Back to Browse Journals » Biologics: Targets and Therapy » Volume 7

PEGylated interferon beta-1a in the treatment of multiple sclerosis – an update

Authors Reuss R

Published Date May 2013 Volume 2013:7 Pages 131—138

DOI http://dx.doi.org/10.2147/BTT.S29948

Received 17 January 2013, Accepted 28 March 2013, Published 29 May 2013

Reinhard Reuss

Department of Neurology, BKH Bayreuth, Bayreuth, Germany

Abstract: Current standard immunomodulatory therapy with interferons (IFNs) for relapsing–remitting multiple sclerosis (MS) exhibits proven, but limited, efficacy and increased side effects due to the need of frequent application of the drug. Therefore, there is a need for more effective and tolerable drugs. Due to their small size, optimization of therapy with IFNs in MS by PEGylation is feasible. PEGylation of an IFN means that at least one molecule of polyethylene glycol (PEG) is covalently added. This modification is a standard procedure to increase the stability, solubility, half-life, and efficacy of a drug, and is applied in several drugs and diseases. Currently, a therapy regimen applying PEG-IFN beta-1a in MS is being developed to achieve an optimized relationship between therapy-related side effects and pharmacokinetic/pharmacodynamic efficacy. Phase I studies demonstrated that subcutaneous PEG-IFN beta-1a at a dose of 125 µg every 2 or 4 weeks might be at least as efficient and safe as the current standard therapy with IFN beta-1a. A global Phase III clinical study is investigating the efficacy of PEG-IFN beta-1a in terms of reduction of the relapse rate in relapsing–remitting MS patients. The latest primary safety and efficacy analysis after 1 year has revealed a favorable risk–benefit profile with no significant difference between dosing regimens. Compared to placebo, the annualized relapse rate was reduced by about one-third and new or newly enlarging T2 brain lesions were reduced by about one-third when dosing every 4 weeks or by two-thirds when dosing every 2 weeks. This presents a significant effect of the dosing interval, favoring administration every 2 weeks. Chronic administration of PEGylated proteins mostly at toxic concentrations causes vacuolation of renal epithelium in animals, which – along with the issue of occurrence of anti-PEG antibodies – has to be addressed by Phase IV studies.

Keywords: PEGylation, relapsing–remitting, side effect, Avonex®, ADVANCE, clinical study

Download Article [PDF] 

Creative Commons License This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution - Non Commercial (unported, v3.0) License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php

Readers of this article also read:

Osteoporosis – a current view of pharmacological prevention and treatment

Das S, Crockett JC

Drug Design, Development and Therapy 2013, 7:435-448

Published Date: 31 May 2013

Tolerance of skin care regimen in healthy, full-term neonates

Iarkowski LE, Tierney NK, Horowitz P

Clinical, Cosmetic and Investigational Dermatology 2013, 6:137-144

Published Date: 29 May 2013

Phenomenological perspectives on self-care in aging

Söderhamn O

Clinical Interventions in Aging 2013, 8:605-608

Published Date: 29 May 2013

Sustained-release pregabalin with methylcobalamin in neuropathic pain: an Indian real-life experience

Dongre YU, Swami OC

International Journal of General Medicine 2013, 6:413-417

Published Date: 29 May 2013

New and emerging treatments for ulcerative colitis: a focus on vedolizumab

Gledhill T, Bodger K

Biologics: Targets and Therapy 2013, 7:123-130

Published Date: 23 May 2013

Bosutinib in the management of chronic myelogenous leukemia

Keller-von Amsberg G, Schafhausen P

Biologics: Targets and Therapy 2013, 7:115-122

Published Date: 6 May 2013