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RANDOMIZED CONTROLLED TRIAL
Robert J Fox, Christopher S Coffey, Robin Conwit, Merit E Cudkowicz, Trevis Gleason, Andrew Goodman, Eric C Klawiter, Kazuko Matsuda, Michelle McGovern, Robert T Naismith, Akshata Ashokkumar, Janel Barnes, Dixie Ecklund, Elizabeth Klingner, Maxine Koepp, Jeffrey D Long, Sneha Natarajan, Brenda Thornell, Jon Yankey, Robert A Bermel, Josef P Debbins, Xuemei Huang, Patricia Jagodnik, Mark J Lowe, Kunio Nakamura, Sridar Narayanan, Ken E Sakaie, Bhaskar Thoomukuntla, Xiaopeng Zhou, Stephen Krieger, Enrique Alvarez, Michelle Apperson, Khurram Bashir, Bruce A Cohen, Patricia K Coyle, Silvia Delgado, L Dana Dewitt, Angela Flores, Barbara S Giesser, Myla D Goldman, Burk Jubelt, Neil Lava, Sharon G Lynch, Harold Moses, Daniel Ontaneda, Jai S Perumal, Michael Racke, Pavle Repovic, Claire S Riley, Christopher Severson, Shlomo Shinnar, Valerie Suski, Bianca Weinstock-Guttman, Vijayshree Yadav, Aram Zabeti
BACKGROUND: There are limited treatments for progressive multiple sclerosis. Ibudilast inhibits several cyclic nucleotide phosphodiesterases, macrophage migration inhibitory factor, and toll-like receptor 4 and can cross the blood-brain barrier, with potential salutary effects in progressive multiple sclerosis. METHODS: We enrolled patients with primary or secondary progressive multiple sclerosis in a phase 2 randomized trial of oral ibudilast (≤100 mg daily) or placebo for 96 weeks...
August 30, 2018: New England Journal of Medicine
#2
MULTICENTER STUDY
R Totaro, A Lugaresi, P Bellantonio, M Danni, G Costantino, C Gasperini, C Florio, E Pucci, M Maddestra, D Spitaleri, G Lus, B Ardito, D Farina, M Rossi, C Di Carmine, E Altobelli, B Maccarone, A Casalena, G De Luca, D Travaglini, M Di Ioia, V Di Tommaso, R Fantozzi, S Ruggieri, L Provinciali, S De Riso, C Mundi, A Fuiani, S Galgani, S Ruggieri, G T Maniscalco, G Giuliani, E Cartechini, V Petretta, M Fratta, G Alfieri, M Gatto, A Carolei
We evaluated efficacy of natalizumab in relapsing-remitting multiple sclerosis patients in a clinical practice setting. We report data on the first consecutive 343 patients receiving natalizumab in 12 multiple sclerosis (MS) Italian centers enrolled between April 2007 and November 2010. The main efficacy endpoints were the proportion of patients free from relapses, disease progression, combined clinical activity, defined as presence of relapse or disease progression, from MRI activity, and from any disease activity defined as the absence of any single or combined activity...
2014: International Journal of Immunopathology and Pharmacology
#3
MULTICENTER STUDY
Paolo A Muraro, Marcelo Pasquini, Harold L Atkins, James D Bowen, Dominique Farge, Athanasios Fassas, Mark S Freedman, George E Georges, Francesca Gualandi, Nelson Hamerschlak, Eva Havrdova, Vassilios K Kimiskidis, Tomas Kozak, Giovanni L Mancardi, Luca Massacesi, Daniela A Moraes, Richard A Nash, Steven Pavletic, Jian Ouyang, Montserrat Rovira, Albert Saiz, Belinda Simoes, Marek Trnený, Lin Zhu, Manuela Badoglio, Xiaobo Zhong, Maria Pia Sormani, Riccardo Saccardi
IMPORTANCE: Autologous hematopoietic stem cell transplantation (AHSCT) may be effective in aggressive forms of multiple sclerosis (MS) that fail to respond to standard therapies. OBJECTIVE: To evaluate the long-term outcomes in patients who underwent AHSCT for the treatment of MS in a large multicenter cohort. DESIGN, SETTING, AND PARTICIPANTS: Data were obtained in a multicenter, observational, retrospective cohort study. Eligibility criteria were receipt of AHSCT for the treatment of MS between January 1995 and December 2006 and the availability of a prespecified minimum data set comprising the disease subtype at baseline; the Expanded Disability Status Scale (EDSS) score at baseline; information on the administered conditioning regimen and graft manipulation; and at least 1 follow-up visit or report after transplant...
April 1, 2017: JAMA Neurology
#4
RANDOMIZED CONTROLLED TRIAL
M Trojano, F Pellegrini, D Paolicelli, A Fuiani, G B Zimatore, C Tortorella, I L Simone, F Patti, A Ghezzi, E Portaccio, P Rossi, C Pozzilli, G Salemi, A Lugaresi, R Bergamaschi, E Millefiorini, M Clerico, G Lus, M Vianello, C Avolio, P Cavalla, P Iaffaldano, V Direnzo, M D'Onghia, V Lepore, P Livrea, G Comi, M P Amato
BACKGROUND: There are a few and conflicting results from randomised controlled trials (RCTs) pertaining to the influence of gender in response to currently used disease modifying drugs in Multiple Sclerosis (MS). Observational studies may be especially valuable for answering effectiveness questions in subgroups not studied in RCTs. OBJECTIVE: To conduct a post-marketing analysis aimed to evaluate the gender effect on Interferon beta (IFNbeta) treatment response in a cohort of relapsing (RR) MS patients...
November 15, 2009: Journal of the Neurological Sciences
#5
JOURNAL ARTICLE
C Bensa, E Bodiguel, D Brassat, D Laplaud, L Magy, J-C Ouallet, H Zephir, J De Seze, F Blanc
The aim of the Multiple Sclerosis Think Tank (Groupe de réflexion sur la sclérose en plaques [GRESEP]) is to prescribe recommendations following a systematic literature search and using a Rand Corporation and California University (RAND/UCLA) appropriateness derived method, in response to practical questions that are raised in the management of patients with multiple sclerosis (MS). The topics of this working program were chosen because they were not addressed in the French recommendations and because of the few data in the literature that enabled practices to be based on validated data...
November 2012: Revue Neurologique
#6
REVIEW
I Smets, L Van Deun, C Bohyn, V van Pesch, L Vanopdenbosch, D Dive, V Bissay, B Dubois
Multiple sclerosis (MS) is an autoimmune, inflammatory demyelinating disease of the central nervous system characterized in the majority of the patients by a relapsing-remitting disease course. For decades high-dosage corticosteroids (CS) are considered the cornerstone in the management of acute MS relapses. However, many unanswered questions remain when it comes to the exact modalities of CS administration. In this review on behalf of the Belgian Study Group for MS we define the efficacy of CS in reducing MS-related morbidity and examine whether the effect is different according to type of CS, route of administration, cumulative dosage, timing of initiation and disease course...
September 2017: Acta Neurologica Belgica
#7
REVIEW
Nancy L Kuntz, Dorothee Chabas, Bianca Weinstock-Guttman, Tanuja Chitnis, E Ann Yeh, Lauren Krupp, Jayne Ness, Moses Rodriguez, Emmanuelle Waubant
IMPORTANCE OF THE FIELD: Pediatric multiple sclerosis is an acquired inflammatory, demyelinating CNS disorder associated with recurrent episodes of neurologic dysfunction. Precise diagnosis is increasingly important as disease modifying therapies have been developed in adults and introduced into pediatric practice. AREAS COVERED IN THIS REVIEW: Literature published over the past two decades relating to pharmacologic treatment of multiple sclerosis (MS) in adults and children is reviewed, with emphasis on current publications...
March 2010: Expert Opinion on Pharmacotherapy
#8
RANDOMIZED CONTROLLED TRIAL
David H Miller, Omar A Khan, William A Sheremata, Lance D Blumhardt, George P A Rice, Michele A Libonati, Allison J Willmer-Hulme, Catherine M Dalton, Katherine A Miszkiel, Paul W O'Connor
BACKGROUND: In patients with multiple sclerosis, inflammatory brain lesions appear to arise from autoimmune responses involving activated lymphocytes and monocytes. The glycoprotein alpha4 integrin is expressed on the surface of these cells and plays a critical part in their adhesion to the vascular endothelium and migration into the parenchyma. Natalizumab is an alpha4 integrin antagonist that reduced the development of brain lesions in experimental models and in a preliminary study of patients with multiple sclerosis...
January 2, 2003: New England Journal of Medicine
#9
JOURNAL ARTICLE
Antonio Bertolotto, Marco Capobianco, Maria Pia Amato, Elisabetta Capello, Ruggero Capra, Diego Centonze, Maria Di Ioia, Antonio Gallo, Luigi Grimaldi, Luisa Imberti, Alessandra Lugaresi, Chiara Mancinelli, Maria Giovanna Marrosu, Lucia Moiola, Enrico Montanari, Silvia Romano, Luigina Musu, Damiano Paolicelli, Francesco Patti, Carlo Pozzilli, Silvia Rossi, Marco Salvetti, Gioachino Tedeschi, Maria Rosaria Tola, Maria Trojano, Maria Troiano, Mauro Zaffaroni, Simona Malucchi
Interferon beta (IFNβ) was the first specific disease-modifying treatment licensed for relapsing-remitting multiple sclerosis, and is still one of the most commonly prescribed treatments. A strong body of evidence supports the effectiveness of IFNβ preparations in reducing the annual relapse rate, magnetic resonance (MRI) disease activity and disease progression. However, the development of binding/neutralizing antibodies (BAbs/NAbs) during treatment negatively affects clinical and MRI outcomes. Therefore, guidelines for the clinical use for the detection of NAbs in MS may result in better treatment of these patients...
February 2014: Neurological Sciences
#10
RANDOMIZED CONTROLLED TRIAL
F Barkhof, J H van Waesberghe, M Filippi, T Yousry, D H Miller, D Hahn, A J Thompson, L Kappos, P Brex, C Pozzilli, C H Polman
Recently, the clinical efficacy of interferon beta-1b (IFNbeta-1b) was demonstrated for secondary progressive (SP) multiple sclerosis in a European multicentre study. We evaluated the effect of IFNbeta-1b treatment on the rate of development of hypointense T(1) MRI lesions, a putative marker of axonal damage. Unenhanced T(1)-weighted images were obtained in a subgroup of 95 multiple sclerosis patients from five centres at 6-month intervals; this subgroup was similar to the total study population for all demographic, clinical and MRI parameters...
July 2001: Brain
#11
JOURNAL ARTICLE
F Sellebjerg, D Barnes, G Filippini, R Midgard, X Montalban, P Rieckmann, K Selmaj, L H Visser, P S Sørensen
Relapses, exacerbations or attacks of multiple sclerosis are the dominating feature of relapsing-remitting multiple sclerosis (MS), but are also observed in patients with secondary progressive MS. High-dose methylprednisolone is the routine therapy for relapses at present, but other treatments are also in current use. The objective of the task force was to review the literature on treatment of MS relapses to provide evidence-based treatment recommendations. Review was carried out on the literature with classification of evidence according to the EFNS guidelines for scientific task forces...
December 2005: European Journal of Neurology
#12
RANDOMIZED CONTROLLED TRIAL
G Comi, M Filippi, F Barkhof, L Durelli, G Edan, O Fernández, H Hartung, P Seeldrayers, P S Sørensen, M Rovaris, V Martinelli, O R Hommes
BACKGROUND: Interferon beta reduces activity in multiple sclerosis as measured clinically and by magnetic resonance imaging (MRI). We assessed the effect of interferon beta-1a on the occurrence of relapses in patients after first presentation with neurological events, who are at high risk of conversion to clinically definite multiple sclerosis. METHODS: Eligible patients had had a first episode of neurological dysfunction suggesting multiple sclerosis within the previous 3 months and had strongly suggestive brain MRI findings...
May 19, 2001: Lancet
#13
RANDOMIZED CONTROLLED TRIAL
N Koch-Henriksen, P S Sørensen, T Christensen, J Frederiksen, M Ravnborg, K Jensen, A Heltberg, O Kristensen, E Stenager, T Petersen, T Hansen
OBJECTIVE: To investigate whether the efficacy of interferon-beta (IFNbeta) treatment of relapsing-remitting MS (RR-MS) was influenced by type, dose, and frequency of administration. METHODS: From June 1996 through October 1997, the authors offered participation to all Danish RR-MS patients who met the following criteria: definite MS, at least two relapses within 2 years, age 18 to 55, and an Expanded Disability Status Scale (EDSS) score of < or = 5.5. The study was multicenter, controlled, open-label, randomized, head-to-head comparing IFNbeta-1a 22 microg once a week (n = 143) with IFNbeta-1b 250 microg every other day (n = 158), both subcutaneously, for 24 months...
April 11, 2006: Neurology
#14
REVIEW
Gianvito Martino, Robin J M Franklin, Anne Baron Van Evercooren, Douglas A Kerr
This article provides an overview of the current knowledge relating to the potential use of transplanted stem cells in the treatment of patients with multiple sclerosis (MS). Two types of stem cells, CNS-derived neural stem/precursor cells (NPCs) and bone marrow-derived mesenchymal stem cells (MSCs) are considered to provide reproducible and robust therapeutic effects when intravenously or intrathecally injected into both rodents and primates with experimental autoimmune encephalomyelitis. Furthermore, preliminary safety data concerning the use of intrathecally injected autologous MSCs in patients with progressive MS are available...
May 2010: Nature Reviews. Neurology
#15
JOURNAL ARTICLE
W M Carroll, T Saida, H J Kim, J Kira, A G Kermode, C P Tsai, K Fujihara, S Kusunoki, M Tanaka, K K Kim, D Bates
Definite diagnosis of inflammatory demyelinating disease (multiple sclerosis (MS) and neuromyelitis optica (NMO)) may require time, but early treatment offers the opportunity to maximize patient outcomes. The purpose of this report is to provide guidance to facilitate early treatment decisions for patients with inflammatory demyelinating disease, before definitive diagnosis. Neurology experts reviewed the existing literature and clinical evidence. A treatment decision pathway was developed, defining patients for whom first-line MS disease-modifying therapies (a) are unlikely to be effective, (b) may be effective but require careful monitoring and (c) are likely to provide benefit...
September 2013: Multiple Sclerosis: Clinical and Laboratory Research
#16
JOURNAL ARTICLE
S Mahurkar, M Moldovan, V Suppiah, M Sorosina, F Clarelli, G Liberatore, S Malhotra, X Montalban, A Antigüedad, M Krupa, V G Jokubaitis, F C McKay, P N Gatt, M J Fabis-Pedrini, V Martinelli, G Comi, J Lechner-Scott, A G Kermode, M Slee, B V Taylor, K Vandenbroeck, M Comabella, F M Boneschi, C King
Up to 50% of multiple sclerosis (MS) patients do not respond to interferon-beta (IFN-β) treatment and determination of response requires lengthy clinical follow-up of up to 2 years. Response predictive genetic markers would significantly improve disease management. We aimed to identify IFN-β treatment response genetic marker(s) by performing a two-stage genome-wide association study (GWAS). The GWAS was carried out using data from 151 Australian MS patients from the ANZgene/WTCCC2 MS susceptibility GWAS (responder (R)=51, intermediate responders=24 and non-responders (NR)=76)...
July 2017: Pharmacogenomics Journal
#17
JOURNAL ARTICLE
T A Chalmer, L M Baggesen, M Nørgaard, N Koch-Henriksen, M Magyari, P S Sorensen
BACKGROUND AND PURPOSE: To assess long-term treatment effectiveness of disease-modifying therapy (DMT) initiated early in disease course versus later treatment start. METHODS: We included all Danish patients with multiple sclerosis (MS) treated with DMT through two nationwide population-based MS registries. Patients were categorized as early treated if treatment started within 2 years after the first MS symptom (n = 2316) and later treated if treatment started between 2 and 8 years after clinical onset (n = 1479)...
October 2018: European Journal of Neurology
#18
RANDOMIZED CONTROLLED TRIAL
M S Freedman, J S Wolinsky, B Wamil, C Confavreux, G Comi, L Kappos, T P Olsson, A Miller, H Benzerdjeb, H Li, C Simonson, P W O'Connor
OBJECTIVE: To evaluate teriflunomide as add-on therapy to ongoing stable-dosed interferon-β (IFNβ) in patients with relapsing forms of multiple sclerosis (RMS). METHODS: A total of 118 patients with RMS were randomly assigned 1:1:1 to receive oral placebo or teriflunomide, 7 or 14 mg, once daily for 24 weeks; 86 patients entered the 24-week extension. The primary objective was to evaluate safety; secondary objectives were to evaluate the effects of treatment on disease activity assessed by MRI and relapse rate...
June 5, 2012: Neurology
#19
RANDOMIZED CONTROLLED TRIAL
Ralf Gold, Gavin Giovannoni, Krzysztof Selmaj, Eva Havrdova, Xavier Montalban, Ernst-Wilhelm Radue, Dusan Stefoski, Randy Robinson, Katherine Riester, Jitesh Rana, Jacob Elkins, Gilmore O'Neill
BACKGROUND: Daclizumab, a humanised monoclonal antibody, modulates interleukin-2 signalling by blocking the α subunit (CD25) of the interleukin-2 receptor. We assessed whether daclizumab high-yield process (HYP) would be effective when given as monotherapy for a 1 year treatment period in patients with relapsing-remitting multiple sclerosis. METHODS: We did a randomised, double-blind, placebo-controlled trial at 76 centres in the Czech Republic, Germany, Hungary, India, Poland, Russia, Ukraine, Turkey, and the UK between Feb 15, 2008, and May 14, 2010...
June 22, 2013: Lancet
#20
RANDOMIZED CONTROLLED TRIAL
Jeremy Chataway, Nadine Schuerer, Ali Alsanousi, Dennis Chan, David MacManus, Kelvin Hunter, Val Anderson, Charles R M Bangham, Shona Clegg, Casper Nielsen, Nick C Fox, David Wilkie, Jennifer M Nicholas, Virginia L Calder, John Greenwood, Chris Frost, Richard Nicholas
BACKGROUND: Secondary progressive multiple sclerosis, for which no satisfactory treatment presently exists, accounts for most of the disability in patients with multiple sclerosis. Simvastatin, which is widely used for treatment of vascular disease, with its excellent safety profile, has immunomodulatory and neuroprotective properties that could make it an appealing candidate drug for patients with secondary progressive multiple sclerosis. METHODS: We undertook a double-blind, controlled trial between Jan 28, 2008, and Nov 4, 2011, at three neuroscience centres in the UK...
June 28, 2014: Lancet
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