Single-use autoinjector for peginterferon-β_1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study

Abstract

Objectives: A sub-study to evaluate safety, tolerability, ease-of-use and patient satisfaction with a single-use autoinjector administering subcutaneous peginterferon-β_1a (a pegylated interferon-β_1a 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.

Methods: Over 8 weeks, patients self-administered peginterferon-β_1a 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.

Results: In 39 patients, the safety profile of peginterferon-β_1a 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.

Conclusion: The safety and tolerability profile of peginterferon-β_1a 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.

Keywords::

• dosing frequency
• drug delivery system
• IFN-β1a
• multiple sclerosis
• patient outcomes assessments
• peginterferon
• pegylation

Acknowledgments

Prior presentation: Data were previously presented in poster format at the 2013 meeting of the American Academy of Neurology (AAN; March 16 – 23, 2013, San Diego, CA, USA). We wish to thank the patients who volunteered for this study and the site staff members who help to conduct the study. We also acknowledge Eric Falkner for his work in the design of the autoinjector device. Sub-study co-investigators: Gregory Anderson, Kenneth Carnes, Samuel Hunter, Ivaylo Tarnev, Zahari Zahariev, Lyubomir Haralanov, Ivan Staikov, Tomasz Zielinski, Waldemar Brola, Zbigniew Cebulski, Wieslaw Drozdowski, Hanka Hertmanowska, Magdalena Kleczkowska. The authors had full editorial control of the manuscript and provided their final approval of all content. AS, SH, YC and SL contributed to the design of the study, data collection, data analysis and critical review of the manuscript. PAC and BS assisted with data analysis and critical review of the manuscript. KS was an Investigator on the sub-study and contributed to critical review of the manuscript. Trial registration: NCT01332019 (ATTAIN).

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