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Multiple Sclerosis

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410 papers 25 to 100 followers
By Alexandros Tsichlakis Medical representative
https://www.readbyqxmd.com/read/28002679/ocrelizumab-versus-interferon-beta-1a-in-relapsing-multiple-sclerosis
#1
RANDOMIZED CONTROLLED TRIAL
Stephen L Hauser, Amit Bar-Or, Giancarlo Comi, Gavin Giovannoni, Hans-Peter Hartung, Bernhard Hemmer, Fred Lublin, Xavier Montalban, Kottil W Rammohan, Krzysztof Selmaj, Anthony Traboulsee, Jerry S Wolinsky, Douglas L Arnold, Gaelle Klingelschmitt, Donna Masterman, Paulo Fontoura, Shibeshih Belachew, Peter Chin, Nicole Mairon, Hideki Garren, Ludwig Kappos
Background B cells influence the pathogenesis of multiple sclerosis. Ocrelizumab is a humanized monoclonal antibody that selectively depletes CD20+ B cells. Methods In two identical phase 3 trials, we randomly assigned 821 and 835 patients with relapsing multiple sclerosis to receive intravenous ocrelizumab at a dose of 600 mg every 24 weeks or subcutaneous interferon beta-1a at a dose of 44 μg three times weekly for 96 weeks. The primary end point was the annualized relapse rate. Results The annualized relapse rate was lower with ocrelizumab than with interferon beta-1a in trial 1 (0...
January 19, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28002688/ocrelizumab-versus-placebo-in-primary-progressive-multiple-sclerosis
#2
RANDOMIZED CONTROLLED TRIAL
Xavier Montalban, Stephen L Hauser, Ludwig Kappos, Douglas L Arnold, Amit Bar-Or, Giancarlo Comi, Jérôme de Seze, Gavin Giovannoni, Hans-Peter Hartung, Bernhard Hemmer, Fred Lublin, Kottil W Rammohan, Krzysztof Selmaj, Anthony Traboulsee, Annette Sauter, Donna Masterman, Paulo Fontoura, Shibeshih Belachew, Hideki Garren, Nicole Mairon, Peter Chin, Jerry S Wolinsky
Background An evolving understanding of the immunopathogenesis of multiple sclerosis suggests that depleting B cells could be useful for treatment. We studied ocrelizumab, a humanized monoclonal antibody that selectively depletes CD20-expressing B cells, in the primary progressive form of the disease. Methods In this phase 3 trial, we randomly assigned 732 patients with primary progressive multiple sclerosis in a 2:1 ratio to receive intravenous ocrelizumab (600 mg) or placebo every 24 weeks for at least 120 weeks and until a prespecified number of confirmed disability progression events had occurred...
January 19, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28108364/from-natalizumab-to-fingolimod-in-eight-weeks-immunological-clinical-and-radiological-data-in-quest-of-the-optimal-switch
#3
Andrea Harrer, Georg Pilz, Katrin Oppermann, Marlene Sageder, Shahrzad Afazel, Elisabeth Haschke-Becher, Theo Rispens, Annick de Vries, Mark McCoy, Vlado Stevanovic, Wolfgang Hitzl, Eugen Trinka, Jörg Kraus, Johann Sellner, Peter Wipfler
Natalizumab (NZB) discontinuation during a treatment change is associated with recurrence of disease activity in a significant proportion of multiple sclerosis (MS) patients. The immunological basis why disease reactivation occurs in selected patients is unresolved. In search of a prognostic biomarker for a safe and effective transition from NZB to fingolimod, we monitored five parameters related to pharmacokinetic and pharmacodynamic effects of the two drugs in 12 MS patients until six months on fingolimod...
March 2017: Clinical Immunology: the Official Journal of the Clinical Immunology Society
https://www.readbyqxmd.com/read/28165319/progressive-multifocal-leukoencephalopathy-in-two-natalizumab-treated-stepsisters-an-intriguing-coincidence
#4
Frédéric Bacchetta, Amandine Mathias, Myriam Schluep, Renaud Du Pasquier
BACKGROUND: Natalizumab, a treatment used in multiple sclerosis (MS), is associated with cases of progressive multifocal leukoencephalopathy (PML). OBJECTIVE: We describe two cases of PML in related but not genetically apparented natalizumab-treated MS patients who are stepsisters. Reported cases/outcomes: While Patient 1 developed PML, Patient 2 was on natalizumab and had contacts with Patient 1. Patient 2 was diagnosed with PML 5 months after Patient 1. CONCLUSION: The clinical and temporal data highly suggest that there was JC virus (JCV) transmission from one patient to the other with development of PML as primo-infection in Patient 2...
February 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/28228564/natalizumab-associated-pml-challenges-with-incidence-resulting-risk-and-risk-stratification
#5
Nicholas Schwab, Tilman Schneider-Hohendorf, Nico Melzer, Gary Cutter, Heinz Wiendl
Progressive multifocal leukoencephalopathy (PML) associated with natalizumab treatment continues to be a severe problem of clinically successful therapy. This is an update of risk stratification developments and discusses the current approach to depict and calculate PML incidence and PML risk. (1) PML incidence and resulting risk used in today's clinical practice are potentially outdated and the risk for patients with prior immunosuppression might have been underestimated. (2) Risk stratification according to treatment duration epochs likely suggests lower risk due to patients stopping treatment within a given epoch...
February 22, 2017: Neurology
https://www.readbyqxmd.com/read/28228569/no-evidence-of-beneficial-effects-of-plasmapheresis-in-natalizumab-associated-pml
#6
Doriana Landi, Nicola De Rossi, Sara Zagaglia, Cristina Scarpazza, Luca Prosperini, Maria Albanese, Fabio Buttari, Francesco Mori, Girolama Alessandra Marfia, Maria Pia Sormani, Ruggero Capra, Diego Centonze
OBJECTIVE: To examine retrospectively the effects of plasmapheresis (PLEX) on the survival and clinical outcomes of patients with multiple sclerosis (MS) and natalizumab (NTZ)-associated progressive multifocal leukoencephalopathy (PML). METHODS: The medical literature was searched for the terms natalizumab and progressive multifocal leukoencephalopathy. A total of 193 international and 34 Italian NTZ-PML cases were included. Clinical outcome was determined by comparing the patients' clinical status at PML diagnosis with status after PML resolution...
February 22, 2017: Neurology
https://www.readbyqxmd.com/read/28183723/%C3%A2-daclizumab-for-ms
#7
(no author information available yet)
▼Daclizumab (Zinbryta-Biogen Idec) is a new injectable disease-modifying drug licensed for the treatment of relapsing forms of multiple sclerosis (MS) in adults.(1) It is a humanised monoclonal antibody that modulates interleukin-2 signalling.(1-3) Here, we review the evidence on daclizumab and consider its place in the management of MS.
February 2017: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/28211007/daclizumab-a-review-in-relapsing-multiple-sclerosis
#8
Matt Shirley
Daclizumab (Zinbryta(®); previously known as daclizumab high-yield process) is a therapeutic monoclonal antibody that has recently been approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Daclizumab is a humanized IgG1 monoclonal antibody directed against CD25, the alpha subunit of the high-affinity interleukin-2 receptor. As demonstrated in the phase III DECIDE trial, once-monthly subcutaneous daclizumab was superior to once-weekly intramuscular interferon (IFN) β-1a in reducing the clinical relapse rate and radiological measures of disease in patients with relapsing-remitting MS...
February 17, 2017: Drugs
https://www.readbyqxmd.com/read/28211024/comparative-effectiveness-research-of-disease-modifying-therapies-for-the-management-of-multiple-sclerosis-analysis-of-a-large-health-insurance-claims-database
#9
Aaron Boster, Jacqueline Nicholas, Ning Wu, Wei-Shi Yeh, Monica Fay, Michael Edwards, Ming-Yi Huang, Andrew Lee
INTRODUCTION: Limited data are available on the real-world effectiveness of newer oral disease-modifying therapies (DMTs) in multiple sclerosis. The purpose of this study was to retrospectively compare the real-world effectiveness of dimethyl fumarate (DMF), fingolimod, teriflunomide, and injectable DMTs in routine clinical practice based on US claims data. METHODS: Patients newly-initiating DMF, interferon beta (IFNβ), glatiramer acetate (GA), teriflunomide, or fingolimod in 2013 were identified in the Truven MarketScan Commercial Claims Databases (N = 6372)...
February 16, 2017: Neurology and Therapy
https://www.readbyqxmd.com/read/28165320/cutaneous-cryptococcosis-in-a-patient-taking-fingolimod-for-multiple-sclerosis-here-come-the-opportunistic-infections
#10
Adam F Carpenter, Shikha J Goodwin, Peter F Bornstein, Andrew J Larson, Christine K Markus
BACKGROUND: Fingolimod is an oral disease-modifying therapy for relapsing forms of multiple sclerosis, which acts by sequestering lymphocytes within lymph nodes. OBJECTIVE: To describe a case of extrapulmonary cryptococcosis in a patient taking fingolimod. METHODS: Case report. RESULTS: A 47-year-old man developed a non-healing skin lesion approximately 16 months after starting treatment with fingolimod. Biopsy revealed cryptococcosis...
February 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/28209331/treatment-effectiveness-of-alemtuzumab-compared-with-natalizumab-fingolimod-and-interferon-beta-in-relapsing-remitting-multiple-sclerosis-a-cohort-study
#11
Tomas Kalincik, J William L Brown, Neil Robertson, Mark Willis, Neil Scolding, Claire M Rice, Alastair Wilkins, Owen Pearson, Tjalf Ziemssen, Michael Hutchinson, Christopher McGuigan, Vilija Jokubaitis, Tim Spelman, Dana Horakova, Eva Havrdova, Maria Trojano, Guillermo Izquierdo, Alessandra Lugaresi, Alexandre Prat, Marc Girard, Pierre Duquette, Pierre Grammond, Raed Alroughani, Eugenio Pucci, Patrizia Sola, Raymond Hupperts, Jeannette Lechner-Scott, Murat Terzi, Vincent Van Pesch, Csilla Rozsa, François Grand'Maison, Cavit Boz, Franco Granella, Mark Slee, Daniele Spitaleri, Javier Olascoaga, Roberto Bergamaschi, Freek Verheul, Steve Vucic, Pamela McCombe, Suzanne Hodgkinson, Jose Luis Sanchez-Menoyo, Radek Ampapa, Magdolna Simo, Tunde Csepany, Cristina Ramo, Edgardo Cristiano, Michael Barnett, Helmut Butzkueven, Alasdair Coles
BACKGROUND: Alemtuzumab, an anti-CD52 antibody, is proven to be more efficacious than interferon beta-1a in the treatment of relapsing-remitting multiple sclerosis, but its efficacy relative to more potent immunotherapies is unknown. We compared the effectiveness of alemtuzumab with natalizumab, fingolimod, and interferon beta in patients with relapsing-remitting multiple sclerosis treated for up to 5 years. METHODS: In this international cohort study, we used data from propensity-matched patients with relapsing-remitting multiple sclerosis from the MSBase and six other cohorts...
February 10, 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28245526/progressive-multifocal-leukoencephalopathy-driven-from-rarity-to-clinical-mainstream-by-iatrogenic-immunodeficiency
#12
REVIEW
Siraj A Misbah
Advances in immune-mediated targeted therapies have proven to be a double-edged sword for patients by highlighting the risk of iatrogenic infective complications. This has been exemplified by progressive multifocal leukoencephalopathy (PML), a hitherto rare devastating viral infection of the brain caused by the neurotropic JC polyoma virus. While PML achieved prominence during the first two decades of the HIV epidemic, effective anti-retroviral treatment and restitution of T cell function has led to PML being less prominent in this population...
February 28, 2017: Clinical and Experimental Immunology
https://www.readbyqxmd.com/read/28247239/effect-of-fingolimod-on-brain-volume-loss-in-patients-with-multiple-sclerosis
#13
REVIEW
Nicola De Stefano, Diego G Silva, Michael H Barnett
Brain atrophy occurs at a faster rate in patients with multiple sclerosis (MS) than in healthy individuals. In three randomized, controlled, phase III trials, fingolimod reduced the annual rate of brain volume loss (BVL) in patients with relapsing MS (RMS) by approximately one-third relative to that in individuals receiving placebo or intramuscular interferon beta-1a. Analysis of brain volume changes during study extensions has shown that this reduced rate of BVL is sustained in patients with RMS receiving fingolimod continuously...
February 28, 2017: CNS Drugs
https://www.readbyqxmd.com/read/27890706/the-sphingosine-1-phosphate-receptor-a-novel-therapeutic-target-for-multiple-sclerosis-and-other-autoimmune-diseases
#14
REVIEW
Yang Mao-Draayer, Jeffrey Sarazin, David Fox, Elena Schiopu
Multiple sclerosis (MS) is a prototype autoimmune disease of the central nervous system (CNS). Currently, there is no drug that provides a cure for MS. To date, all immunotherapeutic drugs target relapsing remitting MS (RR-MS); it remains a daunting medical challenge in MS to develop therapy for secondary progressive MS (SP-MS). Since the approval of the non-selective sphingosine-1-phosphate (S1P) receptor modulator FTY720 (fingolimod [Gilenya®]) for RR-MS in 2010, there have been many emerging studies with various selective S1P receptor modulators in other autoimmune conditions...
February 2017: Clinical Immunology: the Official Journal of the Clinical Immunology Society
https://www.readbyqxmd.com/read/27919497/comparative-efficacy-and-discontinuation-of-dimethyl-fumarate-and-fingolimod-in-clinical-practice-at-12-month-follow-up
#15
COMPARATIVE STUDY
Carrie M Hersh, Thomas E Love, Samuel Cohn, Claire Hara-Cleaver, Robert A Bermel, Robert J Fox, Jeffrey A Cohen, Daniel Ontaneda
BACKGROUND: Dimethyl fumarate (DMF) and fingolimod (FTY) are approved oral disease modifying therapies (DMT) for relapsing multiple sclerosis (MS). Phase 3 trials established these agents as effective and generally well tolerated, though comparative efficacy and discontinuation remain unknown. OBJECTIVE: To assess real-world efficacy and discontinuation of DMF and FTY over 12 months in patients with MS. METHODS: We identified 458 DMF-treated and 317 FTY-treated patients in a large academic MS center...
November 2016: Multiple Sclerosis and related Disorders
https://www.readbyqxmd.com/read/27882532/alemtuzumab-use-in-clinical-practice-recommendations-from-european-multiple-sclerosis-experts
#16
Thomas Berger, Irina Elovaara, Sten Fredrikson, Chris McGuigan, Lucia Moiola, Kjell-Morten Myhr, Celia Oreja-Guevara, Igor Stoliarov, Uwe K Zettl
Alemtuzumab (Lemtrada™) is a humanized monoclonal antibody approved in more than 50 countries. Within the European Union, alemtuzumab is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features; in the USA, the indication states that alemtuzumab should generally be reserved for the treatment of patients with relapsing forms of multiple sclerosis who have had an inadequate response to two or more disease-modifying therapies (DMTs)...
January 2017: CNS Drugs
https://www.readbyqxmd.com/read/27813441/primary-progressive-multiple-sclerosis-current-therapeutic-strategies-and-future-perspectives
#17
Alberto Gajofatto, Marco Turatti, Maria Donata Benedetti
Multiple sclerosis (MS) is a chronic inflammatory condition of the central nervous system with heterogeneous features. Primary progressive (PP) MS is a rare disease subtype characterized by continuous disability worsening from onset. No disease-modifying therapy is currently approved for PP MS due to the negative or inconsistent results of clinical trials conducted on a wide range of interventions, which are reviewed in the present paper. Areas covered: The features and results of randomized trials of disease-modifying treatments for PP MS are discussed, including immunosuppressants, immunomodulators, monoclonal antibodies, and putative neuroprotective agents...
November 15, 2016: Expert Review of Neurotherapeutics
https://www.readbyqxmd.com/read/27006700/fingolimod-in-the-treatment-of-relapsing-remitting-multiple-sclerosis-long-term-experience-and-an-update-on-the-clinical-evidence
#18
REVIEW
Bhupendra O Khatri
Since the approval in 2010 of fingolimod 0.5 mg (Gilenya; Novartis Pharma AG, Basel, Switzerland) in the USA as an oral therapy for relapsing forms of multiple sclerosis, long-term clinical experience with this therapy has been increasing. This review provides a summary of the cumulative dataset from clinical trials and their extensions, plus postmarketing studies that contribute to characterizing the efficacy and safety profile of fingolimod in patients with relapsing forms of multiple sclerosis. Data from the controlled, phase III, pivotal studies [FREEDOMS (FTY720 Research Evaluating Effects of Daily Oral therapy in Multiple Sclerosis), FREEDOMS II and TRANSFORMS (Trial Assessing Injectable Interferon versus FTY720 Oral in Relapsing-Remitting Multiple Sclerosis)] in relapsing-remitting multiple sclerosis have shown that fingolimod has a robust effect on clinical and magnetic resonance imaging outcomes...
March 2016: Therapeutic Advances in Neurological Disorders
https://www.readbyqxmd.com/read/27502119/study-design-of-pangaea-2-0-a-non-interventional-study-on-rrms-patients-to-be-switched-to-fingolimod
#19
MULTICENTER STUDY
Tjalf Ziemssen, Raimar Kern, Christian Cornelissen
BACKGROUND: The therapeutic options for patients with Multiple Sclerosis (MS) have steadily increased due to the approval of new substances that now supplement traditional first-line agents, demanding a paradigm shift in the assessment of disease activity and treatment response in clinical routine. Here, we report the study design of PANGAEA 2.0 (Post-Authorization Non-interventional GermAn treatment benefit study of GilEnyA in MS patients), a non-interventional study in patients with relapsing-remitting MS (RRMS) identify patients with disease activity and monitor their disease course after treatment switch to fingolimod (Gilenya®), an oral medication approved for patients with highly active RRMS...
August 8, 2016: BMC Neurology
https://www.readbyqxmd.com/read/27663260/to-fingolimod-and-beyond-the-rich-pipeline-of-drug-candidates-that-target-s1p-signaling
#20
REVIEW
Wee Siong Chew, Wei Wang, Deron R Herr
Sphingosine 1-phosphate (S1P) is an extracellular lipid signaling molecule that acts as a selective, high-affinity ligand for a family of five G protein-coupled receptors. This signaling system was first identified twenty years ago, and has since been shown to regulate a diverse range of physiological processes and disease states, such as cardiovascular development, immune function, hypoxic responses, and cancer. The therapeutic potential of targeting this system took center stage when it was demonstrated that the immune modulator, fingolimod (FTY720/Gilenya), exerts it lymphopenic effect by acting on S1P receptors, primarily on S1P receptor 1 (S1P1)...
November 2016: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
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