PMID- 25073663
OWN - NLM
STAT- MEDLINE
DCOM- 20150219
LR  - 20181202
IS  - 1744-7593 (Electronic)
IS  - 1742-5247 (Linking)
VI  - 11
IP  - 11
DP  - 2014 Nov
TI  - Single-use autoinjector for peginterferon-beta1a treatment of relapsing-remitting 
      multiple sclerosis: safety, tolerability and patient evaluation data from the 
      Phase IIIb ATTAIN study.
PG  - 1713-20
LID - 10.1517/17425247.2014.944159 [doi]
AB  - OBJECTIVES: A sub-study to evaluate safety, tolerability, ease-of-use and patient 
      satisfaction with a single-use autoinjector administering subcutaneous 
      peginterferon-beta1a (a pegylated interferon-beta1a 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-beta1a 125 microg 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-beta1a 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-beta1a 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.
FAU - Seddighzadeh, Ali
AU  - Seddighzadeh A
AD  - Biogen Idec, Inc. , 14 Cambridge Center, Cambridge, MA 02142 , USA +1 617 679 
      2383 ; ali.seddighzadeh@biogenidec.com.
FAU - Hung, Serena
AU  - Hung S
FAU - Selmaj, Krzysztof
AU  - Selmaj K
FAU - Cui, Yue
AU  - Cui Y
FAU - Liu, Shifang
AU  - Liu S
FAU - Sperling, Bjoern
AU  - Sperling B
FAU - Calabresi, Peter A
AU  - Calabresi PA
LA  - eng
SI  - ClinicalTrials.gov/NCT01332019
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140729
PL  - England
TA  - Expert Opin Drug Deliv
JT  - Expert opinion on drug delivery
JID - 101228421
RN  - 0 (Adjuvants, Immunologic)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 77238-31-4 (Interferon-beta)
RN  - XRO4566Q4R (Interferon beta-1a)
SB  - IM
MH  - Adjuvants, Immunologic/*administration & dosage/adverse effects
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Double-Blind Method
MH  - Drug Delivery Systems/*instrumentation
MH  - Female
MH  - Humans
MH  - Injections/instrumentation
MH  - Injections, Subcutaneous
MH  - Interferon beta-1a
MH  - Interferon-beta/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis, Relapsing-Remitting/*drug therapy/psychology
MH  - Pain Measurement
MH  - Patient Satisfaction
MH  - Polyethylene Glycols/*administration & dosage/adverse effects
MH  - Quality of Life
MH  - Self Administration
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - IFN-beta1a
OT  - dosing frequency
OT  - drug delivery system
OT  - multiple sclerosis
OT  - patient outcomes assessments
OT  - peginterferon
OT  - pegylation
EDAT- 2014/07/31 06:00
MHDA- 2015/02/20 06:00
CRDT- 2014/07/31 06:00
PHST- 2014/07/31 06:00 [entrez]
PHST- 2014/07/31 06:00 [pubmed]
PHST- 2015/02/20 06:00 [medline]
AID - 10.1517/17425247.2014.944159 [doi]
PST - ppublish
SO  - Expert Opin Drug Deliv. 2014 Nov;11(11):1713-20. doi: 
      10.1517/17425247.2014.944159. Epub 2014 Jul 29.