Delving into the Latest Updates on Abetimus sodium with Synapse

Overview

Basic Info

Drug Type

Oligonucleotide

Synonyms

Abetimus, Abetimus sodium (USAN), Riquent

+ [2]

Target-

Mechanism

Immunosuppressants

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal DiseasesUrogenital Diseases

Active Indication-

Inactive Indication

Lupus Nephritis

Originator Organization

La Jolla Pharmaceutical Co.

Active Organization-

Inactive Organization

La Jolla Pharmaceutical Co.Baxter Pharmaceutical Solutions LLC

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

RegulationOrphan Drug (US)

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Structure/Sequence

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Sequence Code 29607834

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Sequence Code 30177267

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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.

01 Sep 2011·The Journal of Rheumatology

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

Communications

Author: 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

01 Feb 2010·International Journal of Rheumatic DiseasesQ4 · MEDICINE

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

Q4 · MEDICINE

Review

Author: 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 Deals associated with Abetimus sodium

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External Link

KEGG	Wiki	ATC	Drug Bank
D03204	-	-	DB06662

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lupus Nephritis	Phase 3	DE	La Jolla Pharmaceutical Co.	03 May 2002
Lupus Nephritis	Phase 3	US	La Jolla Pharmaceutical Co.	03 May 2002
Lupus Nephritis	Phase 3	GB	La Jolla Pharmaceutical Co.	03 May 2002
Lupus Nephritis	Phase 3	ES	La Jolla Pharmaceutical Co.	03 May 2002
Lupus Nephritis	Phase 3	CA	La Jolla Pharmaceutical Co.	03 May 2002
Lupus Nephritis	Phase 3	DE	La Jolla Pharmaceutical Co.	03 May 2002
Lupus Nephritis	Phase 3	GB	La Jolla Pharmaceutical Co.	03 May 2002
Lupus Nephritis	Phase 3	ES	La Jolla Pharmaceutical Co.	03 May 2002
Lupus Nephritis	Phase 3	CA	La Jolla Pharmaceutical Co.	03 May 2002
Lupus Nephritis	Phase 3	US	La Jolla Pharmaceutical Co.	03 May 2002

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00035308 (Pubmed)	Phase 3	Lupus Nephritis	-	Abetimus	ibmmbofszt(khusegpqzf) = ohlecoqwxh jciriljtkz (ouqitryvrc )	Negative	01 Aug 2008
				Placebo	ibmmbofszt(khusegpqzf) = ifgwbmukjk jciriljtkz (ouqitryvrc )
EULAR2008	Not Applicable	anti-dsDNA antibody levels	18	Abetimus sodium 600 mg	(foshctsxwt) = tajmihgqqx irkcgsmvlr (qamhqbywiw ) View more	-	11 Jun 2008
				Abetimus sodium 1200 mg	(foshctsxwt) = tufyzypdqz irkcgsmvlr (qamhqbywiw ) View more
EULAR2008	Not Applicable	Kidney Diseases \| Systemic Lupus Erythematosus anti-dsDNA antibody levels	8	Abetimus sodium	(phqiemzvtt) = tjnumskltm peklzrygtl (nxhcvfaxhl ) View more	-	11 Jun 2008
EULAR2004	Phase 2/3	Systemic Lupus Erythematosus anti-dsDNA antibodies	-	LJP 394	(nvvuupnnko) = changes in anti-dsDNA levels that were inversely correlated with C3 levels (p<0.001 for both RCTs) xyxyfnkshx (spjpiqwigw )	Positive	09 Jun 2004
				Placebo