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 Neurology

Volumn 10, Issue , 2010, Pages

  Devonshire, Virginia ^a   Arbizu, Txomin ^b   Borre, Björn ^c   Lang, Michael ^d   Lugaresi, Alessandra ^e   Singer, Barry ^f   Verdun di Cantogno, Elisabetta ^g   Cornelisse, Peter ^g  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^c Neurokliniken   (Sweden)

^d NeuroPoint Patient Academy and Neurological Practice   (Germany)

^e Ospedale Clinicizzato SS Annunziata   (Italy)

^f MISSOURI BAPTIST MEDICAL CENTER   (United States)

^g MERCK SERONO S A   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

BETA1A INTERFERON;

ADULT; ARTICLE; BILIARY COLIC; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOPENIA; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG SELF ADMINISTRATION; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEASIBILITY STUDY; FEMALE; FLU LIKE SYNDROME; HEADACHE; HEART INFARCTION; HUMAN; HYPERTENSIVE CRISIS; INFUSION SYSTEM; INJECTION SITE ERYTHEMA; INJECTION SITE IRRITATION; INJECTION SITE PAIN; INJECTION SITE REACTION; MAJOR CLINICAL STUDY; MALE; MASTITIS; MULTICENTER STUDY; MULTIPLE SCLEROSIS; PATIENT COMPLIANCE; PATIENT EDUCATION; PATIENT SATISFACTION; PHASE 3 CLINICAL TRIAL; PRURITUS; QUESTIONNAIRE; RASH; SELF INJECTION; SEROMA;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; AGED; ELECTRONICS; FEMALE; FOLLOW-UP STUDIES; HUMANS; INJECTIONS, SUBCUTANEOUS; INTERFERON-BETA; INTERNATIONAL COOPERATION; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; PATIENT SATISFACTION; QUESTIONNAIRES; SELF ADMINISTRATION; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77953652767     PISSN: None     EISSN: 14712377     Source Type: Journal    
DOI: 10.1186/1471-2377-10-28     Document Type: Article

References (19)

1. Compston A, Coles A. Multiple sclerosis. Lancet 2008, 372:1502-1517. 10.1016/S0140-6736(08)61620-7, 18970977.
2. 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. IFNB Multiple Sclerosis Study Group.
3. Jacobs LD, Cookfair DL, Rudick RA, Herndon RM, Richert JR, Salazar AM, Fischer JS, Goodkin DE, Granger CV, Simon JH, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol 1996, 39:285-294. 10.1002/ana.410390304, 8602746.
4. Johnson KP, Brooks BR, Cohen JA, Ford CC, Goldstein J, Lisak RP, Myers LW, Panitch HS, Rose JW, Schiffer RB, 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 1998, 352:1498-1504. 10.1016/S0140-6736(98)03334-0, 9820297, PRISMS Study Group.
6. Cox D, Stone J. Managing self-injection difficulties in patients with relapsing-remitting multiple sclerosis. J Neurosci Nurs 2006, 38:167-171. 10.1097/01376517-200606000-00005, 16817668.
7. Lugaresi A. Addressing the need for increased adherence to multiple sclerosis therapy: can delivery technology enhance patient motivation?. Exper Opin Drug Deliv 2009, 6:995-1002. 10.1517/17425240903134769, 16822225.
8. Mohr DC, Boudewyn AC, Likosky W, Levine E, Goodkin DE. 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. 10.1207/S15324796ABM2302_7, 11394554.
9. Tremlett HL, Oger J. Interrupted therapy: stopping and switching of the beta-interferons prescribed for MS. Neurology 2003, 61:551-554.
10. Treadaway K, Cutter G, Salter A, Lynch S, Simsarian J, Corboy J, Jeffery D, Cohen B, Mankowski K, Guarnaccia J, et al. Factors that influence adherence with disease-modifying therapy in MS. J Neurol 2009, 256:568-576. 10.1007/s00415-009-0096-y, 19444532.
11. 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 2008, 255(Suppl 2):S79.
12. Durelli L, Bongioanni MR, Ferrero B, Ferri R, Imperiale D, Bradac GB, Bergui M, Geuna M, Bergamini L, Bergamasco B. Interferon alpha-2a treatment of relapsing-remitting multiple sclerosis: disease activity resumes after stopping treatment. Neurology 1996, 47:123-129.
13. Cramer JA, Cuffel BJ, Divan V, Al-Sabbagh A, Glassman M. Patient satisfaction with an injection device for multiple sclerosis treatment. Acta Neurol Scand 2006, 113:156-162. 10.1111/j.1600-0404.2005.00568.x, 16441244.
14. Mikol D, Lopez-Bresnahan M, Taraskiewicz S, Chang P, Rangnow J. 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, 11:585-591. 10.1191/1352458505ms1197oa, 16193898.
15. Polman CH, Reingold SC, Edan G, Filippi M, Hartung HP, Kappos L, Lublin FD, Metz LM, McFarland HF, O'Connor P, et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria". Ann Neurol 2005, 58:840-846. 10.1002/ana.20703, 16283615.
16. Giovannoni G, Barbarash O, Casset-Semanaz F, King J, Metz L, Pardo G, Simsarian J, Sorensen P, Stubinski B. Safety and immunogenicity of a new formulation of interferon beta-1a (Rebif(R) New Formulation) in a phase IIIb study in patients with relapsing multiple sclerosis: 96-week results. Mult Scler 2009, 15:219-228. 10.1177/1352458508097299, 18755819.
17. Merck Serono Launches RebiSmart™, First Electronic Injection Device For Delivery of Multiple Sclerosis Treatment Rebif®. News release, June 24 2009 , http://www.merckserono.com/corp.merckserono/en/images/20090624_en_tcm112_42119.pdf
18. Meletiche D, Dickson M, Kozma C, Okuda DT, Fincher C, Bennett R, Al-Sabbagh A. Association between adherence with multiple sclerosis disease-modifying therapy and severe relapses using three measures of medication adherence. J Neurol 2008, 255(Suppl 2):P717.
19. Meletiche D, Kozma C, Bennett R, Al-Sabbagh A. Relationship between severe relapses and adherence to disease-modifying therapy in multiple sclerosis patients. J Neurol 2008, 255(Suppl 2):P826.