New class of monoclonal antibody for MS
Natalizumab (Antegren), a humanised monoclonal antibody,
has been shown to be effective in treating multiple sclerosis, according
to the results of a phase II trial. Natali-zumab, the first in a new class
of agents known as alpha-4 integrin inhibitors, was designed to prevent
the migration of lymphocytes from blood vessels to the site of inflammation.
Professor David Miller, Institute of Neurology,
London, and colleagues assigned 213 patients with either relapsing-remitting
multiple sclerosis or secondary progressive multiple sclerosis to receive
two doses of either natalizumab (3mg/kg or 6mg/kg) or placebo by intravenous
infusion, every four weeks for six months. The trial was conducted at
26 centres in the United Kingdom, United States and Canada.
The researchers found that, based on magnetic resonance
imaging scans, patients treated with natalizumab had fewer new lesions
than those treated with placebo. Natalizumab also reduced the number of
relapses over the treatment period. The number of relapses was 19 in the
natalizumab 3mg/kg group and 14 in the 6mg/kg group, compared with 34
in the placebo group. Certain adverse events occurred more commonly with
natalizumab compared with placebo, such as gastroenteritis, rash, urinary
urgency, back pain and fever.
The data were presented at the annual meeting of
the European Congress on Treatment and Research in Multiple Sclerosis
in Dublin last month.
Elan and Biogen, co-developers of natalizumab, say
that the drug is expected to be studied for use both as monotherapy and
in combination with interferon beta-1a (Avonex) for treating multiple
sclerosis.
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