Single-use autoinjector for peginterferon-β1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study. (November 2014)

• Record Type: Journal Article
• Authors: Seddighzadeh, Ali; Hung, Serena; Selmaj, Krzysztof; Cui, Yue; Liu, Shifang; Sperling, Bjoern; Calabresi, Peter A
• Is Part Of: Expert opinion on drug delivery. Volume 11:Number 11(2014:Nov.)
• Page Start: 1713
• Page End: 1720
• Publication Date: 2014-11
• Subjects: Drug delivery devices -- Periodicals; Drug delivery systems -- Periodicals; 615.605
• DOI: 10.1517/17425247.2014.944159
• Languages: English
• ISSNs: 1742-5247

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <p> <bold> <italic>Objectives:</italic> </bold> A sub-study to evaluate safety, tolerability, ease-of-use and patient satisfaction with a single-use autoinjector administering subcutaneous peginterferon-β<sub>1a</sub> (a pegylated interferon-β<sub>1a</sub> in clinical development) in a subset of relapsing-remitting multiple sclerosis (MS) patients participating in ATTAIN, a long-term dose-frequency blinded extension of the Phase III randomized ADVANCE study.</p> <p> <bold> <italic>Methods:</italic> </bold> Over 8 weeks, patients self-administered peginterferon-β<sub>1a</sub> 125 µg or placebo every 2 weeks (two injections via manual pre-filled syringe [PFS]; two injections via single-use autoinjector). Primary end points were incidence of adverse events (AEs), patient assessment of injection pain score (10-point Visual Analog Scale), and clinician assessment of injection site reactions (ISRs). Secondary objectives included patient assessment of ease-of-use and satisfaction with the autoinjector and evaluation of autoinjector training materials.</p> <p> <bold> <italic>Results:</italic> </bold> In 39 patients, the safety profile of peginterferon-β<sub>1a</sub> was similar when delivered via autoinjector or PFS; AEs were mostly mild or moderate in severity. Clinicians and patients reported a similar tolerability profile using both PFS and autoinjector, and pain scores were low (< 1), with no reports of clinician-assessed ISRs after administration with the autoinjector. Patients perceived the single-use autoinjector to be easy to use and convenient; overall patient satisfaction with the autoinjector and accompanying training materials was high.</p> <p> <bold> <italic>Conclusion:</italic> </bold> The safety and tolerability profile of peginterferon-β<sub>1a</sub> delivered via autoinjector was similar to delivery via PFS. Patients found the autoinjector easy to use and convenient; this device may simplify the injection process for MS patients who require long-term therapy, thereby potentially improving patient's quality of life and adherence.</p> </abstract>