Multiple Sclerosis

Autoinjector Improves Injection-related Tolerability Issues in Patients with Multiple Sclerosis – Exploring the New ExtaviJect™ 30G System for the Injection of Interferon Beta-1b

Wojciech Kozubski Professor of Neurology, Department of Neurology, Poznan University of Medical Sciences

Abstract

Most of the current disease-modifying therapies available for the treatment of multiple sclerosis (MS) are administered by injection. This is a source of fear for many patients and a substantial cause of non-adherence to treatment. Autoinjectors can address this by ensuring that the injection is made at the correct depth and can markedly improve the comfort and tolerability of administration compared with manual syringes. Data from clinical trials support the use of autoinjectors showing that they improve adherence and that smaller gauge needles greatly reduce injection discomfort. As an initiative to improve the tolerability of interferon beta-1b (INFβ-1b) (Extavia®) administration in MS, a new injector system (ExtaviJect 30G™) has been developed that is simple to use and incorporates a narrower needle than is currently used in other injections. A preference survey amongst 200 patients, who had not used the new autoinjector, indicated that it would likely be well received by MS patients and would be easier to use than the currently available autoinjectors.

Keywords Multiple sclerosis, disease-modifying therapies, interferon, autoinjector, tolerability, ExtaviJect 30G™

Disclosure: Wojciech Kozubski has received payment for lectures for Novartis Poland. Received: 16 September 2010 Accepted: 4 November 2010 Citation: European Neurological Review, 2010;5(2):77–81 Correspondence: Wojciech Kozubski, Department of Neurology, University of Medical Sciences in Poznan, 49, Przybyszewskiego St, 60-355 Poznan, Poland. E: wkozubski@ump.edu.pl

Support: Editorial assistance was provided by Touch Briefings and funded by Novartis Pharma AG. The views and opinions expressed are those of the author and not necessarily those of Novartis Pharma AG.

Many of the disease-modifying therapies (DMTs) that are available for the treatment of multiple sclerosis (MS) require frequent administration by subcutaneous or intramuscular injections. Current first-line therapies include interferon beta-1a (INFβ-1a), INFβ-1b and glatiramer acetate. INFβ-1a is available as two formulations: Avonex® is administered as a once-weekly intramuscular injection and Rebif® is injected subcutaneously (SC) three times a week. Interferon β-1b (Betaferon®/Extavia®) is administered as a high-dose SC injection every other day. Glatiramer acetate (Copaxone®) is administered once daily, also by SC injection.

It is accepted that the best treatment paradigm is to prescribe first-line DMTs as early as possible in order to retard neurodegeneration before extensive damage has occurred, delaying disease progression and also to use higher, more frequent doses to gain maximum therapeutic effects.1,2

early, high-dose frequent use of DMTs, particularly INFβ-1b.3–6

Injectable DMTs can be administered either by manual injection procedures using a needle and syringe or an injection device (autoinjector). This article will discuss administration factors that affect the tolerability of DMTs, the impact autoinjectors have had on injection-related tolerability issues and patient adherence, and

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overview key clinical data on the use of autoinjectors for the administration of high-dose, frequent use INFβ-1bs in the treatment of MS. The new ExtaviJect 30G™ device for the administration of INFβ-1b (Extavia) will also be reviewed.

Tolerability Issues Related to Disease-modifying Treatment Injections Frequent injections of most therapeutic medications are associated with adverse side effects, such as injection-site reactions (ISRs) and painful injection procedures. Other issues include suboptimal patient-reported outcomes (i.e. a perceived lack of improved health benefits) and other adverse events (AEs) such as flu-like symptoms and related events.7–9

Moreover, data from clinical trials support the

The majority of ISRs resulting from INFβ administration tend to be mild and localised to the injection site, and although they are not likely to lead to discontinuation, they may affect treatment adherence.10

This is,

in part, because patients may decide not to administer the drug while the ISR or injection-site pain (ISP) symptoms persist but resume drug administration upon ISR or ISP symptom improvement. In addition, the fear of needles can reduce adherence to injectable MS therapies.11,12 Evidence from clinical trials suggests that the majority of patients experienced ISRs at some point during INFβ therapy for the treatment

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