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peginterferon beta-1a

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https://www.readbyqxmd.com/read/28685353/peginterferon-beta-1a-reduces-the-evolution-of-mri-lesions-to-black-holes-in-patients-with-rrms-a-post-hoc-analysis-from-the-advance-study
#1
Douglas L Arnold, Xiaojun You, Carmen Castrillo-Viguera
The presence of chronic black holes, i.e., chronic lesions that are hypointense on T1-weighted images and are indicative of more severe tissue injury, has been increasingly utilized as a surrogate marker of therapeutic outcome in multiple sclerosis. The ADVANCE study was a 2-year, double-blind, pivotal trial evaluating the safety and efficacy of subcutaneous peginterferon beta-1a 125 mcg in 1512 patients with relapsing-remitting multiple sclerosis (RRMS). This report describes the correlation of clinical outcomes with the evolution of acute lesions into chronic black holes in ADVANCE, and the efficacy of peginterferon beta-1a in reducing this evolution...
August 2017: Journal of Neurology
https://www.readbyqxmd.com/read/28530523/cost-effectiveness-of-peginterferon-beta-1a-and-alemtuzumab-in-relapsing-remitting-multiple-sclerosis
#2
Ankur A Dashputre, Khalid M Kamal, Gauri Pawar
BACKGROUND: Multiple sclerosis (MS) is a chronic inflammatory disorder of the central nervous system, affecting 2.5 million people globally and 400,000 people in the United States. While no cure exists for MS, the goal is to manage the disease using disease-modifying therapies (DMTs), which have been shown to slow disease progression and prevent relapses. Relapsing-remitting MS (RRMS) is the most common form of MS at the time of diagnosis. Peginterferon beta-1a (PEG) and alemtuzumab (ALT) were recently approved and have demonstrated good clinical outcomes, including reduced relapse rates in clinical trials...
June 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28450894/peginterferon-beta-1a-reduces-disability-worsening-in-relapsing-remitting-multiple-sclerosis-2-year-results-from-advance
#3
Scott D Newsome, Bernd C Kieseier, Shifang Liu, Xiaojun You, Elizabeth Kinter, Serena Hung, Bjoern Sperling
BACKGROUND: In the pivotal phase III 2-year ADVANCE study, subcutaneous peginterferon beta-1a 125 mcg every 2 weeks demonstrated significant improvements in clinical outcomes, including disability endpoints, in patients with relapsing-remitting multiple sclerosis (RRMS). Here, we aim to further evaluate disability data from ADVANCE, and explore associations between confirmed disability progression (CDP), functional status, and health-related quality of life (HRQoL). METHODS: In total, 1512 patients were randomized to placebo or peginterferon beta-1a 125 mcg every 2 or 4 weeks...
January 2017: Therapeutic Advances in Neurological Disorders
https://www.readbyqxmd.com/read/28394418/population-based-pharmacokinetic-and-exposure-efficacy-analyses-of-peginterferon-beta-1a-in-patients-with-relapsing-multiple-sclerosis
#4
Xiao Hu, Yaming Hang, Yue Cui, Jie Zhang, Shifang Liu, Ali Seddighzadeh, Aaron Deykin, Ivan Nestorov
Peginterferon beta-1a reduced annualized relapse rate as compared with placebo and was approved to treat multiple sclerosis patients. A population pharmacokinetic and an exposure-efficacy model were developed to establish the quantitative relationship between pharmacokinetics and annualized relapse rate. The pharmacokinetics was well described by a 1-compartment model with first-order absorption and linear elimination kinetics. Body mass index was the most significant covariate that impacted both clearance and volume of distribution, which in turn impacted area under the curve and maximum serum concentration...
August 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28183276/peginterferon-beta-1a-improves-mri-measures-and-increases-the-proportion-of-patients-with-no-evidence-of-disease-activity-in-relapsing-remitting-multiple-sclerosis-2-year-results-from-the-advance-randomized-controlled-trial
#5
RANDOMIZED CONTROLLED TRIAL
Douglas L Arnold, Peter A Calabresi, Bernd C Kieseier, Shifang Liu, Xiaojun You, Damian Fiore, Serena Hung
BACKGROUND: Subcutaneous peginterferon beta-1a has previously been shown to reduce the number of T2-hyperintense and gadolinium-enhancing (Gd+) lesions over 2 years in patients with relapsing-remitting multiple sclerosis (RRMS), and to reduce T1-hypointense lesion formation and the proportion of patients showing evidence of disease activity, based on both clinical and radiological measures, compared with placebo over 1 year of treatment. The objectives of the current analyses were to evaluate T1 lesions and other magnetic resonance imaging (MRI) measures, including whole brain volume and magnetization transfer ratio (MTR) of normal appearing brain tissue (NABT), and the proportions of patients with no evidence of disease activity (NEDA), over 2 years...
February 10, 2017: BMC Neurology
https://www.readbyqxmd.com/read/27835061/peginterferon-beta-1a-shows-antitumor-activity-as-a-single-agent-and-enhances-efficacy-of-standard-of-care-cancer-therapeutics-in-human-melanoma-breast-renal-and-colon-xenograft-models
#6
Antonio Boccia, Cyrus Virata, Daniel Lindner, Nicki English, Nuzhat Pathan, Margot Brickelmaier, Xiao Hu, Jennifer L Gardner, Liaomin Peng, Xinzhong Wang, Xiamei Zhang, Lu Yang, Keli Perron, Grace Yco, Rebecca Kelly, James Gamez, Thomas Scripps, Donald Bennett, Ingrid B Joseph, Darren P Baker
Because of its tumor-suppressive effect, interferon-based therapy has been used for the treatment of melanoma. However, limited data are available regarding the antitumor effects of pegylated interferons, either alone or in combination with approved anticancer drugs. We report that treatment of human WM-266-4 melanoma cells with peginterferon beta-1a induced apoptotic markers. Additionally, peginterferon beta-1a significantly inhibited the growth of human SK-MEL-1, A-375, and WM-266-4 melanoma xenografts established in immunocompromised mice...
November 11, 2016: Journal of Interferon & Cytokine Research
https://www.readbyqxmd.com/read/27822961/the-cost-effectiveness-of-disease-modifying-therapies-for-the-treatment-of-relapsing-remitting-multiple-sclerosis
#7
Duygu Bozkaya, Terrie Livingston, Kristen Migliaccio-Walle, Tanner Odom
BACKGROUND: The safety and efficacy of disease-modifying therapies (DMTs) for relapsing-remitting multiple sclerosis (RRMS) has been established; however, it is not clear which provides optimal value, given benefit-risk profiles and costs. AIMS: To compare the cost-effectiveness of current DMTs for patients with RRMS in the US. MATERIALS AND METHODS: A Markov model predicting RRMS course following initiation of a DMT was created comparing outcomes (e...
March 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/27730845/peginterferon-beta-1a-versus-other-self-injectable-disease-modifying-therapies-in-the-treatment-of-relapsing-remitting-multiple-sclerosis-in-scotland-a-cost-effectiveness-analysis
#8
Luis Hernandez, Shien Guo, Hector Toro-Diaz, Stuart Carroll, Syed Feisal Syed Farooq
AIMS: Peginterferon beta-1a 125 mcg administered subcutaneously every 2 weeks, a new disease-modifying therapy (DMT) for relapsing-remitting multiple sclerosis (RRMS), was approved in January 2015 by the Scottish Medicines Consortium. This study assesses long-term clinical and economic outcomes of peginterferon beta-1a compared with other self-injectable DMTs (interferon beta-1a [22 mcg, 30 mcg, and 44 mcg], interferon beta-1b, and glatiramer acetate 20 mg) in the treatment of RRMS, from the National Health Service and Personal Social Services perspective in Scotland...
March 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/27551246/management-strategies-for-flu-like-symptoms-and-injection-site-reactions-associated-with-peginterferon-beta-1a-obtaining-recommendations-using-the-delphi-technique
#9
June Halper, Diego Centonze, Scott D Newsome, DeRen Huang, Christopher Robertson, Xiaojun You, Guido Sabatella, Vladimir Evilevitch, Leslie Leahy
BACKGROUND: Flu-like symptoms (FLSs) and injection-site reactions (ISRs) have been reported with interferon beta treatments for multiple sclerosis (MS). We sought to obtain consensus on the characteristics/management of FLSs/ISRs in patients with relapsing-remitting MS based on experiences from the randomized, placebo-controlled ADVANCE study of peginterferon beta-1a. METHODS: ADVANCE investigators with a predefined number of enrolled patients were eligible to participate in a consensus-generating exercise using a modified Delphi method...
July 2016: International Journal of MS Care
https://www.readbyqxmd.com/read/27314959/subgroup-and-sensitivity-analyses-of-annualized-relapse-rate-over-2%C3%A2-years-in-the-advance-trial-of-peginterferon-beta-1a-in-patients-with-relapsing-remitting-multiple-sclerosis
#10
RANDOMIZED CONTROLLED TRIAL
Scott D Newsome, Bernd C Kieseier, Douglas L Arnold, Shulian Shang, Shifang Liu, Serena Hung, Guido Sabatella
ADVANCE was a 2-year, double-blind, placebo-controlled, Phase 3 study in 1512 patients aged 18-65 years with relapsing-remitting multiple sclerosis, which demonstrated that peginterferon beta-1a 125 mcg administered subcutaneously every 2 or 4 weeks led to significant reductions in annualized relapse rate (ARR) compared with placebo. This analysis examined ARR over 2 years in ADVANCE across subgroups. Patients were treated with peginterferon beta-1a every 2 weeks or every 4 weeks, or placebo during Year 1...
September 2016: Journal of Neurology
https://www.readbyqxmd.com/read/27060836/compare-pharmacokinetic-profiles-of-subcutaneous-peginterferon-beta-1a-and-subcutaneous-interferon-beta-1a-over-2%C3%A2-weeks-in-healthy-subjects
#11
RANDOMIZED CONTROLLED TRIAL
Xiao Hu, Shulian Shang, Ivan Nestorov, Jawad Hasan, Ali Seddighzadeh, Katherine Dawson, Bjørn Sperling, Brian Werneburg
AIM: Subcutaneous (s.c.) peginterferon beta-1a injected once every 2 weeks and s.c. interferon beta-1a injected three times per week (Rebif®) have demonstrated efficacy in relapsing-remitting multiple sclerosis, but direct comparisons of pharmacological activity and tolerability between the two products are lacking. COMPARE was an open label, crossover, pharmacokinetic (PK) study evaluating drug exposure and the safety and tolerability of s.c. peginterferon beta-1a and s.c. interferon beta-1a, over 2 weeks in healthy subjects...
August 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/26947984/cost-effectiveness-analysis-of-peginterferon-beta-1a-compared-with-interferon-beta-1a-and-glatiramer-acetate-in-the-treatment-of-relapsing-remitting-multiple-sclerosis-in-the-united-states
#12
Luis Hernandez, Shien Guo, Elizabeth Kinter, Monica Fay
Objective Peginterferon beta-1a 125 mcg, administered subcutaneously (SC) every 2 weeks, a new disease-modifying therapy (DMT) for relapsing-remitting multiple sclerosis (RRMS), was approved by the US Food and Drug Administration in 2014. This study assesses the cost-effectiveness of peginterferon beta-1a vs interferon beta-1a (44 mcg SC 3 times per week) and glatiramer acetate (20 mg SC once-daily) in the treatment of RRMS from the perspective of a US payer over 10 years. Methods A Markov cohort economic model was developed for this analysis...
July 2016: Journal of Medical Economics
https://www.readbyqxmd.com/read/26852839/evaluation-of-incremental-siliconization-levels-on-soluble-aggregates-submicron-and-subvisible-particles-in-a-prefilled-syringe-product
#13
Shujun Bai, Pavel Landsman, Andrea Spencer, Daniel DeCollibus, Fabian Vega, Deniz B Temel, Damian Houde, Olivia Henderson, Mark L Brader
The evaluation of stability with respect to particles in prefilled syringes is complicated by the presence of silicone oil. The mobility, colloidal characteristics, and kinetic instability of silicone oil in contact with a protein formulation may be influenced in unpredictable ways by pharmaceutical variables, storage, and handling conditions. To provide insight into the impact of these variables on silicone oil originating specifically from the siliconized prefillable syringe (PFS), a series of studies were conducted at incremental syringe barrel siliconization levels...
January 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/26534246/cost-effectiveness-analysis-of-peginterferon-beta-1a-in-italian-relapsing-remitting-multiple-sclerosis-management
#14
S Iannazzo, L Santoni, C Saleri, E Puma, G Vestri, L Giuliani, P L Canonico, D Centonze
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/26534235/cost-effectiveness-analysis-of-peginterferon-beta-1a-in-the-treatment-of-relapsing-remitting-multiple-sclerosis-in-ireland
#15
L Hernandez, S Guo, H Toro-Diaz, S Carroll, S F Syed Farooq
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/26534233/cost-effectiveness-analysis-of-peginterferon-beta-1a-in-the-treatment-of-relapsing-remitting-multiple-sclerosis-in-scotland
#16
L Hernandez, S Guo, H Toro-Diaz, S Carroll, S F Syed Farooq
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/26534213/budget-impact-analysis-for-peginterferon-beta-1a-in-relapsing-remitting-multiple-sclerosis-in-italy
#17
S Iannazzo, L Santoni, C Saleri, E Puma, G Vestri, L Giuliani, D Centonze, P L Canonico
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/26195056/impact-of-peginterferon-beta-1a-and-disease-factors-on-quality-of-life-in-multiple-sclerosis
#18
RANDOMIZED CONTROLLED TRIAL
S D Newsome, S Guo, A Altincatal, I Proskorovsky, E Kinter, G Phillips, X You, G Sabatella
BACKGROUND: The Phase III ADVANCE study has shown clinical benefits for peginterferon beta-1a 125 µg dosed every 2 weeks versus placebo at 1 year in patients with relapsing-remitting multiple sclerosis (MS). This study assessed the impact of peginterferon beta-1a and disease factors on health-related quality of life (HRQoL) using data from ADVANCE. METHODS: HRQoL was assessed at baseline and 12, 24, and 48 weeks using the 29-item Multiple Sclerosis Impact Scale (MSIS-29) and other generic HRQoL measures...
July 2015: Multiple Sclerosis and related Disorders
https://www.readbyqxmd.com/read/26039748/a-network-meta-analysis-of-efficacy-and-evaluation-of-safety-of-subcutaneous-pegylated-interferon-beta-1a-versus-other-injectable-therapies-for-the-treatment-of-relapsing-remitting-multiple-sclerosis
#19
REVIEW
Keith Tolley, Michael Hutchinson, Xiaojun You, Ping Wang, Bjoern Sperling, Ankush Taneja, Mohammed Kashif Siddiqui, Elizabeth Kinter
Subcutaneous pegylated interferon beta-1a (peginterferon beta-1a [PEG-IFN]) 125 μg every two or four weeks has been studied in relapsing-remitting multiple sclerosis (RRMS) patients in the pivotal Phase 3 ADVANCE trial. In the absence of direct comparative evidence, a network meta-analysis (NMA) was conducted to provide an indirect assessment of the relative efficacy, safety, and tolerability of PEG-IFN versus other injectable RRMS therapies. Systematic searches were conducted in MEDLINE, Embase, and the Cochrane Library, and conference proceedings from relevant annual symposia were hand-searched...
2015: PloS One
https://www.readbyqxmd.com/read/25941954/peginterferon-beta-1a-plegridy-for-multiple-sclerosis
#20
REVIEW
(no author information available yet)
Pegylated interferon beta-1a (Plegridy) injected subcutaneously every 2 weeks appears to be similar in its efficacy and adverse effects to older interferon formulations that must be injected more frequently.
May 11, 2015: Medical Letter on Drugs and Therapeutics
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