Interleukin antibody for psoriasis
The safety and efficacy of human interleukin-12/23 monoclonal antibody for the treatment of psoriasis has been demonstrated in a phase II study, published in The New England Journal of Medicine (2007;356:580).
The authors explain that aberrant type 1 immune responses have been linked
to the pathogenesis of psoriasis, and cytokines that elicit these responses
may represent appropriate therapeutic targets. A fully human interleukin-12/23
monoclonal antibody was developed, which binds with high affinity to
the p40 subunit of human interleukin-12 and -23, neutralising their bioactivity
by blocking interactions with their cognate cell surface receptors.
To assess the antibody, 320 patients with moderate-to-severe plaque psoriasis
were randomised to receive one 45mg subcutaneous dose of interleukin-12/23
monoclonal antibody, one 90mg dose, four weekly 45mg doses, four weekly
90mg doses or placebo. At week 20, patients in the placebo group crossed
over to receive one 90mg dose of
interleukin-12/23 monoclonal antibody.
The results show that there was at least 75 per cent improvement in the
psoriasis area and severity index at week 12 in 52 per cent of patients
who received 45mg of antibody, in 59 per cent who received 90mg, in 67
per cent who received four weekly 45mg doses and in 81 per cent who received
four
weekly 90mg doses, compared with 2 per cent who received placebo (P<0.001
for each comparison).
More patients treated with antibody than with placebo experienced adverse
events and serious adverse events, although the differences were not
significant. However, the authors say the trial was not large enough
to detect differences in uncommon serious adverse events. They suggest
that additional studies are needed to characterise the antibody’s
safety and efficacy and to determine a suitable dose schedule.
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