sensitive to the length of interval between administrations (from 3- to 6-weekly) and crossover adjustments.

CONCLUSION:

Within a collaborative and inclusive stakeholder framework, the model submitted to the Australian PBAC found siltuximab to be cost-effective for the treatment of iMCD.

2023-06-01·The Cochrane database of systematic reviews

Interleukin-6 blocking agents for treating COVID-19: a living systematic review.

Review

作者: Lina Ghosn ; Rouba Assi ; Theodoros Evrenoglou ; Brian S Buckley ; Nicholas Henschke ; Katrin Probyn ; Carolina Riveros ; Mauricia Davidson ; Carolina Graña ; Hillary Bonnet ; Alexander Jarde ; Camila Ávila ; Camilla Hansen Nejstgaard ; Sonia Menon ; Gabriel Ferrand ; Philipp Kapp ; Claudia Breuer ; Christine Schmucker ; Yanina Sguassero ; Thu Van Nguyen ; Declan Devane ; Joerg J Meerpohl ; Gabriel Rada ; Asbjørn Hróbjartsson ; Giacomo Grasselli ; David Tovey ; Philippe Ravaud ; Anna Chaimani ; Isabelle Boutron

BACKGROUND:

It has been reported that people with COVID-19 and pre-existing autoantibodies against type I interferons are likely to develop an inflammatory cytokine storm responsible for severe respiratory symptoms. Since interleukin 6 (IL-6) is one of the cytokines released during this inflammatory process, IL-6 blocking agents have been used for treating people with severe COVID-19.

OBJECTIVES:

To update the evidence on the effectiveness and safety of IL-6 blocking agents compared to standard care alone or to a placebo for people with COVID-19.

SEARCH METHODS:

We searched the World Health Organization (WHO) International Clinical Trials Registry Platform, the Living OVerview of Evidence (L·OVE) platform, and the Cochrane COVID-19 Study Register to identify studies on 7 June 2022.

SELECTION CRITERIA:

We included randomized controlled trials (RCTs) evaluating IL-6 blocking agents compared to standard care alone or to placebo for people with COVID-19, regardless of disease severity.

DATA COLLECTION AND ANALYSIS:

Pairs of researchers independently conducted study selection, extracted data and assessed risk of bias. We assessed the certainty of evidence using the GRADE approach for all critical and important outcomes. In this update we amended our protocol to update the methods used for grading evidence by establishing minimal important differences for the critical outcomes.

MAIN RESULTS:

This update includes 22 additional trials, for a total of 32 trials including 12,160 randomized participants all hospitalized for COVID-19 disease. We identified a further 17 registered RCTs evaluating IL-6 blocking agents without results available as of 7 June 2022. The mean age range varied from 56 to 75 years; 66.2% (8051/12,160) of enrolled participants were men. One-third (11/32) of included trials were placebo-controlled. Twenty-two were published in peer-reviewed journals, three were reported as preprints, two trials had results posted only on registries, and results from five trials were retrieved from another meta-analysis. Eight were funded by pharmaceutical companies. Twenty-six included studies were multicenter trials; four were multinational and 22 took place in single countries. Recruitment of participants occurred between February 2020 and June 2021, with a mean enrollment duration of 21 weeks (range 1 to 54 weeks). Nineteen trials (60%) had a follow-up of 60 days or more. Disease severity ranged from mild to critical disease. The proportion of participants who were intubated at study inclusion also varied from 5% to 95%. Only six trials reported vaccination status; there were no vaccinated participants included in these trials, and 17 trials were conducted before vaccination was rolled out. We assessed a total of six treatments, each compared to placebo or standard care. Twenty trials assessed tocilizumab, nine assessed sarilumab, and two assessed clazakizumab. Only one trial was included for each of the other IL-6 blocking agents (siltuximab, olokizumab, and levilimab). Two trials assessed more than one treatment. Efficacy and safety of tocilizumab and sarilumab compared to standard care or placebo for treating COVID-19 At day (D) 28, tocilizumab and sarilumab probably result in little or no increase in clinical improvement (tocilizumab: risk ratio (RR) 1.05, 95% confidence interval (CI) 1.00 to 1.11; 15 RCTs, 6116 participants; moderate-certainty evidence; sarilumab: RR 0.99, 95% CI 0.94 to 1.05; 7 RCTs, 2425 participants; moderate-certainty evidence). For clinical improvement at ≥ D60, the certainty of evidence is very low for both tocilizumab (RR 1.10, 95% CI 0.81 to 1.48; 1 RCT, 97 participants; very low-certainty evidence) and sarilumab (RR 1.22, 95% CI 0.91 to 1.63; 2 RCTs, 239 participants; very low-certainty evidence). The effect of tocilizumab on the proportion of participants with a WHO Clinical Progression Score (WHO-CPS) of level 7 or above remains uncertain at D28 (RR 0.90, 95% CI 0.72 to 1.12; 13 RCTs, 2117 participants; low-certainty evidence) and that for sarilumab very uncertain (RR 1.10, 95% CI 0.90 to 1.33; 5 RCTs, 886 participants; very low-certainty evidence). Tocilizumab reduces all cause-mortality at D28 compared to standard care/placebo (RR 0.88, 95% CI 0.81 to 0.94; 18 RCTs, 7428 participants; high-certainty evidence). The evidence about the effect of sarilumab on this outcome is very uncertain (RR 1.06, 95% CI 0.86 to 1.30; 9 RCTs, 3305 participants; very low-certainty evidence). The evidence is uncertain for all cause-mortality at ≥ D60 for tocilizumab (RR 0.91, 95% CI 0.80 to 1.04; 9 RCTs, 2775 participants; low-certainty evidence) and very uncertain for sarilumab (RR 0.95, 95% CI 0.84 to 1.07; 6 RCTs, 3379 participants; very low-certainty evidence). Tocilizumab probably results in little to no difference in the risk of adverse events (RR 1.03, 95% CI 0.95 to 1.12; 9 RCTs, 1811 participants; moderate-certainty evidence). The evidence about adverse events for sarilumab is uncertain (RR 1.12, 95% CI 0.97 to 1.28; 4 RCT, 860 participants; low-certainty evidence). The evidence about serious adverse events is very uncertain for tocilizumab (RR 0.93, 95% CI 0.81 to 1.07; 16 RCTs; 2974 participants; very low-certainty evidence) and uncertain for sarilumab (RR 1.09, 95% CI 0.97 to 1.21; 6 RCTs; 2936 participants; low-certainty evidence). Efficacy and safety of clazakizumab, olokizumab, siltuximab and levilimab compared to standard care or placebo for treating COVID-19 The evidence about the effects of clazakizumab, olokizumab, siltuximab, and levilimab comes from only one or two studies for each blocking agent, and is uncertain or very uncertain.

AUTHORS' CONCLUSIONS:

In hospitalized people with COVID-19, results show a beneficial effect of tocilizumab on all-cause mortality in the short term and probably little or no difference in the risk of adverse events compared to standard care alone or placebo. Nevertheless, both tocilizumab and sarilumab probably result in little or no increase in clinical improvement at D28. Evidence for an effect of sarilumab and the other IL-6 blocking agents on critical outcomes is uncertain or very uncertain. Most of the trials included in our review were done before the waves of different variants of concern and before vaccination was rolled out on a large scale. An additional 17 RCTs of IL-6 blocking agents are currently registered with no results yet reported. The number of pending studies and the number of participants planned is low. Consequently, we will not publish further updates of this review.

项与司妥昔单抗相关的新闻（医药）

2023-08-28

·GlobeNewswire-Health Care

Elicio Therapeutics Announces Appointment of Megan Filoon as General Counsel and Dr. Thian Kheoh as Senior Vice President of Biometrics

BOSTON, Aug. 28, 2023 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced the appointment of Megan Filoon as General Counsel and Dr. Thian Kheoh as Senior Vice President of Biometrics. Ms. Filoon will oversee all company legal affairs including corporate governance and compliance functions. Dr. Kheoh will provide biostatistical leadership and strategic guidance into the development of the Company’s product candidate portfolio including the ongoing AMPLIFY-201 and AMPLIFY-7P trials of the lead asset, ELI-002. “Megan and Thian are joining us at an exciting time following our recent transition to a public company and as we continue to advance our lead clinical cancer vaccine candidate, ELI-002, for patients with mKRAS-driven cancers,” said Robert Connelly, Chief Executive Officer at Elicio Therapeutics. “Megan and Thian further strengthen an outstanding leadership team and their expertise will be invaluable in strengthening our legal and compliance functions, and processing data from our AMPLIFY trials, respectively.” Megan Filoon most recently served as the General Counsel and Corporate Secretary for Molecular Templates, Inc., a publicly traded, oncology-focused biotech, where she was responsible for providing legal counsel to the company’s board of directors and management team and advising on corporate governance, securities, employment, and real estate matters, among other areas. In this role, Ms. Filoon was responsible for managing the legal, human resources and administrative departments. She joined Molecular Templates as Corporate Counsel and during her time there, held roles of increasing responsibility, becoming General Counsel in February 2022. Prior to joining Molecular Templates, Ms. Filoon was a corporate associate at Blank Rome LLP, where she represented public and private companies in mergers and acquisitions, asset sales, securities offerings, business formation and corporate governance matters. She earned her Juris Doctor from Rutgers School of Law, where she was the Business Editor of the Rutgers Journal of Law and Public Policy, and her Bachelor of Arts in history and political science from Boston University. Thian Kheoh, Ph.D., has over 30 years of drug development and clinical trial experience in the biopharmaceutical industry. He most recently served as Vice President of Biometrics at Mirati Therapeutics where he led the Biometrics team in obtaining the FDA approval of KRAZATI® for KRAS G12C NSCLC patients. Prior to Mirati, he held roles of increasing responsibility at Tocagen, Janssen, Cougar Biotechnology, Biogen-Idec (now Biogen), TAP and Warner Lambert-Parke Davis. His work focused on exploring the application of statistical methodologies in preclinical and clinical studies, introducing novel statistical principles to trial design and strategic planning to bring effective drugs to cancer patients. Dr. Kheoh played an integral role in a number of successful global regulatory submissions and approvals of products that include ERLEADA®, DARZALEX®, OMNICEF®, SYLVANT®, VELCADE®, YONDELIS®, ZYTIGA® and the label expansion of RITUXAN®. Before joining the biopharmaceutical industry, he was an assistant professor at the University of Central Florida conducting research and providing lectures in Statistics. Dr. Kheoh earned his Ph.D. from the University of Western Ontario, Canada. About Elicio Therapeutics Elicio Therapeutics is a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer. By combining expertise in immunology and immunotherapy, Elicio is engineering investigational Amphiphile (AMP) immunotherapies intended to precisely target and fully engage the lymph nodes, the site in our bodies where the immune response is orchestrated. Elicio is engineering lymph node-targeted AMPlifiers, immunomodulators, adjuvants and vaccines for an array of aggressive cancers. Cautionary Note on Forward-Looking Statements Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding Elicio’s planned clinical programs and statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Elicio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to Elicio’s plans to research, develop and commercialize its current and future product candidates. New factors emerge from time to time, and it is not possible for us to predict all such factors, nor can we assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks are more fully discussed in the current report on Form 8-K that was filed with the SEC on June 2, 2023 and Elicio’s periodic reports and other documents filed from time to time with the SEC. Forward-looking statements included in this release are based on information available to Elicio as of the date of this release. Elicio does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this release, except to the extent required by law. Media ContactGloria GasaaturaLifeSci Communicationsggasaatura@lifescicomms.com646-970-4688 Investor Relations ContactHeather DiVecchiaElicio TherapeuticsIR@elicio.com857-209-0153

高管变更免疫疗法疫苗上市批准

2023-07-24

·美通社

7.23国际Castleman病日Castleman病患者关爱倡议书发布

关爱倡议 | 守护Castleman病患者，传递生命之音北京 2023年7月24日 /美通社/ -- 2023年7月23日国际Castleman病日，《Castleman病（铃铛病）患者关爱倡议书》在北京协和医院正式发布，旨在通过多方携手共同为罕见病Castleman病患者发声，更是对罕见病患者的生命呵护。该倡议书的发布是由中华医学会罕见病分会、中华医学会血液学分会血液罕见病学组、中国Castleman病协作组（CCDN）、中国卡斯特曼之家联合指导，百济神州进行公益支持。中华医学会罕见病分会主任委员、北京协和医院院长张抒扬教授，中华医学会罕见病分会秘书长田庄教授，中华医学会血液学分会主任委员、苏州大学附属第一医院吴德沛教授，中华医学会血液学分会罕见病学组副组长张磊教授，中国Castleman病协作组组长、北京协和医院血液内科主任李剑教授，"卡斯特曼之家"主理人林琳女士和百济神州血液肿瘤事业部负责人朱晶岩女士，以及众多行业专家、学者、患者和媒体共同见证了倡议书的发布。倡议书从"知-诊-治-爱"四个维度共同应对Castleman病患者所面临的挑战。"知"，倡议提升公众对Castleman病的认知；"诊"，倡议加强Castleman病诊断能力；"治"，倡议建立多层次Castleman病诊疗体系，促进规范治疗；"爱"，倡议持续关注和支持Castleman病患者。知 -- 提升疾病认知，了解患者困境 Castleman病是血管滤泡性淋巴结增生症或巨大淋巴结病，是一种淋巴结过度增生，炎症反应相关的血液系统的罕见病，以单个或者多个部位的淋巴结肿大为特点，部分患者可伴有全身症状和(或)多系统受累，并于2018年被纳入《中国第一批罕见病目录》 [1] 。 Castleman病的临床和病理表现缺乏特异性。据2023年卡斯特曼之家调研数据显示，72%的Castleman病患者表现为淋巴结肿大，54%的患者表现为疲劳乏力、39%出现贫血、37%发生盗汗、33%出现体重下降、32%出现发热、22%有食欲下降等症状 [2] ，还有肝、肾功能不全、脾大、胸水、腹水等器官并发症。因其多种多样的临床表现，极易与其他疾病混淆，造成误诊和漏诊。多中心型Castleman病（MCD）是一种全身性、进行性且可致命的疾病，伴有多部位淋巴结肿大 [3] ，治疗和治愈面临着较多的困难。尤其是特发性多中心型CD（iMCD）更是一种罕见且危及生命的淋巴组织增生的疾病 [4] ，是Castleman病的诊治重点。中国MCD患者5年生存率为51%，而2020美国血液学会发表的文章显示，真实世界中特发性多中心型Castleman病（iMCD）平均生存仅2.57年 [5] 。因此患者关爱宣言倡议，加强全社会对疾病的科普工作，提升公众对疾病的认知和关注，帮助早期病患和潜在患者及时得到确诊，避免错过治疗黄金期。张抒扬教授表示，中国人口众多，目前罕见病患者群体已超过2,000万 [6] ，而患者一直面临着诊治困难和缺乏药物的现状。要解决这样的困境，其复杂性和艰巨性前所未有，需要来自全社会的投入和支持，才能帮助患者尽早得到规范诊治。诊 -- 建立多层次诊疗体系，满足患者未尽之需罕见病因发病率低，病种繁多且患者分散，很多医务人员缺乏相关的医学知识和诊断能力，导致罕见病的临床诊断能力不足，确诊难、诊断周期长。且因为区域医疗资源分配不均，患者异地就医情况普遍。据卡斯特曼之家调研显示，45%的Castleman病患者需要辗转3家以上医院才得到确诊；41%的患者从初次发病到确诊时间超过6个月；64%的患者常往返就诊于多个科室；58%的Castleman病患者曾经被误诊为其他疾病；67%的患者需要进行多次病理检测才能确诊 [2] 。在患者关爱宣言中，特别强调要加强对罕见病Castleman病的诊断能力，减少误诊漏诊，促进早诊早治。2021年中国Castleman病协作组（CCDN）成立后，不断培养和扩大Castleman专病医生队伍，推动血液科、病理科等相关科室的医务工作者对Castleman病的关注，加强医生对疾病的鉴别及诊断能力，并发布《中国Castleman病诊断与治疗专家共识（2021年版）》（后简称《共识》），建立了相关的诊疗流程和规范。对此，吴德沛教授表示，"依托于像CCDN这样的专病诊疗协作组，将推动包括血液科在内的广大多学科医生对血液罕见病的重视和研究，对于包括Castleman病在内的罕见病规范化诊疗有着重要意义，不仅能切实缩短患者确诊时间，还能改善疾病的误诊和漏诊率，让更多患者获益"。罕见病因其病因复杂，发病机制不明、诊断困难的特性决定它需要跨专业的临床专家、医学遗传专家进行多学科会诊才能得出精准诊断。在患者关爱宣言中，倡议以CCDN覆盖的45个诊疗中心为相应区域的牵头单位，辐射其所在区域的其他医院，促进更多医院建立多层次、多学科的Castleman病诊疗体系，帮助患者实现就近治疗、促进Castleman病在全国范围内的规范诊治。张抒扬教授认为，建立多层次诊疗体系，进行多学科会诊能够实现罕见病患者从诊断治疗到追踪管理的"一站式"服务，为患者提供更高效、便捷的"组团"诊疗，真正实现"以患者需求为导向"的目标。治 -- 促进规范治疗，患者获益最大化一直以来，包括Castleman病在内的罕见病患者还面临着用药难、身体痛苦、生活状态差的现状，无论是在治疗方案，药物可及性，还是患者的生存质量方面都亟待改善。据卡斯特曼之家调研显示，在接受常规治疗后，仍有36%的Castleman病患者存在3项以上血液指标异常，17%的患者有 3项以上疾病症状，且近三分之一的采用常规疗法的患者表示副作用严重影响生活 [2] 。患者关爱宣言指出，2021年《共识》的发布大大推动了疾病规范化诊疗，改善了患者的生存质量。尤其是《共识》将司妥昔单抗推荐为一线iMCD治疗方案，打破了之前中国iMCD患者无标准化治疗困局。目前国内现有大部分治疗方案针对iMCD的复发率和治疗失败率高，且不良反应明显，无法很好地满足患者治疗需求。在全球多中心的临床研究中，司妥昔单抗在iMCD中获得了尤为显著的疗效，34%患者可达18周症状和肿瘤持续缓解，6年疾病控制率高达97%，生存率100% [7] ，有效地延长了患者生存，改善了患者生存质量。对此李剑教授表示，未来的治疗之路不仅要立足当前，还需要以发展的眼光放眼未来，需要对更多的患者进行研究，寻找背后的发病机制，各诊疗中心将在CCDN的框架下继续开展合作，研究出更多前瞻性、规范性的治疗方案，惠及更多Castleman病患者。爱 -- 关爱支持患者，带来新生希望每一个罕见病患者及其家庭在疾病、心理、社交等方面均承受了巨大的压力。患者关爱宣言倡议，学术团体、医疗机构、医药企业与患者群体和公益组织紧密合作，帮助患者应对疾病挑战和持续开展患者关爱行动，为患者提供人文关怀和心理抚慰，帮助患者以积极健康的心态面对疾病与生活。对此，林琳女士表示，作为Castleman 病的患者组织，卡斯特曼之家目前已有900余位患者及家属加入。在成立后就和CCDN紧密合作，并在爱心企业百济神州的支持下，在公益患教、疾病科普、患者调研和绿色就医通道等方面进行了大量工作，并连续三年发起全国患者生存调研活动，今年的调研主要聚焦在真实地反馈患者从发病、诊断到治疗的整个过程，了解疾病造成的影响，挖掘患者未被满足的希望。朱晶岩女士认为，针对Castleman病在内的罕见病患者面临的挑战，需要多方携手合作。百济神州将继续秉承‘患者为先'的宗旨，与医疗机构、患者组织、专家学者以及社会各界持续合力护佑每一位患者，推动相关领域的研究和创新，密切关注包括Castleman病在内的少数患者群体的未尽之需，以期为患者的生活带来更多积极改变。通过全社会的努力和支持，未来才能让罕见病不再"罕见"。《Castleman病（铃铛病）患者关爱倡议书》的发布在汇聚社会力量，共建罕见病精准诊疗体系、提升Castleman病诊疗水平、促进患者早诊早治、改善患者生存质量等方面都具有积极的意义。它唱响了Castleman病患者充满生机的未来，推动更多的人"看见"Castleman病，推动未来Castleman病诊疗领域的进步，从而让更多的患者得到救助，冲破困境，迎接新生。参考文献 [1]《关于公布第一批罕见病目录的通知》. 国卫医发〔2018〕10号. [2] 2023年Castleman病患者诊疗现状调研 [3] https://www.cn-healthcare.com/articlewm/20230517/content-1551707.html [4]《EUSA Pharma 和百济神州宣布 SYLVANT®（注射用司妥昔单抗）在中国的上市申请已获受理》 [5] https://mp.weixin.qq.com/s?__biz=MzA4OTI5MDkwNg==&mid=2447819318&idx=1&sn=af75ba588f4d0b29abae04f7be4ec6c7&chksm=840f43c3b378cad58b99f41d6cddc6d1d82862ecd892b3ca0d6e678f79c69b719531dc8c8bd1&scene=27 [6] https://baijiahao.baidu.com/s?id=1759054316287887849&wfr=spider&for=pc [7] https://mp.weixin.qq.com/s?__biz=MzU4NjkzMDg4Mw==&mid=2247499539&idx=2&sn=59f75e065288a2378485f93a10e88be0&chksm=fdf170bfca86f9a9cb8de216f132187a200a941b1f989d2d9fc2531cd99641592e8c815e8d84&scene=27

2023-07-20

·GlobeNewswire-Health Care

New clinical and real-world data for Roche’s Vabysmo at ASRS reveal improved outcomes for people with two leading causes of vision loss

Late-breaking post-hoc data indicate Vabysmo leads to less fibrosis, which may negatively impact vision, than aflibercept in people with diabetic macular edema (DME)Real-world data reinforce that first-line Vabysmo use improves outcomes and extends treatment intervals rapidly during the first four months for people with neovascular or ‘wet’ age-related macular degeneration (nAMD) and DMEClinical data reiterate Vabysmo’s positive anatomical outcomes, including reduced blood vessel leakage in the macula and greater and faster retinal fluid control Vabysmo is currently approved in over 70 countries to treat nAMD and DME, with more than one million doses distributed globally Basel, 20 July - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that data from its ophthalmology portfolio will be highlighted in 25 abstracts at the 2023 American Society of Retina Specialists (ASRS) Annual Meeting, which will be held from 28 July to 1 August in Seattle, United States. The data further advance the depth of clinical and real-world evidence supporting the use of Vabysmo® (faricimab), the first and only bispecific antibody for the eye, for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).1-14 “The clinical and real-world data at ASRS reinforce the improvement in outcomes brought by Vabysmo in two leading causes of vision loss, particularly new analyses suggesting that Vabysmo is associated with less vision-impacting fibrosis than aflibercept,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “By improving disease control while offering a potentially less frequent treatment regimen, Vabysmo may help people spend less time managing their condition.” Vabysmo is currently approved in over 70 countries to treat nAMD and DME, with public reimbursement in over 20 markets and more than one million doses distributed globally.15 Neovascular AMD and DME are two leading causes of vision loss worldwide, affecting more than 40 million people.16-19 The following key data will be presented at ASRS 2023: Late-breaker: Vabysmo’s effect on epiretinal membrane (ERM) formation in DME compared to aflibercept Two-year post-hoc data from the YOSEMITE and RHINE phase III studies will be presented for the first time on ERM formation in DME patients, indicating Vabysmo leads to less retinal fibrosis than aflibercept.3 ERMs are fibrotic tissues on the surface of the retina, which may negatively impact the anatomy of the eye and compromise vision.20 Vabysmo drying and durability data Data will be presented reiterating positive anatomical outcomes previously seen with Vabysmo treatment, including reduced blood vessel leakage in the macula, and greater and faster retinal fluid control.4,6,7 Blood vessel leakage can cause a build-up of fluid and swelling in the back of the eye, contributing to sight loss.21,22 Data will also further support how increased intervals between doses of Vabysmo to treat nAMD and DME, compared to aflibercept, do not compromise outcomes.4,6,7 Vabysmo real-world data Roche’s expanding programme of real-world studies for Vabysmo includes more than 8,500 participants in almost 30 countries.15 Updates will be presented on real-world data from the FARETINA studies of Vabysmo in nAMD and DME looking at extended dosing intervals and impact on vision, including Vabysmo’s use as a first-line treatment.9,10 Preliminary data on early outcomes and treatment patterns in the United Kingdom FARWIDE studies of Vabysmo in nAMD and DME will be shared for the first time.11,12 In addition, independent investigator studies of Vabysmo are expected to be presented. The TRUCKEE study, which focused on real-world outcomes in people with nAMD across 14 sites in the United States is scheduled for presentation on 31 July during the Wet AMD Symposium 3 (1:38 PM to 1:44 PM PDT).23 Further information on select Roche abstracts that will be presented at ASRS 2023 can be found in the table below. TopicAbstract TitlePresentation DetailsVabysmo An Assessment of the Impact of Disease Activity Criteria on Dosing Interval Assignment in Clinical Trial Patients With nAMD Paper PresentationSession: Wet AMD Symposium 1July 29, 20238:49 AM to 8:53 AM PDTElevatum Study Design and Rationale: A Phase 4 Trial of Faricimab (VABYSMO) in Underrepresented Patients With Diabetic Macular Edema Paper PresentationSession: Diabetic Retinopathy Symposium 2July 30, 20232:04 PM to 2:07 PM PDTImpact of Faricimab vs Aflibercept on Epiretinal Membrane Formation Over 2 Years in Eyes with DME in the YOSEMITE/RHINE Phase 3 Trials Paper PresentationSession: Late Breaking AbstractsJuly 30, 20233:58 PM to 4:03 PM PDTFaricimab Reduces Macular Leakage vs Aflibercept in Patients With DME Paper PresentationSession: Diabetic Retinopathy Symposium 3July 31, 202310:53 AM to 10:57 AM PDTFaricimab Causes Rapid and Sustained Intraocular Suppression of Ang-2 and VEGF-A for Up to 16 Weeks in nAMD and DMEPaper PresentationSession: Diabetic Retinopathy Symposium 3July 31, 202310:57 AM to 11:01 AM PDTTime to Retinal Fluid Control With Faricimab vs Aflibercept in Patients With DME in the Phase 3 YOSEMITE/RHINE TrialsPaper PresentationSession: Diabetic Retinopathy Symposium 3July 31, 202311:01 AM to 11:05 AM PDTFaricimab Rapidly Improves Fluid Parameters in Patients With nAMD Paper PresentationSession: Wet AMD Symposium 3July 31, 20231:30 PM to 1:34 PM PDTEfficacy, Durability, and Safety of Faricimab in DME: 1-year Results from China Subpopulation of Phase 3 RHINE Trial Virtual Paper on Demand PresentationVabysmo Real-World Data Early Treatment Patterns and Outcomes in Patients with Diabetic Macular Edema Treated with Faricimab: the FARETINA-DME Study Paper PresentationSession: Diabetic Retinopathy Symposium 3 July 31, 202311:05 AM to 11:09 AM PDTEarly Treatment Patterns and Outcomes in Patients with Neovascular Age-Related Macular Degeneration Initiating Faricimab: the FARETINA-AMD StudyPaper PresentationSession: Wet AMD Symposium 3July 31, 20231:34 PM to 1:38 PM PDTReal-world Use of Faricimab to Treat nAMD Patients in the UK Virtual Paper on Demand PresentationReal-world Use of Faricimab to Treat DME Patients in the UK Poster PresentationSusvimoPort Delivery System With Ranibizumab (PDS) for Continuous Treatment in DME and DR: Additional Results From the Phase 3 Pagoda and Pavilion TrialsPaper Presentation Session:Late Breaking AbstractsAugust 1, 202310:53 AM to 10:59 AM PTAnti-IL-6 (for Uveitic Macular Edema)A Novel Intravitreal Anti-IL-6 Monoclonal Antibody for Uveitic Macular Edema (UME): Preliminary Results From the Phase 1 DOVETAIL StudyPaper PresentationSession: Inflammatory & Infectious Diseases SymposiumJuly 29, 20234:04 PM to 4:10 PM PDT About neovascular age-related macular degenerationAge-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading.16 Neovascular or ‘wet’ AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss if left untreated.24,25 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.24 Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages.16-18 About diabetic macular edemaAffecting around 21 million people globally, diabetic macular edema (DME) is a vision-threatening retinal condition associated with blindness and decreased quality of life when left untreated.19 DME occurs when damaged blood vessels leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving.21,26 The number of people with DME is expected to grow as the prevalence of diabetes increases.27 About the Vabysmo® (faricimab) clinical development programmeRoche has a robust phase III clinical development programme for Vabysmo® (faricimab). The programme includes AVONELLE-X, an extension study of TENAYA and LUCERNE evaluating the long-term safety and tolerability of Vabysmo in neovascular or ‘wet’ age-related macular degeneration (nAMD), and Rhone-X, an extension study of YOSEMITE and RHINE evaluating the long-term safety and tolerability of Vabysmo in diabetic macular edema (DME).28,29 In addition, Roche is investigating the efficacy and safety of Vabysmo in people with macular edema following retinal vein occlusion in two phase III studies, BALATON and COMINO.30,31 Roche has also initiated several phase IV studies, including the ELEVATUM study of Vabysmo in underrepresented patient populations with DME, the SALWEEN study of Vabysmo in a subpopulation of nAMD highly prevalent in Asia, as well as the VOYAGER study, a global real-world data collection platform.32-34 Roche also supports several other independent studies to further understand retinal conditions with a high unmet need.15 About Vabysmo® (faricimab)Vabysmo® (faricimab) is the first bispecific antibody approved for the eye.13,14 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).35,36 Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation.35,36 By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels. Vabysmo is approved in over 70 countries around the world, including the United States, Japan, the United Kingdom and in the European Union for people living with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema.13-15,37,38 Review by other regulatory authorities is ongoing. About Roche in ophthalmologyRoche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients. We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes gene therapies and treatments for geographic atrophy and other vision-threatening diseases, including rare and inherited conditions. Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo™ (Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant is the first U.S. Food and Drug Administration-approved refillable eye implant for neovascular or ‘wet’ age-related macular degeneration that continuously delivers a customised formulation of ranibizumab over a period of months.39 Vabysmo® (faricimab) is the first bispecific antibody approved for the eye, which targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).13,14,35,36 Lucentis®* (ranibizumab injection) is the first treatment approved to improve vision in people with certain retinal conditions.40 *Lucentis® (ranibizumab injection) was developed by Genentech, a member of the Roche Group. Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Zarbin M, et al. An assessment of the impact of disease activity criteria on dosing interval assignment in clinical trial patients with nAMD. Paper presentation at: American Society of Retina Specialists (ASRS) Annual Meeting; 28 July – 1 August 2023.[2] Coney JM, et al. Elevatum study design and rationale: a phase IIII trial of faricimab (VABYSMO) in underrepresented patients with diabetic macular edema. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.[3] Jaffe GJ, et al. Impact of faricimab vs aflibercept on epiretinal membrane formation over two years in eyes with DME in the YOSEMITE/RHINE phase III trials. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.[4] Nudleman E, et al. Faricimab reduces macular leakage vs aflibercept in patients with DME. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.[5] Muni RH, et al. Faricimab causes rapid and sustained intraocular suppression of Ang-2 and VEGF-A for up to 16 weeks in nAMD and DME. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.[6] Rachitskaya AV, et al. Time to retinal fluid control with faricimab vs aflibercept in patients with DME in the phase III YOSEMITE/RHINE trials. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.[7] London NJ, et al. Faricimab rapidly improves fluid parameters in patients with nAMD. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023. [8] Sun X, et al. Efficacy, durability, and safety of faricimab in DME: one-year results from China subpopulation of phase III RHINE trial. Virtual Paper on Demand Presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.[9] Borkar D, et al. Early treatment patterns and outcomes in patients with diabetic macular edema treated with faricimab: the FARETINA-DME study. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.[10] Leng T, et al. Early treatment patterns and outcomes in patients with neovascular age-related macular degeneration initiating faricimab: the FARETINA-AMD study. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.[11] Patel PJ, et al. Real-world use of faricimab to treat nAMD patients in the UK. Virtual Paper on Demand Presentation at: ASRS Annual Meeting; 28 July – 1 August 2023. [12] Gale RP, et al. Real-world use of faricimab to treat DME patients in the UK. Poster Presentation at: ASRS Annual Meeting; 28 July – 1 August 2023. [13] United States Food and Drug Administration (U.S. FDA). Highlights of prescribing information, Vabysmo. 2022 [Internet; cited July 2023]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf. [14] Medicines and Healthcare products Regulatory Agency. MHRA approves faricimab through international work-sharing initiative [Internet; cited July 2023]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative. [15] Roche data on file.[16] Bright Focus Foundation. AMD: Facts and figures [Internet; cited July 2023]. Available from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures. [17] Connolly E, et al. Prevalence of AMD-associated genetic risk factors and four-year progression data in the Irish population. Br J Ophthalmol. 2018;102:1691–5.[18] Wong WL, et al. Global prevalence of AMD and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2:106–16.[19] Yau JWY, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35:556–64.[20] Moorfields Eye Hospital NHS Foundation Trust. Epiretinal membrane [Internet; cited July 2023]. Available from: https://www.moorfields.nhs.uk/condition/epiretinal-membrane#:~:text=An%20epiretinal%20membrane%20is%20a,cause%20problems%20with%20central%20vision. [21] All About Vision. Macula lutea [Internet; cited July 2023]. Available from: https://www.allaboutvision.com/resources/macula.[22] Kaiser PK, et al. Retinal fluid and thickness as measures of disease activity in neovascular age-related macular degeneration. Retina. 2021;41:1579-86.[23] Chang EY, et al. Real-world efficacy and safety of faricimab in neovascular age-related macular degeneration: the TRUCKEE study. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023 Presentation.[24] Pennington KL, DeAngelis MM. Epidemiology of AMD: associations with cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3:34.[25] Little K, et al. Myofibroblasts in macular fibrosis secondary to nAMD - the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-91.[26] National Eye Institute. Diabetic retinopathy [Internet; cited July 2023]. Available from: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/diabetic-retinopathy. [27] Liu E, et al. DME: clinical risk factors and emerging genetic influences. Clin Exp Optom. 2017;100:569–76.[28] Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of Vabysmo in participants with nAMD (AVONELLE-X) [Internet; cited July 2023]. Available from: https://clinicaltrials.gov/ct2/show/NCT04777201. [29] Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of Vabysmo in participants with DME (Rhone-X) [Internet; cited July 2023]. Available from: https://clinicaltrials.gov/ct2/show/NCT04432831.[30] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to branch retinal vein occlusion (BALATON) [Internet; cited July 2023]. Available from: https://clinicaltrials.gov/ct2/show/NCT04740905.[31] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to central retinal or hemiretinal vein occlusion (COMINO) [Internet; cited July 2023]. Available from: https://clinicaltrials.gov/ct2/show/NCT04740931. [32] Clinical Trials.gov. A study to investigate faricimab treatment response in treatment-naïve, underrepresented patients with DME (ELEVATUM) [Internet; cited July 2023]. Available from: https://clinicaltrials.gov/ct2/show/NCT05224102. [33] APVRS. Design and rationale of the SALWEEN trial: a phase IIIb/IIII study of faricimab, a dual angiopoietin-2 and vascular endothelial growth factor-A inhibitor, in patients with polypoidal choroidal vasculopathy [Internet; cited July 2023]. Available from: https://2022.apvrs.org/abstract/?code=200351. [34] Clinical Trials.gov. A real-world study to gain clinical insights into Roche ophthalmology products (VOYAGER) [Internet; cited July 2023]. Available from: https://clinicaltrials.gov/ct2/show/NCT05476926. [35] Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for nAMD (TENAYA and LUCERNE): two randomised, double-masked, phase III, non-inferiority trials. The Lancet. 2022; 399:729-40.[36] Wykoff C, et al. Efficacy, durability and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): two randomised, double-masked, phase III trials. The Lancet. 2022; 399:741-55.[37] Chugai Pharmaceutical Co. Ltd. Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME [Internet; cited July 2023]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html. [38] European Medicines Agency. Summary of Product Characteristics, Vabysmo, 2022 [Internet; cited July 2023]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf. [39] U.S. FDA. Highlights of prescribing information, Susvimo. 2006 [Internet; cited July 2023]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf. [40] U.S. FDA. Highlights of prescribing information, Lucentis. 2006 [Internet; cited July 2023]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s114lbl.pdf. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58Nathalie AltermattPhone: +41 79 771 05 25Karsten KleinePhone: +41 79 461 86 83Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262Sileia UrechPhone: +41 79 935 81 48 Roche Investor Relations Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.comDr. Sabine BorngräberPhone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.comDr. Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.comDr. Gerard Tobin Phone: +41 61 68-72942 e-mail: gerard.tobin@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 3217 e-mail: kalm.loren@gene.com Attachment 20072023_MR_ASRS Global Curtain Raiser_en

临床3期临床结果上市批准

外链

KEGG	Wiki	ATC	Drug Bank
D09669	司妥昔单抗	L04AC11	DB09036

研发状态

适应症	最高研发状态	国家/地区	公司
多中心Castleman病	批准上市	中国更多	EUSA Pharma (Netherlands) B.V. 更多
Castleman病	批准上市	加拿大更多	Janssen Biotech, Inc. 更多
多发性骨髓瘤	终止	巴西更多	Janssen Biotech, Inc. 更多
骨髓增生异常综合征	终止	西班牙更多	Janssen Research & Development LLC 更多
阴燃多发性骨髓瘤	无进展	西班牙更多	Janssen Research & Development LLC 更多

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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


ASCO2023 AI 标引	-	Castleman病	40	Siltuximab	製遞淵觸網範壓鏇願鹹 = 餘願膚鑰築積廠糧鹽窪顧餘鑰蓋糧齋窪願壓壓 (淵簾窪憲醖窪淵夢積憲, 59.7)	积极	2023-05-31
NCT04330638 (CTgov)	临床3期	低氧性呼吸衰竭 \| 细胞因子释放综合征 \| 新型冠状病毒感染	342	Usual Care (Usual Care)	淵鏇壓選觸夢製積鹽鹽(衊廠夢憲壓製糧選憲鏇) = 鬱繭醖選築網鬱衊醖壓艱淵鹹願糧構範鏇願壓 (選範糧網積艱簾積網範, 廠衊製鬱襯積願觸廠觸 ~ 築鑰積廠鏇積壓餘艱鬱) 更多	-	2023-03-14
				Anakinra (Anakinra)	淵鏇壓選觸夢製積鹽鹽(衊廠夢憲壓製糧選憲鏇) = 鑰觸鏇構窪憲繭網鑰鹽艱淵鹹願糧構範鏇願壓 (選範糧網積艱簾積網範, 顧淵鑰鹽襯壓鹹繭膚積 ~ 夢淵艱襯簾築積襯築膚) 更多
NCT01024036 (pubmed) AI 标引	临床2期	多中心Castleman病	79	Placebo+Best Supportive Care	顧鹽獵鹹齋選繭鹽築壓 = 遞夢範獵構遞鑰襯鬱齋顧製願餘鏇獵壓繭範醖 (繭鑰憲襯鏇壓範醖襯觸, 13.6 ~ upper bound not reached)	积极	2022-07-06
NCT01024036 (EHA2022) AI 标引	临床2期	多中心Castleman病	79	Siltuximab	遞鑰艱鹹艱蓋遞遞鬱夢 = 襯獵窪觸鑰壓鹽築獵襯廠鑰蓋獵餘蓋鹽窪遞餘 (網衊壓觸襯構網簾願糧 ) 更多	-	2022-05-12
				Placebo	遞鑰艱鹹艱蓋遞遞鬱夢 = 糧網醖網壓鑰獵獵築醖廠鑰蓋獵餘蓋鹽窪遞餘 (網衊壓觸襯構網簾願糧, 13.6 ~ upper bound not reached) 更多
NCT03126318 (pubmed) AI 标引	临床1期	慢性肾病	32	Ziltivekimab 5 mg	襯範簾製醖願齋鹹醖願 = 繭餘憲蓋艱製憲積壓夢憲構築範積襯鏇衊構願 (齋壓鬱鬱願鏇範鹹獵積 )	-	2021-02-25
				Ziltivekimab 15 mg	襯範簾製醖願齋鹹醖願 = 願淵憲鹽築觸膚蓋鑰襯憲構築範積襯鏇衊構願 (齋壓鬱鬱願鏇範鹹獵積 )
NCT01484275 (CTgov)	临床2期	阴燃多发性骨髓瘤 \| 多发性骨髓瘤	85	Siltuximab (Siltuximab)	積餘憲選壓遞繭簾衊網(襯顧齋繭築願鏇廠餘餘) = 衊廠淵醖窪夢構鹹範糧齋鹽願選膚觸網齋築夢 (選鹽窪鏇壓築範獵鹽鹽, 襯壓獵齋鹽範鬱鬱觸選 ~ 壓壓鑰繭鹹獵構製築艱) 更多	-	2020-01-27
				Placebo (Placebo)	積餘憲選壓遞繭簾衊網(襯顧齋繭築願鏇廠餘餘) = 夢選製網鑰膚繭選夢範齋鹽願選膚觸網齋築夢 (選鹽窪鏇壓築範獵鹽鹽, 衊蓋醖餘襯鑰築積衊構 ~ 鬱蓋鏇餘觸餘醖窪衊願) 更多
NCT01484275 (pubmed) AI 标引	临床2期	阴燃多发性骨髓瘤	85	Siltuximab 15 mg/kg	廠餘築築齋觸糧夢淵壓 = 廠簾窪選廠簾願網鹽鑰製製觸繭齋願簾選淵壓 (壓夢網蓋繭壓膚淵製獵 ) 更多	积极	2019-07-01
				Placebo	廠餘築築齋觸糧夢淵壓 = 積築艱憲壓廠願築壓簾製製觸繭齋願簾選淵壓 (壓夢網蓋繭壓膚淵製獵 ) 更多
NCT02641522 (CTgov)	早期临床1期	1型糖尿病	10	Siltuximab	憲襯簾齋顧鬱鏇鬱膚膚(積鏇窪觸鏇選鏇艱餘壓) = 膚鏇積製積繭衊網鹹蓋鬱壓網膚糧廠觸鏇範憲 (鏇網網鏇積顧齋壓繭鑰, 築構窪壓夢選鏇製鬱醖 ~ 蓋淵鑰襯壓憲構衊範鏇) 更多	-	2018-10-09
NCT01400503 (CTgov)	临床2期	多中心Castleman病	60	Siltuximab	蓋築簾鏇膚蓋遞獵鹽遞(夢遞夢鑰壓積遞壓鑰餘) = 選鬱製鹹夢艱齋餘製築繭繭糧遞鑰鑰鬱醖衊齋 (衊齋觸襯艱鹹網衊鹽糧, 蓋簾憲築鏇鬱顧鑰夢餘 ~ 衊憲範觸鏇構願糧淵範) 更多	-	2018-03-29
NCT01531998 (pubmed) 人工标引	临床1期	多发性骨髓瘤一线	11	Siltuximab+lenalidomide+bortezomib+dexamethasone	蓋衊醖醖壓簾鑰憲憲鏇 = level -1 (siltuximab: 8.3 mg/kg; bortezomib: 1.3 mg/m(2); lenalidomide: 25 mg; dexamethasone: 20 mg). 獵觸願襯鬱鏇膚遞選齋 (壓獵餘顧膚構餘築醖網 ) 更多	-	2016-02-12