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Halifax,
N.S.-- Short-course, low-dose cyclosporin may be effective in
controlling chronic idiopathic urticaria (CIU), according to a study
presented at the annual CDA meeting here. In addition, it may have
a possible role in inducing remission, Simon Nigen, MD, said.
Urticaria, itchy mucocutaneous swelling secondary to transient plasma
and cytokines leakage, is defined as chronic when a patient has
recurrent urticaria for at least six weeks, at least twice a week,
and where no causal factor is identified. Traditional treatment
of severe CIU is often of limited benefit, and there are few therapeutic
alternatives. "CIU usually responds to antihistaminic drugs
but other medications are often required," said Dr. Nigen,
L'Hotel-Dieu de Québec, Quebec City.
The randomized, controlled, double-blind study enrolled 20 patients
with moderate to severe CIU, not fully controlled with antihistamines.
Ten were treated with cyclosporin (Neoral) at 2.5 mg/kg/day, and
10 were given placebo for 28 days. A rating scale for evaluating
the efficacy of treatment included pruritis, number of skin lesions,
and the effect of urticaria on daily activities. Blood pressure
and serum creatinine were monitored.
All 20 patients completed the four-week protocol and were followed.
No serious adverse events were reported. Blood pressure and creatinine
remained normal in all patients.
When compared to patients on placebo, those on cyclosporin showed
greater improvement of all evaluated parametres. Globally, those
on cyclosporin improved by 54 per cent at four weeks compared with
23 per cent with placebo. In addition, cetirizine intake was reduced
by half, with an average dosage of 6.8mg/day for patients on placebo
compared to 3.4mg/day for patients on cyclosporin after one month.
Dr. Nigen said cyclosporin has several modes of action. It inhibits
cell immunity by down-regulating the TH1 lymphocyte responses, and
it inhibits antibody formation by B lymphocytes.
"Therefore, cyclosporin effect on CIU could have a direct effect
on mast cells. The mechanism of cyclosporin in CIU can be attributed
to a direct effect on mastocytes and basophils by an inhibition
of release of anti IgE-induced histamine and others cytokines and
to an inhibition of cell-mediated immunity by downregulating TH1
lymphocyte responses and antibody formation by B lymphocytes).
"This study shows that a short course of low-dose, cyclosporin
is safe and effective for chronic idiopathic urticaria, in support
of proper evidence, for a role of HRF (histamine-releasing factor)
in the pathogenesis of this chronic, idiopathic disease," he
concluded.
Further studies are needed to determine the extent of the statistical
significance in a larger group of patients, he said. "We are
planning to continue our study with more people, and perhaps for
two months of cyclosporin. We are working on a second phase of the
study for two months, with more patients."
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