阿贝莫司钠(Abetimus sodium) - _专利_临床

概要

基本信息

药物类型

寡核苷酸

别名

Abetimus、Abetimus sodium (USAN)、Riquent

+ [2]

靶点-

作用机制

免疫抑制剂

治疗领域

免疫系统疾病皮肤和肌肉骨骼疾病泌尿生殖系统疾病

在研适应症-

非在研适应症

狼疮性肾炎

原研机构

La Jolla Pharmaceutical Co.

在研机构-

非在研机构

La Jolla Pharmaceutical Co.Baxter Pharmaceutical Solutions LLC

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)终止

特殊审评孤儿药 (美国)

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结构/序列

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Sequence Code 29607834

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Sequence Code 30177267

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关联

5

项与阿贝莫司钠相关的临床试验

EUCTR2006-000674-73-BG

/ Not yet recruitingN/A

A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease

开始日期2008-08-14

申办/合作机构

La Jolla Pharmaceutical Co.

SLCTR/2008/006

/ TerminatedN/A

A randomized, double blind, placebo-controlled, three arm, parallel group, multicenter, multinational safety and efficacy trial of 300 mg and 900 mg of abetimus sodium in systemic lupus erythematosus (SLE) patients with a history of renal disease

开始日期2008-04-07

申办/合作机构

La Jolla Pharmaceutical Co.

NCT00390091

/ Withdrawn临床2期

A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetic and Pharmacodynamic Effects of Abetimus Sodium in Patients With Systemic Lupus Erythematosus (SLE)

The primary purpose of this study is to assess the safety and pharmacodynamic effect of LJP 394 at doses of 100 mg, 300 mg and 900 mg on anti-dsDNA antibody levels in patients with SLE.

开始日期2006-09-01

申办/合作机构

La Jolla Pharmaceutical Co.

100 项与阿贝莫司钠相关的临床结果

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100 项与阿贝莫司钠相关的转化医学

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100 项与阿贝莫司钠相关的专利（医药）

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48

项与阿贝莫司钠相关的文献（医药）

2018-10-01·Seminars in Arthritis and Rheumatism2区 · 医学

Systematic review, and meta-analysis of steroid-sparing effect, of biologic agents in randomized, placebo-controlled phase 3 trials for systemic lupus erythematosus

2区 · 医学

Review

作者: Shereen Oon ; Timothy Godfrey ; Mandana Nikpour ; Molla Huq

OBJECTIVESTo systematically review, and conduct a meta-analysis of steroid-sparing effect in, phase 3 randomized, placebo-controlled trials of biologic therapies for systemic lupus erythematosus (SLE).METHODSStudies were identified by searching Medline (via Pubmed), EMBASE, CINAHL and SCOPUS databases, the Cochrane library, and clinicaltrials.gov. Adult human studies published in English in the last ten years (until 18/04/2017) were included. A random-effects meta-analysis comparing a common corticosteroid-reduction endpoint in the trials of rituximab, belimumab, tabalumab and epratuzumab in SLE, was conducted.RESULTSTwenty-eight studies were identified; nine were conducted in SLE, five in lupus nephritis and the remaining 14 were post hoc analyses of phase 3 trials in SLE. All therapies trialed targeted B-cells (rituximab (anti-CD20 monoclonal antibody (mAb)), belimumab (anti-BAFF mAb), tabalumab (anti-BAFF mAb), epratuzumab (anti-CD22 mAb), atacicept (TACI-Ig), ocrelizumab (anti-CD20 mAb)), except for abetimus sodium and abatacept (CTLA4-Ig). Only the three trials of belimumab met their primary endpoints, although benefit in secondary endpoints and reduction in serological activity was often seen in the other studies. Meta-analysis showed that most therapies (belimumab, tabalumab, and epratuzumab) had a steroid-sparing effect, compared to placebo (pooled RR 1.36 (1.19, 1.56), I² = 0, p < 0.67). Therapies were generally well tolerated; however, three studies were terminated prematurely due to serious side effects.CONCLUSIONSWith the exception of belimumab, none of the phase 3 trials of biologic therapy in SLE have met their primary endpoint. However, the significant steroid-sparing effect of these agents suggests that future trials may need to include steroid dose in a composite primary endpoint.

2011-09-01·The Journal of Rheumatology

Generic Versus Disease-specific Measures of Health-related Quality of Life in Systemic Lupus Erythematosus

Communications

作者: CHU, ALVINA D. ; STRAND, VIBEKE

Systemic lupus erythematosus (SLE) is an autoimmune inflammatory disease that significantly affects health-related quality of life (HRQOL): physical, psychologic, mental, and social aspects of well-being that are influenced by disease, in the context of life experiences and expectations specific to each patient1. A relapsing, remitting chronic disease, SLE results in disability in 20%–40% of afflicted young and middle-aged women and men2. In patients with SLE, HRQOL is influenced by disease activity and symptoms of fatigue, depression, pain, sleep disturbances, and cognitive dysfunction3. Across 5 randomized controlled trials (RCT) in SLE, baseline HRQOL scores were low and were similar to those of subjects following myocardial infarction or with chronic congestive heart failure4. Lower scores were highly correlated with history of renal disease, presence of anti-dsDNA antibodies, higher disease activity scores by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and/or Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI), hypocomplementemia, African American descent, and age. A variety of therapeutic interventions, including pharmacologic and biologic therapies, have been shown in RCT to improve HRQOL, including prasterone, mycophenolate mofetil, abetimus sodium, oral contraceptive, and hormone replacement therapy in the SELENA trials, as well as monoclonal antibodies epratuzumab and belimumab5,6,7,8. In 1998, an international consensus conference on outcome measures in rheumatology (OMERACT 4) recommended that 4 core domains be assessed in RCT and longitudinal observational studies (LOS) in SLE: disease activity, HRQOL, adverse events, and damage9. OMERACT has also recommended that both generic and disease-specific instruments be utilized to measure HRQOL. Ongoing efforts to develop promising therapies for SLE have demonstrated the importance of including patient-reported outcomes (PRO) to assess HRQOL in RCT. Measurement of HRQOL adds a unique dimension to … Address correspondence to Dr. Strand; E-mail: vstrand{at}stanford.edu

2010-02-01·International Journal of Rheumatic Diseases4区 · 医学

The immunological basis of B‐cell therapy in systemic lupus erythematosus

4区 · 医学

Review

作者: Mok, Mo Yin

AbstractLoss of B‐cell tolerance is a hallmark feature of the pathogenesis in systemic lupus erythematosus (SLE), an autoimmune disease that is characterized by hypergammaglobulinemia and autoantibody production. These autoantibodies lead to formation of immune‐complex deposition in internal organs causing inflammation and damage. Autoreactive B‐cells are believed to be central in the pathophysiology of SLE. Other than its role in the production of antibodies that mediate humoral immune response, B‐cells also function as antigen‐presenting cells and are capable of activating T‐cells. Activated B‐cells may also produce pro‐inflammatory cytokines that aggravate local inflammation. Abnormal B‐cell homeostasis has been described in SLE patients. This may occur as a result of intrinsic B‐cell defect or from aberrant regulation by maturation and survival signals. B‐cell‐based therapy is the current mainstream of research and development of novel therapies in SLE patients with severe and refractory disease. Potential cellular and molecular targets for B‐cell therapies include cell surface molecules such as CD20 (rituximab) and CD22 (epratuzumab); co‐stimulatory molecules involved in B‐cell–T‐cell interaction such as CTLA4 and B7 molecules (abatacept); maturation and growth factors such as B‐cell activating factor and a proliferation‐inducing ligand (belimumab, briobacept, atacicept) and B‐cell tolerogen (abetimus). This article provides an overview on normal B‐cell physiology and abnormal B‐cell biology in SLE that form the immunological basis of B‐cell‐targeted therapy in the treatment of these patients with refractory diseases.

100 项与阿贝莫司钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03204	-	-	DB06662

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
狼疮性肾炎	临床3期	德国	La Jolla Pharmaceutical Co.	2002-05-03
狼疮性肾炎	临床3期	美国	La Jolla Pharmaceutical Co.	2002-05-03
狼疮性肾炎	临床3期	英国	La Jolla Pharmaceutical Co.	2002-05-03
狼疮性肾炎	临床3期	西班牙	La Jolla Pharmaceutical Co.	2002-05-03
狼疮性肾炎	临床3期	加拿大	La Jolla Pharmaceutical Co.	2002-05-03
狼疮性肾炎	临床3期	德国	La Jolla Pharmaceutical Co.	2002-05-03
狼疮性肾炎	临床3期	英国	La Jolla Pharmaceutical Co.	2002-05-03
狼疮性肾炎	临床3期	西班牙	La Jolla Pharmaceutical Co.	2002-05-03
狼疮性肾炎	临床3期	加拿大	La Jolla Pharmaceutical Co.	2002-05-03
狼疮性肾炎	临床3期	美国	La Jolla Pharmaceutical Co.	2002-05-03

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临床结果

适应症

分期

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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


NCT00035308 (Pubmed)	临床3期	狼疮性肾炎	-	Abetimus	淵簾鹽壓構積鹹範製鹽(衊蓋網艱築遞鹹觸糧鹹) = 願餘壓壓製艱鏇鹽艱範醖選憲積遞繭壓齋繭鑰 (膚選窪網積網製淵襯繭 )	不佳	2008-08-01
				Placebo	淵簾鹽壓構積鹹範製鹽(衊蓋網艱築遞鹹觸糧鹹) = 夢衊築築廠衊選築餘衊醖選憲積遞繭壓齋繭鑰 (膚選窪網積網製淵襯繭 )
EULAR2008	N/A	anti-dsDNA antibody levels	18	Abetimus sodium 600 mg	(願鹹製繭廠顧鹹製鹹鬱) = 選鏇選憲顧齋鏇遞遞蓋鹽壓網鹽廠醖鬱範膚窪 (糧積襯獵積鑰願獵積膚 ) 更多	-	2008-06-11
				Abetimus sodium 1200 mg	(願鹹製繭廠顧鹹製鹹鬱) = 襯顧餘襯鏇築蓋鹹壓鬱鹽壓網鹽廠醖鬱範膚窪 (糧積襯獵積鑰願獵積膚 ) 更多
EULAR2008	N/A	肾脏疾病 \| 系统性红斑狼疮 anti-dsDNA antibody levels	8	Abetimus sodium	(觸膚構製廠製壓獵窪遞) = 夢艱淵鹽艱鏇選糧衊鏇壓餘觸選遞鬱齋餘憲顧 (糧鏇網鹹鬱網夢餘繭鹽 ) 更多	-	2008-06-11
EULAR2004	临床2/3期	系统性红斑狼疮 anti-dsDNA antibodies	-	LJP 394	(鏇網窪網窪繭醖構鏇築) = changes in anti-dsDNA levels that were inversely correlated with C3 levels (p<0.001 for both RCTs) 淵獵襯積憲夢範廠鹽艱 (壓積蓋繭鏇鑰積製遞夢 )	积极	2004-06-09
				Placebo