title: Natural interferon-beta treatment of relapsing-remitting and secondary-progressive multiple sclerosis patients. A two-year study.
abstract: OBJECTIVE
  To evaluate clinical and MRI effects of natural interferon beta treatment in both relapsing-remitting (RR) and secondary-progressive (SP) multiple sclerosis patients.
  
  
  METHODS
  A double-blind, randomized trial of natural interferon beta (nIFN-beta) in 58 ambulatory patients with RR and 40 with SP multiple sclerosis. Forty-nine patients (29 RR and 20 SP) were treated with intramuscular nIFN-beta6 MIU three times a week for 24 months and 49 control patients were treated with placebo.
  
  
  RESULTS
  Primary clinical endpoints were differences in exacerbation rates and proportion of patients remaining exacerbation-free. There were no significant baseline differences between the treated and placebo groups. In the treated RR group a significant reduction in exacerbation rate, an increase in the probability of remaining exacerbation-free, and an improvement in mean EDSS were found at 24 months. MRI activity and total lesion burden were significantly reduced in treated RR patients. In the SP group, nIFN-beta produced a significant reduction in EDSS score, a significant reduction in active lesion number, a marginally significant favourable difference in total lesion burden but no significant effect on the number of gadolinium-enhancing lesions. Side effects were transient and mild in treated patients.
  
  
  CONCLUSIONS
  These observations confirm that nIFN-beta is a promising and well-tolerated treatment for either RR or SP MS patients.
authors.affiliation: Department of Neurological Sciences, MS Center, University of Catania, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Patti
authors.forename: M R
authors.initials: MR
authors.lastname: L'Episcopo
authors.forename: M L
authors.initials: ML
authors.lastname: Cataldi
authors.forename: A
authors.initials: A
authors.lastname: Reggio
mesh_terms: D000293:Adolescent; D000328:Adult; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016899:Interferon-beta / Q000494:pharmacology / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000473:pathology; D012008:Recurrence; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D016899:Interferon-beta