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peginterferon beta-1a

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...
April 10, 2017: Journal of Clinical Pharmacology
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
(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
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
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
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
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