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Dorothea Buck, Till Fm Andlauer, Wilmar Igl, Eva-Maria Wicklein, Mark Mühlau, Frank Weber, Karl Köchert, Christoph Pohl, Barry Arnason, Giancarlo Comi, Stuart Cook, Massimo Filippi, Hans-Peter Hartung, Douglas Jeffery, Ludwig Kappos, Frederik Barkhof, Gilles Edan, Mark S Freedman, Xavier Montalbán, Bertram Müller-Myhsok, Bernhard Hemmer
BACKGROUND: Treatment of multiple sclerosis (MS) with interferon β can lead to the development of antibodies directed against interferon β that interfere with treatment efficacy. Several observational studies have proposed different HLA alleles and genetic variants associated with the development of antibodies against interferon β. OBJECTIVE: To validate the proposed genetic markers and to identify new markers. METHODS: Associations of genetic candidate markers with antibody presence and development were examined in a post hoc analysis in 941 patients treated with interferon β-1b in the Betaferon® Efficacy Yielding Outcomes of a New Dose (BEYOND) and BEtaseron® /BEtaferon® in Newly Emerging multiple sclerosis For Initial Treatment (BENEFIT) prospective phase III trials...
March 1, 2018: Multiple Sclerosis: Clinical and Laboratory Research
Lydia Asrat Haile, Swamy Kumar Polumuri, Roshni Rao, Logan Kelley-Baker, Dimitri Kryndushkin, Rajesh Rajaiah, Tomer Israely, V Ashutosh Rao, Daniela Verthelyi
Immunogenicity can have devastating consequences on the safety and efficacy of therapeutic proteins. Therefore, evaluating and mitigating the risk of product immunogenicity is critical for the development these products. This study, showed that Betaseron and Extavia, which are reported to be more immunogenic among IFNβ products in clinical usage, contain residual innate immune response modulating impurities (IIRMIs) capable of activating NF-κB and induced expression of inflammatory mediators. These IIRMIs were undetectable in Rebif or Avonex...
September 5, 2017: Scientific Reports
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
Thomas R Einarson, Basil G Bereza, Márcio Machado
BACKGROUND: Differences between interferons have been evaluated for over 20 years. While randomized controlled trial (RCT) data is mainly used for assessments and strong data for causal inferences, it does not necessarily reflect everyday practice. Real-world data may provide additional information. PURPOSE: To assess the results, quality, and representativeness of observational studies directly comparing interferons (IFNs) in RRMS. METHODS: Medline and Embase were searched for observational studies comparing IFN-beta-1a 30 mcg IM (Avonex (1) ), IFN-beta-1a 44 mcg SC (Rebif (2) ) and/or IFN-beta-1b 250 mcg SC (Betaseron (3) )...
March 2017: Current Medical Research and Opinion
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
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
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
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
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
Kristina Candido, Henry Soufi, Mausumi Bandyopadhyay, Subhajit Dasgupta
Multiple sclerosis (MS) is a female predominant autoimmune demyelinating disease of central nervous system. The proper etiology is not clear. The existing therapies with interferon beta (Betaseron, Rebif), glatiramer acetate (copolymer 1, copaxone) are found to be promising for MS patients. The alpha-4 integrin antagonist monoclonal antibody Natalizumab has been found to decrease brain inflammation in relapsing-remitting MS via inhibition of alpha-4 beta- 1 integrinmediated mode of action of antigen -primed T cells to enter into central nervous system through blood brain barrier...
2016: Mini Reviews in Medicinal Chemistry
Daniel Harari, Irit Orr, Ron Rotkopf, Sergio E Baranzini, Gideon Schreiber
We analysed gene expression microarray data from whole blood samples from 228 multiple sclerosis (MS) patients either untreated or treated with one of three alternative commonly used interferon beta (IFNβ) disease modifying drugs: Avonex (×1 weekly), Betaseron (every second day) or Rebif (×3 weekly). Patient injections were not timed to coordinate sample collections, thus providing a global transcriptomic profile for each population of patients studied. Three hundred and fifty one genes were significantly differentially expressed by at least one of the IFNβ drugs...
June 1, 2015: Human Molecular Genetics
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
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
P K Coyle, S M Sinclair, A E Scheuerle, J M Thorp, J D Albano, M J Rametta
OBJECTIVE: Women with multiple sclerosis are often diagnosed and treated during their reproductive years. Limited data are available on the safety of treatment during pregnancy. The Betaseron Pregnancy Registry prospectively monitored women exposed to interferon β-1b (IFNβ-1b) during pregnancy to estimate the rates of birth defects, spontaneous abortions (SABs) and other negative outcomes in this population. DESIGN: From 2006 to 2011, this observational registry enrolled women exposed prior to conception or during pregnancy (but prior to or without abnormalities on prenatal screening)...
May 12, 2014: BMJ Open
Bianca Weinstock-Guttman
Disease-modifying therapies (DMTs), known to actively reduce relapses and delay disability progression, have been used for the treatment of relapsing-remitting multiple sclerosis (RRMS) for over a decade. These well-known therapies include intramuscular (IM) interferon (IFN) beta-1a (Avonex), subcutaneous (SC) IFN beta-1a (Rebif), SC IFN beta- 1b (Betaseron; Extavia), and SC glatiramer acetate (Copaxone). These first-line therapies have shown only partial benefits for controlling multiple sclerosis (MS) disease activity and are often associated with inadequate patient adherence...
November 2013: American Journal of Managed Care
Suhayl Dhib-Jalbut, Clyde Markowitz, Payal Patel, Francis Boateng, Mark Rametta
There is limited clinical evidence on the impact of nurse support and adverse event (AE) mitigation techniques on adherence to interferon beta-1b (IFNβ-1b) therapy in multiple sclerosis (MS) in a real-world setting. The aim of the Success of Titration, analgesics, and BETA nurse support on Acceptance Rates in MS Treatment (START) trial was to assess the combined effect of titration, analgesics, and BETA (Betaseron Education, Training, Assistance) nurse support on adherence to IFNβ-1b therapy in patients with early-onset MS and to evaluate safety...
2012: International Journal of MS Care
Ashley N Newton, Christina M Stica
The purpose of this study was to examine the cost-effectiveness of four disease-modifying drugs (DMDs) used to treat multiple sclerosis (MS): glatiramer acetate (GA; Copaxone), interferon beta-1a (IFNβ-1a) intramuscular (IM) injection (Avonex), IFNβ-1a subcutaneous (SC) injection (Rebif), and interferon beta-1b (IFNβ-1b) SC injection (Betaseron). Cost-effectiveness analyses are useful in countering the financial uncertainties and treatment efficacy concerns faced by people with MS. We conducted simulation analyses of the principal findings of a 2009 study by Goldberg et al...
2011: International Journal of MS Care
Alberto Ascherio, Kassandra L Munger, Rick White, Karl Köchert, Kelly Claire Simon, Chris H Polman, Mark S Freedman, Hans-Peter Hartung, David H Miller, Xavier Montalbán, Gilles Edan, Frederik Barkhof, Dirk Pleimes, Ernst-Wilhelm Radü, Rupert Sandbrink, Ludwig Kappos, Christoph Pohl
IMPORTANCE: It remains unclear whether vitamin D insufficiency, which is common in individuals with multiple sclerosis (MS), has an adverse effect on MS outcomes. OBJECTIVES: To determine whether serum concentrations of 25-hydroxyvitamin D (25[OH]D), a marker of vitamin D status, predict disease activity and prognosis in patients with a first event suggestive of MS (clinically isolated syndrome). DESIGN, SETTING, AND PARTICIPANTS: The Betaferon/Betaseron in Newly Emerging multiple sclerosis For Initial Treatment study was a randomized trial originally designed to evaluate the impact of early vs delayed interferon beta-1b treatment in patients with clinically isolated syndrome...
March 2014: JAMA Neurology
Mohammad Ali Sahraian, Abdorreza Naser Moghadasi, Mahsa Owji, Mehrdad Maboudi, Farid Kosari, Jeanie C McGee, Alireza Minagar
INTRODUCTION: Several cases of sarcoidosis following treatment with interferon-α have been reported in the literature, but those following interferon-β are very rare. We report the case of a patient with multiple sclerosis who developed pulmonary and cutaneous sarcoidosis following treatment with Betaseron® (interferon-β-1b). CASE PRESENTATION: A 33-year-old Caucasian woman with a history of multiple sclerosis, treated with interferon-β-1b for 2.5 years developed erythema nodosum in her lower limbs, a breast abscess, and unilateral adenopathy of her left lung...
2013: Journal of Medical Case Reports
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