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https://www.readbyqxmd.com/read/28906152/relapse-outcomes-safety-and-treatment-patterns-in-patients-diagnosed-with-relapsing-remitting-multiple-sclerosis-and-initiated-on-subcutaneous-interferon-%C3%AE-1a-or-dimethyl-fumarate-a-real-world-study
#1
Frank R Ernst, Peri Barr, Riad Elmor, Schiffon L Wong
OBJECTIVE: To estimate real-world treatment patterns, safety, and relapse outcomes of subcutaneous (sc) interferon (IFN) β-1a (Rebif®) versus dimethyl fumarate (DMF; Tecfidera(®)), to treat relapsing-remitting multiple sclerosis (RRMS). METHODS: A U.S. retrospective chart review of 450 randomly selected adults newly diagnosed with RRMS who received sc IFN β-1a (n = 143) or DMF (n = 307) was conducted. Patients were either (a) treatment-naïve, initiating first-line treatment with sc IFN β-1a or DMF, or (b) previously treated, switching to sc IFN β-1a or DMF...
September 14, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28874687/cell-based-assay-identifies-tlr2-and-tlr4-stimulating-impurities-in-interferon-beta
#2
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
https://www.readbyqxmd.com/read/28835403/alemtuzumab-care-ms-ii-5-year-follow-up-efficacy-and-safety-findings
#3
Alasdair J Coles, Jeffrey A Cohen, Edward J Fox, Gavin Giovannoni, Hans-Peter Hartung, Eva Havrdova, Sven Schippling, Krzysztof W Selmaj, Anthony Traboulsee, D Alastair S Compston, David H Margolin, Karthinathan Thangavelu, Madalina C Chirieac, Darlene Jody, Panos Xenopoulos, Richard J Hogan, Michael A Panzara, Douglas L Arnold
OBJECTIVE: To evaluate 5-year efficacy and safety of alemtuzumab in patients with active relapsing-remitting multiple sclerosis and inadequate response to prior therapy. METHODS: In the 2-year Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) II study (NCT00548405), alemtuzumab-treated patients received 2 courses (baseline and 12 months later). Patients could enter an extension (NCT00930553), with as-needed alemtuzumab retreatment for relapse or MRI activity...
September 12, 2017: Neurology
https://www.readbyqxmd.com/read/28831635/a-multicenter-observational-prospective-study-of-self-and-parent-reported-quality-of-life-in-adolescent-multiple-sclerosis-patients-self-administering-interferon-%C3%AE-1a-using-rebismart%C3%A2-the-future-study
#4
A Ghezzi, A Bianchi, D Baroncini, A Bertolotto, S Malucchi, V Bresciamorra, R Lanzillo, N Milani, V Martinelli, F Patti, C Chisari, M Rottoli, M Simone, D Paolicelli, A Visconti
Besides the impact of disease per se, the use of immunomodulatory therapies in adolescents with relapsing-remitting multiple sclerosis (RRMS) may have an effect on quality of life (QL). The FUTURE (Quality of liFe in adolescent sUbjecTs affected by mUltiple sclerosis treated with immunomodulatoRy agEnt using self-injecting device) study was designed to evaluate the changes in QL of Italian adolescents with RRMS receiving treatment with IFN-β1a (Rebif; 22 μg), administered subcutaneously three times weekly using the RebiSmart™ electronic autoinjection device over a 52-week period...
August 22, 2017: Neurological Sciences
https://www.readbyqxmd.com/read/28717427/comparison-of-the-effects-of-low-dose-interferon-and-high-dose-interferon-on-reduction-of-the-number-and-size-of-plaques-in-patients-with-multiple-sclerosis-a-historical-cohort
#5
Payam Khomand, Ghobad Moradi, Behrooz Ahsan, Setareh Abtahi
Background: This study was performed to compare the effects of low dose interferon beta-1 (IFN-β-1) (CinnoVex, 30 mcg) and high dose IFN-β-1 (REBIF, 44 mcg) on the reduction of the number and size of plaques in magnetic resonance imaging (MRI) in patients with multiple sclerosis (MS). Methods: This historical cohort study, which was performed in 2014 in Sanandaj (western part of Iran). 43 MS patients in two groups were investigated. The first group, which included 19 patients, was treated using high dose IFN (44 mcg) and the second group, which was consisted of 24 patients, was treated using low dose IFN (30 mcg)...
January 5, 2017: Iranian Journal of Neurology
https://www.readbyqxmd.com/read/28626781/both-cladribine-and-alemtuzumab-may-effect-ms-via-b-cell-depletion
#6
David Baker, Samuel S Herrod, Cesar Alvarez-Gonzalez, Lukasz Zalewski, Christo Albor, Klaus Schmierer
OBJECTIVE: To understand the efficacy of cladribine (CLAD) treatment in MS through analysis of lymphocyte subsets collected, but not reported, in the pivotal phase III trials of cladribine and alemtuzumab induction therapies. METHODS: The regulatory submissions of the CLAD Tablets Treating Multiple Sclerosis Orally (CLARITY) (NCT00213135) cladribine and Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, study one (CARE-MS I) (NCT00530348) alemtuzumab trials were obtained from the European Medicine Agency through Freedom of Information requests...
July 2017: Neurology® Neuroimmunology & Neuroinflammation
https://www.readbyqxmd.com/read/28617368/-a-comparative-placebo-controlled-clinical-study-on-the-efficacy-and-safety-of-interferon-beta-1a-for-subcutaneous-injections-in-patients-with-remitting-multiple-sclerosis-results-of-the-first-year-of-observations
#7
A N Boyko, L P Bosenko, V V Vasilovskiy, L I Volkova, M N Zakharova, S V Kotov, E V Lekomtseva, T I Negrich, E V Parshina, O P Patrusheva, S V Prokopenko, D V Sazonov, P V Timchenko, Yu V Trinitatskiy, F A Khabirov, M Ya Khavunka, L V Chichanovskaya, M A Sherman, Yu N Lin'kova, A V Zinkina-Orikhan, K B Tursunova
AIM: To prove the equivalent efficacy of teberif (BCD-033, interferon beta-1) and rebif (interferon beta-1a) in patients with remitting multiple sclerosis (RMS). MATERIAL AND METHODS: A multicenter double blind placebo-controlled comparative randomized III phase study included 163 patients with RMS. Patients were randomized into three equal groups (teberif, rebif or placebo). RESULTS AND CONCLUSION: After 52 weeks, the equivalent efficacy of teberif and the brand drug rebif was shown...
2017: Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova
https://www.readbyqxmd.com/read/28604916/interpreting-lymphocyte-reconstitution-data-from-the-pivotal-phase-3-trials-of-alemtuzumab
#8
MULTICENTER STUDY
David Baker, Samuel S Herrod, Cesar Alvarez-Gonzalez, Gavin Giovannoni, Klaus Schmierer
Importance: Alemtuzumab, a CD52-depleting monoclonal antibody, effectively inhibits relapsing multiple sclerosis (MS) but is associated with a high incidence of secondary B-cell autoimmunities that limit use. These effects may be avoided through control of B-cell hyperproliferation. Objective: To investigate whether the data describing the effect of alemtuzumab on lymphocyte subsets collected during the phase 3 trial program reveal mechanisms explaining efficacy and the risk for secondary autoimmunity with treatment of MS...
August 1, 2017: JAMA Neurology
https://www.readbyqxmd.com/read/28440858/treatment-with-disease-modifying-drugs-for-people-with-a-first-clinical-attack-suggestive-of-multiple-sclerosis
#9
REVIEW
Graziella Filippini, Cinzia Del Giovane, Marinella Clerico, Omid Beiki, Miriam Mattoscio, Federico Piazza, Sten Fredrikson, Irene Tramacere, Antonio Scalfari, Georgia Salanti
BACKGROUND: The treatment of multiple sclerosis has changed over the last 20 years. The advent of disease-modifying drugs in the mid-1990s heralded a period of rapid progress in the understanding and management of multiple sclerosis. With the support of magnetic resonance imaging early diagnosis is possible, enabling treatment initiation at the time of the first clinical attack. As most of the disease-modifying drugs are associated with adverse events, patients and clinicians need to weigh the benefit and safety of the various early treatment options before taking informed decisions...
April 25, 2017: Cochrane Database of Systematic Reviews
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
#10
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/28247216/antitumor-activity-of-interferon-%C3%AE-1a-in-hormone-refractory-prostate-cancer-with-neuroendocrine-differentiation
#11
A Dicitore, E S Grassi, M O Borghi, G Gelmini, M C Cantone, G Gaudenzi, L Persani, M Caraglia, G Vitale
PURPOSE: Type I interferons (IFN-α and IFN-β) are a class of cytokines that exert several biological activities, such as modulation of cell proliferation and differentiation and of the immune system. Although these cytokines interact with a common receptor complex, IFN-β showed a more potent antitumor activity than IFN-α in several tumor models. New recombinant human IFN-β products, such as IFN-β1a and IFN-β1b, have been produced in order to improve the stability and bioavailability of natural IFN-β...
March 1, 2017: Journal of Endocrinological Investigation
https://www.readbyqxmd.com/read/28039317/subcutaneous-interferon-%C3%AE-1a-in-the-treatment-of-clinically-isolated-syndromes-3-year-and-5-year-results-of-the-phase-iii-dosing-frequency-blind-multicentre-reflexion-study
#12
RANDOMIZED CONTROLLED TRIAL
Giancarlo Comi, Nicola De Stefano, Mark S Freedman, Frederik Barkhof, Bernard M J Uitdehaag, Marlieke de Vos, Kurt Marhardt, Liang Chen, Delphine Issard, Ludwig Kappos
OBJECTIVE: Early treatment following a first clinical demyelinating event (FCDE) delays further disease activity in patients with multiple sclerosis (MS). This study determined the effects of early versus delayed treatment (DT) with subcutaneous interferon (sc IFN) β-1a 44 μg in patients with an FCDE up to 60 months postrandomisation. METHODS: Patients who completed the 24-month double-blind REFLEX (REbif FLEXible dosing in early MS) study entered an extension (REFLEXION, REbif FLEXible dosing in early MS extensION): patients initially randomised to sc IFN β-1a and not reaching clinically definite MS (clinically definite MS, CDMS (second attack or sustained Expanded Disability Status Scale (EDSS) score increase)) continued original treatment (three times weekly (tiw) or once weekly (qw)); placebo patients switched to tiw (DT); patients with CDMS switched to tiw...
April 2017: Journal of Neurology, Neurosurgery, and Psychiatry
https://www.readbyqxmd.com/read/28027680/comparative-effectiveness-of-interferons-in-relapsing-remitting-multiple-sclerosis-a-meta-analysis-of-real-world-studies
#13
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
https://www.readbyqxmd.com/read/27995531/effect-on-cognition-of-estroprogestins-combined-with-interferon-beta-in-multiple-sclerosis-analysis-of-secondary-outcomes-from-a-randomised-controlled-trial
#14
Laura De Giglio, Fabiana Marinelli, Valeria T Barletta, Veronica A Pagano, Floriana De Angelis, Fulvia Fanelli, Nikolaos Petsas, Patrizia Pantano, Valentina Tomassini, Carlo Pozzilli
INTRODUCTION: Cognitive impairment is a disabling symptom in multiple sclerosis (MS). While its management remains challenging, beneficial effects on cognition of interferon beta (IFN-β) have been reported and a positive effect from estroprogestins has been hypothesised, suggesting that the combination of the two medications in women with MS could offer a promising treatment strategy. OBJECTIVES: We investigated whether a combination of estroprogestins and IFN-β can improve cognition in women with MS...
February 2017: CNS Drugs
https://www.readbyqxmd.com/read/27885061/alemtuzumab-improves-quality-of-life-outcomes-compared-with-subcutaneous-interferon-beta-1a-in-patients-with-active-relapsing-remitting-multiple-sclerosis
#15
Rafael Arroyo González, Mariko Kita, Heidi Crayton, Eva Havrdova, David H Margolin, Stephen L Lake, Gavin Giovannoni
BACKGROUND: Alemtuzumab was superior on clinical and magnetic resonance imaging (MRI) outcomes versus subcutaneous interferon beta-1a in phase 3 trials in patients with relapsing-remitting multiple sclerosis. OBJECTIVE: To examine quality-of-life (QoL) outcomes in the alemtuzumab phase 3 trials. METHODS: Patients who were treatment naive (Comparison of Alemtuzumab and Rebif(®) Efficacy in Multiple Sclerosis I [CARE-MS I]) or had an inadequate response to prior therapy (CARE-MS II) received annual courses of alemtuzumab 12 mg/day at baseline (5 days) and Month 12 (3 days) or subcutaneous interferon beta-1a 44 µg three times/week...
September 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/27828855/the-cross-reactivity-of-binding-antibodies-with-different-interferon-beta-formulations-used-as-disease-modifying-drugs-in-multiple-sclerosis-patients
#16
Agnieszka Wencel-Warot, Slawomir Michalak, Marcin Warot, Alicja Kalinowska-Lyszczarz, Radoslaw Kazmierski
Interferon beta (IFNb) preparations are commonly used as first-line therapy in relapsing-remitting multiple sclerosis (RRMS). They are, however, characterized by limited efficacy, partly due to the formation of anti-IFNb antibodies in patients.In this pilot study, we assessed with the ELISA method the presence of the binding antibodies (BAbs) against interferon beta after 2 years of therapy with subcutaneous interferon beta 1a (Rebif) in 49 RRMS patients. Antibody levels were established again within 1 year after treatment withdrawal...
November 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27733571/alemtuzumab-improves-preexisting-disability-in-active-relapsing-remitting-ms-patients
#17
RANDOMIZED CONTROLLED TRIAL
Gavin Giovannoni, Jeffrey A Cohen, Alasdair J Coles, Hans-Peter Hartung, Eva Havrdova, Krzysztof W Selmaj, David H Margolin, Stephen L Lake, Susan M Kaup, Michael A Panzara, D Alastair S Compston
OBJECTIVE: To characterize effects of alemtuzumab treatment on measures of disability improvement in patients with relapsing-remitting multiple sclerosis (RRMS) with inadequate response (≥1 relapse) to prior therapy. METHODS: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) II, a 2-year randomized, rater-blinded, active-controlled, head-to-head, phase 3 trial, compared efficacy and safety of alemtuzumab 12 mg with subcutaneous interferon-β-1a (SC IFN-β-1a) 44 μg in patients with RRMS...
November 8, 2016: Neurology
https://www.readbyqxmd.com/read/27590291/superior-mri-outcomes-with-alemtuzumab-compared-with-subcutaneous-interferon-%C3%AE-1a-in-ms
#18
RANDOMIZED CONTROLLED TRIAL
Douglas L Arnold, Elizabeth Fisher, Vesna V Brinar, Jeffrey A Cohen, Alasdair J Coles, Gavin Giovannoni, Hans-Peter Hartung, Eva Havrdova, Krzysztof W Selmaj, Miroslav Stojanovic, Howard L Weiner, Stephen L Lake, David H Margolin, David R Thomas, Michael A Panzara, D Alastair S Compston
OBJECTIVE: To describe detailed MRI results from 2 head-to-head phase III trials, Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis Study I (CARE-MS I; NCT00530348) and Study II (CARE-MS II; NCT00548405), of alemtuzumab vs subcutaneous interferon β-1a (SC IFN-β-1a) in patients with active relapsing-remitting multiple sclerosis (RRMS). METHODS: The impact of alemtuzumab 12 mg vs SC IFN-β-1a 44 μg on MRI measures was evaluated in patients with RRMS who were treatment-naive (CARE-MS I) or who had an inadequate response, defined as at least one relapse, to prior therapy (CARE-MS II)...
October 4, 2016: Neurology
https://www.readbyqxmd.com/read/27526201/long-term-adherence-to-ifn-beta-1a-treatment-when-using-rebismart%C3%A2-device-in-patients-with-relapsing-remitting-multiple-sclerosis
#19
O Fernández, R Arroyo, S Martínez-Yélamos, M Marco, J A García Merino, D Muñoz, E Merino, A Roque
The effectiveness of disease-modifying drugs in the treatment of multiple sclerosis is associated with adherence. RebiSmart® electronic device provides useful information about adherence to the treatment with subcutaneous (sc) interferon (IFN) β-1a (Rebif®). The aim of the study was to determine long-term adherence to this treatment in patients with relapsing-remitting multiple sclerosis (RRMS). This retrospective multicentre observational study analysed 258 patients with RRMS who were receiving sc IFN β-1a (Rebif®) treatment by using RebiSmart® until replacement (36 months maximum lifetime) or treatment discontinuation...
2016: PloS One
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
#20
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
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