Numerous controlled studies as well as case reports have demonstrated that
Omalizumab can be employed successfully in approximately 75 % of patients with
chronic spontaneous urticaria, leading to a dramatic decrement in symptoms with very few side effects. No other
drug currently available is comparable, and the success rate in patients resistant to
antihistamines is no different. In the U.S., Phase I and Phase II trials are complete and we await the results of a Phase III multicenter study, with a view to eventual submission to the Food and Drug Administration in the U.S. and to comparable agencies abroad seeking approval for this indication.
Omalizumab is currently marketed for the treatment of severe allergic
asthma. Case reports suggest efficacy in difficult cases of physical
urticaria, but no controlled trails have been done. Other agents require further evaluation for possible efficacy in the treatment of
chronic spontaneous urticaria, including antibody to CD20, a B-lymphocyte cell surface marker, anti-TNFα, and anti-
Interleukin 1. Thus far, targeting TNFα has been disappointing for this indication, while targeting
Interleukin I has dramatically ameliorated autoinflammatory disorders with
urticaria or
urticaria-vasculitic-like lesions such as cold-induced autoinflammatory
syndrome, Muckle-Wells syndrome, and
Schnitzler syndrome.