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Statements

Subject Item
n2:RIV%2F00064165%3A_____%2F12%3A11797%21RIV13-MZ0-00064165
rdf:type
skos:Concept n11:Vysledek
rdfs:seeAlso
http://dx.doi.org/10.1056/NEJMoa1206328
dcterms:description
In this phase 3, randomized study, we investigated the efficacy and safety of oral BG-12, at a dose of 240 mg two or three times daily, as compared with placebo in patients with relapsing-remitting multiple sclerosis. An active agent, glatiramer acetate, was also included as a reference comparator. The primary end point was the annualized relapse rate over a period of 2 years. The study was not designed to test the superiority or noninferiority of BG-12 versus glatiramer acetate. RESULTS At 2 years, the annualized relapse rate was significantly lower with twice-daily BG-12 (0.22), thrice-daily BG-12 (0.20), and glatiramer acetate (0.29) than with placebo (0.40) (relative reductions: twice-daily BG-12, 44%, P<0.001; thrice-daily BG-12, 51%, P<0.001; glatiramer acetate, 29%, P = 0.01). Reductions in disability progression with twice-daily BG-12, thrice-daily BG-12, and glatiramer acetate versus placebo (21%, 24%, and 7%, respectively) were not significant. As compared with placebo, twice-daily BG-12, thrice-daily BG-12, and glatiramer acetate significantly reduced the numbers of new or enlarging T2-weighted hyperintense lesions (all P<0.001) and new T-1-weighted hypointense lesions (P<0.001, P<0.001, and P = 0.002, respectively). In post hoc comparisons of BG-12 versus glatiramer acetate, differences were not significant except for the annualized relapse rate (thrice-daily BG-12), new or enlarging T2-weighted hyperintense lesions (both BG-12 doses), and new T1-weighted hypointense lesions (thrice-daily BG-12) (nominal P<0.05 for each comparison). Adverse events occurring at a higher incidence with an active treatment than with placebo included flushing and gastrointestinal events (with BG-12) and injection-related events (with glatiramer acetate). There were no malignant neoplasms or opportunistic infections reported with BG-12. Lymphocyte counts decreased with BG-12. In this phase 3, randomized study, we investigated the efficacy and safety of oral BG-12, at a dose of 240 mg two or three times daily, as compared with placebo in patients with relapsing-remitting multiple sclerosis. An active agent, glatiramer acetate, was also included as a reference comparator. The primary end point was the annualized relapse rate over a period of 2 years. The study was not designed to test the superiority or noninferiority of BG-12 versus glatiramer acetate. RESULTS At 2 years, the annualized relapse rate was significantly lower with twice-daily BG-12 (0.22), thrice-daily BG-12 (0.20), and glatiramer acetate (0.29) than with placebo (0.40) (relative reductions: twice-daily BG-12, 44%, P<0.001; thrice-daily BG-12, 51%, P<0.001; glatiramer acetate, 29%, P = 0.01). Reductions in disability progression with twice-daily BG-12, thrice-daily BG-12, and glatiramer acetate versus placebo (21%, 24%, and 7%, respectively) were not significant. As compared with placebo, twice-daily BG-12, thrice-daily BG-12, and glatiramer acetate significantly reduced the numbers of new or enlarging T2-weighted hyperintense lesions (all P<0.001) and new T-1-weighted hypointense lesions (P<0.001, P<0.001, and P = 0.002, respectively). In post hoc comparisons of BG-12 versus glatiramer acetate, differences were not significant except for the annualized relapse rate (thrice-daily BG-12), new or enlarging T2-weighted hyperintense lesions (both BG-12 doses), and new T1-weighted hypointense lesions (thrice-daily BG-12) (nominal P<0.05 for each comparison). Adverse events occurring at a higher incidence with an active treatment than with placebo included flushing and gastrointestinal events (with BG-12) and injection-related events (with glatiramer acetate). There were no malignant neoplasms or opportunistic infections reported with BG-12. Lymphocyte counts decreased with BG-12.
dcterms:title
Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis
skos:prefLabel
Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis
skos:notation
RIV/00064165:_____/12:11797!RIV13-MZ0-00064165
n11:predkladatel
n12:ico%3A00064165
n3:aktivita
n5:Z n5:I
n3:aktivity
I, Z(MSM0021620849)
n3:cisloPeriodika
12
n3:dodaniDat
n4:2013
n3:domaciTvurceVysledku
n16:8895465
n3:druhVysledku
n17:J
n3:duvernostUdaju
n9:S
n3:entitaPredkladatele
n14:predkladatel
n3:idSjednocenehoVysledku
158782
n3:idVysledku
RIV/00064165:_____/12:11797
n3:jazykVysledku
n13:eng
n3:klicovaSlova
Dimethyl fumarate; oxidative stress; relapse rate; disability; lesions; activation; pathway; acetate
n3:klicoveSlovo
n10:Dimethyl%20fumarate n10:disability n10:relapse%20rate n10:acetate n10:pathway n10:oxidative%20stress n10:activation n10:lesions
n3:kodStatuVydavatele
US - Spojené státy americké
n3:kontrolniKodProRIV
[5A4BCA4F4846]
n3:nazevZdroje
New England Journal of Medicine
n3:obor
n15:FH
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
12
n3:rokUplatneniVysledku
n4:2012
n3:svazekPeriodika
367
n3:tvurceVysledku
Havrdová, Eva Hutchinson, M. Fox, R. J. Miller, DH Phillips, JT
n3:wos
000308861800004
n3:zamer
n18:MSM0021620849
s:issn
0028-4793
s:numberOfPages
11