Peginterferon Beta-1a: A Review of Its Use in Patients with Relapsing-Remitting Multiple Sclerosis
Tóm tắt
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. Significant reductions versus placebo were also observed in the risk of relapse and disability progression, the number of new or newly enlarging T2-weighted hyperintense lesions, and various other magnetic resonance imaging endpoints. The efficacy of peginterferon beta-1a was sustained over 96 weeks, with preliminary data from the first year of an ongoing 2-year extension of ADVANCE indicating continued benefit longer-term. In ADVANCE, peginterferon beta-1a had an acceptable tolerability profile that was consistent with that of established interferon beta treatments. Adverse events were generally mild or moderate in severity, with injection-site erythema and influenza-like illness reported most commonly. Amongst other adverse events of special interest, peginterferon beta-1a was not associated with an increased risk of autoimmune disorders, depression/suicidal ideation, infections or seizures. In the absence of head-to-head studies, definitive conclusions on the comparative efficacy and tolerability of peginterferon beta-1a versus existing therapies are not yet possible. Although final data from the extension of ADVANCE are awaited, current evidence suggests subcutaneous peginterferon beta-1a every 2 weeks extends the treatment options currently available for adults with RRMS, with the dosing regimen imparting potential compliance advantages over non-PEGylated interferon beta formulations that require more frequent administration.
Tài liệu tham khảo
Lipsy RJ, Schapiro RT, Prostko CR. Current and future directions in MS management: key considerations for managed care pharmacists. J Manag Care Pharm. 2009; 15(9 Suppl A):S2–15.
Nylander A, Hafler DA. Multiple sclerosis. J Clin Invest. 2012;122(4):1180–8.
Goldenberg MM. Multiple sclerosis review. P&T. 2012;37(3):175–84.
Baker DP, Pepinsky RB, Brickelmaier M, et al. PEGylated interferon beta-1a: meeting an unmet medical need in the treatment of relapsing multiple sclerosis. J Interferon Cytokine Res. 2010;30(10):777–85.
Kieseier BC, Calabresi PA. PEGylation of interferon-beta-1a: a promising strategy in multiple sclerosis. CNS Drugs. 2012;26(3):205–14.
Girouard N, Soucy N. Patient considerations in the management of multiple sclerosis: development and clinical utility of oral agents. Patient Prefer Adherence. 2011;5:101–8.
European Medicines Agency. Plegridy: EU summary of product characteristics. 2014. http://www.ema.europa.eu/ema/. Accessed 16 Jan 2015.
Biogen Idec Inc. PLEGRIDY (peginterferon beta-1a), for subcutaneous injection: US prescribing information. 2014. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125499lbl.pdf. Accessed 16 Jan 2015.
Goodin DS, Frohman EM, Garmany GP Jr, et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology. 2002;58(2):169–78.
European Medicines Agency. Plegridy: assessment report. 2014. http://www.ema.europa.eu/ema/. Accessed 16 Jan 2015.
Hu X, Miller L, Richman S, et al. A novel PEGylated interferon beta-1a for multiple sclerosis: safety, pharmacology, and biology. J Clin Pharmacol. 2012;52(6):798–808.
Calabresi PA, Kieseier BC, Arnold DL, et al. Pegylated interferon beta-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study. Lancet Neurol. 2014;13(7):657–65.
Kieseier BC, Arnold DL, Balcer LJ, et al. Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE. Mult Scler. 2014;. doi:10.1177/1352458514557986.
Kinter ET, Guo S, Altincatal A, et al. Impact of treatment-related flu-like symptoms and injection site reactions on quality of life in patients with multiple sclerosis: ADVANCE study (abstract no. 799 plus poster). Mult Scler J. 2014; 20(Suppl 1):417.
Oh J, Calabresi PA. Emerging injectable therapies for multiple sclerosis. Lancet Neurol. 2013;12(11):1115–26.
National Institute for Health and Care Excellence. Multiple sclerosis: management of multiple sclerosis in primary and secondary care. 2003. http://www.nice.org.uk/guidance/CG8. Accessed 16 Jan 2014.
Tolley K, Hutchinson M, Pachner A, et al. Systematic literature review and network meta-analysis of peginterferon beta-1a and injectable therapies for relapsing-remitting multiple sclerosis (abstract no. P318 plus poster). Mult Scler J. 2014; 20(Suppl 1):209.
Webster R, Didier E, Harris P, et al. PEGylated proteins: evaluation of their safety in the absence of definitive metabolism studies. Drug Metab Dispos. 2007;35(1):9–16.