Ease of use of two autoinjectors in patients with multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: results of the randomized, crossover REDEFINE study

被引:7
作者
Wray, Sibyl [1 ]
Hayward, Brooke [2 ]
Dangond, Fernando [2 ]
Singer, Barry [3 ]
机构
[1] Hope Neurol Multiple Sclerosis Ctr, 501 20th St 505, Knoxville, TN 37922 USA
[2] EMD Serono Inc, Billerica, MA USA
[3] Missouri Baptist Med Ctr, MS Ctr Innovat Care, St Louis, MO USA
关键词
Drug delivery systems; interferon beta-1a; multiple sclerosis; neurology; patient preference; subcutaneous injections; SINGLE-USE AUTOINJECTOR; QUALITY-OF-LIFE; SELF-INJECTION; ELECTRONIC DEVICE; PHASE IIIB; OPEN-LABEL; SATISFACTION; ADHERENCE; TOLERABILITY; MULTICENTER;
D O I
10.1080/17425247.2018.1407755
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Background: For interferon beta-1a subcutaneously three times weekly (IFN beta-1a SC tiw), administration options include manually injected prefilled syringes; a preassembled, single-use autoinjector; and a reusable autoinjector. This study evaluated patient-perceived ease of use of two injection devices. Research design and methods: REDEFINE, a Phase IV, multicenter crossover study, randomized patients with multiple sclerosis and 5 weeks' IFN beta-1a 44 g SC tiw use to 4 weeks using a single-use autoinjector, then 4 weeks using a reusable autoinjector, or vice versa. The primary endpoint was the proportion rating each 'easy' or 'very easy', with/without regard to previous device experience. Results: Of 97 randomized patients, 29 had most recent experience with manual injection; 23 with single-use autoinjector; and 45 with reusable autoinjector. 68.4% found using the single-use autoinjector very easy or easy, versus 77.9% for the reusable device (difference -9.5%; p = 0.200). 40.0% versus 29.5% found the respective devices very easy (difference 10.5%; p = 0.203). Conclusions: Most patients found both autoinjectors easy or very easy to use. Having two viable options may help accommodate patient preferences. Ease of administration and patient satisfaction relates to adherence; satisfied patients may more likely be adherent.
引用
收藏
页码:127 / 135
页数:9
相关论文
共 22 条
[1]   Adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational SMART study [J].
Bayas, Antonios ;
Ouallet, Jean Christophe ;
Kallmann, Boris ;
Hupperts, Raymond ;
Fulda, Ulrich ;
Marhardt, Kurt .
EXPERT OPINION ON DRUG DELIVERY, 2015, 12 (08) :1239-1250
[2]   ExtaviJect (R) 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study [J].
Boeru, Gabriel ;
Milanov, Ivan ;
De Robertis, Francesca ;
Kozubski, Wojciech ;
Lang, Michael ;
Rojas-Farreras, Sonia ;
Tomlinson, Mark .
MEDICAL DEVICES-EVIDENCE AND RESEARCH, 2013, 6 (01) :175-184
[3]   Reduction of injection site reactions in multiple sclerosis (MS) patients newly started on interferon beta 1b therapy with two different devices. [J].
Brochet, B. ;
Lemaire, G. ;
Beddiaf, A. .
REVUE NEUROLOGIQUE, 2006, 162 (6-7) :735-740
[4]   Patient satisfaction with an injection device for multiple sclerosis treatment [J].
Cramer, JA ;
Cuffel, BJ ;
Divan, V ;
Al-Sabbagh, A ;
Glassman, M .
ACTA NEUROLOGICA SCANDINAVICA, 2006, 113 (03) :156-162
[5]   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 [J].
D'Arcy, Caroline ;
Thomas, Del ;
Stoneman, Dee ;
Parkes, Laura .
PATIENT PREFERENCE AND ADHERENCE, 2012, 6 :55-61
[6]   Assessment of new application system in Portuguese patients with relapsing-remitting multiple sclerosis [J].
de Sa, J. ;
Urbano, G. ;
Reis, L. .
CURRENT MEDICAL RESEARCH AND OPINION, 2010, 26 (09) :2237-2242
[7]   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 [J].
Devonshire, Virginia ;
Arbizu, Txomin ;
Borre, Bjorn ;
Lang, Michael ;
Lugaresi, Alessandra ;
Singer, Barry ;
di Cantogno, Elisabetta Verdun ;
Cornelisse, Peter .
BMC NEUROLOGY, 2010, 10
[8]   Multiple sclerosis patients treated with intramuscular IFN-β-1a autoinjector in a real-world setting: prospective evaluation of treatment persistence, adherence, quality of life and satisfaction [J].
Hupperts, Raymond ;
Becker, Veit ;
Friedrich, Janne ;
Gobbi, Claudio ;
Salgado, Antonio Vasco ;
Sperling, Bjorn ;
You, Xiaojun .
EXPERT OPINION ON DRUG DELIVERY, 2015, 12 (01) :15-25
[9]  
Lugaresi A, 2008, CLIN NEUROPHARMACOL, V31, P167, DOI [10.1097/wnf.0b013e3181571a8e, 10.1097/WNF.0b013e3181571a8e]
[10]   Long-term adherence of patients with relapsing-remitting multiple sclerosis to subcutaneous self-injections of interferon β-1a using an electronic device: the RIVER study [J].
Lugaresi, Alessandra ;
De Robertis, Francesca ;
Clerico, Marinella ;
Morra, Vincenzo Brescia ;
Centonze, Diego ;
Borghesan, Stefano ;
Maniscalco, Giorgia Teresa .
EXPERT OPINION ON DRUG DELIVERY, 2016, 13 (07) :931-935