Review of subcutaneous interferon β-1a, delivered via the electronic self-injection device RebiSmart™, for the treatment of multiple sclerosis

Therapeutic Delivery

Volumn 2, Issue 11, 2011, Pages 1455-1465

  Devonshire, Virginia A ^a   Verdun Di Cantogno, Elisabetta ^b  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b MERCK SERONO S A   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

BETA1A INTERFERON; GLATIRAMER; INTERFERON BETA SERINE;

CLINICAL EFFECTIVENESS; DOSE CALCULATION; DOSE RESPONSE; DRUG EFFECT; DRUG SAFETY; DRUG STORAGE; DRUG TOLERABILITY; ELECTRONICS; EQUIPMENT DESIGN; FLU LIKE SYNDROME; HUMAN; INJECTION SITE CONTUSION; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE REACTION; INJECTION SITE SWELLING; MICROINJECTOR; MULTIPLE SCLEROSIS; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PATIENT SATISFACTION; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; REVIEW; TREATMENT DURATION;

EID: 80054929771     PISSN: 20415990     EISSN: 20416008     Source Type: Journal    
DOI: 10.4155/tde.11.116     Document Type: Review

References (52)

1. Compston A, Coles A. Multiple sclerosis. Lancet 372(9648), 1502-1517 (2008).
2. Confavreux C, Vukusic S. Natural history of multiple sclerosis: a unifying concept. Brain 129(Pt 3), 606-616 (2006).
3. IFNB Multiple Sclerosis Study Group. Interferon β-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 43(4), 655-661 (1993).
4. Jacobs LD, Cookfair DL, Rudick RA et al. Intramuscular interferon β-1a for disease progression in relapsing multiple sclerosis. Ann. Neurol. 39(3), 285-294 (1996).
5. Johnson KP, Brooks BR, Cohen JA et al. Copolymer 1 reduces relapse rate and improves disability in relapsing- remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. Neurology 45(7), 1268-1276 (1995).
6. Cohen BA, Rivera VM. PRISMS: the story of a pivotal clinical trial series in multiple sclerosis. Curr. Med. Res. Opin. 26(4), 827-838 (2010).
7. Tintoré M. Early MS treatment. Int. MS J. 14(1), 5-10 (2007).
8. Al-Sabbagh A, Bennet R, Kozma C, Dickson M, Meletiche D. 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. 255(Suppl. 2), S79 (2008).
9. Rivera V, Jeffery D. Continuous versus non-continuous long-term, subcutaneous, interferon β-1a treatment in relapsing-remitting multiple sclerosis. Int. J. MS Care 11(Suppl. 2), S44 (2009).
10. 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. 18(1), 69-77 (2010). Identified the key factors involved in adherence to therapy for patients with multiple sclerosis (MS), including forgetfulness and injection-related issues.
11. 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 Pref. Adherence 5, 173-180 (2011).
12. Devonshire V, Arbizu T, Borre B et al. Patient-rated suitability of a novel electronic device for self-injection of subcutaneous interferon β-1a in relapsing multiple sclerosis: an international, single-arm, multicentre, Phase IIIb study. BMC Neurol. 10(1), 28 (2010). Survey of patient opinions on the RebiSmart™ device, suggesting that patients would find the RebiSmart device useful in their treatment.
13. Riñón A, Verdun E, Buch M, Holley D. Physician and patient perspectives in multiple sclerosis: results from the MS Choices survey. J. Neurol. 257(Suppl. 1), S75-S76 (2010).
14. Steinberg SC, Faris RJ, Chang CF, Chan A, Tankersley MA. Impact of adherence to interferons in the treatment of multiple sclerosis: a non-experimental, retrospective, cohort study. Clin. Drug Investig. 30(2), 89-100 (2010). 3-year study of the effect of treatment adherence on MS relapses, hospital admissions and emergency department visits. Poor adherence significantly increased relapse rates and increased healthcare utilization.
15. Cuche M, Nilsson M, Chowdhury CA, Lukasik KD, Castaneda E. Impact of multiple sclerosis disease-modifying drugs on healthcare costs: application to the Swedish health system. Mult. Scler. 16(Suppl. 10), S72 (2010).
16. Andrade SE, Kahler KH, Frech F, Chan KA. Methods for evaluation of medication adherence and persistence using automated databases. Pharmacoepidemiol. Drug Saf. 15(8), 565-574 (2006).
17. Freedman MS, Patry DG, Grand'Maison F, Myles ML, Paty DW, Selchen DH. Treatment optimization in multiple sclerosis. Can. J. Neurol. Sci. 31(2), 157-168 (2004).
18. Treadaway K, Cutter G, Salter A et al. Factors that influence adherence with disease-modifying therapy in MS. J. Neurol. 256(4), 568-576 (2009). Alternative study examining the factors involved in adherence to treatment in MS.
19. Tremlett HL, Oger J. Interrupted therapy: stopping and switching of the β-interferons prescribed for MS. Neurology 61(4), 551-554 (2003). Explores the rates of and reasons for treatment discontinuation and switching to other MS therapies from the first prescribed MS treatment.
20. Cramer JA, Cuffel BJ, Divan V, Al-Sabbagh A, Glassman M. Patient satisfaction with an injection device for multiple sclerosis treatment. Acta Neurol. Scand. 113(3), 156-162 (2006).
21. Lugaresi A. Addressing the need for increased adherence to multiple sclerosis therapy: can delivery technology enhance patient motivation? Expert Opin. Drug Deliv. 6, 995-1002 (2009).
22. Girouard N, Theoret G. Management strategies for improving the tolerability of interferons in the treatment of multiple sclerosis. Can. J. Neurosci. Nurs. 30(4), 18-25 (2008).
23. Dahlgren J. Easypod: a new electronic injection device for growth hormone. Expert Rev. Med. Devices 5(3), 297-304 (2008).
24. Cohen BA. Adherence to disease-modifying therapy for multiple sclerosis. Int. J. MS Care (Suppl.), 32-37 (2006).
25. Osterberg L, Blaschke T. Adherence to medication. N. Engl. J. Med. 353(5), 487-497 (2005).
26. Kaur P, Bennett JL. Optic neuritis and the neuro-ophthalmology of multiple sclerosis. Int. Rev. Neurobiol. 79, 633-663 (2007).
27. McKeage K, Wagstaff AJ. Subcutaneous interferon-β-1a: new formulation. CNS Drugs 21(10), 871-876 (2007).
28. Jaber A, Bozzato GB, Vedrine L, Prais WA, Berube J, Laurent PE. A novel needle for subcutaneous injection of interferon β-1a: effect on pain in volunteers and satisfaction in patients with multiple sclerosis. BMC Neurol. 8, 38 (2008). Demonstrates that thinner needles reduce pain compared with thicker needles for subcutaneous injection. The reduced pain was expected to improve treatment compliance.
29. Verdun E, Devonshire V, Cornelisse P, The RebiSmart™ User Trial Study Group. Characterizing the factors affecting treatment experience of patients with relapsing-remitting multiple sclerosis using an electronic auto-injection device for subcutaneous interferon β-1a. Eur. J. Neurol. 17(Suppl. 3), 501-501 (2010).
30. Lugaresi A, Bellantonio B, Brescia-Morra V. BRIDGE: a 12-week, multicentre, open-label, single-arm, Phase IV study of the effect of a new electronic autoinjection device on adherence to subcutaneous interferon β-1a treatment for relapsing-remitting multiple sclerosis. Presented at: XLI Congress of the Italian Society of Neurology. Catania, Italy, 23-27 October 2010.
31. Baldinetti F, Ghazi-Visser L. Assessment of adherence to subcutaneous interferon β-1a treatment in clinical practice among patients with relapsing multiple sclerosis using an electronic self-injection device. Eur. J. Neurol. 17(Suppl. 3), 232-232 (2010).
32. Devonshire V, Feinstein A, Moriarty P. MEASURE: a Multicentre, single-arm, observational, 96-week, Phase IV study to evaluate treatment adherence when using RebiSmart™ for Self-injection of Rebif® in mUlti-dose cartridges in subjects with Relapsing multiplE sclerosis. J. Neurol. Sci. 285(Suppl. 1), S203 (2009).
33. Chen CC, Kasven N, Karpatkin HI, Sylvester A. Hand strength and perceived manual ability among patients with multiple sclerosis. Arch. Phys. Med. Rehabil. 88(6), 794-797 (2007).
34. Brandes DW, Callender T, Lathi E, O'Leary S. A review of disease-modifying therapies for MS: maximizing adherence and minimizing adverse events. Curr. Med. Res. Opin. 25(1), 77-92 (2009).
35. Cohen BA, Rieckmann P. Emerging oral therapies for multiple sclerosis. Int. J. Clin. Pract. 61(11), 1922-1930 (2007).
36. O'Rourke KE, Hutchinson M. Stopping β-interferon therapy in multiple sclerosis: an analysis of stopping patterns. Mult. Scler. 11(1), 46-50 (2005). Examines how frequently and at what point in the course of interferon-β treatment that patients discontinued therapy. The study also examined if the disease type at treatment initiation influenced the discontinuation rate.
37. National Multiple Sclerosis Society. Who gets MS? www.nationalmssociety. org/about-multiple-sclerosis/what-we-know-about-ms/who-gets-ms/index.aspx (Accessed 18 March 2010)
38. WHO. Adherence to long-term therapies: evidence for action. www.who.int/chp/knowledge/publications/adherence-report/en/index.html (Accessed 17 February 2011)
39. Merck Serono. Merck Serono launches RebiSmart™, first electronic injection device for delivery of multiple sclerosis treatment Rebif®. http://blog.taragana.com/pr/merck-serono-launches-rebismart™-first- electronic-injection-device-for-delivery-of-multiple-sclerosis-treatment-rebifr- 3480 (Accessed 2 March 2011)
40. Merck Serono. European Union recommends approval of multiple sclerosis treatment Rebif.www.huliq.com/25792/european-union-recommends-approval-of- multiple-sclerosis-treatment-rebif (Accessed 2 March 2011)
41. European Medicines Agency. Rebif: procedural steps taken and scientific information after the authorisation. www.ema.europa.eu/docs/en-GB/document- library/EPAR---Procedural-steps-taken-and-scientific-information-after- authorisation/human/000136/WC500048684.pdf (Accessed 2 March 2011) 106 iMed. www.imed.org (Accessed 2 March 2011)
42. Merck Serono S.A. RebiSmart™. www.rebismart.com/en/index.html (Accessed 2 March 2011)
43. EMD Serono. Rebiject II®. www.rebif.com/pages/starting-rebif/ rebiject-ii (Accessed 2 March 2011)
44. Merck Serono S.A. RebiDose™. www.merckserono.net/en/products/ neurodegenerative-diseases/multiple-sclerosis/rebif/rebidose.html (Accessed 2 March 2011)
45. Bayer Healthcare. Injecting Betaferon® with the Betaject® Lite. www.ms-gateway.com/betaferonreg-user-guide/injecting-betaferonreg-with-the- betajectreg-lite-160.htm (Accessed 2 March 2011)
46. Bayer Healthcare. Injecting Betaferon® with the Betaject® Comfort. www.ms-gateway.com/betaferonreg-user-guide/injecting-betaferonreg-with- the-bjectreg-comfort-159.htm (Accessed 2 March 2011)
47. Novartis Pharmaceuticals. EXTAVIA®: interferon β-1b for sc injection. www.extavia.com/index.jsp (Accessed 2 March 2011)
48. Biogen Idec. AVOJECT IM®. www.biogenidec.fr/avo/avoject.php (Accessed 2 March 2011)
49. Union Medico. AVOJECT IM®. www.avoject.com (Accessed 2 March 2011)
50. Union Medico. Personal Injector™. www.personalinjector.com (Accessed 2 March 2011)
51. Owen Mumford. Autoject® 2. www.owenmumford.com/om-drugdelivery/ Autoject2.htm (Accessed 2 March 2011)
52. Teva Neuroscience. What is the Autoject® 2 for glass syringe? www.copaxone.com/faq/copaxfaqs.aspx#wit (Accessed 2 March 2011)