TY - JOUR
T1 - Single-use autoinjector for peginterferon-β1a treatment of relapsing-remitting multiple sclerosis
T2 - Safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study
AU - Seddighzadeh, Ali
AU - Hung, Serena
AU - Selmaj, Krzysztof
AU - Cui, Yue
AU - Liu, Shifang
AU - Sperling, Bjoern
AU - Calabresi, Peter A.
N1 - Funding Information:
This study was sponsored by Biogen Idec, Inc. (Cambridge, MA, USA). P Calabresi has received grant support from Biogen Idec, Inc., and Novartis; A Seddighzadeh, S Hung, Y Cui, S Liu and B Sperling are employees of Biogen Idec, Inc; K Selmaj has no conflicts of interest. The authors were assisted in the preparation of the manuscript by Shelley Davies PhD, a professional medical writer contracted to CircleScience (Tytherington, UK). Writing support was funded by Biogen Indec, Inc.
Publisher Copyright:
© 2014 Informa UK, Ltd.
PY - 2014/11/1
Y1 - 2014/11/1
N2 - Objectives: A sub-study to evaluate safety, tolerability, ease-of-use and patient satisfaction with a single-use autoinjector administering subcutaneous peginterferon-β1a (a pegylated interferon-β1a 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-β1a 125g 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-β1a 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-β1a 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.
AB - Objectives: A sub-study to evaluate safety, tolerability, ease-of-use and patient satisfaction with a single-use autoinjector administering subcutaneous peginterferon-β1a (a pegylated interferon-β1a 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-β1a 125g 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-β1a 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-β1a 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.
KW - Dosing frequency
KW - Drug delivery system
KW - IFN-β1a
KW - Multiple sclerosis
KW - Patient outcomes assessments
KW - Peginterferon
KW - Pegylation
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U2 - 10.1517/17425247.2014.944159
DO - 10.1517/17425247.2014.944159
M3 - Article
C2 - 25073663
AN - SCOPUS:84911498695
VL - 11
SP - 1713
EP - 1720
JO - Expert Opinion on Drug Delivery
JF - Expert Opinion on Drug Delivery
SN - 1742-5247
IS - 11
ER -