Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 15-25 |
| Number of pages | 11 |
| Journal | Expert Opinion on Drug Delivery |
| Volume | 12 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Jan 2015 |
Keywords
- clinical trial
- IFN-beta-1a
- medication adherence
- multiple sclerosis
- Phase IV
- self-administration
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