Chronic Spontaneous Urticaria Clinical Trial
Official title:
Efficacy of Levocetirizine Fourfold Dosage in Chronic Spontaneous Urticaria Resistant to the Licensed Dosage
Chronic Spontaneous Urticaria (CSU), defined by the persistence of daily or almost daily
urticaria over 6 weeks, affects 0.5% to 1% of the general population. In more than half of
the cases, it lasts more than 2 years. It can dramatically alter the quality of life, in
particular sleep, and generates numerous consultations and hospitalizations, with an average
annual cost per patient close to 2000 euros in Europe. The treatment is based on the
validated 2nd generation anti-H1 antihistamines dosage of one tablet per day whose
effectiveness is satisfactory, however about half the time. In cases of severe CSU refractory
to treatment with anti-H1 licensed dosage, few therapeutic alternatives exist, still
off-label: the monketulast, an anti-leukotriene, ciclosporine or methotrexate, as
immunosuppressants. Various studies have shown the important benefit of an expensive anti-IgE
biological: the omaluzimab. Several open studies have also suggested superior efficacy and
good tolerability of anti-H1 in higher dosage (double, triple or quadruple) including
levocetirizine.
The off-label use of these high dosages of anti-H1 is growing very rapidly in France, tending
to replace the use of anti-H1 first generation or substitution to another 2nd generation
anti-H1 recommended by the French Society of Dermatology.
This study, under the aegis of the Urticaria Group of the French Society of Dermatology,
intends to compare the efficacy of levocetirizine 4 tablets/day versus 1 tablet/day in the
treatment of CSU resistant to anti-H1 licensed dosage.
n/a
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