PLEGRIDY (peginterferon beta-1a) receives SMC approval for the treatment of relapsing remitting multiple sclerosis
Peginterferon beta-1a is the only approved pegylated treatment for MS. Utilising the pegylation process allows patients to receive the benefits of an interferon treatment with fewer injections, which may be an attractive option for patients with RRMS seeking such a benefit. Less frequent dosing is one of the factors which have been associated with improved adherence to disease- modifying therapies in patients with relapsing-remitting multiple sclerosis.2
As well as pegylation allowing less frequent dosing, it also allows peginterferon beta-1a to be stored outside a refrigerator at room temperature (up to 25°C) for up to 30 days (but it must be kept away from light) 3 offering flexibility to patients in terms of how they store their medication.
Peginterferon beta-1a has demonstrated an efficacy and safety profile consistent with the established interferon class. It is dosed fortnightly and is administered subcutaneously with the PLEGRIDY PEN, a new, ready-to-use autoinjector. Other disease modifying treatments for multiple sclerosis are dosed between one and seven times a week.4 Data from patients treated up to 2 years with peginterferon beta-1a suggests that less than 1% (5/715) developed persistent- neutralising antibodies (which can reduce clinical efficacy) to the interferon beta-1a portion of peginterferon beta-1a.3
Dr James Overell, Consultant neurologist, South General Hospital, Glasgow said, “PLEGRIDY offers a strong efficacy and safety profile, with the additional benefits of a fortnightly dosing schedule and a convenient method of administration where patients don’t need to see the needle.
It represents a suitable option for appropriate newly diagnosed patients or patients with tolerability and compliance issues considering a switch from other injectable or oral agents.”
The SMC approval of peginterferon beta-1a is based on results from one of the largest pivotal studies of a beta interferon conducted, ADVANCE5, which involved more than 1,500 patients with RRMS.
In the ADVANCE clinical trial, peginterferon beta-1a, dosed once every two weeks, significantly reduced annualised relapse rate (ARR) at one year by 36 percent compared to placebo (p=0.0007). Peginterferon beta-1a reduced the risk of sustained disability progression confirmed at twelve weeks by 38 percent (p=0.0383) and at twenty four weeks by 54 percent (p=0.0069, post-hoc analysis). In addition, the number of gadolinium-enhancing [Gd+] lesions was significantly reduced by 86 percent (p<0.0001) compared to placebo.
Results over two years of ADVANCE confirm that its efficacy was maintained beyond the placebo-controlled first year of the study.
1 SMC Advice Briefing on peginterferon beta-1a https://www.scottishmedicines.org.uk/SMC_Advice/Briefing_Note/Briefing_Note
2 Devonshire V et al. The Global Adherence Project (GAP): a multicenter observational study on adherence to disease-modifying therapies in patients with relapsing-remitting multiple sclerosis. Eur. Journal of Neurology 2010. Jan;18(1):69-77. Date accessed: Jan. 08 2015. http://www.ncbi.nlm.nih.gov/pubmed/20561039
3 PLEGRIDY SPC. Accessed January 2015. Available at: http://www.medicines.org.uk/emc/search
?4 MS Society. MS Essentials. Date accessed: Jan. 05, 2015. Available at: http://www.mssociety.org.uk/sites/default/files/Documents/Essentials/Disease-modifying-drugs-Mar-13.pdf
5 Calabresi PA et al. Pegylated interferon ?-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study. Lancet Neurol. 2014 Jul;13(7):657-65.
6 Bailon P and Won CY. PEG-modified biopharmaceuticals. Expert Opin Drug Deliv 6: 1-16, 2009.
7 Reuss R. PEGylated interferon beta-1a in the treatment of multiple sclerosis – an update. Biologics: Targets and Therapy 7: 131-139, 2013. Accessed January 2015. Available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3686537/pdf/btt-7-131.pdf
8 MS Society Website. About MS. Accessed January 2015. Available at http://www.mssociety.org.uk/what-is-ms/information-about-ms/about-ms
9 MS Trust. Prevalence and incidence of multiple sclerosis. Date accessed: January 2015. http://www.mstrust.org.uk/atoz/prevalence_incidence.jsp
10 MS Society Website. Types of MS. Date accessed January 2015. Available at: http://www.mssociety.org.uk/what-is-ms/types-of-ms
Source: Biogen Idec