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https://www.readbyqxmd.com/read/28104251/efficacy-safety-and-pharmacokinetics-of-natalizumab-in-japanese-multiple-sclerosis-patients-a-double-blind-randomized-controlled-trial-and-open-label-pharmacokinetic-study
#1
Takahiko Saida, Jun-Ichi Kira, Shuji Kishida, Takashi Yamamura, Yukiko Sudo, Kazutaka Ogiwara, J T Tibung, Nisha Lucas, Meena Subramanyam
BACKGROUND: Natalizumab, an anti-α4 integrin monoclonal antibody, has demonstrated efficacy in phase 2 and 3 studies of predominantly Caucasian patients with relapsing-remitting multiple sclerosis (RRMS). OBJECTIVE: To evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of natalizumab in Japanese RRMS patients. METHODS: This multicenter, phase 2 study included an open-label PK/PD study in 12 patients (part A) and a double-blind, placebo-controlled, randomized (computer-generated sequence) study in 94 patients (part B)...
January 2017: Multiple Sclerosis and related Disorders
https://www.readbyqxmd.com/read/28090055/natalizumab-is-effective-for-the-treatment-of-relapsing-remitting-tumefactive-multiple-sclerosis
#2
Masataka Nakamura, Kumi Itani, Kousuke Miyake, Takenobu Kunieda, Satoshi Kaneko, Hirofumi Kusaka
We herein report the case of a 57-year-old woman presenting with a biopsy-proven tumefactive demyelinating lesion as her first clinical event. Subsequently, she displayed a relapsing-remitting course with recurrence of large demyelinating lesions exceeding 2 cm in diameter rather than the small ovoid lesions characteristic of multiple sclerosis. Administration of interferon beta did not suppress the disease activity. Finally, treatment with natalizumab, which is a humanized monoclonal antibody against the cell-adhesion molecule α4-integrin, was initiated, resulting in clinical and radiological stabilization...
2017: Internal Medicine
https://www.readbyqxmd.com/read/28087821/selection-of-first-line-therapy-in-multiple-sclerosis-using-risk-benefit-decision-analysis
#3
David Bargiela, Matthew T Bianchi, M Brandon Westover, Lori B Chibnik, Brian C Healy, Philip L De Jager, Zongqi Xia
OBJECTIVE: To integrate long-term measures of disease-modifying drug efficacy and risk to guide selection of first-line treatment of multiple sclerosis. METHODS: We created a Markov decision model to evaluate disability worsening and progressive multifocal leukoencephalopathy (PML) risk in patients receiving natalizumab (NTZ), fingolimod (FGL), or glatiramer acetate (GA) over 30 years. Leveraging publicly available data, we integrated treatment utility, disability worsening, and risk of PML into quality-adjusted life-years (QALYs)...
January 13, 2017: Neurology
https://www.readbyqxmd.com/read/28081190/inflammatory-activity-on-natalizumab-predicts-short-term-but-not-long-term-disability-in-multiple-sclerosis
#4
Joel Raffel, Arie R Gafson, Samer Dahdaleh, Omar Malik, Brynmor Jones, Richard Nicholas
BACKGROUND: In people with multiple sclerosis treated with interferon-beta or glatiramer acetate, new MRI lesions and relapses during the first year of treatment predict a poor prognosis. OBJECTIVE: To study this association in those receiving natalizumab. METHODS: Data were collected on relapses, new MRI activity, and Modified Rio Score after initiation of natalizumab in an observational cohort of 161 patients with high baseline disability...
2017: PloS One
https://www.readbyqxmd.com/read/28078634/natalizumab-for-achieving-relapse-free-t1-gadolinium-enhancing-lesion-free-and-t2-lesion-free-status-in-japanese-multiple-sclerosis-patients-a-phase-2-trial-subanalysis
#5
Takahiko Saida, Jun-Ichi Kira, Shuji Kishida, Takashi Yamamura, Nobuhisa Ohtsuka, Qunming Dong, J T Tibung
INTRODUCTION: In a phase 2 trial of natalizumab in Japanese patients with relapsing-remitting multiple sclerosis (RRMS), treatment-related changes in relapses, brain lesions, and disability worsening were found to be comparable with those observed in the phase 3 studies of natalizumab in primarily non-Asian RRMS patients. METHODS: This subanalysis of the placebo-controlled phase 2 trial of natalizumab in Japanese RRMS patients (n = 94) evaluated the effects of natalizumab versus placebo on the proportion of patients who achieved relapse-free, T1 gadolinium-enhancing (Gd+) lesion-free, and new/newly enlarged T2 lesion-free status, defined as "no evidence of inflammatory disease activity" (NEDA)-like status, after 24 weeks of treatment...
January 11, 2017: Neurology and Therapy
https://www.readbyqxmd.com/read/28077493/disease-modifying-therapies-modulate-retinal-atrophy-in-multiple-sclerosis-a-retrospective-study
#6
Julia Button, Omar Al-Louzi, Andrew Lang, Pavan Bhargava, Scott D Newsome, Teresa Frohman, Laura J Balcer, Elliot M Frohman, Jerry Prince, Peter A Calabresi, Shiv Saidha
OBJECTIVE: To retrospectively investigate whether disease-modifying therapies (DMTs) exert differential effects on rates of retinal atrophy in relapsing-remitting multiple sclerosis (RRMS), as assessed using optical coherence tomography (OCT). METHODS: A total of 402 patients with RRMS followed at the Johns Hopkins MS Center who underwent Cirrus-HD OCT were assessed for eligibility. Inclusion criteria included at least 1 year of OCT follow-up and adherence to a single DMT during the period of follow-up...
January 11, 2017: Neurology
https://www.readbyqxmd.com/read/28077489/rescue-of-severe-brain-and-cervical-cord-iris-by-restarting-natalizumab-in-a-pregnant-ms-patient
#7
Thomas H Massey, Rachel Smith, Shaheena Sadiq, Christopher Overton, Owen R Pearson
No abstract text is available yet for this article.
January 11, 2017: Neurology
https://www.readbyqxmd.com/read/28052269/observational-study-of-switching-from-natalizumab-to-immunomodulatory-drugs
#8
Ramón Villaverde-González, Julia Gracia Gil, Angel Pérez Sempere, Jorge Millán Pascual, José Marín Marín, María Carcelén Gadea, Laura Gabaldón Torres, Antonio Moreno Escribano, Antonio Candeliere Merlicco
OBJECTIVE: To determine the effect of disease-modifying drugs (DMDs) on disease activity rebound in patients discontinuing natalizumab (NTZ). METHODS: Twenty-one patients with relapsing-remitting multiple sclerosis (RRMS) treated with NTZ for ≥1 year and who switched to DMDs (glatiramer acetate [GA] or interferon) were followed up for 12 months in clinical practice. Clinical outcomes after NTZ cessation were assessed every 3 months for 1 year and MRI was performed at 12 months...
January 5, 2017: European Neurology
https://www.readbyqxmd.com/read/28052250/ebi2-expression-and-function-robust-in-memory-lymphocytes-and-increased-by-natalizumab-in-multiple-sclerosis
#9
Aurélie S Clottu, Amandine Mathias, Andreas W Sailer, Myriam Schluep, Jörg D Seebach, Renaud Du Pasquier, Caroline Pot
The interaction between oxysterols and the G protein-coupled receptor Epstein-Barr virus-induced gene 2 (EBI2) fine-tunes immune cell migration, a mechanism efficiently targeted by several disease-modifying treatments developed to treat multiple sclerosis (MS), such as natalizumab. We previously showed that memory CD4(+) T lymphocytes migrate specifically in response to 7α,25-dihydroxycholesterol (7α,25-OHC) via EBI2 in the MS murine model experimental autoimmune encephalomyelitis. However, the EBI2 expression profile in human lymphocytes in both healthy and MS donors is unknown...
January 3, 2017: Cell Reports
https://www.readbyqxmd.com/read/28036121/study-of-the-anti-jcv-antibody-levels-in-a-spanish-multiple-sclerosis-cohort
#10
María I Dominguez-Mozo, Macarena Rus, Jose L Santiago, Guillermo Izquierdo, Ignacio Casanova, Victoria Galan, M Angel Garcia-Martinez, Ana M Arias-Leal, Marta García-Montojo, Silvia Pérez-Pérez, Rafael Arroyo, Roberto Alvarez-Lafuente
One of the risk factor to develop progressive multifocal leukoencephalopathy (PML) among natalizumab-treated patients is the presence and high levels of anti-JCV antibodies. Our purpose was to test the association of different clinical and demographic variables with the presence and levels of anti-JCV antibodies in a Spanish cohort of multiple sclerosis (MS) patients during natalizumab treatment MATERIALS AND METHODS: All MS patients from two hospitals with at least one measure of the anti-JCV antibodies levels (2011-2014) were recruited, among them two PML cases...
December 30, 2016: European Journal of Clinical Investigation
https://www.readbyqxmd.com/read/28008769/a-discrete-event-simulation-to-model-the-cost-utility-of-fingolimod-and-natalizumab-in-rapidly-evolving-severe-relapsing-remitting-multiple-sclerosis-in-the-uk
#11
Stephen Montgomery, Maciej Maruszczak, David Slater, Jeanette Kusel, Richard Nicholas, Nicholas Adlard
OBJECTIVE: Two disease modifying therapies are licensed in the EU for use in rapidly-evolving severe (RES) relapsing-remitting multiple sclerosis (RRMS), fingolimod and natalizumab. Here a discrete event simulation (DES) model to analyse the cost-effectiveness of natalizumab and fingolimod in the RES population, from the perspective of the National Health Service (NHS) in the UK, is reported. METHODS: A DES model was developed to track individual RES patients, based on Expanded Disability Status Scale scores...
December 23, 2016: Journal of Medical Economics
https://www.readbyqxmd.com/read/28004598/natalizumab-treatment-of-multiple-sclerosis-new-insights
#12
Serena Delbue, Manola Comar, Pasquale Ferrante
Natalizumab is a monoclonal antibody directed against the α4 chain of the very late activating antigen 4 and α4β7 integrins, present on the leukocytes surface, used as monotherapy for the treatment of relapsing-remitting multiple sclerosis. It substantially reduces relapse rate and the accumulation of disability, but its use is associated with a very adverse event, that is the development of progressive multifocal leukoencephalopathy, a fatal demyelinating disease of the CNS, due to the lytic replication of the human polyomavirus JC...
December 22, 2016: Immunotherapy
https://www.readbyqxmd.com/read/27999525/antidepressant-drug-treatment-in-association-with-multiple-sclerosis-disease-modifying-therapy-using-explorys-in-the-ms-population
#13
Matthew M Mirsky, Ruth Ann Marrie, Alexander Rae-Grant
Background: The Explorys Enterprise Performance Management (EPM) database contains de-identified clinical data for 50 million patients. Multiple sclerosis (MS) disease-modifying therapies (DMTs), specifically interferon beta (IFNβ) treatments, may potentiate depression. Conflicting data have emerged, and a large-scale claims-based study by Patten et al. did not support such an association. This study compares the results of Patten et al. with those using the EPM database. Methods: "Power searches" were built to test the relationship between antidepressant drug use and DMT in the MS population...
November 2016: International Journal of MS Care
https://www.readbyqxmd.com/read/27997580/natalizumab-related-progressive-multifocal-leukoencephalopathy-in-multiple-sclerosis-findings-from-an-italian-independent-registry
#14
Luca Prosperini, Nicola de Rossi, Cristina Scarpazza, Lucia Moiola, Mirco Cosottini, Simonetta Gerevini, Ruggero Capra
BACKGROUND: The monoclonal antibody natalizumab (NTZ) is a highly effective treatment for patients with multiple sclerosis (MS). However, this drug is associated with increased risk of developing Progressive Multifocal Leukoencephalopathy (PML), an opportunistic infection of central nervous system (CNS) caused by the John Cunningham polyomavirus (JCV). OBJECTIVE: To describe the 12-month clinical course of 39 patients with MS (28 women, 11 men) who developed NTZ-related PML after a mean exposure of 39 infusions...
2016: PloS One
https://www.readbyqxmd.com/read/27994897/progressive-multifocal-leukoencephalopathy-in-a-multiple-sclerosis-patient-diagnosed-after-switching-from-natalizumab-to-fingolimod
#15
Tim Sinnecker, Jalal Othman, Marc Kühl, Imke Metz, Thoralf Niendorf, Annett Kunkel, Friedemann Paul, Jens Wuerfel, Juergen Faiss
Background. Natalizumab- (NTZ-) associated progressive multifocal leukoencephalopathy (PML) is a severe and often disabling infectious central nervous system disease that can become evident in multiple sclerosis (MS) patients after NTZ discontinuation. Recently, novel diagnostic biomarkers for the assessment of PML risk in NTZ treated MS patients such as the anti-JC virus antibody index have been reported, and the clinical relevance of milky-way lesions detectable by MRI has been discussed. Case Presentation and Conclusion...
2016: Case Reports in Neurological Medicine
https://www.readbyqxmd.com/read/27993870/possible-implication-of-gstp1-and-nqo1-polymorphisms-on-natalizumab-response-in-multiple-sclerosis
#16
Athanasia Alexoudi, Sophia Zachaki, Chrysa Stavropoulou, Stavroula Gavrili, Chara Spiliopoulou, Stavroula Papadodima, Clementine E Karageorgiou, Constantina Sambani
Oxidative stress plays a pivotal role in the pathogenesis of multiple sclerosis (MS). Inactivating polymorphism of genes encoding detoxification enzymes, such as NQO1 and GSTP1 could influence susceptibility to MS. The monoclonal antibody natalizumab is an effective treatment in MS. Natalizumab's efficacy in MS patients with regard to NQO1 and GSTP1 genetic polymorphisms is investigated. 130 patients with definite MS according to the Mc Donald's criteria treated monthly with natalizumab were included in the study...
December 2016: Annals of Clinical and Laboratory Science
https://www.readbyqxmd.com/read/27976804/a-longitudinal-real-life-comparison-study-of-natalizumab-and-fingolimod
#17
R Lanzillo, A Carotenuto, M Moccia, F Saccà, C V Russo, M Massarelli, A De Rosa, V Brescia Morra
BACKGROUND: Different retrospective studies compared natalizumab and fingolimod in relapsing-remitting multiple sclerosis (RRMS), with conflicting results. We aimed to explore the prescriptive attitude and the clinical outcome of the two therapies. METHODS: We retrospectively included all RRMS patients treated with natalizumab (n=101) or fingolimod (n=78) as their first second-line therapy with at least 24-month follow-up. Demographic and clinical features were recorded to calculate the propensity score (PS)...
December 15, 2016: Acta Neurologica Scandinavica
https://www.readbyqxmd.com/read/27970911/a-regional-analysis-of-relapsing-remitting-ms-rrms-patients-treated-with-natalizumab-suggests-a-need-to-diagnose-and-treat-early-in-latin-americans
#18
P Serafini, D Callegaro, S Apostolos, D Sato, E Jones, J Pike
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27970896/the-societal-impact-of-natalizumab-treatment-in-the-italian-relapsing-remitting-multiple-sclerosis-clinical-practice-the-tysabri%C3%A2-pharmacoeconomics-type-study
#19
B Polistena, F Spandonaro, C Gasperini, G B Zimatore, L Santoni, S Fantaccini, R Capra
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27970881/cost-utility-analysis-of-alemtuzumab-versus-natalizumab-for-the-treatment-of-relapsing-remitting-multiple-sclerosis-us-payer-perspective
#20
A Smith, L Hashemi, I Ma
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
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