RebiSmart™ (version 1.5) device for multiple sclerosis treatment delivery and adherence

Expert Opinion on Drug Delivery

Volumn 10, Issue 2, 2013, Pages 273-283

  Lugaresi, Alessandra ^a  

^a UNIVERSITY OF CHIETI   (Italy)

Author keywords

Adherence; Disease modifying drug; Electronic autoinjection device; Interferon 1a; Multiple sclerosis

Indexed keywords

BETA1A INTERFERON;

ARTICLE; DRUG DELIVERY SYSTEM; DRUG DOSE; DRUG STORAGE; HUMAN; MULTIPLE SCLEROSIS; PATIENT COMPLIANCE;

ADJUVANTS, IMMUNOLOGIC; DRUG DELIVERY SYSTEMS; EQUIPMENT DESIGN; HUMANS; INJECTIONS; INJECTIONS, SUBCUTANEOUS; INTERFERON-BETA; MULTIPLE SCLEROSIS; SELF ADMINISTRATION;

EID: 84872739719     PISSN: 17425247     EISSN: 17447593     Source Type: Journal    
DOI: 10.1517/17425247.2013.746311     Document Type: Article

References (65)

1. Goodin DS, Frohman EM, Garmany GP, 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;58:169-78 (Pubitemid 34086933)
2. Uitdehaag B, Constantinescu C, Cornelisse P, et al. Impact of exposure to interferon beta-1a on outcomes in patients with relapsing-remitting multiple sclerosis: exploratory analyses from the PRISMS long-term follow-up study. Ther Adv Neurol Disord 2011;4:3-14
3. Goodin DS, Reder AT, Ebers GC, et al. Survival in MS: a randomized cohort study 21 years after the start of the pivotal IFN beta-1b trial. Neurology 2012;78:1315-22
4. Miller AE, Rhoades RW. Treatment of relapsing-remitting multiple sclerosis: current approaches and unmet needs. Curr Opin Neurol 2012;25(Suppl):S4-S10
5. Comi G. Shifting the paradigm toward earlier treatment of multiple sclerosis with interferon beta. Clin Ther 2009;31:1142-57
6. Tintoré M. Early MS treatment. Int MS J 2007;14:5-10 (Pubitemid 46917293)
7. 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
8. Ebers GC, Traboulsee A, Li D, et al. Analysis of clinical outcomes according to original treatment groups 16 years after the pivotal IFNB-1b trial. J Neurol Neurosurg Psychiatry 2010;81:907-12
9. Goodin DS, Traboulsee A, Knappertz V, et al. Relationship between early clinical characteristics and long term disability outcomes: 16 year cohort study (followup) of the pivotal interferon beta-1b trial in multiple sclerosis. J Neurol Neurosurg Psychiatry 2012;83:282-7
10. Brandes DW. The role of glatiramer acetate in the early treatment of multiple sclerosis. Neuropsychiatr Dis Treat 2010;6:329-36
11. Trojano M, Pellegrini F, Paolicelli D, et al. Real-life impact of early interferon beta therapy in relapsing multiple sclerosis. Ann Neurol 2009;66:513-20
12. Al-Sabbagh A, Bennet R, Kozma C, et al. Medication gaps in disease-modifying therapy for multiple sclerosis are associated with an increased risk of relapse: findings from a national managed care database. J Neurol 2008;255(Suppl 2):S79
13. Steinberg SC, Faris RJ, Chang CF, et al. Impact of adherence to interferons in the treatment of multiple sclerosis: a non-experimental, retrospective, cohort study. Clin Drug Investig 2010;30:89-100
14. Cohen JA, Barkhof F, Comi G, et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med 2010;362:402-15
15. Kappos L, Radue EW, O'Connor P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med 2010;362:387-401
16. Portaccio E. Evidence-based assessment of potential use of fingolimod in treatment of relapsing multiple sclerosis. Core Evid 2011;6:13-21
17. Portaccio E, Zipoli V, Siracusa G, et al. Long-term adherence to interferon beta therapy in relapsing-remitting multiple sclerosis. Eur Neurol 2008;59:131-5 (Pubitemid 351301255)
18. Pozzilli C, Schweikert B, Ecari U, et al. Supportive strategies to improve adherence to IFN beta-1b in Multiple Sclerosis-results of the BetaPlus observational cohort study. J Neurol Sci 2011;307:120-6
19. Treadaway K, Cutter G, Salter A, et al. Factors that influence adherence with disease-modifying therapy in MS. J Neurol 2009;256:568-76
20. Wong J, Gomes T, Mamdani M, et al. Adherence to multiple sclerosis disease-modifying therapies in Ontario is low. Can J Neurol Sci 2011;38:429-33
21. Fernandez O, Aguera J, Izquierdo G, et al. Adherence to interferon beta-1b treatment in patients with multiple sclerosis in Spain. PLoS One 2012;7:e35600
22. Giovannoni G, Southam E, Waubant E. Systematic review of disease-modifying therapies to assess unmet needs in multiple sclerosis: tolerability and adherence. Mult Scler 2012;18:932-46
23. Devonshire V, Lapierre Y, Macdonell R, 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 J Neurol 2011;18:69-77
24. Meyniel C, Spelman T, Jokubaitis VG, et al. Country, sex, EDSS change and therapy choice independently predict treatment discontinuation in multiple sclerosis and clinically isolated syndrome. PLoS One 2012;7:e38661
25. O'Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med 2011;365:1293-303
26. Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012;367:1087-97
27. Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012;367:1098-107
28. Tremlett HL, Oger J. Interrupted therapy: stopping and switching of the beta-interferons prescribed for MS. Neurology 2003;61:551-4 (Pubitemid 37025380)
29. Beer K, Muller M, Hew-Winzeler AM, et al. The prevalence of injection-site reactions with disease-modifying therapies and their effect on adherence in patients with multiple sclerosis: an observational study. BMC Neurol 2011;11:144
30. O'Rourke KE, Hutchinson M. Stopping beta-interferon therapy in multiple sclerosis: an analysis of stopping patterns. Mult Scler 2005;11:46-50 (Pubitemid 40259974)
31. Mohr DC, Boudewyn AC, Likosky W, et al. Injectable medication for the treatment of multiple sclerosis: the influence of self-efficacy expectations and injection anxiety on adherence and ability to self-inject. Ann Behav Med 2001;23:125-32 (Pubitemid 32488430)
32. Verdun di Cantogno E, Russell S, Snow T. Understanding and meeting injection device needs in multiple sclerosis: a survey of patient attitudes and practices. Patient Prefer Adherence 2011;5:173-80
33. Lugaresi A. Addressing the need for increased adherence to multiple sclerosis therapy: can delivery technology enhance patient motivation? Expert Opin Drug Deliv 2009;6:995-1002
34. Patti F. Optimizing the benefit of multiple sclerosis therapy: the importance of treatment adherence. Patient Prefer Adherence 2010;4:1-9
35. Bayas A, Japp G, Fulda U, et al. Injection devices in the basic therapy of multiple sclerosis. Survey among neurologists, MS nurses and patients [in German]. Nervenheilkunde 2010;29:57-62
36. 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 (Pubitemid 44046655)
37. 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
38. 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
39. de Sá J, Urbano G, Reis L. Assessment of new application system in Portuguese patients with relapsing-remitting multiple sclerosis. Curr Med Res Opin 2010;26:2237-42
40. Exell S, Verdun E, Driebergen R. A new electronic device for subcutaneous injection of IFN beta-1a. Expert Rev Med Devices 2011;85:543-53
41. Devonshire VA, Verdun di Cantogno E. Review of subcutaneous interferon beta-1a, delivered via the electronic self-injection device RebiSmart, for the treatment of multiple sclerosis. Ther Deliv 2011;2:1455-65
42. Thompson I. New-generation auto-injectors-taking self-injection beyond prefilled syringes. Available from: www. touchbriefings. com/pdf/1859/Ypsomed- tech2. pdf [Last accessed 3 August 2012]
43. Rebi Smart. Geneva, Switzerland: Merck Serono S. A., 2012. Available from: www. rebismart. com/en/index. html [Last accessed 24 August 2012]
44. Rebiject II. Rockland, Massachusetts, USA: EMD Serono, 2012. Available from: www. rebif. com/pages/starting-rebif/rebiject-ii [Last accessed 24 August 2012]
45. Rebi Dose. Geneva, Switzerland: Merck Serono S. A., 2010. Available from: www. merckserono. com/en/products/neurodegenerative-diseases/multiple- sclerosis/rebif/rebidose. html [Last accessed 24 August 2012]
46. Injecting interferon beta-1b with the Betaject Lite. Berlin, Germany: Bayer Healthcare, 2007. Available from: www. ms-gateway. com/interferon-beta-1b- user-guide/injecting-interferon-beta-1b-with-thebetajectreg-lite-160. htm [Last accessed 24 August 2012]
47. Injecting interferon beta-1b with the Betaject Comfort. Berlin, Germany: Bayer Healthcare, 2007. Available from: www. ms-gateway. com/interferon-beta- 1buser-guide/injecting-interferon-beta-1bwith-the-betajectreg-comfort-159. htm [Last accessed 24 August 2012]
48. Personal Injector. Copenhagen, Denmark: Union Medico, 2001. Available from: www. personalinjector. com/uk/11. php [Last accessed 24 August 2012]
49. Avonexpen. Cambridge, Massachusetts, USA: Biogen Idec, 2012. Available from: www. avonex. com/avonex-pen-injection. xml [Last accessed 24 August 2012]
50. Autoject 2. Marietta, Georgia, USA: Owen Mumford, 2012. Available from: www. owenmumford. com/us/range/35/autoject-2. html [Last accessed 24 August 2012]
51. Extaviject II. East Hanover, New Jersey, USA: Novartis, 2010. Available from: quo. novartis. com/productinfosite/infosites/content/extavia/resources/ EXDStarterInjectionTrainingManual. pdf [Last accessed 23 July 2012]
52. 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
53. Dahlgren J. Easypod: a new electronic injection device for growth hormone. Expert Rev Med Devices 2008;5:297-304
54. Giovannoni G, Barbarash O, Casset-Semanaz F, et al. Safety and immunogenicity of a new formulation of interferon-1a (Rebif New Formulation) in a phase IIIb study in patients with relapsing multiple sclerosis: 96-week results. Mult Scler 2009;15:219-28
55. McKeage K, Wagstaff AJ. Subcutaneous interferon-beta-1a : new formulation. CNS Drugs 2007;21:871-6
56. 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
57. Singer B, Wray S, Miller T, et al. Patient-rated ease of use and functional reliability of an electronic autoinjector for self-injection of subcutaneous interferon beta-1a for relapsing multiple sclerosis. Mult Scler Relat Disord 2012;1:87-94
58. D'Arcy C, Thomas D, Stoneman D, et al. Patient assessment of an electronic device for subcutaneous self-injection of interferon beta-1a for multiple sclerosis: an observational study in the UK and Ireland. Patient Prefer Adherence 2012;6:55-61
59. Lugaresi A, Florio C, Brescia-Morra V, et al. Patient adherence to and tolerability of self-administered interferon beta-1a using an electronic autoinjection device: a multicentre, open-label, phase IV study. BMC Neurol 2012;12:7
60. NCT01108887: An observational study for the assessment of adherence, effectiveness and convenience of Rebif treatment in relapsing multiple sclerosis patients using RebiSmart. Bethesda, Maryland, USA: National Institutes of Health, 2012. Available from: clinicaltrials. gov/archive/NCT01108887 [Last accessed 29 October 2012]
61. Devonshire V, Feinstein A, Enciu C. MEASURE: a multi-centre, single-arm, observational, 96 week, Phase IV study to evaluate treatment adherence when using RebiSmartfor self-injection of subcutaneous interferon-beta 1a in multi-dose cartridges in subjects with relapsing multiple sclerosis. J Neurol 2011;258(Suppl 1):S265-6
62. Clinical trials of RebiSmart. Bethesda, Maryland, USA: National Institutes of Health, 2012. Available from: clinicaltrials. gov/ct2/results? term=rebismart [Last accessed 24 August 2012]
63. READOUTsmart: REal ADherence mOnitoring in mUlTiple sclerosis applying the electronic device RebiSmart. Berlin, Germany: Die forschenden Pharma-Unternehmen, 2011. Available from: www. vfa. de/de/arzneimittel- forschung/datenbanken-zuarzneimitteln/nisdb/nis-details/-633 [Last accessed 29 October 2012]
64. Devonshire V, Feinstein A, Fortin K. Anxiety and adherence in patients with relapsing multiple sclerosis using RebiSmart for self-injection: preliminary results from the MEASURE study. J Neurol 2012;259(Suppl 1):S111
65. Devonshire V, Feinstein A, Gillett A. Patients with cognitive impairment maintain good treatment adherence with RebiSmart. Int J MS Care 2012;14(Suppl 2):75