title: Comparing efficacy and side effects of a weekly intramuscular biogeneric/biosimilar interferon beta-1a with Avonex in relapsing remitting multiple sclerosis: a double blind randomized clinical trial.
abstract: OBJECTIVE
  We compared the efficacy and safety of two biosimilar forms of interferon beta-1a in the treatment of multiple sclerosis: Avonex (Biogen Idec, USA) and CinnoVex (CinnaGen, Iran).
  
  
  METHODS
  In a double blind randomized clinical trial study 84 patients with relapsing remitting multiple sclerosis (RRMS) with Expanded Disability Status Scale (EDSS) score of 0-5.5 were randomly allocated to two groups of 42 subjects.
  
  
  RESULTS
  Twenty-four patients lost to follow-up. Finally, 31 patients (mean±SD of age=33.7±7.0; 7 males and 24 females) in the Avonex and 29 patients (mean±SD of age=32.2±9.2; 8 males and 21 females) in the CinnoVex group completed full 24 months of study period. Decrease in EDSS was 1.05±0.24, p=0.62 in the Avonex and 0.16±0.88, p=1.0 in the CinnoVex group after 12 months and 0.27±1.05, p=0.46 in the Avonex and 0.16±1.06, p=1.0 in the CinnoVex group after 24 months. There was no statistically significant difference in attack number between two groups (1.0±1.2 in Avonex and 1.2±1.3 in CinnoVex; p=0.46). Volume of T2-weighted lesions on MRI showed a progressive significant increase in the 12th month (28056±23693) in Avonex treated patients compared with first image (16353±11172) (p=0.01). But number of gadolinium-enhancing lesions in CinnoVex showed statistically significant decrease after 12 months (0.08±0.28 vs. 1.00±1.22; p=0.03). However, there were no significant differences between groups after 24 months. There were no significant differences between 2 groups regarding frequency and duration of most considerable side effects, as well. Neutralizing antibodies were not positive in any patients.
  
  
  CONCLUSIONS
  CinnoVex can be used as a safe and effective alternative to Avonex in treatment of RRMS.
authors.affiliation: Department of Neurology, Tehran University of Medical Sciences, Shariati Hospital, Tehran, Iran. nafisi@sina.tums.ac.ir
authors.forename: Shahriar
authors.initials: S
authors.lastname: Nafissi
authors.forename: Amirreza
authors.initials: A
authors.lastname: Azimi
authors.forename: Ali
authors.initials: A
authors.lastname: Amini-Harandi
authors.forename: Shiva
authors.initials: S
authors.lastname: Salami
authors.forename: Mohammad Amir
authors.initials: MA
authors.lastname: shahkarami
authors.forename: Ramin
authors.initials: R
authors.lastname: Heshmat
mesh_terms: D000293:Adolescent; D000328:Adult; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007273:Injections, Intramuscular; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D012008:Recurrence; D055815:Young Adult
chemical_list: D016899:Interferon-beta; D000068556:Interferon beta-1a