Natural interferon-beta treatment of relapsing-remitting and secondary-progressive multiple sclerosis patients. A two-year study.
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.
Patti
F
F
Department of Neurological Sciences, MS Center, University of Catania, Italy.
L'Episcopo
M R
MR
Cataldi
M L
ML
Reggio
A
A
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
D016899:Interferon-beta