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https://www.readbyqxmd.com/read/29363396/long-term-follow-up-of-pediatric-ms-patients-starting-treatment-with-injectable-first-line-agents-a-multicentre-italian-retrospective-observational-study
#1
Damiano Baroncini, Mauro Zaffaroni, Lucia Moiola, Lorena Lorefice, Giuseppe Fenu, Pietro Iaffaldano, Marta Simone, Fulvia Fanelli, Francesco Patti, Emanuele D'Amico, Marco Capobianco, Antonio Bertolotto, Paolo Gallo, Monica Margoni, Silvia Miante, Nicoletta Milani, Maria Pia Amato, Isabella Righini, Paolo Bellantonio, Cinzia Scandellari, Gianfranco Costantino, Elio Scarpini, Roberto Bergamaschi, Giulia Mallucci, Giancarlo Comi, Angelo Ghezzi
BACKGROUND: Few data are available on very long-term follow-up of pediatric multiple sclerosis (MS) patients treated with disease modifying treatments (DMTs). OBJECTIVES: To present a long-term follow-up of a cohort of Pediatric-MS patients starting injectable first-line agents. METHODS: Data regarding treatments, annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) score, and serious adverse event were collected. Baseline characteristics were tested in multivariate analysis to identify predictors of disease evolution...
January 1, 2018: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/29280018/correction-to-management-of-pregnancy-related-issues-in-multiple-sclerosis-patients-the-need-for-an-interdisciplinary-approach
#2
Maria Pia Amato, Antonio Bertolotto, Roberto Brunelli, Paola Cavalla, Benedetta Goretti, Maria Giovanna Marrosu, Francesco Patti, Carlo Pozzilli, Leandro Provinciali, Nicola Rizzo, Nicola Strobelt, Gioacchino Tedeschi, Maria Trojano, Giancarlo Comi
The original version contained a mistake. The authors have specified only in a few paragraphs that all the contents of the paper are meant for Copaxone but not for unbranded glatiramer acetate, Authors ask to add the specification of Copaxone or branded glatiramer acetate everytime.
February 2018: Neurological Sciences
https://www.readbyqxmd.com/read/29168242/compositional-differences-between-copaxone-and-glatopa-are-reflected-in-altered-immunomodulation-ex-vivo-in-a-mouse-model
#3
Iris Grossman, Sarah Kolitz, Arthur Komlosh, Benjamin Zeskind, Vera Weinstein, Daphna Laifenfeld, Adrian Gilbert, Oren Bar-Ilan, Kevin D Fowler, Tal Hasson, Attila Konya, Kevin Wells-Knecht, Pippa Loupe, Sigal Melamed-Gal, Tatiana Molotsky, Revital Krispin, Galia Papir, Yousif Sahly, Michael R Hayden
Copaxone (glatiramer acetate, GA), a structurally and compositionally complex polypeptide nonbiological drug, is an effective treatment for multiple sclerosis, with a well-established favorable safety profile. The short antigenic polypeptide sequences comprising therapeutically active epitopes in GA cannot be deciphered with state-of-the-art methods; and GA has no measurable pharmacokinetic profile and no validated pharmacodynamic markers. The study reported herein describes the use of orthogonal standard and high-resolution physicochemical and biological tests to characterize GA and a U...
November 2017: Annals of the New York Academy of Sciences
https://www.readbyqxmd.com/read/29049356/treatment-satisfaction-with-injectable-disease-modifying-therapies-in-patients-with-relapsing-remitting-multiple-sclerosis-the-stick-study
#4
Oscar Fernández, Eduardo Duran, Teresa Ayuso, Luis Hernández, Inmaculada Bonaventura, Mireia Forner
BACKGROUND: Treatment satisfaction in patients with relapsing-remitting multiple sclerosis (RRMS) may impact adherence and thus clinical outcomes. The objective of this study was to measure the satisfaction of patients with RRMS with injectable disease-modifying therapies (DMTs) and to evaluate the factors associated with treatment satisfaction. MATERIAL AND METHODS: In this observational retrospective study conducted in the neurology departments of 35 hospitals throughout Spain, demographic data, disease characteristics, and information on treatment with injectable DMTs were collected at a single scheduled visit...
2017: PloS One
https://www.readbyqxmd.com/read/28724581/mri-evidence-of-acute-inflammation-in-leukocortical-lesions-of-patients-with-early-multiple-sclerosis
#5
RANDOMIZED CONTROLLED TRIAL
Josefina Maranzano, David A Rudko, Kunio Nakamura, Stuart Cook, Diego Cadavid, Leo Wolansky, Douglas L Arnold, Sridar Narayanan
OBJECTIVE: To identify gadolinium-enhancing lesions affecting the cortex of patients with early multiple sclerosis (MS) and to describe the frequency and evolution of these lesions. METHODS: We performed a retrospective, observational, longitudinal analysis of MRI scans collected as part of the Betaseron vs Copaxone in Multiple Sclerosis with Triple-Dose Gadolinium and 3T MRI Endpoints (BECOME) study. Seventy-five patients with early-stage MS were scanned monthly, over a period of 12-24 months, using 3T MRI after administration of triple-dose gadolinium...
August 15, 2017: Neurology
https://www.readbyqxmd.com/read/28706565/once-daily-glatiramer-acetate-decreases-magnetic-resonance-imaging-disease-activity-in-japanese-patients-with-relapsing-remitting-multiple-sclerosis
#6
Takashi Yamamura, Natalia Ashtamker, David Ladkani, Toshiyuki Fukazawa, Hideki Houzen, Masami Tanaka, Toshiro Miura, Volker Knappertz
OBJECTIVE: Multiple sclerosis (MS) prevalence, clinical patterns, and treatment responses vary between races and geographical latitudes. Glatiramer acetate (GA; Copaxone) has provided a safe, effective treatment option for relapsing-remitting MS patients in the USA, European nations, and other countries for decades. The objective of the present study was to assess the safety and efficacy of GA in reducing magnetic resonance imaging disease activity in Japanese patients with active relapsing-remitting MS...
May 2017: Clinical & Experimental Neuroimmunology
https://www.readbyqxmd.com/read/28569182/a-pharmacogenetic-signature-of-high-response-to-copaxone-in-late-phase-clinical-trial-cohorts-of-multiple-sclerosis
#7
Colin J Ross, Fadi Towfic, Jyoti Shankar, Daphna Laifenfeld, Mathis Thoma, Matthew Davis, Brian Weiner, Rebecca Kusko, Ben Zeskind, Volker Knappertz, Iris Grossman, Michael R Hayden
BACKGROUND: Copaxone is an efficacious and safe therapy that has demonstrated clinical benefit for over two decades in patients with relapsing forms of multiple sclerosis (MS). On an individual level, patients show variability in their response to Copaxone, with some achieving significantly higher response levels. The involvement of genes (e.g., HLA-DRB1*1501) with high inter-individual variability in Copaxone's mechanism of action (MoA) suggests the potential contribution of genetics to treatment response...
May 31, 2017: Genome Medicine
https://www.readbyqxmd.com/read/28431621/two-decades-of-glatiramer-acetate-from-initial-discovery-to-the-current-development-of-generics
#8
REVIEW
Bianca Weinstock-Guttman, Kavita V Nair, Joseph L Glajch, Tanmoy C Ganguly, Daniel Kantor
Multiple sclerosis (MS) is a chronic, incurable, inflammatory disease of the central nervous system (CNS). In the United States, several US Food and Drug Administration (FDA)-approved disease-modifying treatments (DMTs) are available, including glatiramer acetate (GA; Copaxone®), one of the most longstanding treatments. GA was discovered serendipitously in the late 1960s/early 1970s while attempting to produce a synthetic antigen capable of inducing experimental autoimmune encephalomyelitis (EAE), an animal model of autoimmune inflammatory CNS disorders, including MS...
May 15, 2017: Journal of the Neurological Sciences
https://www.readbyqxmd.com/read/28427690/factors-associated-with-adherence-to-disease-modifying-therapy-in-multiple-sclerosis-an-observational-survey-from-a-referral-center-in-lithuania
#9
Neringa Duchovskiene, Dalia Mickeviciene, Giedre Jurkeviciene, Birute Dirziuviene, Renata Balnyte
AIM OF THE STUDY: To investigate adherence to disease modifying therapy (DMT) in Lithuanian population of multiple sclerosis patients and factors associated to it. METHODS: Patients receiving one of the following DMT's: Interferon β 1a (Rebif) 44 micrograms three times a week subdermally (s/c) or Interferon β 1a (Avonex) 30 micrograms weekly intramuscularly (i/m), or Interferon β 1b (Betaferon, Extavia) 250 micrograms once in two days s/c, or Glatiramer acetate (Copaxone) 20mg daily s/c, were presented with a questionnaire inquiring their demographic and clinical characteristics and adherence to treatment profile, as well as HAD scale and SF-36 questionnaire...
April 2017: Multiple Sclerosis and related Disorders
https://www.readbyqxmd.com/read/28240190/demonstration-of-biological-and-immunological-equivalence-of-a-generic-glatiramer-acetate
#10
Josephine D Alessandro, Kevin Garofalo, Ganlin Zhao, Christopher Honan, Jay Duffner, Ishan Capila, Ian Fier, Ganesh Kaundinya, Daniel Kantor, Tanmoy Ganguly
BACKGROUND: In April 2015, the US Food and Drug Administration approved the first generic glatiramer acetate, Glatopa® (M356), as fully substitutable for Copaxone® 20 mg/mL for relapsing forms of multiple sclerosis (MS). This approval was accomplished through an Abbreviated New Drug Application that demonstrated equivalence to Copaxone. METHOD: This article will provide an overview of the methods used to establish the biological and immunological equivalence of the two glatiramer acetate products, including methods evaluating antigenpresenting cell (APC) biology, T-cell biology, and other immunomodulatory effects...
2017: CNS & Neurological Disorders Drug Targets
https://www.readbyqxmd.com/read/28236206/glutamate-t-cells-and-multiple-sclerosis
#11
REVIEW
Mia Levite
Glutamate is the major excitatory neurotransmitter in the nervous system, where it induces multiple beneficial and essential effects. Yet, excess glutamate, evident in a kaleidoscope of acute and chronic pathologies, is absolutely catastrophic, since it induces excitotoxicity and massive loss of brain function. Both the beneficial and the detrimental effects of glutamate are mediated by a large family of glutamate receptors (GluRs): the ionotropic glutamate receptors (iGluRs) and the metabotropic glutamate receptors (mGluRs), expressed by most/all cells of the nervous system, and also by many non-neural cells in various peripheral organs and tissues...
July 2017: Journal of Neural Transmission
https://www.readbyqxmd.com/read/28231624/targets-and-mechanisms-in-prevention-of-parkinson-s-disease-through-immunomodulatory-treatments
#12
REVIEW
M von Euler Chelpin, T Vorup-Jensen
Parkinson's disease (PD) is the second most common neurodegenerative disease in the world; however, there is no cure for it. Current treatments only relieve some of the symptoms, without ceasing the disease, and lose efficacy with prolonged treatment. Considerable evidence shows that persistent inflammatory responses, involving T cell infiltration and glial cell activation, are common characteristics of human patients and play a crucial role in the degeneration of dopaminergic neurons. Therefore, it is important to develop therapeutic strategies that can impede or halt the disease through the modulation of the peripheral immune system by aiming at controlling the existing neuroinflammation...
May 2017: Scandinavian Journal of Immunology
https://www.readbyqxmd.com/read/28195026/from-academic-laboratory-to-the-market-disclosed-and-undisclosed-narratives-of-commercialization
#13
Adi Sapir, Amalya L Oliver
This paper examines how the Weizmann Institute of Science has been telling the story of the successful commercialization of a scientific invention, through its corporate communication channels, from the early 1970s to today. The paper aims to shed light on the transformation processes by which intellectual-property-based commercialization activities have become widely institutionalized in universities all over the world, and on the complexities, ambiguities and tensions surrounding this transition. We look at the story of the scientific invention of Copolymer-1 at the Weizmann Institute of Science and its licensing to Teva Pharmaceutical Industries, which subsequently developed the highly successful drug Copaxone for the treatment of multiple sclerosis...
February 2017: Social Studies of Science
https://www.readbyqxmd.com/read/28090798/switching-from-branded-to-generic-glatiramer-acetate-15-month-gate-trial-extension-results
#14
Krzysztof Selmaj, Frederik Barkhof, Anna N Belova, Christian Wolf, Evelyn Rw van den Tweel, Janine Jl Oberyé, Roel Mulder, David F Egging, Norbert P Koper, Jeffrey A Cohen
BACKGROUND: Open-label 15-month follow-up of the double-blind, placebo-controlled Glatiramer Acetate clinical Trial to assess Equivalence with Copaxone® (GATE) trial. OBJECTIVE: To evaluate efficacy, safety, and tolerability of prolonged generic glatiramer acetate (GTR) treatment and to evaluate efficacy, safety, and tolerability of switching from brand glatiramer acetate (GA) to GTR treatment. METHODS: A total of 729 patients received GTR 20 mg/mL daily...
December 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/27785417/metabolic-response-to-glatiramer-acetate-therapy-in-multiple-sclerosis-patients
#15
Lidia De Riccardis, Alessandra Ferramosca, Antonio Danieli, Giorgio Trianni, Vincenzo Zara, Francesca De Robertis, Michele Maffia
Glatiramer acetate (GA; Copaxone) is a random copolymer of glutamic acid, lysine, alanine, and tyrosine used for the treatment of patients with multiple sclerosis (MS). Its mechanism of action has not been already fully elucidated, but it seems that GA has an immune-modulatory effect and neuro-protective properties. Lymphocyte mitochondrial dysfunction underlines the onset of several autoimmune disorders. In MS first diagnosis patients, CD4(+), the main T cell subset involved in the pathogenesis of MS, undergo a metabolic reprogramming that consist in the up-regulation of glycolysis and in the down-regulation of oxidative phosphorylation...
December 2016: BBA Clinical
https://www.readbyqxmd.com/read/27473139/mtr-recovery-in-brain-lesions-in-the-become-study-of-glatiramer-acetate-vs-interferon-%C3%AE-1b
#16
RANDOMIZED CONTROLLED TRIAL
Robert A Brown, Sridar Narayanan, Nikola Stikov, Stuart Cook, Diego Cadavid, Leo Wolansky, Douglas L Arnold
OBJECTIVE: To compare magnetization transfer changes in new brain MRI lesions identified during monthly imaging in patients with multiple sclerosis (MS) randomized to treatment with 250 μg subcutaneous interferon-β-1b (IFN-β-1b) every other day or daily 20 mg glatiramer acetate (GA) in a post hoc study using data from the Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI (BECOME) trial. METHODS: T1-weighted images acquired with and without fat saturation pulses in the BECOME study were evaluated and found to exhibit magnetization transfer ratio (MTR) effects, and were used to compute MTR images (FSMTR)...
August 30, 2016: Neurology
https://www.readbyqxmd.com/read/27411339/innate-phagocytosis-by-peripheral-blood-monocytes-is-altered-in-alzheimer-s-disease
#17
Ben J Gu, Xin Huang, Amber Ou, Alan Rembach, Christopher Fowler, Pavan K Avula, Adam Horton, James D Doecke, Victor L Villemagne, S Lance Macaulay, Paul Maruff, Erica L Fletcher, Robyn Guymer, James S Wiley, Colin L Masters
Sporadic Alzheimer's disease (AD) is characterised by the deposition and accumulation of specific protein aggregates. Failure of clearance could underlie this process, and recent genetic association studies point towards involvement of the phagocytosis and autophagy pathways. We developed a real-time tri-color flow cytometry method to quantitate the phagocytic function of human peripheral blood monocyte subsets including non-classic CD14(dim)CD16(+), intermediate CD14(+)CD16(+) and classic CD14(+)CD16(-) monocytes...
September 2016: Acta Neuropathologica
https://www.readbyqxmd.com/read/27404942/an-association-between-glatiramer-acetate-and-malignant-melanoma
#18
John Walker, AnneLiese Smylie, Michael Smylie
A 43-year-old female receiving immunomodulatory therapy with glatiramer acetate (copaxone, GA) for relapsing, remitting multiple sclerosis was diagnosed with stage IIIB melanoma that recurred <7 months after resection and lymphadenectomy. In preparation for systemic therapy the patient discontinued GA, and shortly thereafter experienced spontaneous and complete clinical and radiographic resolution of her disease. The development and subsequent regression of melanoma in this patient may be due to the use and subsequent discontinuation of GA, and our discussion of the case includes the potential immunologic mechanisms that may provide an explanation for our findings...
September 2016: Journal of Immunotherapy
https://www.readbyqxmd.com/read/27277705/survey-of-us-patients-with-multiple-sclerosis-comparison-of-the-new-electronic-interferon-beta-1b-autoinjector-betaconnect%C3%A2-with-mechanical-autoinjectors
#19
Donald A Barone, Barry A Singer, Lubo Merkov, Mark Rametta, Gustavo Suarez
INTRODUCTION: Patients with multiple sclerosis (MS) generally undergo long-term treatment with disease-modifying therapies (DMTs). In the US, patients taking glatiramer acetate, interferon beta-1a, or interferon beta-1b, typically use a mechanical autoinjector. Recent survey results have shown that using an electronic autoinjector, such as BETACONNECT™ (Bayer Pharma AG) for interferon beta-1b/Betaseron(®) (Bayer Pharma AG) may reduce injection discomfort and increase patient satisfaction with treatment...
December 2016: Neurology and Therapy
https://www.readbyqxmd.com/read/27131971/autoantigen-specific-immunosuppression-with-tolerogenic-peripheral-blood-cells-prevents-relapses-in-a-mouse-model-of-relapsing-remitting-multiple-sclerosis
#20
Christian Kleist, Elisabeth Mohr, Sadanand Gaikwad, Laura Dittmar, Stefanie Kuerten, Michael Platten, Walter Mier, Michael Schmitt, Gerhard Opelz, Peter Terness
BACKGROUND: Dendritic cells (DCs) rendered suppressive by treatment with mitomycin C and loaded with the autoantigen myelin basic protein demonstrated earlier their ability to prevent experimental autoimmune encephalomyelitis (EAE), the animal model for multiple sclerosis (MS). This provides an approach for prophylactic vaccination against autoimmune diseases. For clinical application such DCs are difficult to generate and autoantigens hold the risk of exacerbating the disease. METHODS: We replaced DCs by peripheral mononuclear cells and myelin autoantigens by glatiramer acetate (Copaxone(®)), a drug approved for the treatment of MS...
May 1, 2016: Journal of Translational Medicine
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