title: Long-term adherence of patients with relapsing-remitting multiple sclerosis to subcutaneous self-injections of interferon β-1a using an electronic device: the RIVER study.
abstract: The BRIDGE study has previously shown a high short-term (12 weeks) adherence rate (>85%) of patients with relapsing-remitting multiple sclerosis (RRMS) to subcutaneous self-injections of interferon β-1a using an electronic auto-injection device (RebiSmart®). The primary goal of the RIVER study was to investigate in a real-life setting the long-term adherence to the use of RebiSmart among patients enrolled in the parent BRIDGE study.
  
  
  
  The RIVER study was designed as a real-life extension study of the BRIDGE trial. RRMS patients who completed BRIDGE and still had an indication for treatment were included. Data were collected prospectively through the RebiSmart device, and analyzed retrospectively. Long term adherence (administration of ≥ 80% of injections) to and safety of RebiSmart were assessed. The expected follow-up period ranged from 19 to 26 months.
  
  
  
  A total of 57 RRMS patients participated in the follow-up study. The mean observation period was 20.5 ± 5.7 months. The overall adherence to the use of RebiSmart in the entire study cohort was 79.8% (median = 85.2%, range = 16-100%). There were 36 patients (63.2%) who completed at least 80% of the scheduled injections. No statistically significant differences were found between adherent and non-adherent patients in terms of age, sex, duration of the observation period, and occurrence of relapses. No serious treatment-related adverse events occurred.
  
  
  
  This study showed a high level of long-term adherence to the use of RebiSmart, with 63.2% of participants meeting the criterion for adherence to treatment.
authors.affiliation: a Department of Neuroscience, Imaging and Clinical Sciences , G. 'd'Annunzio University' - S.S. Annunziata Hospital , Chieti , Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Lugaresi
authors.affiliation: b Department of Neurology , AUSL 'Vito Fazzi' , Lecce , Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: De Robertis
authors.affiliation: c Division of Neurology, Department of Clinical and Biological Science , S. 'Luigi Gonzaga' Hospital, University of Turin , Orbassano , Italy.
authors.forename: Marinella
authors.initials: M
authors.lastname: Clerico
authors.affiliation: d Department of Neurological Science , 'Federico II' University , Naples , Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Brescia Morra
authors.affiliation: e Department of Neuroscience , Tor Vergata University, Rome & IRCCS Neuromed , Pozzilli , IS , Italy.
authors.forename: Diego
authors.initials: D
authors.lastname: Centonze
authors.affiliation: f Medical Affairs Department Merck Serono , Rome , Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Borghesan
authors.affiliation: g Neurology Clinic, Antonio Cardarelli Hospital , Naples , Italy.
authors.forename: Giorgia Teresa
authors.initials: GT
authors.lastname: Maniscalco
mesh_terms: D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D000068556:Interferon beta-1a / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D010349:Patient Compliance; D011446:Prospective Studies; D012189:Retrospective Studies
chemical_list: D000068556:Interferon beta-1a
keywords: Auto-injection device; drug delivery system; interferon β-1a; long-term adherence; multiple sclerosis; patient outcome assessments