title: Multiple sclerosis patients treated with intramuscular IFN-β-1a autoinjector in a real-world setting: prospective evaluation of treatment persistence, adherence, quality of life and satisfaction.
abstract: OBJECTIVE
  The 12-month observational PERSIST study (NCT01405872) evaluated adherence associated with the intramuscular IFNβ-1a (i.m. IFN-β-1a) autoinjector pen in multiple sclerosis (MS) patients.
  
  
  METHODS
  MS patients initiating i.m. IFN-β-1a autoinjector treatment were prospectively assessed for physician-reported persistence (percentage of patients remaining on therapy) and patient-reported outcomes, including adherence (percentage of unmissed injections), compliance (percentage of patients missing no injections), tolerability (injection-site reactions [ISRs] and pain) and satisfaction.
  
  
  RESULTS
  The intent-to-treat population included 232 patients; of the 188 physician-reported 12-month completers, 182 patients remained on treatment (96.8% persistence). Monthly compliance rates were 87.5 - 96.2%. Mean monthly pain scores were 1.5 - 1.8 (scale: 0 = 'no pain'; 10 = 'extremely painful'). At 12 months, 73.5% of respondents reported no ISRs, 94.9% were satisfied/very satisfied with the autoinjector and 88.2% found using the device easy/very easy. Injection fear, injection anxiety and need for injection assistance by caregivers decreased from the initial visit to 12 months. No new safety signals were observed.
  
  
  CONCLUSIONS
  The autoinjector pen is associated with high levels of persistence, compliance, adherence, and satisfaction, little-to-no pain and low need for caregiver assistance. Although these data are limited by reliance on patient questionnaires and the absence of a direct comparator group, this treatment may reduce barriers to injection therapy, while supporting long-term MS management.
authors.affiliation: Orbis Medisch Centrum, Maastricht University Medical Center , Postbus 5500, 6130 MB Sittard , The Netherlands +088 4597811 ; +088 4597984 ; r.hupperts@orbisconcern.nl.
authors.forename: Raymond
authors.initials: R
authors.lastname: Hupperts
authors.forename: Veit
authors.initials: V
authors.lastname: Becker
authors.forename: Janne
authors.initials: J
authors.lastname: Friedrich
authors.forename: Claudio
authors.initials: C
authors.lastname: Gobbi
authors.forename: Antonio Vasco
authors.initials: AV
authors.lastname: Salgado
authors.forename: Bjørn
authors.initials: B
authors.lastname: Sperling
authors.forename: Xiaojun
authors.initials: X
authors.lastname: You
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular / Q000295:instrumentation; D016899:Interferon-beta / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy*; D010549:Personal Satisfaction; D011446:Prospective Studies; D011788:Quality of Life; D012646:Self Administration / Q000295:instrumentation; D011795:Surveys and Questionnaires; D016903:Drug Monitoring
chemical_list: D000276:Adjuvants, Immunologic; D016899:Interferon-beta
keywords: IFN-β-1a; Phase IV; clinical trial; medication adherence; multiple sclerosis; self-administration