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237 results on '"Montalbán X"'

1. Radiologic MS disease activity during natalizumab treatment interruption: findings from RESTORE

Author

Kaufman, M, Cree, BAC, De Sèze, J, Fox, RJ, Gold, R, Hartung, H-P, Jeffery, D, Kappos, L, Montalbán, X, Weinstock-Guttman, B, Ticho, B, Duda, P, Pace, A, and Campagnolo, D

Subjects
Gadolinium-enhancing lesions, MRI, Multiple sclerosis, Natalizumab, Treatment interruption, Clinical Research, Clinical Trials and Supportive Activities, Cancer, Biomedical Imaging, 6.1 Pharmaceuticals, Neurology & Neurosurgery, Clinical Sciences, Neurosciences
Abstract

The objective of this study is to characterize the timing and extent of radiologic MS disease recurrence during the 24-week natalizumab treatment interruption period in RESTORE. RESTORE was a randomized, partially placebo-controlled exploratory study. Natalizumab-treated patients with no gadolinium-enhancing (Gd+) lesions at screening (n = 175) were randomized 1:1:2 to continue natalizumab (n = 45), switch to placebo (n = 42), or switch to other therapies (n = 88) for 24 weeks. MRI assessments were performed every 4 weeks. Predictors of increased numbers of Gd+ lesions during natalizumab treatment interruption were evaluated. The numbers of Gd+ lesions were compared with retrospectively collected pre-natalizumab MRI reports and data from placebo-treated patients from two historical randomized clinical trials. Gd+ lesions were detected in 0 % (0/45) of natalizumab patients, 61 % (25/41) of placebo patients, and 48 % (39/81) of other-therapies patients during the randomized treatment period. Gd+ lesions were detected starting at week 12; most were observed at week 16 or later. Thirteen percent (14/107) of patients had >5 Gd+ lesions on ≥1 (of 6) scans during the randomized treatment period versus 7 % (7/107) of patients pre-natalizumab (based on medical record of a single scan). Younger patients and those with more Gd+ lesions pre-natalizumab were more likely to have increased MRI activity. Distribution of total and persistent Gd+ lesions in RESTORE patients was similar to placebo-treated historical control patients. In most patients, recurring radiological disease activity during natalizumab interruption did not exceed pre-natalizumab levels or levels seen in historical control patients.

Published
2014

2. MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study

Author

Cree, Bruce, Fox, RJ, Cree, BAC, De, J, Gold, R, Hartung, HP, Jeffery, D, Kappos, L, Kaufman, M, Montalbán, X, and Weinstock-Guttman, B

Abstract

Objective: RESTORE was a randomized, partially placebo-controlled exploratory study evaluating multiple sclerosis (MS) disease activity during a 24-week interruption of natalizumab. Methods: Eligible patients were relapse-free through the prior year on nat

Published
2014

9. Immunology

Author

Montalban, X., Comi, Giancarlo, editor, Meldolesi, Jacopo, editor, Ecari, Ugo, editor, Filippi, Massimo, editor, and Martino, Gianvito, editor

Published
2002
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18. Short-term adaptation to a simple motor task: A physiological process preserved in multiple sclerosis

Author

Mancini, L., Ciccarelli, O., Manfredonia, F., Thornton, J.S., Agosta, F., Barkhof, F., Beckmann, C., De Stefano, N., Enzinger, C., Fazekas, F., Filippi, M., Gass, A., Hirsch, J.G., Johansen-Berg, H., Kappos, L., Korteweg, T., Manson, S.C., Marino, S., Matthews, P.M., Montalban, X., Palace, J., Polman, C., Rocca, M., Ropele, S., Rovira, A., Wegner, C., Friston, K., Thompson, A., and Yousry, T.

Published
2009
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22. Reproducibility of fMRI in the clinical setting: Implications for trial designs

Author

Bosnell, R., Wegner, C., Kincses, Z.T., Korteweg, T., Agosta, F., Ciccarelli, O., De Stefano, N., Gass, A., Hirsch, J., Johansen-Berg, H., Kappos, L., Barkhof, F., Mancini, L., Manfredonia, F., Marino, S., Miller, D.H., Montalban, X., Palace, J., Rocca, M., Enzinger, C., Ropele, S., Rovira, A., Smith, S., Thompson, A., Thornton, J., Yousry, T., Whitcher, B., Filippi, M., and Matthews, P.M.

Published
2008
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31. Four-year safety and effectiveness data from patients with multiple sclerosis treated with fingolimod: The Spanish GILENYA registry.

Author

Meca-Lallana, J. E., Oreja-Guevara, C., Muñoz, D., Olascoaga, J., Pato, A., Ramió-Torrentà, L., Meca-Lallana, V., Hernández, M. A., Marzo, M. E., Álvarez- Cermeño, J. C., Rodríguez-Antigüedad, A., Montalbán, X., and Fernández, O.

Subjects
NATALIZUMAB, FINGOLIMOD, MULTIPLE sclerosis, GLATIRAMER acetate, URINARY tract infections
Abstract

Objective: To describe the profile of patients with multiple sclerosis (MS) treated with fingolimod in Spain and to assess the effectiveness and safety of fingolimod after 4 years of inclusion in the Spanish Gilenya Registry. Methods: An observational, retrospective/prospective, multicenter case registry, including all patients with relapsing-remitting MS (RRMS) starting treatment with fingolimod in 43 centers in Spain. Analyses were performed in the overall population and in subgroups according to prior disease-modifying therapy (DMT): glatiramer acetate/interferon beta-1 (BRACE), natalizumab, other treatment, or naïve. Results: Six hundred and sixty-six evaluable patients were included (91.1% previously treated with at least one DMT). The mean annualized relapse rate (ARR) prior to fingolimod was 1.12, and the mean EDSS at fingolimod initiation was 3.03. Fingolimod reduced the ARR by 71.4%, 75%, 75.5%, and 80.3%, after 1, 2, 3 and 4 years, respectively (p<0.001). This significant reduction in the ARR continued to be observed in all subgroups. After 4 years, the EDSS showed a minimal deterioration, with the EDSS scores from year 1 to year 4 remaining mostly stable. The percentage of patients without T1 Gd+ lesions progressively increased from 45.6% during the year prior to fingolimod initiation to 88.2% at year 4. The proportion of patients free from new/enlarged T2 lesions after 4 years of fingolimod treatment was 80.3%. This trend in both radiological measures was also observed in the subgroups. Adverse events (AEs) were experienced by up to 41.6% of patients (most commonly: lymphopenia [12.5%] and urinary tract infection [3.7%]). Most AEs were mild in severity, 3.6% of patients had serious AEs. Conclusions: The patient profile was similar to other observational studies. The results obtained from the long-term use of fingolimod showed that it was effective, regardless of prior DMT, and it had adequate safety results, with a positive benefit-risk balance. [ABSTRACT FROM AUTHOR]

Published
2021
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34. Genome-wide meta-analysis identifies novel multiple sclerosis susceptibility loci

Author

Patsopoulos NA, Esposito F, Reischl J, Lehr S, Bauer D, Heubach J, Sandbrink R, Pohl C, Edan G, Kappos L, Miller D, Montalbán X, Polman CH, Freedman MS, Hartung HP, Arnason BGW, COMI , GIANCARLO, Cook S, FILIPPI , MASSIMO, Goodin DS, Jeffery D, O'Connor P, Ebers GC, Langdon D, Reder AT, Traboulsee A, Zipp F, Schimrigk J, Hillert J, Bahlo M, Booth DR, BroadleyS, Brown MA, Browning BL, Browning SR, Butzkueven H, Carroll WM, Chapman C, Foote SJ, Griffiths L, Kermode AG, Kilpatrick TJ, Lechner Scott J, Marriott M, Mason D, Moscato P, Heard RN, Pender MP, Perreau VM, Perera D, Rubio JP, Scott RJ, Slee M, Stankovich J, Stewart GJ, Taylor BV, Tubridy N, Willoughby E, Wiley J, Matthews P, Boneschi F, Compston A, Haines J, Hauser SL, McCauley J, Ivinson A, Oksenberg JR, Pericak Vance M, Sawcer SJ, De Jager PL, Hafler DA, de Bakker PIW, the BSP MS Genetics working group, the steering committees of studies evaluating IFNb 1b, a. CCR1 antagonist, ANZgene Consortium, GeneMSA, International Multiple Sclerosis Genetics Consortium, Neurology, NCA - Multiple Sclerosis and Other Neuroinflammatory Diseases, Patsopoulos, Na, Esposito, F, Reischl, J, Lehr, S, Bauer, D, Heubach, J, Sandbrink, R, Pohl, C, Edan, G, Kappos, L, Miller, D, Montalbán, X, Polman, Ch, Freedman, M, Hartung, Hp, Arnason, Bgw, Comi, Giancarlo, Cook, S, Filippi, Massimo, Goodin, D, Jeffery, D, O'Connor, P, Ebers, Gc, Langdon, D, Reder, At, Traboulsee, A, Zipp, F, Schimrigk, J, Hillert, J, Bahlo, M, Booth, Dr, Broadleys, Brown, Ma, Browning, Bl, Browning, Sr, Butzkueven, H, Carroll, Wm, Chapman, C, Foote, Sj, Griffiths, L, Kermode, Ag, Kilpatrick, Tj, Lechner Scott, J, Marriott, M, Mason, D, Moscato, P, Heard, Rn, Pender, Mp, Perreau, Vm, Perera, D, Rubio, Jp, Scott, Rj, Slee, M, Stankovich, J, Stewart, Gj, Taylor, Bv, Tubridy, N, Willoughby, E, Wiley, J, Matthews, P, Boneschi, F, Compston, A, Haines, J, Hauser, Sl, Mccauley, J, Ivinson, A, Oksenberg, Jr, Pericak Vance, M, Sawcer, Sj, De Jager, Pl, Hafler, Da, de Bakker, Piw, the BSP MS Genetics working, Group, the steering committees of studies evaluating IFNb, 1b, A., CCR1 antagonist, Anzgene, Consortium, Genemsa, and International Multiple Sclerosis Genetics, Consortium

Subjects
Male, Encephalomyelitis, Autoimmune, Experimental, Multiple Sclerosis, Single-nucleotide polymorphism, Genome-wide association study, Quantitative trait locus, Biology, Polymorphism, Single Nucleotide, Article, Major Histocompatibility Complex, Animals, Humans, Genetic Predisposition to Disease, International HapMap Project, Genetic association, 25-Hydroxyvitamin D3 1-alpha-Hydroxylase, Genetics, T-Lymphocytes, Helper-Inducer, Genetic architecture, Neurology, Mutation, Expression quantitative trait loci, Female, Disease Susceptibility, Neurology (clinical), Imputation (genetics)
Abstract

OBJECTIVE: To perform a 1-stage meta-analysis of genome-wide association studies (GWAS) of multiple sclerosis (MS) susceptibility and to explore functional consequences of new susceptibility loci. METHODS: We synthesized 7 MS GWAS. Each data set was imputed using HapMap phase II, and a per single nucleotide polymorphism (SNP) meta-analysis was performed across the 7 data sets. We explored RNA expression data using a quantitative trait analysis in peripheral blood mononuclear cells (PBMCs) of 228 subjects with demyelinating disease. RESULTS: We meta-analyzed 2,529,394 unique SNPs in 5,545 cases and 12,153 controls. We identified 3 novel susceptibility alleles: rs170934(T) at 3p24.1 (odds ratio [OR], 1.17; p = 1.6 × 10(-8)) near EOMES, rs2150702(G) in the second intron of MLANA on chromosome 9p24.1 (OR, 1.16; p = 3.3 × 10(-8)), and rs6718520(A) in an intergenic region on chromosome 2p21, with THADA as the nearest flanking gene (OR, 1.17; p = 3.4 × 10(-8)). The 3 new loci do not have a strong cis effect on RNA expression in PBMCs. Ten other susceptibility loci had a suggestive p < 1 × 10(-6) , some of these loci have evidence of association in other inflammatory diseases (ie, IL12B, TAGAP, PLEK, and ZMIZ1). INTERPRETATION: We have performed a meta-analysis of GWAS in MS that more than doubles the size of previous gene discovery efforts and highlights 3 novel MS susceptibility loci. These and additional loci with suggestive evidence of association are excellent candidates for further investigations to refine and validate their role in the genetic architecture of MS.

Published
2016

50. Immunoglobulin M oligoclonal bands: biomarker of targetable inflammation in primary progressive multiple sclerosis

Author

Villar LM, Casanova B, Ouamara N, Comabella M, Jalili F, Leppert D, de Andrés C, Izquierdo G, Arroyo R, Avsar T, Lapin SV, Johnson T, Montalbán X, Fernández O, Álvarez-Lafuente R, Masterman D, García-Sánchez MI, Coret F, Siva A, Evdoshenko E, Álvarez-Cermeño JC, and Bar-Or A

Subjects
Adult, Inflammation, Male, Cross-Sectional Studies, Phenotype, Immunoglobulin M, Oligoclonal Bands, Humans, Female, Longitudinal Studies, Middle Aged, Multiple Sclerosis, Chronic Progressive, Biomarkers
Abstract

Objective: To identify a biomarker distinguishing patients who, despite a primary progressive multiple sclerosis (PPMS) clinical course, may nonetheless benefit from immune therapy. Methods: The presence or absence of both immunoglobulin (Ig) G and IgM oligoclonal bands (OCB) was blindly examined in paired cerebrospinal fluid (CSF) and serum samples from a large PPMS patient cohort, and related to clinical and imaging evidence of focal inflammatory disease activity. Results: Using both cross-sectional samples and serial sampling in a subgroup of patients followed prospectively as part of the placebo-controlled OLYMPUS study of rituximab in PPMS, we found that the presence of CSF-restricted IgM OCB (but not of IgG OCB) is associated with an active inflammatory disease phenotype in PPMS patients. This finding was confirmed in an independent, multicenter validation cohort. Interpretation: The presence of CSF IgM OCB may be a biomarker for a subset of PPMS patients with more active inflammatory disease, who may benefit from immune-directed treatments.

Published
2013

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