Biologic agents in the treatment of urticaria.

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.