OBJECTIVE: To compare clinical responses to once-weekly intramuscular interferon-beta-1 a [IFNbeta-1 a, Avonex, Biogen] in multiple sclerosis (MS) patients with baseline Expanded Disability Status Scale (EDSS) < or = 3.5 or > 3.5. METHODS:Patients with relapsing-remitting MS (RRMS), 124 with baseline EDSS < or = 3.5 and 64 RRMS patients with EDSS > 3.5, were consecutively recruited to receive IFNbeta-1 a 30 microg as a once weekly injection for 18 months. The primary endpoint of the study was the number of patients in each group with sustained worsening in disability, defined as 1-point deterioration in EDSS that persisted for at least 6 months during the 18 month follow-up period. Subordinate endpoints included relapse rates and the number of treatment dropouts. RESULTS: Among patients with baseline EDSS < or = 3.5,16.9% experienced a deterioration in EDSS of at least 1 point; 22.5% experienced a deterioration of at least 0.5%. Corresponding rates in patients with baseline EDSS > 3.5 were 23.4% and 29% respectively (no significant differences between patients stratified according to baseline EDSS status). The proportion of patients discontinuing therapy was significantly higher in patients with baseline EDSS > 3.5 than in those with baseline EDSS < or = 3.5 (16/64 versus 12/124; p = 0.005). At the conclusion of follow-up, IFNbeta-1 a therapy was associated with a 31.7% reduction in relapse rate in patients with baseline EDSS < or = 3.5 and a 37% reduction in those with baseline EDSS > 3.5 (difference not significant). CONCLUSIONS: During 18 months of treatment and follow-up, no difference was observed in clinical responses to IFNbeta-1 a between RRMS patients with mild and moderate disability but discontinuation of therapy was more frequent in the more disabled group.
RCT Entities:
OBJECTIVE: To compare clinical responses to once-weekly intramuscular interferon-beta-1 a [IFNbeta-1 a, Avonex, Biogen] in multiple sclerosis (MS) patients with baseline Expanded Disability Status Scale (EDSS) < or = 3.5 or > 3.5. METHODS:Patients with relapsing-remitting MS (RRMS), 124 with baseline EDSS < or = 3.5 and 64 RRMS patients with EDSS > 3.5, were consecutively recruited to receive IFNbeta-1 a 30 microg as a once weekly injection for 18 months. The primary endpoint of the study was the number of patients in each group with sustained worsening in disability, defined as 1-point deterioration in EDSS that persisted for at least 6 months during the 18 month follow-up period. Subordinate endpoints included relapse rates and the number of treatment dropouts. RESULTS: Among patients with baseline EDSS < or = 3.5,16.9% experienced a deterioration in EDSS of at least 1 point; 22.5% experienced a deterioration of at least 0.5%. Corresponding rates in patients with baseline EDSS > 3.5 were 23.4% and 29% respectively (no significant differences between patients stratified according to baseline EDSS status). The proportion of patients discontinuing therapy was significantly higher in patients with baseline EDSS > 3.5 than in those with baseline EDSS < or = 3.5 (16/64 versus 12/124; p = 0.005). At the conclusion of follow-up, IFNbeta-1 a therapy was associated with a 31.7% reduction in relapse rate in patients with baseline EDSS < or = 3.5 and a 37% reduction in those with baseline EDSS > 3.5 (difference not significant). CONCLUSIONS: During 18 months of treatment and follow-up, no difference was observed in clinical responses to IFNbeta-1 a between RRMS patients with mild and moderate disability but discontinuation of therapy was more frequent in the more disabled group.
Authors: Paulus S Rommer; Ron Milo; May H Han; Sammita Satyanarayan; Johann Sellner; Larissa Hauer; Zsolt Illes; Clemens Warnke; Sarah Laurent; Martin S Weber; Yinan Zhang; Olaf Stuve Journal: Front Immunol Date: 2019-07-11 Impact factor: 7.561