Source:http://linkedlifedata.com/resource/pubmed/id/15709924
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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
1
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pubmed:dateCreated |
2005-2-15
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pubmed:abstractText |
The safety and efficacy of abetimus sodium (abetimus) has been evaluated in 13 controlled and uncontrolled clinical trials involving > 800 patients or subjects. The two pivotal trials enrolled a total of 547 patients with systemic lupus erythematosus (SLE) who had a history of lupus nephritis. Evidence of clinical effectiveness of abetimus comes from analyses of data from patients with SLE and high-affinity antibodies to the DNA epitope of abetimus at baseline; a retrospective subgroup in the pivotal Phase II/III LJP-394-90-05 trial (90-05 trial) and the intent-to-treat population in the Phase III LJP-394-90-09 trial (90-09 trial). These studies enrolled SLE patients who had experienced prior renal manifestations of their disease and had elevated anti-dsDNA antibodies at baseline by Farr assay. Both were long-term studies, with a mean duration of treatment participation of 371 days in 90-05 and 310 days in 90-09 for the population of patients with high-affinity antibodies at baseline. The 90-05 and 90-09 studies, as well as all other clinical studies of abetimus, consistently showed that treatment with abetimus resulted in durable and persistent reductions in anti-dsDNA antibodies in SLE patients. Treatment with abetimus was associated with statistically significant decreases in anti-dsDNA antibody levels from baseline compared with placebo in both the 90-09 and 90-05 trials. Positive trends were noted for the incidence of renal flares and major SLE flares in patients treated with abetimus. Abetimus appeared to be well tolerated for treatment periods of < or = 22 months.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Jan
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pubmed:issn |
1744-7658
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pubmed:author | |
pubmed:issnType |
Electronic
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pubmed:volume |
14
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
77-88
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pubmed:dateRevised |
2007-11-15
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pubmed:meshHeading |
pubmed-meshheading:15709924-Clinical Trials as Topic,
pubmed-meshheading:15709924-Humans,
pubmed-meshheading:15709924-Incidence,
pubmed-meshheading:15709924-Kidney Diseases,
pubmed-meshheading:15709924-Lupus Erythematosus, Systemic,
pubmed-meshheading:15709924-Oligonucleotides,
pubmed-meshheading:15709924-Time Factors
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pubmed:year |
2005
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pubmed:articleTitle |
Abetimus sodium: a new therapy for delaying the time to, and reducing the incidence of, renal flare and/or major systemic lupus erythematosus flares in patients with systemic lupus erythematosus who have a history of renal disease.
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pubmed:affiliation |
Hospital General Dr Miguel Silva, Isidro Huarte y Samuel Ramos S/N, Morelia, Michoacán, CP 58000, México. morrelia@att.net.mx
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pubmed:publicationType |
Journal Article,
Review
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