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Natural interferon‐β treatment of relapsing—remitting and secondary‐progressive multiple sclerosis patients. A two‐year study
Author(s) -
Patti F.,
L'Episcopo M. R.,
Cataldi M. L.,
Reggio A.
Publication year - 1999
Publication title -
acta neurologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.967
H-Index - 95
eISSN - 1600-0404
pISSN - 0001-6314
DOI - 10.1111/j.1600-0404.1999.tb00397.x
Subject(s) - medicine , exacerbation , multiple sclerosis , placebo , interferon beta 1a , expanded disability status scale , randomized controlled trial , lesion , surgery , gastroenterology , immunology , pathology , interferon beta , alternative medicine
Objectives ‐ To evaluate clinical and MRI effects of natural interferon β treatment in both relapsing‐remitting (RR) and secondary‐progressive (SP) multiple sclerosis patients. Material and methods ‐ A double‐blind, randomized trial of natural interferon β (nIFN‐β) 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‐β 6 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‐β 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‐β is a promising and well‐tolerated treatment for either RR or SP MS patients.