Autoinjector Improves Injection-related Tolerability Issues in Patients with Multiple Sclerosis
aspects of the newer device and proportions expressing a preference in each case were: the size of the needle (95%), the ease of use and maintenance of sterility (85%), the ease and speed of loading (83%), the design and features (86%), the injection depth (91%) and the application kit size (84%). Overall, the new ExtaviJect 30G retains the simplicity of the previous Extavia autoinjector, it is likely to be very easy to use in terms of loading, injecting and dismantling and is likely to be well received based on those patients surveyed to date.
Future Directions in Autoinjector Device Development
A number of autoinjectors are currently being developed in addition to the ExtaviJect 30G. The RebiSmart™ is an electronic injection system used with INFβ-1a, Rebif and instead of being pen-sized, it is similar in size to a mobile telephone.
The open-label, single-arm phase IIIb study to assess the suitability of the RebiSmart for the subcutaneous injection INFβ-1a 44µg three times a week reported that local ISRs (pain, swelling, redness or bruising) occurred in 74.5% of the 106 patients over 12 weeks. Most were mild or moderate in severity.27
The study also reported that 71.6% (73/102) of patients rated the device as ‘very suitable’ or ‘suitable’ for self-injection and 7.8% (eight of 102) found the device ‘not at all suitable’. However, approximately 20% of patients did not rate each device feature as either ‘very useful’
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Kappos L, Freedman MS, Polman CH, et al., Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial, Lancet Neurol, 2009;8:987–97.
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Kappos L, Freedman MS, Polman CH, et al., Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study, Lancet, 2007;370:389–97.
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Baum K, O’Leary C, Coret Ferrer F, et al., Comparison of injection site pain and injection site reactions in relapsing-remitting multiple sclerosis patients treated
or ‘useful’, suggesting that although the device has a lot of features, they may not be appropriate for everyone. Furthermore, not all patients will want to use or understand how to use such a sophisticated high-technology device.
The decreased incidence of ISRs with autoinjectors compared with manual injection observed in clinical trials, and the ease of use of autoinjectors, suggests that patient adherence to therapy may be increased, and thus improve health outcomes for some patients. As with all autoinjectors, the Extavia delivery device, ExtaviJect 30G, will continue to evolve in line with feedback from patients, nurses and neurologists, and endeavour to boost patient comfort when delivering INFβ-1b. n
Wojciech Kozubski is a Professor in and Chairman of the Department of Neurology at the Poznan University of Medical Sciences. He is the author or co-author of over 190 papers focusing on the pathophysiology of migraine and related headaches, pathophysiology of stroke and the treatment of headaches and stroke. He is a co-author and co-editor of handbooks of clinical neurology for medical students and neurologists. Professor Kozubski graduated from medical school in
Lodz in 1980 and subsequently spent time training in neurology at the Academic Unit of Neuroscience at the Charing Cross and Westminster Medical School at the University of London, the Department of Neurology at the Sackler School of Medicine in Tel Aviv and the Department of Neurology at the University of Trondheim.
with interferon beta-1a or 1b, Mult Scler, 2007;13: 1153–60.
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Cox D, Stone J, Managing self-injection difficulties in patients with relapsing-remitting multiple sclerosis, J Neurosci Nurs, 2006;38:167–71.
Turner AP, Williams RM, Sloan AP, et al., Injection anxiety remains a long-term barrier to medication adherence in multiple sclerosis, Rehabil Psychol, 2009;54:116–21.
The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group, Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial, Neurology, 1995;45:1277–85.
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Barkhof F, Polman CH, Radue EW, et al., Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results, Arch Neurol, 2007;64:1292–8.
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Kappos L, Polman CH, Freedman MS, et al., Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes, Neurology, 2006;67:1242–9.
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Patti F, Optimizing the benefit of multiple sclerosis therapy: the importance of treatment adherence, Patient Prefer Adherence, 2010;4:1–9.
Treadaway K, Cutter G, Salter A, et al., Factors that influence adherence with disease-modifying therapy in MS, J Neurol, 2009;256:568–76.
Cramer JA, Cuffel BJ, Divan V, et al., Patient satisfaction with an injection device for multiple sclerosis treatment, Acta Neurol Scand, 2006;113:156–62.
Arendt-Nielsen L, Egekvist H, Bjerring P, Pain following controlled cutaneous insertion of needles with different diameters, Somatosens Mot Res, 2006;23:37–43.
Jaber A, Bozzato GB, Vedrine L, et al., A novel needle for subcutaneous injection of interferon beta-1a: effect on pain in volunteers and satisfaction in patients with multiple sclerosis, BMC Neurol, 2008;8:38.
21. Freedman SM, Cox D, Rosebrough T, A prospective 28. 29. 30. 26. 22. 23. 24.
baseline versus on-treatment study assessing patient perceptions of using a smaller needle when injecting intramuscular interferon beta-1 a (Avonex), J Neurosci Nurs, 2008;40:350–5.
Palmon SC, Lloyd AT, Kirsch JR, The effect of needle gauge and lidocaine pH on pain during intradermal injection, Anesth Analg, 1998;86:379–81.
Burks JS, The changing face of multiple sclerosis and disease modifying therapies, US Neurol Rev, 2005;51–6.
Mikol D, Lopez-Bresnahan M, Taraskiewicz S, et al., A randomized, multicentre, open-label, parallel-group trial of the tolerability of interferon beta-1a (Rebif) administered by autoinjection or manual injection in relapsing-remitting multiple sclerosis, Mult Scler, 2005;11:585–91.
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Lugaresi A, Durastanti V, Gasperini C, et al., Safety and tolerability in relapsing-remitting multiple sclerosis patients treated with high-dose subcutaneous interferon-beta by Rebiject autoinjection over a 1-year period: the CoSa study, Clin Neuropharmacol, 2008;31: 167–72.
Brochet B, Lemaire G, Beddiaf A, Reduction of injection site reactions in multiple sclerosis (MS) patients newly started on interferon beta 1b therapy with two different devices, Rev Neurol (Paris), 2006;162:735–40.
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Devonshire V, Arbizu T, Borre B, et al., Patient-rated suitability of a novel electronic device for self-injection of subcutaneous interferon beta-1a in relapsing multiple sclerosis: an international, single-arm, multicentre, Phase IIIb study, BMC Neurol, 2010;10:28.
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Novartis, Extavia: Summary of Product Characteristics, Web Page, 2010,
www.medicines.org.uk/emc/medicine/ 21659/SPC/#PRODUCTINFO.
Russell Research Inc., ExtaviJect 30G report, September 2010. Russell Research Inc. One Meadowlands Plaza, Suite 1001, East Rutherford, NJ 07073 USA, Data on file.
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