title: Adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational SMART study.
abstract: BACKGROUND
  Patients with multiple sclerosis who have poor adherence to treatment have a higher risk of relapse than adherent patients. This study assessed adherence to, and effectiveness and convenience of, treatment with subcutaneous (sc) interferon (IFN) β-1a (Rebif®, Merck Serono SA) 44 or 22 μg three times weekly in patients with relapsing multiple sclerosis (RMS) using the RebiSmart® electronic, multidose, autoinjector for 1 year.
  
  
  METHODS
  European, multicentre, observational study among neurologists: inclusion criteria included RMS, Expanded Disability Status Scale score ≤ 6, sc IFN β-1a administered by RebiSmart for ≤ 6 weeks. The primary endpoint was cumulative adherence recorded by RebiSmart.
  
  
  RESULTS
  The safety population included 912 patients, 77.4% (n = 823) of whom completed the Month-12 visit. Mean (± standard deviation) cumulative adherence was 97.1 ± 7.3% (n = 791). The most common reason for missed injection was 'forgot to inject' (37.0%). At Month 12/ED, 79.5% of patients were relapse-free. Of 353 patients who rated the convenience of the device, 68.3% found injecting 'very easy'. No unknown safety issues were detected.
  
  
  CONCLUSIONS
  Patients with RMS self-injecting sc IFN β-1a with RebiSmart had excellent adherence at Month 12/ED, which was associated with good clinical outcomes and no unexpected safety issues. Patients rated RebiSmart as convenient and easy to use.
authors.affiliation: Department of Neurology, Klinikum Augsburg , Stenglinstr 2, D-86156, Augsburg , Germany +49 821 400 3892 ; +49 821 400 2691 ; antonios.bayas@klinikum-augsburg.de.
authors.forename: Antonios
authors.initials: A
authors.lastname: Bayas
authors.forename: Jean Christophe
authors.initials: JC
authors.lastname: Ouallet
authors.forename: Boris
authors.initials: B
authors.lastname: Kallmann
authors.forename: Raymond
authors.initials: R
authors.lastname: Hupperts
authors.forename: Ulrich
authors.initials: U
authors.lastname: Fulda
authors.forename: Kurt
authors.initials: K
authors.lastname: Marhardt
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D000068556:Interferon beta-1a / Q000008:administration & dosage*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000068556:Interferon beta-1a
keywords: adherence; autoinjector; interferon β; multiple sclerosis