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Interferon beta in relapsing-remitting multiple sclerosis: an independent postmarketing study in southern Italy

Department of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy, mtrojano{at}neurol.uniba.it

Maria Liguori

Department of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy

Damiano Paolicelli

Department of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy

Giovanni Bosco Zimatore

Department of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy

Francesca De Robertis

Department of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy

Carlo Avolio

Department of Neurology, University of Foggia, Foggia, Italy

Fabrizio Giuliani

Department of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy

Aurora Fuiani

Department of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy

Paolo Livrea

Department of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy

Southern Italy MS Group

This independent, population-based surveillance study monitored the efficacy and safety of interferon beta (IFNb) products in 1033 patients with relapsing -remitting multiple sclerosis (RRMS) from 15 centres in Italy. Relapses, Expanded Disability Status Scale (EDSS) scores, and adverse events were evaluated for up to 24 months. Data of patients with a baseline EDSS score 5-3.5 are reported. The proportions of relapse-free patients were similar among the groups at 12 and 24 months (P =0.10). IFNb products produced significant reductio ns from baseline in relapse rates at 12 and 24 months (P B-0.001), with no differences among treatments (P =0.2). There were no significant differences in mean EDSS change among groups at 12 or 24 months. The IFNb-1b group showed a higher incidence of adverse events during the first year of treatment (P B-0.05) than IFNb-1a groups, and more withdrawals (10%) compared with Avonex (5%) at 24 months. IFNb products are equally effective in low disability RRMS, but IFNb-1a may have a more favorable efficacy/tolerability ratio.

Key Words: IFNß-1 • IFNb-1ß • interferon beta • multiple sclerosis • phase IV trial

Multiple Sclerosis, Vol. 9, No. 5, 451-457 (2003)
DOI: 10.1191/1352458503ms948oa


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