title: Patient-rated ease of use and functional reliability of an electronic autoinjector for self-injection of subcutaneous interferon beta-1a for relapsing multiple sclerosis.
abstract: BACKGROUND
  For patients with multiple sclerosis (MS), electronic autoinjectors may improve convenience and reduce discomfort associated with chronic injections.
  
  
  OBJECTIVE
  To assess ease of use, patient satisfaction, and functional reliability of an investigational electronic autoinjector for self-injection of subcutaneous interferon beta-1a (IFNβ-1a).
  
  
  METHODS
  This prospective, multicenter, open-label, single-arm, 12-week, Phase IIIb study enrolled patients aged 18-65 years with relapsing MS receiving IFNβ-1a 44μg subcutaneously 3 times weekly for ≥12 weeks before enrollment. Thereafter, patients continued their regimen using an electronic autoinjector. The primary endpoint was the proportion of patients rating the autoinjector 'easy to use' or 'very easy to use' on a User Trial Questionnaire at week 12. Secondary endpoints included patient responses to questions regarding device reliability, patient satisfaction, and convenience.
  
  
  RESULTS
  Of 103 patients enrolled, 88 completed the study. The primary objective was met, with most patients (78%) indicating the device was 'easy to use' or 'very easy to use' at week 12 (worst-case imputation). In an analysis of secondary endpoints, over 60% of patients responded favorably to each of the User Trial questions regarding device ease-of-use and their satisfaction with the device. Overall convenience was judged the most important benefit of the device. Adverse events reported were consistent with the known safety profile of IFNβ-1a, with injection site reactions the most frequently reported.
  
  
  CONCLUSIONS
  These data show that patients found the electronic autoinjector for delivery of subcutaneous IFNβ-1a reliable and easy to use, suggesting the device may help patients with relapsing MS to administer self-injections.
authors: Missouri Baptist Medical Center, 3009N Ballas Rd., Suite 207B, St. Louis, MO 63131, USA. Electronic address: bnvsinger@earthlink.net.
authors: B
authors: B
authors: Singer
authors: Hope Neurology MS Center, 10800 Parkside Dr NW, Suite 202, Knoxville, TN 37934, USA. Electronic address: sewray@comcast.net.
authors: S
authors: S
authors: Wray
authors: Advanced Neurology of Colorado, LLC, 2121 East Harmony Road, Suite 180, Ft. Collins, CO 80528, USA. Electronic address: PMMiller1@aol.com.
authors: T
authors: T
authors: Miller
authors: Tampa Neurology Associates, South Tampa MS Center, 2919W. Swann Avenue, Suite 401, Tampa, FL 33609, USA. Electronic address: me@markcascione.com.
authors: M
authors: M
authors: Cascione
authors: Indiana University Medical School, Fort Wayne Neurological Center, 2622 Lake Avenue, Fort Wayne, IN 46805, USA. Electronic address: agupta@fwnc.com.
authors: A
authors: A
authors: Gupta
authors: OMRF Multiple Sclerosis Center of Excellence, Oklahoma Medical Research Foundation, 825N.E. 13th Street, Oklahoma City, OK 73104, USA. Electronic address: gabriel-pardo@omrf.org.
authors: G
authors: G
authors: Pardo
authors: Pfizer Inc, 445 Eastern Point Road, Groton, CT 06340, USA. Electronic address: eric.j.watsky@pfizer.com.
authors: E
authors: E
authors: Watsky
authors: EMD Serono, Inc., 1 Technology Pl, Rockland, MA 02370, USA. Electronic address: brooke.hayward@emdserono.com.
authors: B
authors: B
authors: Hayward
authors: EMD Serono, Inc., 1 Technology Pl, Rockland, MA 02370, USA. Electronic address: brian.mercer@emdserono.com.
authors: B
authors: B
authors: Mercer
authors: EMD Serono, Inc., 1 Technology Pl, Rockland, MA 02370, USA. Electronic address: Fernando.dangond@emdserono.com.
authors: F
authors: F
authors: Dangond
keywords: Beta interferon; Disease modifying therapies; Injection devices; Multiple sclerosis; Relapsing–remitting; Self-injection