Patient assessment of an electronic device for subcutaneous self-injection of interferon β-1a for multiple sclerosis: An observational study in the UK and Ireland

Patient Preference and Adherence

Volumn 6, Issue , 2012, Pages 55-61

  D'Arcy, Caroline ^a   Thomas, Del ^b   Stoneman, Dee ^c   Parkes, Laura ^c  

^a CHARING CROSS HOSPITAL   (United Kingdom)

^b WYE VALLEY NHS TRUST   (United Kingdom)

^c Merck Serono Ltd   (United Kingdom)

Author keywords

Drug delivery; Injection device; Interferon beta 1a; Multiple sclerosis; Training

Indexed keywords

BETA1A INTERFERON;

ADULT; AGE DISTRIBUTION; AGED; ARTICLE; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; DRUG EFFICACY; EQUIPMENT DESIGN; HUMAN; IRELAND; MAJOR CLINICAL STUDY; MEDICAL DEVICE; MULTICENTER STUDY; MULTIPLE SCLEROSIS; OBSERVATIONAL STUDY; PATIENT ATTITUDE; PATIENT SATISFACTION; PHASE 4 CLINICAL TRIAL; PRESCRIPTION; QUESTIONNAIRE; SELF INJECTION; UNITED KINGDOM; VISUAL ANALOG SCALE;

EID: 84863395331     PISSN: None     EISSN: 1177889X     Source Type: Journal    
DOI: 10.2147/PPA.S26250     Document Type: Article

References (28)

1. Bennett JL, Stuve O. Update on inflammation, neurodegeneration, and immunoregulation in multiple sclerosis: therapeutic implications. Clin Neuropharmacol. 2009;32:121-132.
2. Lublin FD, Reingold SC. Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. Neurology. 1996;46:907-911.
3. Jacobs LD, Cookfair DL, Rudick RA, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol. 1996;39:285-294.
4. 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. 1995;45:1268-1276.
5. PRISMS Study Group. Randomised, double-blind, placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. Lancet Neurol. 1998;352:1498-1504.
6. The IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology. 1993;43:655-661.
7. Kappos L, Traboulsee A, Constantinescu C, et al. Long-term subcutaneous interferon beta-1a therapy in patients with relapsing-remitting MS. Neurology. 2006;67:944-953.
8. PRISMS Study Group, University of British Columbia MS/MRI Analysis Group. PRISMS-4: long-term efficacy of interferon-beta-1a in relapsing MS. Neurology. 2001;56:1628-1636.
9. Costello K, Kennedy P, Scanzillo J. Recognizing nonadherence in patients with multiple sclerosis and maintaining treatment adherence in the long term. Medscape J Med. 2008;10:225.
10. Cox D, Stone J. Managing self-injection difficulties in patients with relapsing-remitting multiple sclerosis. J Neurosci Nurs. 2006;38: 167-171.
11. 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;23:125-132.
12. Treadaway K, Cutter G, Salter A, et al. Factors that influence adherence with disease-modifying therapy in MS. J Neurol. 2009;256:568-576.
13. Tremlett HL, Oger J. Interrupted therapy: stopping and switching of the beta-interferons prescribed for MS. Neurology. 2003;61:551-554.
14. Al-Sabbagh A, Bennet R, Kozma C, et al. Medication gaps in diseasemodifying 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.
15. World Health Organization. Adherence to long-term therapies: evidence for action. Available from: http://www.who.int/chp/knowledge/publications/adherence_report/en/index.html. Accessed August 24, 2011.
16. 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.
17. Cramer JA, Cuffel BJ, Divan V, et al. Patient satisfaction with an injection device for multiple sclerosis treatment. Acta Neurol Scand. 2006;113:156-162.
18. 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 auto-injection or manual injection in relapsing-remitting multiple sclerosis. Mult Scler. 2005;11: 585-591.
19. 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.
20. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guideline for Good Clinical Practice E6(R1). Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1_Guideline.pdf. Accessed July 11, 2011.
21. The European Parliament and the Council of the European Union. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Available from: http://www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf. Accessed July 11, 2011.
22. World Medical Association. Declaration of Helsinki: Recommendations guiding physicians in biomedical research involving human subjects. 1996.
23. Association of British Neurologists. Revised (2009) Association of British Neurologists' guidelines for prescribing in multiple sclerosis. Available from: http://www.abn.org.uk/abn/userfiles/file/ABN_MS_Guidelines_2009_Final(1).pdf. Accessed July 21, 2011.
24. Polman CH, Reingold SC, Edan G, et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria". Ann Neurol. 2005; 58:840-846.
25. Exell S, Verdun E, Driebergen R. A new electronic device for subcutaneous injection of IFN beta-1a. Expert Rev Med Devices. 2011;8:543-553.
26. ®. News release, June 24, 2009. Available from: http://www.merckserono.com/corp.merckserono/en/images/20090624_en_tcm112_42119.pdf. Accessed July 11, 2011.
27. National Audit Office. Prescribing costs in primary care. Available from: http://www.nao.org.uk/publications/0607/prescribing_costs_in_primary_c.aspx. Accessed February 24, 2011.
28. Bruce JM, Hancock LM, Lynch SG. Objective adherence monitoring in multiple sclerosis: initial validation and association with self-report. Mult Scler. 2010;16:112-120.