oral glatiramer acetate

[Guest guest]

http://www.sciencedirect.com/science?_ob=ArticleURL & _udi=B6X3F-4J32JK2-1 & _co

verDate=03%2F31%2F2006 & _alid=370977573 & _rdoc=1 & _fmt= & _orig=search & _qd=1 & _cdi

=7297 & _sort=d & view=c & _acct=C000010182 & _version=1 & _urlVersion=0 & _userid=12579

5 & md5=61feaa56ef2ee519c18a787f6e8821df

Effects of oral glatiramer acetate on clinical and MRI-monitored disease

activity in patients with relapsing multiple sclerosis: a multicentre,

double-blind, randomised, placebo-controlled study

Summary

Background

Parenterally administered glatiramer acetate reduces the frequency of

relapses and the formation of active brain lesions seen with MRI in multiple

sclerosis. This study assessed whether two doses of glatiramer acetate given

orally could improve clinical and MRI measures of inflammation and

neurodegeneration in a large cohort of patients with relapsing-remitting

multiple sclerosis.

Methods

1912 patients with relapsing-remitting multiple sclerosis were screened and

1651 were randomised to receive 50 mg or 5 mg of glatiramer acetate or

placebo by daily oral administration over 14 months. The intention-to-treat

cohort consisted of 1644 patients who took at least one dose of study

medication (50 mg glatiramer acetate [n=543], 5 mg glatiramer acetate

[n=553], placebo [n=548]). After baseline investigation, clinical

assessments were done every 2 months and MRI was obtained for all patients

at baseline and at study exit. Additionally, MRI was undertaken every 2

months for a cohort of 486 patients. The primary outcome was the total

number of confirmed relapses observed during the study period. Several

prespecified clinical and MRI secondary and tertiary outcomes assessed

treatment efficacy on inflammation and neurodegeneration due to multiple

sclerosis.

Findings

The cumulative number of confirmed relapses did not differ between the two

active treatment groups and the placebo group. Relative to placebo, the rate

ratio for the 50 mg glatiramer acetate treated group was 0.92 (95% CI

0.77-1.08, p=0.30) and for the 5 mg glatiramer acetate treated group was

0.98 (0.83-1.15, p=0.76). No drug effect was seen for any of the secondary

and tertiary endpoints. The study drug was safe and well tolerated.

Interpretation

5 mg and 50 mg glatiramer acetate administered orally on a daily basis do

not affect relapse rate or other clinical and MRI parameters of disease

activity and burden in patients with relapsing-remitting multiple sclerosis.

Treatment with oral formulations of glatiramer acetate at the doses tested

cannot be recommended.

Correspondence to: Dr Massimo Filippi, Neuroimaging Research Unit,

Scientific Institute and University Ospedale San Raffaele, via Olgettina 60,

20132 Milan, Italy