Journal of Neurology
Abstract Volume 249 Issue 2 (2002) pp 184-187
P. Vermersch (1), J. de Seze (1), T. Stojkovic (1), P. Hautecoeur (2) on behalf of the G-SEP (Groupe Septentrional d'Etudes et de Recherches sur la SEP).
(1) Department of Neurology, Hôpital R. Salengro, CHRU of Lille, 59037 Lille cédex, France, Tel.: +33-03 20 44 57 65, Fax: +33-32 0 44 44 84
(2) Department of Neurology, Hôpital St Philibert, 59160 Lomme, France
To compare clinical responses to once-weekly intramuscular interferon-<beta>-1 a [IFN<beta>-1 a, Avonex®, Biogen] in multiple sclerosis (MS) patients with baseline Expanded Disability Status Scale (EDSS) \leq 3.5 or > 3.5.
Patients with relapsing-remitting MS (RRMS), 124 with baseline EDSS \geq 3.5 and 64 RRMS patients with EDSS > 3.5, were consecutively recruited to receive IFN<beta>-1 a 30 µg 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.
Among patients with baseline EDSS \leq 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 \leq 3.5 (16/64 versus 12/124 ; p = 0.005). At the conclusion of follow-up, IFN<beta>-1 a therapy was associated with a 31.7 % reduction in relapse rate in patients with baseline EDSS \leq 3.5 and a 37 % reduction in those with baseline EDSS > 3.5 (difference not significant).
During 18 months of treatment and
follow-up, no difference was observed in clinical responses to IFN<beta>-1
a between RRMS patients with mild and moderate disability but discontinuation
of therapy was more frequent in the more disabled group.
© Steinkopff Verlag 2002