title: Single-use autoinjector for peginterferon-β1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study.
abstract: OBJECTIVE
  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 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-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.
  
  
  CONCLUSIONS
  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.
authors: Biogen Idec, Inc. , 14 Cambridge Center, Cambridge, MA 02142 , USA +1 617 679 2383 ; ali.seddighzadeh@biogenidec.com.
authors: Ali
authors: A
authors: Seddighzadeh
authors: Serena
authors: S
authors: Hung
authors: Krzysztof
authors: K
authors: Selmaj
authors: Yue
authors: Y
authors: Cui
authors: Shifang
authors: S
authors: Liu
authors: Bjoern
authors: B
authors: Sperling
authors: Peter A
authors: PA
authors: Calabresi
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D016503:Drug Delivery Systems / Q000295:instrumentation*; D005260:Female; D006801:Humans; D007267:Injections / Q000295:instrumentation; D007279:Injections, Subcutaneous; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000523:psychology; D010147:Pain Measurement; D017060:Patient Satisfaction; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D012646:Self Administration; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D011092:Polyethylene Glycols; D016899:Interferon-beta; D000068556:Interferon beta-1a
keywords: IFN-β1a; dosing frequency; drug delivery system; multiple sclerosis; patient outcomes assessments; peginterferon; pegylation