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001-es BibID:	BIBFORM067748
Első szerző:	Kappos, Ludwig
Cím:	The 11-year long-term follow-up study from the randomized BENEFIT CIS trial / Ludwig Kappos, Gilles Edan, Mark S. Freedman, Xavier Montalbán, Hans-Peter Hartung, Bernhard Hemmer, Edward J. Fox, Frederik Barkhof, Sven Schippling, Andrea Schulze, Dirk Pleimes, Christoph Pohl, Rupert Sandbrink, Gustavo Suarez, Eva-Maria Wicklein, BENEFIT Study Group
Dátum:	2016
ISSN:	0028-3878
Megjegyzések:	Objective: To assess outcomes for patients treated with interferon beta-1b immediately after clinically isolated syndrome (CIS) or after a short delay.Methods: Participants in BENEFIT (Betaferon/Betaseron in Newly Emerging MS for Initial Treatment) were randomly assigned to receive interferon beta-1b (early treatment) or placebo (delayed treatment). After conversion to clinically definite multiple sclerosis (CDMS) or 2 years, patients on placebo could switch to interferon beta-1b or another treatment. Eleven years after randomization, patients were reassessed.Results: Two hundred seventy-eight (59.4%) of the original 468 patients (71.3% of those eligible atparticipating sites) were enrolled (early: 167 [57.2%]; delayed: 111 [63.1%]). After 11 years, risk of CDMS remained lower in the early-treatment arm compared with the delayed-treatment arm (p 50.0012), with longer time to first relapse (median [Q1, Q3] days: 1,888 [540, not reached] vs 931 [253, 3,296]; p50.0005) and lower overall annualized relapse rate (0.21 vs 0.26; p50.0018). Only25 patients (5.9%, overall; early, 4.5%; delayed, 8.3%) converted to secondary progressive multiple sclerosis. Expanded Disability Status Scale scores remained low and stable, with no differencebetween treatment arms (median [Q1,Q3]: 2.0 [1.0, 3.0]). The early-treatment group had better Paced Auditory Serial Addition Task?3 total scores (p 5 0.0070). Employment rates remained high, and health resource utilization tended to be low in both groups.MRI metrics did not differ between groups.Conclusions: Although the delay in treatment was relatively short, several clinical outcomes favored earlier treatment. Along with low rates of disability and disease progression in bothgroups, this supports the value of treatment at CIS.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:	Neurology 87 : 10 (2016), p. 978-987. -
További szerzők:	Edan, Gilles Freedman, Mark S. Montalbán, Xavier Hartung, Hans-Peter Hemmer, Bernhard Fox, Edward J. Barkhof, Frederik Schippling, Sven Schulze, Andrea Pleimes, Dirk Pohl, Christoph Sandbrink, Rupert Suarez, Gustavo Wicklein, Eva-Maria Csiba László (1952-) (neurológus, pszichiáter) Csépány Tünde (1956-) (neurológus, pszichiáter) BENEFIT Study Group
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001-es BibID:	BIBFORM005123
Első szerző:	Kappos, Ludwig
Cím:	Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis : a multicentre, randomised, double-blind, placebo-controlled phase IIb studye / Kappos L., Gold R., Miller D. H., Macmanus D. G., Havrdova E., Limmroth V., Polman C. H., Schmierer K., Yousry T. A., Yang M., Eraksoy M., Meluzinova E., Rektor I., Dawson K. T., Sandrock A. W., O'Neill G. N., BG-12 Phase IIb Study Investigators
Dátum:	2008
Megjegyzések:	Oral fumarate (BG00012) might have dual anti-inflammatory and neuroprotective eff ects. Our aim was to assess the efficacy and safety of BG00012 in patients with relapsing-remitting multiple sclerosis. Methods 257 patients, aged 18-55 years, with relapsing-remitting multiple sclerosis were randomly assigned to receive 120 mg once daily (n=64), 120 mg three times daily (n=64), or 240 mg three times daily (n=64) BG00012, or placebo (n=65) for 24 weeks. During an extension period of 24 weeks for safety assessment, patients treated with placebo received BG00012 240 mg three times daily. The primary endpoint was total number of new gadolinium enhancing (GdE) lesions on brain MRI scans at weeks 12, 16, 20, and 24. Additional endpoints included cumulative number of new GdE lesions (weeks 4-24), new or enlarging T2-hyperintense lesions, new T1-hypointense lesions at week 24, and annualised relapse rate. Analysis was done on the effi cacy-evaluable population. Safety and tolerability were also assessed. This study is registered with ClinicalTrials.gov, number NCT00168701. Findings Treatment with BG00012 240 mg three times daily reduced by 69% the mean total number of new GdE lesions from week 12 to 24 compared with placebo (1-4 vs 4-5, p<0-0001). It also reduced number of new or enlarging T2-hyperintense (p=0-0006) and new T1-hypointense p=0-014) lesions compared with placebo. BG00012 reduced annualised relapse rate by 32% (0-44 vs 0-65 for placebo; p=0-272). Adverse events more common in patients given BG00012 than in those given placebo included abdominal pain, flushing, and hot flush. Dose-related adverse events in patients on BG00012 were headache, fatigue, and feeling hot. Interpretation The anti-inflammatory effects and favourable safety profi le of BG00012 warrant further long-term phase III studies in large patient groups.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:	Lancet. - 372 : 9648 (2008), p. 1463-1472. -
További szerzők:	Gold, Ralf Miller, David H. Macmanus, David G. Havrdova, Eva Limmroth, Volker Polman, Chris H. Schmierer, Klaus Yousry, Tarek A. Yang, Minhua Eraksoy, Mefkure Meluzinova, Eva Rektor, Ivan Dawson, Katherine T. Sandrock, Alfred W. O'Neill, Gilmore N. Csépány Tünde (1956-) (neurológus, pszichiáter) Csiba László (1952-) (neurológus, pszichiáter) BG-12 Phase IIb Study Investigators
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001-es BibID:	BIBFORM069440
Első szerző:	Lublin, Fred
Cím:	Oral fingolimod in primary progressive multiple sclerosis (INFORMS) : a phase 3, randomised, double-blind, placebo-controlled trial / Lublin Fred, Miller David H., Freedman Mark S., Cree Bruce A. C., Wolinsky Jerry S., Weiner Howard, Lubetzki Catherine, Hartung Hans-Peter, Montalban Xavier, Uitdehaag Bernard M. J., Merschhemke Martin, Li Bingbing, Putzki Norman, Liu Fonda C., Häring Dieter A., Kappos Ludwig, INFORMS study investigators
Dátum:	2016
ISSN:	0140-6736
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:	Lancet 387 : 10023 (2016), p. 1075-1084. -
További szerzők:	Miller, David H. Freedman, Mark S. Cree, Bruce A. C. Wolinsky, Jerry S. Weiner, Howard Lubetzki, Catherine Hartung, Hans-Peter Montalbán, Xavier Uitdehaag, Bernard M. J. Merschhemke, Martin Li, Bingbing Putzki, Norman Liu, Fonda C. Häring, Dieter A. Kappos, Ludwig Csiba László (1952-) (neurológus, pszichiáter) INFORMS study investigators
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