title: An open-label, multicenter study to evaluate the safe and effective use of the single-use autoinjector with an Avonex® prefilled syringe in multiple sclerosis subjects.
abstract: BACKGROUND
  The ability to self-inject in patients with multiple sclerosis (MS) has been associated with a reduced risk of missed injections and drug discontinuation, and a beneficial effect on patients' independence. However, injection anxiety, needle phobia and disease-related disability are major barriers to a patient's ability to self-administer treatment. Use of an autoinjector may improve patients' ability to self-inject. This study evaluated the safe and effective use of Avonex Pen™ (prefilled pen), a single use autoinjector, for intramuscular delivery of interferon beta-1a (IM IFNβ-1a, Avonex) in MS patients.
  
  
  METHODS
  This was a Phase IIIb, open-label, single-country, multicenter trial in MS patients currently using IM IFNβ-1a prefilled syringes. Patients received weekly 30 mcg IM IFNβ-1a treatment over 4 weeks. On Day 1, patients self-administered IM IFNβ-1a using a prefilled syringe at the clinic. On Day 8, patients received training on the prefilled pen and self-administered IM IFNβ-1a using the device. On Day 15, patients self-administered IM IFNβ-1a at home using the prefilled pen. A final injection occurred at the clinic on Day 22 when patients self-administered IM IFNβ-1a using the prefilled pen while clinic staff observed and completed a detailed questionnaire documenting patients' ability to self-inject with the device. Serum neopterin levels were evaluated pre and post-injection on Days 1 and 8. Adverse events were monitored throughout.
  
  
  RESULTS
  Seventy-one (96%) patients completed the study. The overall success rate in safely and effectively using the prefilled pen was 89%. No device malfunctions occurred. One unsuccessful administration occurred at Day 22 due to patient error; no patient injury resulted. Patients gave the prefilled pen high ratings (8.7-9.3) on a 10-point scale for ease of use (0 = extremely difficult, 10 = extremely easy). Ninety-four percent of patients preferred the prefilled pen over the prefilled syringe. Induction of serum neopterin levels, serving as a biomarker for type 1 interferon action, was similar to that of the prefilled syringe. The prefilled pen demonstrated a safety profile comparable to the prefilled syringe.
  
  
  CONCLUSIONS
  The prefilled pen is a safe and effective device for administration of IM IFNβ-1a and represents an alternative method for self-injection for MS patients using this therapy.
  
  
  BACKGROUND
  This study is registered at clinicaltrials.gov, identifier: NCT00828204.
authors: Texas Neurology, 6301 Gaston Ave, West Tower, #100, Dallas, Texas, USA.
authors: J Theodore
authors: JT
authors: Phillips
authors: Edward
authors: E
authors: Fox
authors: William
authors: W
authors: Grainger
authors: Dianne
authors: D
authors: Tuccillo
authors: Shifang
authors: S
authors: Liu
authors: Aaron
authors: A
authors: Deykin
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D054316:Biomarkers, Pharmacological / Q000097:blood; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular / Q000295:instrumentation* / Q000523:psychology*; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000097:blood / Q000188:drug therapy* / Q000523:psychology*; D019798:Neopterin / Q000097:blood; D010342:Patient Acceptance of Health Care / Q000523:psychology / Q000706:statistics & numerical data; D057240:Patient Preference / Q000706:statistics & numerical data; D012646:Self Administration / Q000379:methods / Q000523:psychology* / Q000706:statistics & numerical data; D013594:Syringes
chemical_list: D000276:Adjuvants, Immunologic; D054316:Biomarkers, Pharmacological; D019798:Neopterin; D016899:Interferon-beta; D000068556:Interferon beta-1a