更新于：2024-04-26
Teriflunomide
特立氟胺
更新于：2024-04-26
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2012-09-12), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C12H9F3N2O2 |
InChIKeyUTNUDOFZCWSZMS-YFHOEESVSA-N |
CAS号163451-81-8 |
关联
68
项与 特立氟胺 相关的临床试验The Combination of Teriflunomide and High-dose Dexamethasone vs High-dose Dexamethasone Alone as First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia (ITP): A Prospective, Multicenter, Randomized Trial
A randomized, open-label, multicenter study to compare the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).
开始日期2023-12-19 |
申办/合作机构 北京大学人民医院 [+9] |
A Multicenter, Open-label, Randomized, Controlled, Phase 2 Trial Comparing the Efficacy and Safety of Teriflunomide Plus Danazol in Patients With Steroid-resistant/Relapse ITP
To compare the efficacy and safety of teriflunomide plus danazol versus danazol in patients with steroid-resistant/relapse ITP
开始日期2023-12-05 |
申办/合作机构 北京大学人民医院 [+9] |
A Single-arm, Open-label Phase II Study to Determine the Safety and Efficacy of Teriflunomide in Patients With Steroid-resistant/Relapse Thrombocytopenia
Single-arm, open-label, single-center study to evaluate the efficacy and safety of teriflunomide for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).
开始日期2023-12-05 |
申办/合作机构 |
100 项与 特立氟胺 相关的临床结果
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100 项与 特立氟胺 相关的转化医学
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100 项与 特立氟胺 相关的专利（医药）
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983
项与 特立氟胺 相关的文献（医药）2024-12-31·Journal of Medical Economics
Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom
Article
作者: Karabudak, R ; Horakova, D ; Girard, M ; Castillo-Triviño ; Hodgkinson, S ; Gerlach, O ; Gray, O ; Cartechini, E ; de Gans, K ; McCombe, P ; Spitaleri, D ; Solaro, C ; Garber, J ; Sas, A ; Alroughani, R ; Duquette, P ; Prevost, J ; Ramo-Tello, C ; van Pesch, V ; Skibina, O ; Van Wijmeersch, B ; Patti, F ; Aguera Morales, E ; Oreja-Guevara ; Laureys, G ; van der Walt, A ; Shaygannejad, V ; John, N ; Spelman, T ; Gouider, R ; Rajda, C ; Csepany, T ; Izquierdo, G ; Grand'Maison, F ; Trojano, M ; Onofrj, M ; Ozakbas, S ; Jose Sa, M ; Hughes, S ; Soysal, A ; Buzzard, K ; Havrdova, E K ; De Luca, G ; Eichau, S ; Butzkueven, H ; Herring, W L ; Slee, M ; Iuliano, G ; Jokubaitis, V G ; Petersen, T ; Acosta, C ; Lugaresi, A ; Hyde, R ; Pucci, E ; Ferraro, D ; Sanchez-Menoyo, J L ; Moore, F ; Kalincik, T ; Rozsa, C ; Terzi, M ; Granella, F ; Simo, M ; Ampapa, R ; Fragoso, Y ; Bergamaschi, R
AIM:
To evaluate the real-world comparative effectiveness and the cost-effectiveness, from a UK National Health Service perspective, of natalizumab versus fingolimod in patients with rapidly evolving severe relapsing-remitting multiple sclerosis (RES-RRMS).
METHODS:
Real-world data from the MSBase Registry were obtained for patients with RES-RRMS who were previously either naive to disease-modifying therapies or had been treated with interferon-based therapies, glatiramer acetate, dimethyl fumarate, or teriflunomide (collectively known as BRACETD). Matched cohorts were selected by 3-way multinomial propensity score matching, and the annualized relapse rate (ARR) and 6-month-confirmed disability worsening (CDW6M) and improvement (CDI6M) were compared between treatment groups. Comparative effectiveness results were used in a cost-effectiveness model comparing natalizumab and fingolimod, using an established Markov structure over a lifetime horizon with health states based on the Expanded Disability Status Scale. Additional model data sources included the UK MS Survey 2015, published literature, and publicly available sources.
RESULTS:
In the comparative effectiveness analysis, we found a significantly lower ARR for patients starting natalizumab compared with fingolimod (rate ratio [RR] = 0.65; 95% confidence interval [CI], 0.57-0.73) or BRACETD (RR = 0.46; 95% CI, 0.42-0.53). Similarly, CDI6M was higher for patients starting natalizumab compared with fingolimod (hazard ratio [HR] = 1.25; 95% CI, 1.01-1.55) and BRACETD (HR = 1.46; 95% CI, 1.16-1.85). In patients starting fingolimod, we found a lower ARR (RR = 0.72; 95% CI, 0.65-0.80) compared with starting BRACETD, but no difference in CDI6M (HR = 1.17; 95% CI, 0.91-1.50). Differences in CDW6M were not found between the treatment groups. In the base-case cost-effectiveness analysis, natalizumab dominated fingolimod (0.302 higher quality-adjusted life-years [QALYs] and £17,141 lower predicted lifetime costs). Similar cost-effectiveness results were observed across sensitivity analyses.
CONCLUSIONS:
This MSBase Registry analysis suggests that natalizumab improves clinical outcomes when compared with fingolimod, which translates to higher QALYs and lower costs in UK patients with RES-RRMS.
2024-02-13·Neurology
Adverse Events Associated With Disease-Modifying Drugs for Multiple Sclerosis
Article
作者: Fisk, John D ; Zhu, Feng ; Ekuma, Okechukwu ; Yao, Shenzhen ; Marrie, Ruth Ann ; Zhao, Yinshan ; Ng, Huah Shin ; Lu, Xinya ; Tremlett, Helen ; Evans, Charity
BACKGROUND AND OBJECTIVES:
It is not possible to fully establish the safety of a disease-modifying drug (DMD) for multiple sclerosis (MS) from randomized controlled trials as only very common adverse events occurring over the short-term can be captured, and the quality of reporting has been variable. We examined the relationship between the DMDs for MS and potential adverse events in a multiregion population-based study.
METHODS:
We identified people with MS using linked administrative health data from 4 Canadian provinces. MS cases were followed from the most recent of first MS or related demyelinating disease event on January 1, 1996, until the earliest of emigration, death, or December 31, 2017. DMD exposure primarily comprised β-interferon, glatiramer acetate, natalizumab, fingolimod, dimethyl fumarate, teriflunomide, and alemtuzumab. We examined associations between DMD exposure and infection-related hospitalizations and physician visits using recurrent events proportional means models and between DMD exposure and 15 broad categories of incident adverse events using stratified multivariate Cox proportional hazard models.
RESULTS:
We identified 35,894 people with MS. While virtually all DMDs were associated with a 42%-61% lower risk of infection-related hospitalizations, there was a modest increase in infection-related physician visits by 10%-33% for select DMDs. For incident adverse events, most elevated risks involved a second-generation DMD, with alemtuzumab's hazard of thyroid disorders being 19.42 (95% CI 9.29-36.51), hypertension 4.96 (95% CI 1.78-13.84), and cardiovascular disease 3.72 (95% CI 2.12-6.53). Natalizumab's highest risk was for cardiovascular disease (adjusted hazard ratio [aHR] 1.61; 95% CI 1.24-2.10). For the oral DMDs, fingolimod was associated with higher hazards of cerebrovascular (aHR 2.04; 95% CI 1.27-3.30) and ischemic heart diseases (aHR 1.64; 95% CI 1.10-2.44) and hypertension (aHR 1.73; 95% CI 1.30-2.31); teriflunomide with higher hazards of thyroid disorders (aHR 2.30; 95% CI 1.11-4.74), chronic liver disease (aHR 1.94; 95% CI 1.19-3.18), hypertension (aHR 1.76; 95% CI 1.32-2.37), and hyperlipidemia (aHR 1.61; 95% CI 1.07-2.44); and from complementary analyses (in 1 province), dimethyl fumarate with acute liver injury (aHR 6.55; 95% CI 1.96-21.87).
DISCUSSION:
Our study provides an extensive safety profile of several different DMDs used to treat MS in the real-world setting. Our findings not only complement those observed in short-term clinical trials but also provide new insights that help inform the risk-benefit profile of the DMDs used to treat MS in clinical practice. The results of this study highlight the continued need for long-term, independent safety studies of the DMDs used to treat MS.
CLASSIFICATION OF EVIDENCE:
This study provides Class III evidence that for patients with MS, while DMD exposure reduces the risk of infection-related hospitalizations, there are increased risks of infection-related physician visits and incident adverse events for select DMDs.
2024-02-01·Journal of Neurology, Neurosurgery & Psychiatry
Trajectories of cognitive processing speed and physical disability over 11 years following initiation of a first multiple sclerosis disease-modulating therapy
Article
作者: Gunnarsson, Martin ; Piehl, Fredrik ; Fogdell-Hahn, Anna ; Olsson, Tomas ; Longinetti, Elisa ; Nilsson, Petra ; Lycke, Jan ; Englund, Simon ; Mellergård, Johan ; Langer-Gould, Annette Magdalene ; Svenningsson, Anders ; Fink, Katharina ; Frisell, Thomas ; Hillert, Jan ; Burman, Joachim ; Salzer, Jonatan
Background:
We analysed the COMparison Between All immunoTherapies for Multiple Sclerosis (NCT03193866), a Swedish nationwide observational study in relapsing-remitting multiple sclerosis (RRMS), to identify trajectories of processing speed and physical disability after disease-modulating therapy (DMT) start.
Methods:
Using a group-modelling approach, we assessed trajectories of processing speed with oral Symbol Digit Modalities Test (SDMT) and physical disability with Expanded Disability Status Scale, from first DMT start among 1645 patients with RRMS followed during 2011–2022. We investigated predictors of trajectories using group membership as a multinomial outcome and calculated conditional probabilities linking membership across the trajectories.
Results:
We identified 5 stable trajectories of processing speed: low SDMT scores (mean starting values=29.9; 5.4% of population), low/medium (44.3; 25.3%), medium (52.6; 37.9%), medium/high (63.1; 25.8%) and high (72.4; 5.6%). We identified 3 physical disability trajectories: no disability/stable (0.8; 26.8%), minimal disability/stable (1.6; 58.1%) and moderate disability (3.2; 15.1%), which increased to severe disability. Older patients starting interferons were more likely than younger patients starting rituximab to be on low processing speed trajectories. Older patients starting teriflunomide, with more than one comorbidity, and a history of pain treatment were more likely to belong to the moderate/severe physical disability trajectory, relative to the no disability one. There was a strong association between processing speed and physical disability trajectories.
Conclusions:
In this cohort of actively treated RRMS, patients’ processing speed remained stable over the years following DMT start, whereas patients with moderate physical disability deteriorated in physical function. Nevertheless, there was a strong link between processing speed and disability after DMT start.
201
项与 特立氟胺 相关的新闻（医药）2024-04-25
·药渡
来源：药渡撰文：四月的雨 编辑：哦呼近日，fiercepharma公布了2023年度全球药企收入排行TOP20，强生重回榜首，2023年度销售额达852亿美元，同比增长6.5%，而辉瑞由于新冠疫苗Comirnaty和新冠抗病毒药物Paxlovid的销量下降，销售额由2022年的1003亿美元降至585亿美元，下降41%。除上述两家制药公司外，大家熟知的罗氏、默沙东、诺华、GSK以及阿斯利康等公司纷纷入榜，下表1为2023年度全球药企收入排行TOP1-TOP10。表1.2023年度全球药企收入排行TOP1-TOP10TOP1强生2023年收入：851.6亿美元，相比于2022年的799.9亿美元，同比增长6.5%。药物方面，强生最畅销的药物依旧是免疫学药物Stelara，2023年销售额达108.6亿美元，2022年销售额为97.2亿美元。而让强生较为头疼的是，Stelara的专利期仅剩一年，该药物即将面对生物类似药的冲击。除了Stelara之外，强生的银屑病药物Tremfya销售额为31.5亿美元，同比增长18%。为了应对Stelara专利到期，强生预计到2030年将新增20多种上市药物以及50种适应症扩展。TOP2罗氏2023年收入：653.2亿美元，相比于2022年的662.6亿美元，同比下降7.2%。产品方面，2023年新冠相关的收入减少43亿法郎，约48亿美元，但眼病药物Vabysmo成为了罗氏的一匹黑马，在上市第二年Vabysmo的销售额已达到27亿美元，罗氏2023年最畅销产品依旧是多发性硬化症药物Ocrevus，销售额达71.3亿美元。罗氏目前正进行着包含82种新分子实体在内的共146个临床项目，其中肿瘤学是其研发工作的核心领域。TOP3默沙东2023年收入：601亿美元，相比于2022年的593亿美元，同比增长1.4%。谈到默沙东，自然就避不开其核心产品“药王”Keytruda，该药物预计将于2028年专利到期，去年该药物的收入达250亿美元，占默沙东公司总收入的41%。Edward Jones医疗保健分析师John Boylan预计该药物2025年销售额将达到300亿美元。但不可避免的是，一款药物的专利期时长终究是有限的，Keytruda将于2028年在美国和中国失去专利保护，所以默沙东需要找到一种可以替代甚至超越Keytruda的药物来规避专利到期对销售额所带来的的影响。因此默沙东频频出手扩大产品管线，2021年收购Acceleron以及2023年收购Prometheus位列当年生物制药行业并购交易前三名。除了直接收购生物技术外，默沙东公司在10月份还引起了轰动，它预先花费了40亿美元，并承诺支付180亿美元的持续付款和里程碑付款，以获得第一三共公司三种抗体药物偶联物的权利。默沙东在ADC领域动作频频，颇有大展拳脚的架势。全力推进ADC管线的研发，足以见得默沙东对于ADC药物的重视。TOP4辉瑞2023年收入：585亿美元，相比于2022年的1003亿美元，同比下降41%。受新冠疫情影响，辉瑞在2022年大展神威，全年销售额达1003亿美元。而当新冠褪去，辉瑞逐渐回归现实。尽管辉瑞2023年销售额下降41%，但若是去掉新冠药物及疫苗收入后，辉瑞2023年销售额还增长了7%。药物方面，辉瑞的几种关键药物和疫苗正在崛起。RSV疫苗Abrysvo在5月份获得初步批准后，去年创造了8.9亿美元的收入。除了Abrysvo之外，辉瑞的Nurtec ODT在2023年的收入为9.28亿美元，销售额同比增长335%。此外，辉瑞的心脏病药物Vyndaqel和Vyndamax继续保持强劲的势头，2023年销售额达33亿美元，同比增长36%。交易方面，辉瑞也是出手阔绰。2023年5月，辉瑞斥资430亿美元收购ADC药企Seagen，以扩大其肿瘤业务，该交易于2023年12月完成。Seagen目前已批准了25种癌症药物，涵盖40多种适应症，其中九种药物是重磅药物或有潜力成为重磅药物（年销售额达10亿美元）。TOP5艾伯维2023年收入：543亿美元，相比于2022年的581亿美元，同比下降6%。艾伯维在2013年开始崭露头角，仅用10年时间便位列全球制药企业前5名，完成这一大壮举很大程度上要归功于修美乐（Humira）。但修美乐从2023年初开始就面临美国生物类似药的竞争。随着多家企业推出生物类似药，修美乐市场份额被不断瓜分，2023全年销售额同比下降32%。修美乐专利到期，寻找到新的继任者则至关重要。免疫学药物Skyrizi（瑞莎珠单抗）和Rinvoq作为双子星，可以一定程度上弥补修美乐专利到期所造成的影响。2023年，Skyrizi的销售额为77亿美元，同比增长50%，Rinvoq销售额为39亿美元，同比增长57%。两者销售额共计超过100亿美元，到2027年将超过修美乐达到270亿美元的峰值收入。尽管如此，目前这对组合的强劲表现仍不足以抵消修美乐销售额下滑带来的影响。为应对修美乐专利到期，艾伯维屡屡完成重大交易。2019年，艾伯维以630亿美元收购Allergan，2023年以101亿美元收购了ADC药物公司ImmunoGen，一周后，艾伯维又以87亿美元收购Cerevel Therapeutics的交易，以加强神经领域产品管线。TOP6赛诺菲2023年收入：466亿美元，相比于2022年的452亿美元，同比增长0.2%。与默沙东的处境相类似，赛诺菲也对一款药物严重依赖，这款药物就是这Dupixent（度普利尤单抗）。Dupixent由再生元和赛诺菲联合开发，2023年销售额为115.88亿美元，同比增长33%，自2017年首次获得FDA批准用于治疗特应性皮炎以来，其商业势头持续强劲，该药物约占赛诺菲收入的25%。除此之外，赛诺菲的多发性硬化症药物Aubagio在2023年收到仿制的冲击，销售额暴跌53%至9.55亿欧元。疫苗组中，赛诺菲和阿斯利康针对婴儿的新型RSV抗体Beyfortus去年为赛诺菲分得5.47亿欧元，随着使用量的持续增加，今年的Beyfortus销售额将超10亿美元。TOP7阿斯利康2023年收入：458.1亿美元，相比于2022年的443.5亿美元，同比增长3.3%。早在2014年，阿斯利康就制定了2023年实现450亿美元收入的目标，如今也是按照预期实现了这一目标。产品方面，肿瘤领域药物再次实现最大增长，销售额达到171亿美元，增长20%，其中还不包括第一三共的抗体药物偶联物Enhertu带来的约10亿美元的收入。除了Enhertu之外，AZ（AstraZeneca，阿斯利康）的免疫肿瘤药物组合Imfinzi和Imjudo合计销售额达42亿美元，同比增长55%。在AZ的肿瘤产品中，最火热的药物仍属于Tagrisso，该药物销售额为58亿美元，同比增长9%。而AZ的头把交椅给到了SGLT2抑制剂Farxiga，2023年Farxiga销售额达近60亿美元。交易方面，为了进一步加强其在代谢疾病领域的地位，AZ于2023年11月同意向中国的Eccogene公司支付1.85亿美元购买口服GLP-1激动剂，AZ认为该药物具有很大的潜力。TOP8诺华2023年收入：454.4亿美元，相比于2022年的422.1亿美元，同比增长7.7%。诺华公司去年剥离其仿制药和生物类似药业务山德士后，成为一家纯粹的创新药物公司。由于分拆，诺华的报告销售额下降，其在全球最大制药公司中的排名也下降。2023年，诺华收入达454亿美元，而山德士的净销售额为96亿美元。产品方面，其心脏病药物Entresto和多发性硬化症注射剂Kesimpta贡献了最多的销售额，分别为60亿美元和20亿美元。除此以外，Pluvicto以及CDK4/抑制剂Kisqali也引起了大家的关注。诺华于 2022年底首次报告称，Pluvicto治疗早期前列腺癌的PSMAfore试验已达到目标。Kisqali更是预计在转移性疾病领域的销售额能够达到40亿美元，在辅助治疗领域的销售额超过30亿美元。此外，诺华的siRNA药物PCSK9抑制剂Leqvio获批上市，2023年销售额约为4亿美元。在并购方面，诺华去年以32亿美元收购了Chinook Therapeutics。随后的3期临床结果显示，该交易的核心产品Atrasentan已达到治疗IgA肾病的主要终点。诺华还预付了5亿美元购买了专注于siRNA的DTx Pharma，其中包括针对遗传性神经肌肉疾病的临床前治疗，目前尚无批准的药物可用于治疗这种疾病。RNA、放射性配体、细胞和基因治疗是诺华除传统小分子和生物制剂之外重点发展的三个技术平台。TOP9百时美施贵宝2023年收入：450亿美元，相比于2022年的462亿美元，同比下降2%。受专利悬崖和未来与通货膨胀削减法案 (IRA) 相关的影响，当前的百时美施贵宝正处于过渡期。与辉瑞合作的血液稀释剂Eliquis被列为首批医保谈判的10种药物之一，在这种影响下，百时美施贵宝坚守住了阵地。2023年Eliquis的全球销售额为122 亿美元，同比增长4%。仅在美国，销售额就增长了10%，达到86亿美元。但由于将于2026年生效的新IRA定价，这一增长速度可能很快就会放缓。除了Eliquis之外，来那度胺仍然是卖的最火热药物之一，2023年销售额为60亿美元。此外，BMS的PD-1抑制剂Opdivo在2023年贡献了90亿美元的销售额，加上小野制药报告的该药物的1481亿日元（10 亿美元）销售额，该药物突破了100亿美元销售额大关。TOP10葛兰素史克2023年收入：384亿美元，相比于2022年的361亿美元，同比增长3.4%。疫苗是葛兰素史克增长的动力之一，带状疱疹疫苗Shingrix在2023年销售额达34亿英镑，RSV疫苗Arexvy获FDA批准，这是世界上首款针对60岁及以上成年人的RSV疫苗。Arexvy在上市当年就创造了12亿英镑的收入，GSK预计Arexvy的峰值销售额将达到30亿英镑。除了Arexvy之外，葛兰素史克的口服贫血药物Jesduvroq去年获得FDA批准，成为首个进入美国市场治疗慢性肾病的HIF-PH抑制剂。交易及并购方面，葛兰素史克去年斥资20亿美元收购了Bellus Health，并获得了临床3期P2X3拮抗剂camlipixant。小结以上就是2023年度全球药企收入排行TOP20中的前十名，由于文章篇幅有限，第11-20名将在下篇文章中介绍，谁会成为你心中的Number one？参考文献[1]https://www.fiercepharma.com/pharma/top-20-pharma-companies-2023-revenue*声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！点击下方“药渡“，关注更多精彩内容FDA正式发声，黑框警告下的CAR-T疗法2024年值得关注的5个细胞和基因治疗决策TPD技术最新发展：溶酶体或蛋白酶体直接参与的靶向蛋白质降解点击蓝字 关注我们
专利到期并购抗体药物偶联物生物类似药疫苗
2024-04-19
关注并星标CPHI制药在线 在关注新药上市的同时，III期临床失败的案例也是医药领域值得关注的重点内容。如何正确解读这些失败的III期临床结果也为将来的后续研究提供关键指导。 • Relyvrio Amylyx Pharmaceuticals 的ALS（肌萎缩侧索硬化症）药物Relyvrio曾经给患者带去巨大的希望，然而其上市后验证性研究的失败也令这款兴勃亡忽的药物开发萧瑟落幕。 Relyvrio 在2022 年凭借其II期临床晦涩的实验数据有些意外地获得了FDA加速批准，当时Amylyx 已向 FDA 保证，如果批准后试验失败，他们将主动撤市。 Relyvrio的失败早有迹象，它的II期研究CENTAUR结果虽然获得了统计上的显著性，但临床益处并不明显。Relyvrio 的II 期 CENTAUR 研究使用ALSFRS-R评分系统作为对主要终点的评判标准，获得了0.03的p值，效应大小约为0.4。考虑到基于小样本的统计数据，这样的结果并不能让人完全心安。事实也验证了人们当初的担忧，在规模大得多的 PHOENIX III期研究中，所有主要终点（与安慰剂相比，ALS 功能评定量表的改善）和次要终点（患者自我报告、呼吸功能、总体生存率等）均未达到。在报告III期结果之后几周，Amylyx 就言出必行地将Relyvrio的加速批准撤回，同时裁员70%。 所幸的是，Relyvrio是一种"单纯"的无效药物，在安全性上并不存在问题。然而其每年15.8万美元的标价背后，是被行业内部人戏谑为"还不如薄荷糖"的天价药物，而且有效成分也是两个结构非常简单的小分子苯丁酸钠和taurursodiol。Relyvrio的2023年销售额为3.81亿美元，纯利润4900万美元。 • Evobrutinib 布鲁顿酪氨酸激酶 (BTK) 抑制剂已经在肿瘤学产品领域获得成功，Genentech 的 Rituxan 等药物已经重磅炸弹加身。人们希望BTK抑制剂能够在多发性硬化症"树上开花"。这样的愿景引发了一系列相关研发，催生了诸如赛诺菲2020 年37 亿美元收购 Principia Biopharma 的交易。 然而Merck KgaA的努力并没有完成"抟扶摇而上"的理想，他们的BTK抑制剂候选药物evobrutinib鲲鹏展翅的希望在两项III期试验 (evolutionRMS 1 和 evolutionRMS 2) 失败面前严重受挫。这些研究将evobrutinib与赛诺菲的 Aubagio (teriflunomide) 进行比较，但结果显示，evobrutinib在减少复发性多发性硬化症的终点上不优于对照药物。Merck KgaA在公布结果的第二天，他们的股价在法兰克福证券交易所中下跌 14%，创 2009 年以来最大跌幅，市值蒸发超过 50 亿欧元。 Jefferies的一位分析师在一份报告中指出，Merck KGaA的失败可能是由于试验招募了更健康的患者，总体上复发率较低。Merck KGaA发布的结果显示evobrutinib对复发性多发性硬化症具有疗效，但并不能减缓疾病进展。BTK抑制剂在与Aubagio相比，要显示出在年复发率(ARR)上的优势是比较困难的。关键原因在于evobrutinib的研究可能招募了基线复发较少或无症状病变的患者，无意中提高了阈值。随着时间的推移，研究的纳入标准变得不那么严格，研究人员可能倾向于招募"处于炎症活动阈值底端的患者"，而不是招募那些已经在服用有效药物且疾病程度较高的患者。这意味着入组evolutionRMS ½ 研究的多发性硬化症患者群体可能更加健康。 虽然evobrutinib已公布的III期数据不利，但这并不意味着这款候选药的完结。从基本机制的角度来看，药物必须真正渗透到中枢神经系统才能真正减缓多发性硬化症症状。目前可用的多发性硬化症药物，例如单克隆抗体，很少能够穿过血脑屏障并做到这一点。相比而言，小分子的BTK 抑制剂可以更容易地穿过血脑屏障， 因此evobrutinib缓解多发性硬化症的希望依然存在，需要等待完全数据的公布。Evobrutinib输掉了一场战役，但并没有失去战争获胜的希望。 • Pimavanserin Acadia Pharmaceuticals 3月11日宣布，针对精神分裂症阴性症状疗法Pimavanserin（Nuplazid）的3期临床试验ADVANCE-2未能达到主要终点。ADVANCE-2研究的主要终点是 NSA-16（阴性症状评估-16）总分从基线到第 26 周的变化。第26周治疗组和安慰剂组的 NSA-16 评分变化分别为 -11.8% 和 -11.1%，治疗效果没有统计显著性。Nuplazid是一种非典型抗精神病药，用于治疗与帕金森病相关的精神病引起的幻觉和妄想，它是该适应症的唯一获批药物，于2016年4月29日获得FDA的监管审批。Acadia希望将其适应症扩大到精神分裂症，但其III期研究ADVANCE-2的数据显示p值=0.48；效应大小（Cohen's d）= 0.07，无论从统计角度还是实际疗效角度来看都不具备显著性。不仅p值从统计学角度不显著，而且效应大小也显示了这款药物在实际疗效上与安慰剂几乎无异。 • Olaparib（Lynparza） 默沙东近期宣布了他们的PD-1疗法Keytruda联合PARP抑制剂Lynparza（olaparib）的III期KEYLYNK-006试验失败。这款联合疗法作为一线疗法针对转移性非鳞状非小细胞肺癌（NSCLC）的研究未能到达总生存期和无进展生存期的双重主要终点。 除此之外，默沙东在2023年12月还终止了Keytruda + Lynparza治疗转移性鳞状非小细胞肺癌的III期研究。研究显示，患者接受Keytruda + Lynparza治疗，相对于Keytruda+安慰剂并没有显示出总生存期的改善，无进展生存期也缺乏统计学显著性。 此前的2022年8月，默沙东宣布Keytruda的两项III期临床试验未能达到终点。一项研究使用的是Keytruda与卫材的lenvatinib (Lenvima)的联合疗法，治疗新诊断的肝癌。另一项失败的III期研究是Keytruda + Lynparza 治疗转移性去势抵抗性前列腺癌。 • Enspryng 3月21日，中外制药公布了Enspryng（satralizumab-mwge）治疗全身性重症肌无力（gMG）的III期LUMINESCE研究结果。尽管其主要终点具有统计学显著性，但研究结果并未达到预期的临床获益水平。 Enspryng 是一种白细胞介素 6 (IL-6) 受体拮抗剂，于 2020 年 8 月获得美国 FDA 批准，用于治疗抗水通道蛋白 4 (AQP4) 抗体呈阳性的神经和脊髓视神经炎光谱障碍 (NMOSD) 成人患者。随后，2021年5月，satralizumab在中国获批上市，成为国内第一个治疗视神经脊髓炎谱系障碍的药物。中外制药表示，全身性重症肌无力的研究结果并不影响 Enspryng 在 NMOSD 患者中的使用。该公司还在开发 Enspryng 用于其他神经自身免疫性疾病和炎症性疾病。 DATA如何审查临床实验数据 主要终点是临床试验用来评估是否有效的第一结果。次要终点就是治疗有效性的额外衡量标准。 在评价临床试验是否成功时，第一决策点是主要终点的p值。P 值是统计显著性的度量。临床研究中，统计学显著性的阈值通常设定为0.05（5%），这是预设的显著性水平 (significance level, α) 决定的。小于α的p值被认为具有统计显著性，而大于它的p值则认为不具统计显著性。这是判断临床研究是否失败的主要依据之一。如果主要终点的p值大于显著性水平，那么临床研究人员通常会去检查次要终点的p值。如果次要终点的p值也大于显著性水平的话，那么研究人员可能会有两种选择。一是宣告临床研究的失败，二是求诸spin。临床研究结果的 spin指的是以一种不完全或者有偏见的方式呈现研究结果，使得研究结果看起来更加正面，以影响受众的理解或者看法。这种做法可能会夸大结果的重要性或影响，或者试图隐藏研究结果中的不利部分。图1. 从主要终点和次要终点p值定性临床结果的decision tree。（图片来源：STAT） 当主要终点未能达到统计显著性但次要终点达到统计显著性时，就会出现复杂的情况。如果研究者宣布其研究的治疗方法有效，这种行为也有可能被视为SPIN的一种延申。 需要强调的是，在解读临床数据时将p值奉为圭臬的做法也是一种常见的错误。尽管p值决定统计显著性，但不应该一叶障目地完全凭借p值来解读临床试验。在现实世界中，p值达到了统计显著性而被FDA否决的项目也并不罕见。FDA更重视的是临床益处，即现实显著性，而统计显著性是另一个维度供参考的结果。 如果单一终点未能达到显著性标准，采取复合终点（composite endpoint）是另一种spin的手段。例如，2001 年的一项试验将高血压药物irbesartan（一种血管紧张素受体拮抗剂）与安慰剂对糖尿病肾病患者进行比较，其主要终点就是这样一个复合终点，包括死亡、终末期肾病、需要肾移植、一些心血管措施 ，以及血清肌酐水平增加（后者是肾功能血液生物标志物，通常越低越好）。研究人员报告称，治疗的主要复合终点（primary composite endpoint）风险相对于安慰剂降低了 20%，相对于对照药物amlodipine (Norvasc) 治疗的患者降低 23% ，对应p 值分别为 0.02 和 0.006，满足通常的统计显著性。 乍一看，这似乎是成功的：试验达到了主要终点。但当你逐个检查主要复合终点中的单项时就会发现问题。 Irbesartan血清肌酐增加的风险的确比安慰剂组低 33%（P=0.003），比amlodipine组低 37%（P<0.001），具有统计学意义。然而终末期肾病风险降低并无统计学意义。对于死亡率或心血管指标也没有统计学上显著益处。导致Irbesartan"看上去很美"的因素只是肌酐一项。也就是说，复合终点的统计显著结果几乎完全由血清肌酐水平这一项生物标志物驱动，而不是人们期望的真正临床益处：即保持生命、不需要肾移植、避免终末期肾病。由于复合终点有可能将真正重要指标的无效性隐介藏形，因此人们在面对这样的终点解读时一定需要谨慎对待。 另外一个常见的临床结果解读误区，是仅仅看重"相对优势"数据，而无视其绝对效果。绝大多数临床试验以相对方式报告结果，即治疗组与安慰剂或标准治疗组相比。这在本质上对于批准新药来说并没有问题，但如果只关注相对疗效而忽视绝 对效果的话，就可能导致"谬之千里"的似是而非。例如在 2003 年一项著名的大型研究中，研究者比较了两种高血压药物，他们给一半的参与者服用血管紧张素转换酶抑制剂（ACE 抑制剂），另一半服用利尿剂，并计算了每个人在一段时间内（中位数4.1年）经历了多少次中风和其他高血压相关事件。他们得出结论是，服用 ACE 抑制剂"似乎会带来更好的结果"。临床结果看起来可以支持这一结论：ACE 组每 100 名患者年（patient year, 医学统计学术语，用于表示研究中患者在观察期内的累积时间总和）有 4.2 例中风和其他"事件"，利尿剂组有 4.6 例，相对风险降低了 11%。但11%在具体的环境中有多大的实际临床益处？每 100 名"患者年"仅降低0.4 次不良事件是否具有实际显著性？这意味着每名患者必须活到 250岁才能少发生一次中风。相对于11%的"相对数据"，这个250年少一次（即千年少四回）的绝对数据才是更值得关注的评估依据。 Ref. Lowe, D. An ALS Drug Fails. Again. Science. 08. 03. 2024. Johnson, A. Here's Why ALS Drug Relyvrio Is Being Removed From Market-And What That Means For Patients. Forbes. 04. 04. 2024. Kraemer, J. et al. Bruton tyrosine kinase inhibitors for multiple sclerosis. Nature Reviews Neurology. 2023. 19, 289-304. Neimark, J. Experts Take a 'Wait and See' Approach as BTK Inhibitors Stumble in MS. BioSpace. 29. 01. 2024. Loh, T. Merck KGaA's Multiple Sclerosis Drug Fails Final-Stage Studies. Bloomberg News. 05. 12. 2023. Gardner, J. Roche autoimmune disease drug disappoints in closely watched trial. Biopharma Dive. 21. 03. 2024. Summary of Global Clinical Trial Failures in March 2024. Synapse. 12. 04. 2024. Parrish, M. 3 big recent trial flops. Pharma Voice. 12. 04. 2024. STAT's Guide To Interpreting Clinical Trial Results. STAT. Retrieved on 14. 04. 2024.【智药研习社近期直播预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~
临床3期财报并购加速审批临床失败
2024-04-18
NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), announced that it has been awarded a national contract with the Department of Veterans Affairs (VA) for BRIUMVI® (ublituximab-xiiy) to be the preferred agent listed on the VA National Formulary for Anti-CD20 Antibody indications for patients with relapsing forms of multiple sclerosis (RMS).
Michael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics stated, “We are immensely proud to collaborate with the National VA Health System in bringing BRIUMVI to Veterans across the country afflicted with RMS at a significant discount. We believe this contract signifies a vote of confidence in the value that BRIUMVI brings to patients with RMS and are pleased that Veterans with MS will now have access to the only anti-CD20 therapy that offers a one-hour twice a year therapy, following the first dose.”
The contract period includes the base year ordering period of June 17, 2024 to June 16, 2025, as well as four one-year option periods that may be exercised unilaterally by the U.S. Government. Pursuant to the contract, BRIUMVI will be required for new patient starts unless clinically contraindicated. While not required, patients currently prescribed other agents in the anti-CD20 class may be switched over to BRIUMVI at the discretion of their doctor. The total award amount of the contract has a potential value of $186,776,520. This potential value assumes all MS patients estimated to be treated with anti-CD20 therapies by the VA annually, are treated with BRIUMVI each year for a five-year period at the contract price.
ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.
BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
A list of authorized specialty distributors can be found at .
IMPORTANT SAFETY INFORMATION
Contraindications: BRIUMVI is contraindicated in patients with:
Active Hepatitis B Virus infection
A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS
Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.
Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.
Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.
Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.
Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for surface premedantigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.
Progressive Multifocal Leukoencephalopathy (PML): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies.
If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.
If PML is confirmed, treatment with BRIUMVI should be discontinued.
Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.
Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.
Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.
Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.
Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.
Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit .
ABOUT BRIUMVI PATIENT SUPPORT
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at .
ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1
ABOUT TG THERAPEUTICS
TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit , and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn.
BRIUMVI® is a registered trademark of TG Therapeutics, Inc.
Cautionary Statement
This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below.
Such forward looking statements include but are not limited to statements regarding expectations for the commercial launch of BRIUMVI® (ublituximab-xiiy) for RMS in the United States; anticipated healthcare professional (HCP) and patient acceptance and use of BRIUMVI for the approved indications; and the potential impact of the contract awarded by the Department of Veterans Affairs.
Additional factors that could cause our actual results to differ materially include the following: the Company’s ability to continue to maintain a commercial infrastructure for BRIUMVI, and to successfully market and sell BRIUMVI; the failure to maintain the contract with the VA; the risk that the VA does not exercise any or all of the option year periods; the risk that the total potential award amount from the contract with the VA is not realized due to a high degree of expected variability in the assumptions that underly the total contract amount, including but not limited to, the VA does not exercise their option to continue the contract beyond year one, the total number of estimated MS patients treated by the VA with an anti-CD20 therapy each year is less than estimated, that fewer than all patients new to anti-CD20 will go on BRIUMVI and fewer than all the patients currently treated with an anti-CD20 at the VA will be switched to BRIUMVI, and the projected vial count per patient per year is less than assumed by the VA; the risk that HCP or patient interest in BRIUMVI will not be sufficient; the risk that the Company’s BRIUMVI U.S. net revenue targets will not be achieved; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements, the potential for variation from the Company’s projections and estimates about the potential market for BRIUMVI due to a number of factors, including, further limitations that regulators may impose on the required labeling for BRIUMVI (such as modifications, resulting from safety signals that arise in the post-marketing setting or in the long-term extension study from the ULTIMATE I and II clinical trials); the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain, pharmacovigilance, and sales and marketing); the Company’s reliance on third parties for manufacturing, distribution and supply, and other support functions for its clinical and commercial products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; and general political, economic and business conditions. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in our other filings with the SEC.
Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at . The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
CONTACT:
Investor Relations
Email: ir@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 4
Media Relations:
Email: media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6
1. MS Prevalence. National Multiple Sclerosis Society website. . Accessed October 26, 2020.
2. Multiple Sclerosis International Federation, 2013 via Datamonitor p. 236.
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研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 多发性硬化症 | 批准上市 | 中国 更多 | |
| 复发-缓解型多发性硬化 | 批准上市 | 欧盟 更多 |  Mylan NV更多 |
| 放射学孤立综合征 | 临床3期 | 法国 更多 | |
| 复发性多发性硬化 | 临床3期 | 黎巴嫩 更多 | |
| 流感病毒感染 | 无进展 | - |
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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 |
|---|
N/A | 325 | Teriflunomide | 繭觸膚網壓願製構醖願(淵製廠衊鬱網齋鬱選壓) = DMT-naive experienced a greater and significant reduction (improvement) in psychological MSIS-29 score at month 24 compared to switch group 艱壓築艱鏇鏇蓋簾衊鹽 (繭壓艱鬱繭餘齋衊製憲 ) | 积极 | 2023-04-25 | ||
Teriflunomide | |||||||
临床3期 | 166 | 簾選鏇網範蓋窪鏇製膚(築積鹽鑰壓衊膚窪廠鏇) = 齋觸願憲窪鏇齋鹽襯鹹 簾積積遞憲齋範夢壓選 (築製網築鬱襯鏇淵鬱範 ) | - | 2023-01-12 | |||
Placebo | 簾選鏇網範蓋窪鏇製膚(築積鹽鑰壓衊膚窪廠鏇) = 艱衊積鹹淵鹹繭襯齋壓 簾積積遞憲齋範夢壓選 (築製網築鬱襯鏇淵鬱範 ) | ||||||
临床4期 | 55 | 獵遞醖夢衊顧鹽積淵夢(鏇構鹹鹹淵選窪衊繭網) = 衊選構夢糧繭齋鏇齋構 糧衊遞鹽餘觸築築蓋獵 (選鏇鬱夢鹹簾餘選網構, 夢壓築鹽網遞鹽壓選範 ~ 鏇艱淵選範糧醖選鹹醖) 更多 | - | 2022-10-20 | |||
N/A | 24 | 廠觸積繭願鏇鬱網襯鏇(夢獵淵簾積艱遞糧鑰鬱) = 觸廠獵壓繭醖獵選膚簾 憲遞鑰遞鏇襯顧遞廠餘 (繭鹹窪構積憲衊築簾壓 ) 更多 | 积极 | 2022-06-01 | |||
N/A | 217 | 襯願觸繭願繭廠鑰鏇製(選願選鏇鹹鏇衊構窪鹽) = 獵艱廠艱鬱築觸築願廠 壓鏇艱醖膚鹹餘製齋製 (積鹹憲蓋製壓糧顧衊膚 ) 更多 | 积极 | 2022-04-11 | |||
临床3期 | 1,133 | 鹽壓構積夢鹹簾顧衊鬱(餘壓選窪遞艱鏇鏇艱鬱) = 齋廠膚衊醖構鏇範襯願 築顧顧衊顧襯壓鏇糧顧 (遞願鑰鑰製製廠餘獵網 ) | 优效 | 2021-05-01 | |||
鹽壓構積夢鹹簾顧衊鬱(餘壓選窪遞艱鏇鏇艱鬱) = 構齋壓糧餘醖鑰遞廠選 築顧顧衊顧襯壓鏇糧顧 (遞願鑰鑰製製廠餘獵網 ) | |||||||
N/A | 176 | Teriflunomide-treated patients with MS and confirmed COVID-19 infection | 廠顧遞餘選襯觸糧蓋鏇(鹽鏇鹽鹽鹹齋蓋鬱鏇遞) = 積鑰衊鹽襯獵鹽衊鏇網 夢鹹網鑰顧積蓋鹹淵製 (鹽網窪築繭構齋繭夢膚 ) 更多 | 积极 | 2021-04-13 | ||
Teriflunomide-treated patients with MS and suspected COVID-19 infection | 廠顧遞餘選襯觸糧蓋鏇(鹽鏇鹽鹽鹹齋蓋鬱鏇遞) = 憲顧膚鹽網鑰構壓鹹醖 夢鹹網鑰顧積蓋鹹淵製 (鹽網窪築繭構齋繭夢膚 ) 更多 | ||||||
临床3期 | 751 | 築醖淵醖蓋鏇選廠範鑰(鑰構鹹積膚觸築鑰遞醖) = low and stable over time 淵夢齋築鬱糧壓鹹鑰築 (鹹鑰鑰繭積鏇廠醖願積 ) | 积极 | 2020-11-01 | |||
临床2/3期 | - | (Treatment naive) | 積醖顧範襯築餘鹽構選(觸醖觸鏇齋醖憲遞餘夢) = 獵簾網淵膚製顧醖廠築 製夢艱鑰憲糧糧鬱構蓋 (願醖鏇蓋顧夢憲鹹糧廠 ) | - | 2020-10-06 | ||
(Previously treated with another DMT) | 積醖顧範襯築餘鹽構選(觸醖觸鏇齋醖憲遞餘夢) = 鏇顧窪鹹獵鬱餘鹹艱築 製夢艱鑰憲糧糧鬱構蓋 (願醖鏇蓋顧夢憲鹹糧廠 ) | ||||||
N/A | JCPyV | - | 觸蓋鑰遞築鹽襯淵膚醖(獵築築遞廠醖襯簾衊糧) = Teriflunomide reduced cell proliferation of most cell lines tested, with minimal impact on cell viability 網顧窪積遞網壓鹽壓窪 (網積蓋製蓋艱鹹廠製獵 ) | - | 2020-04-14 | ||
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