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. (January 2015)

• Record Type: Journal Article
• Authors: Hupperts, Raymond; Becker, Veit; Friedrich, Janne; Gobbi, Claudio; Salgado, Antonio Vasco; Sperling, Bjørn; You, Xiaojun
• Is Part Of: Expert opinion on drug delivery. Volume 12:Number 1(2015:Jan.)
• Page Start: 15
• Page End: 25
• Publication Date: 2015-01
• Subjects: Drug delivery devices -- Periodicals; Drug delivery systems -- Periodicals; 615.605
• DOI: 10.1517/17425247.2015.989209
• Languages: English
• ISSNs: 1742-5247

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <p> <bold> <italic>Objectives:</italic> </bold> The 12-month observational PERSIST study (NCT01405872) evaluated adherence associated with the intramuscular IFNβ-1a (i.m. IFN-β-1a) autoinjector pen in multiple sclerosis (MS) patients.</p> <p> <bold> <italic>Methods:</italic> </bold> MS patients initiating i.m. IFN-β-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.</p> <p> <bold> <italic>Results:</italic> </bold> 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.</p> <p> <bold> <italic>Conclusions:</italic> </bold> 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.</p> </abstract>