Immunomodulating agent for MS promising
A new oral immunomodulating agent called fingolimod has shown promise in a proof-of-concept study for the treatment of relapsing multiple sclerosis.
Fingolimod is thought to modify the course of relapsing multiple sclerosis
by sequestering lymphocytes in secondary lymphoid organs through an interaction
with
G protein-coupled receptors for sphingosine-1-phosphate. Thus, peripheral
lymphocyte counts and recirculation of lymphocytes to the central nervous
system is reduced.
Researchers randomly assigned 281 patients to receive fingolimod 1.25mg,
5mg or placebo once daily for six months. Magnetic resonance imaging
was used to measure the number of new inflammatory lesions at monthly
intervals.
The median total cumulative number of lesions was lower in the fingolimod
1.25mg group (one lesion; P<0.001) and the fingolimod 5mg group (three
lesions; P=0.006) than in the placebo group (five lesions). At six months,
the number of patients who were free of lesions was greater in both treatment
groups than in the placebo group (P<0.001), with separation beginning
at two months. Annual relapse rates were reduced significantly in patients
receiving treatment.
A six-month extension study, in which patients on placebo were re-randomised
to receive fingolimod showed that the number of lesions in the two continuous
treatment groups remained low and the number decreased among patients
who switched from placebo to fingolimod. Frequently reported adverse
events associated with fingolimod were nasopharyngitis, dyspnoea, headache,
diarrhoea and nausea.
The researchers conclude that fingolimod may be a treatment option for
MS but larger-scale, longer-term clinical studies are needed to evaluate
further its benefits and risks (New England Journal of Medicine 2006;355;1124). |
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