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Multiple Sclerosis
Improving Patient Satisfaction with Injection Devices in
Multiple Sclerosis Improves Adherence
Karl Baum
Chief of Neurology, Hennigsdorf Hospital
Abstract
Various studies have demonstrated that regular injections of interferon beta (IFN-β), whether subcutaneously or intramuscular, are effective as
maintenance therapy in multiple sclerosis (MS), with acceptable safety and tolerability profiles. While tolerability and adverse events are reported
to be comparable across the three most commonly available formulations of IFN-β (Betaferon
®
, Bayer Schering Pharma; Rebif
®
, Merck Serono;
and Avonex
®
, Biogen Idec), the formulation of IFN, needle diameter and injection method have been implicated in the rate of injection-site
reactions (ISRs) and injection-site pain (ISP), which can ultimately affect a patient’s adherence to therapy. Providing MS patients with information
and education regarding their condition and available treatments is considered to be of high importance among patients, and the availability
and support of specialist MS nurses, or even an educational website, has been associated with improved quality of life among MS patients.
Recent data from European surveys of patients and nurses show consistently high satisfaction with a new Betaferon auto-injection system,
which offers automatic withdrawal of the needle, reduced needle size and variable depth adjustment. IFN formulation, nursing support and use
of an auto-injector can therefore have a major impact on adherence to therapy.
Keywords
Multiple sclerosis, interferon-β, safety, tolerability, injection-site reactions, injection-site pain, auto-injectors
Disclosure: Karl Baum has received lecturing honoraria from Bayer Schering, Biogen idec, Merck-Serono, TEVA/sanofi-aventis and Novartis, and is a consultant for Bayer Schering.
Received: 11 December 2009 Accepted: 26 February 2010
Correspondence: Karl Baum, Department of Neurology (MS Centre), Klinik Hennigsdorf, Marwitzer Straße 91, Hennigsdorf, 16761, Germany. E: kb.hennigsdorf@gmx.net
Interferon beta (IFN-β) is now established as an effective maintenance administration. Although a number of orally administered drugs are
therapy for multiple sclerosis (MS) that can both slow disease in development for the treatment of MS, none is currently
progression and reduce clinical exacerbations.
1–6
Studies have approved, thus continued research into minimising the ISP and ISRs
demonstrated that the three widely used IFN-βa formulations – associated with IFN-β could improve adherence to the therapies
IFN-β1b 250µg (8MIU) by subcutaneous (SC) injection every other day that are widely used today. The use of auto-injectors has been
(EOD; Betaferon
®
, Bayer Schering Pharma); IFN-β1a 44µg (12MIU) by shown to be one approach that can reduce ISRs. Auto-injectors
SC injection three times per week (Rebif
®
, Merck Serono); and IFN-β1a were linked with significantly lower rates of ISRs in over 1,800
30µg (6MIU) by intramuscular (IM) injection once per week (Avonex
®
, patients with relapsing–remitting MS (RRMS) receiving IFN-β over
Biogen Idec) – all offer acceptable tolerability and safety profiles.
7,8
three weeks (79% versus 85% with physician-assessed ISRs and
Data suggest that the two higher-dose, more frequent formulations 66% versus 72% with patient-reported ISRs; p<0.001 for both
(Betaferon and Rebif) offer better efficacy than the lower-dose, less comparisons).
11
An earlier report suggested that auto-injectors
frequent Avonex.
7–9
Adverse events (AEs) are reported to be similar could reduce ISRs by close to 60% compared with manual
across all three formulations.
7,8
However, according to one injection.
12
Interestingly, in the pivotal IFN-β1b trial, which utilised
comparative study there may be an increase in headaches and manual injections, 69% of patients in the active treatment group
injection-site reactions (ISRs) with higher-dose SC formulations reported at least one ISR compared with 6% of those receiving
compared with lower-dose IM IFN-β.
7
However, this study pre-dated placebo.
13
By contrast, the more recent BENEFIT trial, in which
the development of new SC injector technology that is likely to IFN-β1b was predominantly administered by auto-injector, the
influence ISRs. Injection-site pain (ISP) and ISRs are a common reported ISR rate was 48% versus 8.5% with placebo.
14
concern with injectable therapies and can impair adherence to
treatment and potentially contribute to discontinuation of therapy.
7,8,10
Other factors that could affect ISRs and ISP include the formulation
This article reviews evidence on factors influencing ISRs, ISP and of IFN and needle diameter. Low-dose and reduced frequency of
adherence, and presents the results of patient and nurse surveys on administration of IFN-β1a may offer fewer ISRs and less ISP than
a new IFN-β auto-injector. either high-frequency IFN-β formulation, but data suggest that the
efficacy of low-frequency IFN-β1a is significantly lower than that of
Impact of Injection-site Pain and Reactions the alternative formulations.
7–9
Therefore, a balance between efficacy
The growing recognition of the importance of ISP and ISRs has and tolerability must be achieved. Evidence is now emerging that
fuelled research into drug formulations and mechanisms of there are also differences in terms of ISRs and ISP between the two
64
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