title: Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study.
abstract: BACKGROUND
  In a multicentre, single-arm, observational, phase IV study, we evaluated 24-week treatment adherence of relapsing multiple sclerosis (RMS) patients using an electronic auto-injection device (RebiSmart(®)) for subcutaneous injection of interferon (IFN) β-1a.
  
  
  METHODS
  A total of 162 adult participants with RMS were enrolled into the study to use RebiSmart(®) to self-administer IFN β-1a 44 μg three times weekly for a maximum of 96 weeks. The number of administered injections was recorded in the electronic device log. Adherence to treatment was defined as the administration of ≥80% of expected injections. Cognitive impairment and injection anxiety were assessed via questionnaires.
  
  
  RESULTS
  Overall, 91.8 and 82.9% of participants were adherent to treatment at weeks 12 and 24, respectively. By weeks 12 and 24, 8.2 and 13.9% of participants had discontinued treatment. There were no statistically significant differences in adherence rates at weeks 12 and 24 according to cognitive impairment status or injection anxiety. By week 24, 69.9% of participants were less fearful of injection than when they started the study. According to participant evaluations, the absence of a visible needle, comfort settings, and the calendar for tracking the injection schedule were all important features of the RebiSmart(®) injection system. At week 24, 99.3% of participants reported that they would like to continue using RebiSmart(®) as their injector.
  
  
  CONCLUSIONS
  RebiSmart(®) use is associated with high treatment adherence, as objectively assessed using electronic injection logs. Future research should examine if RebiSmart(®) use improves long-term treatment outcomes in RMS. This study was registered with ClinicalTrials.gov as NCT01128075, on May 20, 2010.
authors.affiliation: Department of Neurology, University of British Columbia, Vancouver, Canada. vdev@shaw.ca.
authors.forename: Virginia A
authors.initials: VA
authors.lastname: Devonshire
authors.affiliation: Department of Psychiatry, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada. antfeinstein@aol.com.
authors.forename: Anthony
authors.initials: A
authors.lastname: Feinstein
authors.affiliation: A division of EMD Inc., EMD Serono, 2695 North Sheridan Way, Suite 200, Mississauga, ON, L5K 2N6, Canada. Patrick.moriarty@emdserono.com.
authors.forename: Patrick
authors.initials: P
authors.lastname: Moriarty
mesh_terms: D000328:Adult; D001007:Anxiety / Q000503:physiopathology / Q000523:psychology; D003072:Cognition Disorders / Q000503:physiopathology / Q000523:psychology; D004581:Electronics; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D007279:Injections, Subcutaneous; D000068556:Interferon beta-1a / Q000627:therapeutic use*; D008297:Male; D055118:Medication Adherence / Q000523:psychology*; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy / Q000276:immunology / Q000503:physiopathology / Q000523:psychology*; D012008:Recurrence; D012646:Self Administration / Q000295:instrumentation / Q000523:psychology*; D011795:Surveys and Questionnaires
chemical_list: D007155:Immunologic Factors; D000068556:Interferon beta-1a