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Łukasz Jernas, Jacek Wencel, Andrzej Wiak, Marek Bieniek, Halina Bartosik-Psujek
INTRODUCTION: Adherence to treatment, including early treatment discontinuation, in patients with multiple sclerosis or clinically isolated syndrome can be affected by: treatment tolerability, route of drug administration, patient age, disease duration, comorbidities, medical care, and support from their caregivers. AIM: This study aimed to identify the risk factors for poor adherence to Betaferon® treatment, including early discontinuation and omitting doses. MATERIALS AND METHODS: 852 adult patients treated with Betaferon participated in this 24-month study...
2016: PloS One
Ludwig Kappos, Gilles Edan, Mark S Freedman, Xavier Montalbán, Hans-Peter Hartung, Bernhard Hemmer, Edward J Fox, Frederik Barkhof, Sven Schippling, Andrea Schulze, Dirk Pleimes, Christoph Pohl, Rupert Sandbrink, Gustavo Suarez, Eva-Maria Wicklein
OBJECTIVE: To assess outcomes for patients treated with interferon beta-1b immediately after clinically isolated syndrome (CIS) or after a short delay. METHODS: Participants in BENEFIT (Betaferon/Betaseron in Newly Emerging MS for Initial Treatment) were randomly assigned to receive interferon beta-1b (early treatment) or placebo (delayed treatment). After conversion to clinically definite multiple sclerosis (CDMS) or 2 years, patients on placebo could switch to interferon beta-1b or another treatment...
September 6, 2016: Neurology
Heinz-Peter Schultheiss, Cornelia Piper, Olaf Sowade, Finn Waagstein, Joachim-Friedrich Kapp, Karl Wegscheider, Georg Groetzbach, Matthias Pauschinger, Felicitas Escher, Eloisa Arbustini, Harald Siedentop, Uwe Kuehl
BACKGROUND: Chronic viral infections of the heart are considered one antecedent event leading to progressive dysfunction of the myocardium, often with an impaired prognosis due to a virus- or immune-mediated myocardial injury. Symptomatic treatment does not influence the viral cause of heart failure, and the effect of antiviral treatment has not been determined, yet. METHODS AND RESULTS: In this phase II study 143 patients with symptoms of heart failure and biopsy-based confirmation of the enterovirus (EV), adenovirus, and/or parvovirus B19 genomes in their myocardial tissue were randomly assigned to double-blind treatment, and received either placebo (n = 48) or 4 × 10(6) (n = 49) and 8 × 10(6) IU (n = 46) interferon beta-1b (IFN-β-1b) for 24 weeks, in addition to standard heart failure treatment...
September 2016: Clinical Research in Cardiology: Official Journal of the German Cardiac Society
Mohadeseh Haji Abdolvahab, Ahmad Fazeli, Andhyk Halim, Ahmad S Sediq, Mohammad Reza Fazeli, Huub Schellekens
Determining to what extent biophysical characteristics of aggregates affect immunogenicity of therapeutic interferon beta-1b. Three recombinant human interferon beta-1b (rhIFNβ-1b) samples with different levels of aggregates generated by copper oxidation, thermal stress, or left untreated, as well as Avonex(®) drug substance and Betaferon(®) drug product, were injected intraperitoneally in nontransgenic and interferon beta transgenic FVB/N mice 5 times per week for 3 weeks. Antibodies against interferon beta were measured using enzyme-linked immunosorbent assay...
April 2016: Journal of Interferon & Cytokine Research
Mohadeseh Haji Abdolvahab, Ahmad Fazeli, Mazda Radmalekshahi, M Reza Nejadnik, Mohammad Reza Fazeli, Huub Schellekens
Human serum albumin (HSA)-free formulation of Escherichia coli-derived human interferon beta (IFNβ-1b) with a high percentage of monomeric protein and low immunogenicity is developed and characterized in the current study. UV spectroscopy, fluorescence spectroscopy, dynamic light scattering, sodium dodecyl sulfate polyacrylamide gel electrophoresis, Western blotting, Micro-Flow Imaging, resonant mass measurement, size exclusion, and reversed-phase high performance liquid chromatographies were applied to assess the effect of excipients on the stability of IFNβ-1b to establish a HSA-free formulation...
March 2016: Journal of Interferon & Cytokine Research
Masoud Mehrpour, Fahimeh H Akhoundi, Maryam Delgosha, Hosein Keyvani, Mohammad R Motamed, Behnam Sheibani, Alipasha Meysamie
OBJECTIVES: To investigate the potential role of disease-modifying therapies (DMTs) used to treat multiple sclerosis on inducing brain-derived neurotrophic factor (BDNF) production. METHODS: A total of 82 patients entered the study. Sixty (73%) patients were on DMTs (15 on Avonex, 13 on Rebif, 27 on Betaferon, 3 on Mitoxantrone, and 2 on IVIg), whereas 22 received no DMTs. The degree of neurological impairment was recorded using the expanded disability status scale (EDSS)...
October 2015: Neurologist
Kathryn C Fitzgerald, Kassandra L Munger, Karl Köchert, Barry G W Arnason, Giancarlo Comi, Stuart Cook, Douglas S Goodin, Massimo Filippi, Hans-Peter Hartung, Douglas R Jeffery, Paul O'Connor, Gustavo Suarez, Rupert Sandbrink, Ludwig Kappos, Christoph Pohl, Alberto Ascherio
IMPORTANCE: Low serum 25-hydroxyvitamin D (25[OH]D) levels are associated with an increased risk of multiple sclerosis (MS) as well as with increased disease activity and rate of progression in clinically isolated syndromes and early MS. OBJECTIVE: To assess the association between 25(OH)D and disease course and prognosis in patients with relapsing-remitting MS treated with interferon beta-1b. DESIGN, SETTING, AND PARTICIPANTS: We conducted a prospective cohort study assessing 25(OH)D levels and subsequent MS disease course and progression characterized by magnetic resonance imaging (MRI) and clinical end points...
December 2015: JAMA Neurology
Kassandra L Munger, Kathryn C Fitzgerald, Mark S Freedman, Hans-Peter Hartung, David H Miller, Xavier Montalbán, Gilles Edan, Frederik Barkhof, Gustavo Suarez, Ernst-Wilhelm Radue, Rupert Sandbrink, Ludwig Kappos, Christoph Pohl, Alberto Ascherio
OBJECTIVE: To evaluate whether Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody levels or tobacco use were associated with conversion to multiple sclerosis (MS) or MS progression/activity in patients presenting with clinically isolated syndrome (CIS). METHODS: In this prospective, longitudinal study, we measured EBV IgG antibody and cotinine (biomarker of tobacco use) levels at up to 4 time points (baseline, months 6, 12, and 24) among 468 participants with CIS enrolled in the BENEFIT (Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment) clinical trial...
November 10, 2015: Neurology
Zahra Tolou-Ghamari, Fereshteh Ashtari, Vahid Shaygannejad, Abbas-Ali Palizban
BACKGROUND: Multiple sclerosis (MS) is a multifactorial disease that could result from demyelination of the myelin sheath. The aim of this study is to investigate the demographic features and rank the immunomodulating drugs in patients with MS. MATERIALS AND METHODS: This study was conducted in the MS clinic of the Isfahan Kashani Hospital, from 22 May, 2011 to 18 March, 2013. The data analyses (n = 1067) were divided into two periods: (1) 2011/05/22 to 2012/03/18 denoted as P1 and (2) 2012/04/02 to 2013/03/18 denoted as P2...
2015: Advanced Biomedical Research
M H Harirchian, A Taalimi, B Siroos
We describe a case of tumefactive multiple sclerosis, based on characteristic imaging features and excluding alternative diagnoses, presented with relapse 18 weeks after switching betaferon to fingolimod. Recent reported cases of this paradoxical demyelinating reaction in a setting of fingolimod-related immune system alterations seem to be something more than an accidental event. Immune cell shifting underlying a genetic susceptibility factor has been suggested to participate in this disastrous adverse effect...
September 2015: Multiple Sclerosis and related Disorders
Karthik Govindappa, Jean Sathish, Kevin Park, Jamie Kirkham, Munir Pirmohamed
PURPOSE: Interferon beta (IFN-β) is the drug of choice for treatment of relapsing forms of multiple sclerosis and is known to reduce the frequency and severity of relapses. This systematic review determines the occurrence of neutralising antibodies (NAbs) against different formulations of IFN-β: IFN-β-1a Avonex™, IFN-β-1a Rebif™ and IFN-β-1b Betaferon/Betaseron™. METHODS: The databases used in the review included MEDLINE Ovid (from 1950 to March 2015), Embase Ovid (from 1980 to March 2015), CENTRAL on The Cochrane Library (2011, Issue 4) and ClinicalTrials...
November 2015: European Journal of Clinical Pharmacology
Kerstin Hansen, Katrin Schüssel, Marita Kieble, Johanna Werning, Martin Schulz, Robert Friis, Dieter Pöhlau, Norbert Schmitz, Joachim Kugler
BACKGROUND: Long-term therapies such as disease modifying therapy for Multiple Sclerosis (MS) demand high levels of medication adherence in order to reach acceptable outcomes. The objective of this study was to describe adherence to four disease modifying drugs (DMDs) among statutorily insured patients within two years following treatment initiation. These drugs were interferon beta-1a i.m. (Avonex), interferon beta-1a s.c. (Rebif), interferon beta-1b s.c. (Betaferon) and glatiramer acetate s...
2015: PloS One
Naghmeh Mokhber, Amir Azarpazhooh, Elias Orouji, Bita Khorram, Morteza Modares Gharavi, Sorayya Kakhi, Hoda Khallaghi, Mahmoud Reza Azarpazhooh
AIMS: The aim of this study was to evaluate the effect of various disease-modifying therapies (DMT) on quality of life in multiple sclerosis (MS). METHODS: This was a three-arm parallel study with balanced randomization in which 90 newly diagnosed, definite MS subjects referred to Ghaem Medical Center, Mashhad, Iran were enrolled between 2006 and 2009. Patients were randomly allocated into three DMT groups: Avonex, Rebif and Betaferon. Health-related quality of life was assessed in MS patients at baseline and 12 months after treatment with DMT using the MS Quality of Life-54 questionnaire...
October 2015: Psychiatry and Clinical Neurosciences
Ebrima Gibbs, Mohammad Ehsanul Karim, Joel Oger
A proportion of multiple sclerosis (MS) patients treated with interferon-β (IFNβ) develop neutralizing antibodies (NAbs), which can reduce therapeutic efficacy. In the Betaseron/Betaferon in Newly Emerging MS for Initial Treatment (BENEFIT) study, 88/277 patients developed NAbs, 48 having transient positivity and 29 having sustained positivity. This study aimed to investigate the antibody binding characteristics of serial sera in a subset of these two patient groups. Using Biacore™, a surface plasmon resonance-based technology that monitors biomolecular interactions in real time, we immobilized pure IFNβ-1b and analyzed antibody binding responses and dissociation rates of these sera...
March 2015: Clinical Immunology: the Official Journal of the Clinical Immunology Society
Sreeram Ramagopalan, Radek Wasiak, Andrew P Cox
BACKGROUND: Multiple sclerosis (MS) is a common complex disorder, with new treatment options emerging each year. Social media is being increasingly used to investigate opinions about drugs, diseases and procedures. In this descriptive exploratory study, we sought to investigate opinions about currently available MS treatments. METHODS: The Twitter resource Topsy was searched for tweets mentioning the following MS treatments: Aubagio, Avonex, Betaferon or Betaseron, Copaxone, Extavia, Gilenya, Lemtrada, Novantrone, Rebif, Tysabri and Tecfidera between 1 Jan 2006 to 31 Jul 2014...
2014: F1000Research
Hirofumi Ochi
Interferon-β (IFNβ) products are widely used as first-line treatment for multiple sclerosis and have well-established benefit-risk profiles over the short- and long-term. Commercially available agents in Japan include subcutaneous IFNβ-1β (Betaferon) and intramuscular IFNβ-1a(Avonex). Although these IFNβ products differ in dosage, frequency of administration and rout of delivery, both reduce relapse rate by about 30% and new lesion activity by about 65%. In addition, IFNβ products were shown to reduce the disability progression...
November 2014: Nihon Rinsho. Japanese Journal of Clinical Medicine
Mark S Freedman
The BEtaferon®/BEtaseron® in Newly Emerging MS For Initial Treatment (BENEFIT) trial assessed the efficacy of early versus delayed treatment with interferon beta-1b for patients with clinically isolated syndrome (CIS). Patients were randomly assigned to receive either interferon beta-1b 250 μg every other day (early treatment, n = 292) or placebo (delayed treatment, n = 176) for 2 years or until progression to clinically definite multiple sclerosis. Clinical and magnetic resonance imaging (MRI) outcomes were assessed after 2 years (at the end of the placebo-controlled phase) and then again at 3, 5, and 8 years post randomization...
November 2014: Therapeutic Advances in Neurological Disorders
Lise Aagaard, Ebba Holme Hansen
OBJECTIVE: To characterize adverse drug reactions (ADRs) reported by European (EU) consumer for antineoplastic and immunomodulating medications. METHODS: ADRs reported by consumers of antineoplastic and immunomodulating medications (anatomical therapeutic chemical [ATC]) group L from 2007 to 2011 and located in the EU ADR database, EudraVigilance, were analyzed. Data were categorized with respect to age and sex, category, and seriousness of reported ADRs and medications...
January 2013: Journal of Research in Pharmacy Practice
A V Sabanov, A V Luneva, N V Matveev
OBJECTIVE: To perform pharmacoeconomic assessment of interferone-1a for intramuscular and subcortical infusions, interferon-beta-1b, glatiramer acetate and natalizumab in the treatment of relapsing-remitting multiple sclerosis (RRMS). MATERIAL AND METHODS: Modeling and "cost-effectiveness" analysis as well as evaluation of "disease cost" were performed. A model was based on the data on the efficacy of the drugs, summarized in the meta-analysis of G.Filippini et al, and treatment costs in the Russian health care system...
2014: Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova
Naghmeh Mokhber, Amir Azarpazhooh, Elias Orouji, Stephen M Rao, Bita Khorram, Mohammad Ali Sahraian, Mohsen Foroghipoor, Morteza Modares Gharavi, Sorayya Kakhi, Karim Nikkhah, Mahmoud Reza Azarpazhooh
BACKGROUND: Multiple sclerosis (MS) is a chronic autoimmune disease that can deteriorate cognitive function in at least 50% of patients even in the early stages. OBJECTIVE: We conducted a three-arm parallel study with balanced randomization to evaluate the effect of various disease-modifying therapies (DMTs) on cognitive function in MS. METHODS: Ninety newly diagnosed, definite MS subjects referred to Ghaem Medical Center, Mashhad, Iran, were enrolled into this study between 2006 and 2009...
July 15, 2014: Journal of the Neurological Sciences
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