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

被引:19
作者
Hupperts, Raymond [1 ]
Becker, Veit [2 ]
Friedrich, Janne [3 ]
Gobbi, Claudio [4 ]
Salgado, Antonio Vasco [5 ]
Sperling, Bjorn [6 ]
You, Xiaojun [6 ]
机构
[1] Maastricht Univ, Med Ctr, Orbis Med Ctr, NL-6130 MB Sittard, Netherlands
[2] Neurol Praxis Eppendorf, Hamburg, Germany
[3] Naestved Hosp, Naestved, Denmark
[4] Osped Reg Lugano, Neuroctr Southern Switzerland, Lugano, Switzerland
[5] Hosp Fernando Fonseca, Amadora, Portugal
[6] Biogen Idec Inc, Cambridge, MA USA
关键词
clinical trial; IFN-beta-1a; medication adherence; multiple sclerosis; Phase IV; self-administration; DISEASE-MODIFYING THERAPIES; SUBCUTANEOUS INTERFERON BETA-1A; INJECTION-SITE REACTIONS; SINGLE-USE AUTOINJECTOR; DOUBLE-BLIND; OPEN-LABEL; PHASE-3; TRIAL; MULTICENTER; MS; TOLERABILITY;
D O I
10.1517/17425247.2015.989209
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Objectives: The 12-month observational PERSIST study (NCT01405872) evaluated adherence associated with the intramuscular IFN beta-1a (i.m. IFN-beta-1a) autoinjector pen in multiple sclerosis (MS) patients. Methods: MS patients initiating i.m. IFN-beta-1a autoinjector treatment were prospectively assessed for physician-reported persistence (percentage of patients remaining on therapy) and patient-reported outcomes, including adherence (percentage of unmissed injections), compliance (percentage of patients missing no injections), tolerability (injection-site reactions [ISRs] and pain) and satisfaction. Results: The intent-to-treat population included 232 patients; of the 188 physician-reported 12-month completers, 182 patients remained on treatment (96.8% persistence). Monthly compliance rates were 87.5 - 96.2%. Mean monthly pain scores were 1.5 - 1.8 (scale: 0 = 'no pain'; 10 = 'extremely painful'). At 12 months, 73.5% of respondents reported no ISRs, 94.9% were satisfied/very satisfied with the autoinjector and 88.2% found using the device easy/very easy. Injection fear, injection anxiety and need for injection assistance by caregivers decreased from the initial visit to 12 months. No new safety signals were observed. Conclusions: The autoinjector pen is associated with high levels of persistence, compliance, adherence, and satisfaction, little-to-no pain and low need for caregiver assistance. Although these data are limited by reliance on patient questionnaires and the absence of a direct comparator group, this treatment may reduce barriers to injection therapy, while supporting long-term MS management.
引用
收藏
页码:15 / 25
页数:11
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