Controlled clinical trials demonstrated the efficacy of Interferon beta (IFN-β) in reducing the number of relapses and new lesions seen on magnetic resonance imaging (MRI), and in delaying the progression of disability in patients with relapsing-remitting multiple sclerosis (RRMS). Subjects and methods. Standardized clinical and laboratory data on 1727 MS patients who received IFN-β (792 on Avonex, 588 on Betaferon, and 347 on Rebif) were collected from 16 MS centers in southern Italy. The frequency of clinical and hematological side effects, the clinical efficacy (relapse rate and EDSS changes) and the number and causes of drop-outs, for each trimester of treatment, were evaluated and compared in two subgroups who completed a treatment period of two years (244 with Betaferon and 134 with Avonex) (Fisher exact, Mann-Whitney, Friedmann and Dunn's post-hoc tests). Results. In the first trimester of treatment, a significantly higher frequency (p < 0.05) of both clinical (local reaction, fever) and hematological (leukopenia, anemia, bilirubinemia) side effects occurred in the Betaferon compared to the Avonex group. In both groups, the frequency of adverse events gradually decreased after the first trimester (p < 0.005). The baseline relapse rate significantly decreased during the first and second years of treatment in both groups (p < 0.001 ), but the baseline EDSS did not change during treatment in the Avonex group, whereas it tended to increase in the second year of treatment in patients receiving Betaferon (p < 0.005). The age of the patient at which IFN was started, the pretreatment duration of disease and the relapse-rate correlated significantly (/; < 0.01) with the changes in EDSS and relapse rate. Conclusion. The results confirm that IFN-β is well tolerated and effective in RRMS. The age at initiation of IFN therapy, the pre-treatment disease duration and relapse rate seem to influence the clinical response to treatment. © Springer-Verlag 2001.
Post-marketing surveillance of interferon beta treatment in relapsing-remitting multiple sclerosis in southern italy
Liguori M.;
2001
Abstract
Controlled clinical trials demonstrated the efficacy of Interferon beta (IFN-β) in reducing the number of relapses and new lesions seen on magnetic resonance imaging (MRI), and in delaying the progression of disability in patients with relapsing-remitting multiple sclerosis (RRMS). Subjects and methods. Standardized clinical and laboratory data on 1727 MS patients who received IFN-β (792 on Avonex, 588 on Betaferon, and 347 on Rebif) were collected from 16 MS centers in southern Italy. The frequency of clinical and hematological side effects, the clinical efficacy (relapse rate and EDSS changes) and the number and causes of drop-outs, for each trimester of treatment, were evaluated and compared in two subgroups who completed a treatment period of two years (244 with Betaferon and 134 with Avonex) (Fisher exact, Mann-Whitney, Friedmann and Dunn's post-hoc tests). Results. In the first trimester of treatment, a significantly higher frequency (p < 0.05) of both clinical (local reaction, fever) and hematological (leukopenia, anemia, bilirubinemia) side effects occurred in the Betaferon compared to the Avonex group. In both groups, the frequency of adverse events gradually decreased after the first trimester (p < 0.005). The baseline relapse rate significantly decreased during the first and second years of treatment in both groups (p < 0.001 ), but the baseline EDSS did not change during treatment in the Avonex group, whereas it tended to increase in the second year of treatment in patients receiving Betaferon (p < 0.005). The age of the patient at which IFN was started, the pretreatment duration of disease and the relapse-rate correlated significantly (/; < 0.01) with the changes in EDSS and relapse rate. Conclusion. The results confirm that IFN-β is well tolerated and effective in RRMS. The age at initiation of IFN therapy, the pre-treatment disease duration and relapse rate seem to influence the clinical response to treatment. © Springer-Verlag 2001.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
