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peginterferon beta-1a

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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
#1
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
#2
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...
November 21, 2016: 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
#3
Luis Hernandez, Shien Guo, Hector Toro-Diaz, Stuart Carroll, Syed Feisal Syed Farooq
AIMS: Peginterferon beta-1a 125 mcg administered subcutaneously every two 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...
October 12, 2016: 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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
https://www.readbyqxmd.com/read/25846320/new-fda-approved-disease-modifying-therapies-for-multiple-sclerosis
#16
REVIEW
Clayton English, Joseph J Aloi
PURPOSE: Interferon injectables and glatiramer acetate have served as the primary disease-modifying treatments for multiple sclerosis (MS) since their introduction in the 1990s and are first-line treatments for relapsing-remitting forms of MS (RRMS). Many new drug therapies were launched since early 2010, expanding the drug treatment options considerably in a disease state that once had a limited treatment portfolio. The purpose of this review is to critically evaluate the safety profile and efficacy data of disease-modifying agents for MS approved by the US Food and Drug Administration (FDA) from 2010 to the present and provide cost and available pharmacoeconomic data about each new treatment...
April 1, 2015: Clinical Therapeutics
https://www.readbyqxmd.com/read/25673895/oritavancin-diphosphate
#17
Dennis J Cada, Danial E Baker
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line...
December 2014: Hospital Pharmacy
https://www.readbyqxmd.com/read/25666445/peginterferon-beta-1a-a-review-of-its-use-in-patients-with-relapsing-remitting-multiple-sclerosis
#18
REVIEW
Sheridan M Hoy
Peginterferon beta-1a (Plegridy™), an interferon beta-1a conjugated to a methoxy polyethylene glycol (PEG) molecule, is available in the EU and the USA for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS). In a 96-week multinational, phase III study in this patient population (ADVANCE), subcutaneous peginterferon beta-1a 125 µg every 2 weeks significantly reduced the adjusted annualized relapse rate over 48 weeks, compared with placebo, corresponding to 36% fewer relapses per patient-year...
February 2015: CNS Drugs
https://www.readbyqxmd.com/read/25551571/effect-of-peginterferon-beta-1a-on-mri-measures-and-achieving-no-evidence-of-disease-activity-results-from-a-randomized-controlled-trial-in-relapsing-remitting-multiple-sclerosis
#19
RANDOMIZED CONTROLLED TRIAL
Douglas L Arnold, Peter A Calabresi, Bernd C Kieseier, Sarah I Sheikh, Aaron Deykin, Ying Zhu, Shifang Liu, Xiaojun You, Bjoern Sperling, Serena Hung
BACKGROUND: Subcutaneous peginterferon beta-1a provided clinical benefits at Year 1 (placebo-controlled period) of the 2-Year Phase 3 ADVANCE study in relapsing-remitting multiple sclerosis (RRMS). Here we report the effect of peginterferon beta-1a on brain magnetic resonance imaging (MRI) lesions, and no evidence of disease activity (NEDA; absence of clinical [relapses and 12-week confirmed disability progression] and MRI [gadolinium-enhancing, and new or newly-enlarging T2 hyperintense lesions] disease activity) during Year 1...
December 31, 2014: BMC Neurology
https://www.readbyqxmd.com/read/25432952/peginterferon-beta-1a-in-multiple-sclerosis-2-year-results-from-advance
#20
RANDOMIZED CONTROLLED TRIAL
Bernd C Kieseier, Douglas L Arnold, Laura J Balcer, Alexey A Boyko, Jean Pelletier, Shifang Liu, Ying Zhu, Ali Seddighzadeh, Serena Hung, Aaron Deykin, Sarah I Sheikh, Peter A Calabresi
OBJECTIVE: To evaluate the efficacy and safety of subcutaneous peginterferon beta-1a over 2 years in patients with relapsing-remitting multiple sclerosis in the ADVANCE study. METHODS: Patients were randomized to placebo or 125 µg peginterferon beta-1a every 2 or 4 weeks. For Year 2 (Y2), patients originally randomized to placebo were re-randomized to peginterferon beta-1a every 2 weeks or every 4 weeks. Patients randomized to peginterferon beta-1a in Year 1 (Y1) remained on the same dosing regimen in Y2...
July 2015: Multiple Sclerosis: Clinical and Laboratory Research
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