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OBJECTIVE: To examine the available treatment choices for chronic spontaneous urticaria (CSU) and discuss a new paradigm for treating such patients.
DATA SOURCES: The literature regarding treatment is reviewed, including considerations of published guidelines. Attention is focused on the most recent evidence indicating particular efficacy of omalizumab.
RESULTS: Omalizumab has been found to have considerable efficacy in phase 2 and phase 3 trials in which more than 900 patients have been studied. A response rate of 65% is seen in patients resistant to antihistamines as well as to histamine2 blockers and leukotriene antagonists, and 40% of patients are completely free of hives as long as therapy is continued. In addition, serious adverse events have not been seen. Only cyclosporine can match this response rate (excluding steroids), but the adverse effect profile (blood pressure and renal function) is substantial by comparison. Double-blind, placebo-controlled studies of other agents often listed as alternatives are lacking (ie, whether their success rate exceeds the 25%-30% placebo response is uncertain). The mechanism by which omalizumab works in CSU is not clear because the response rate is unrelated to the autoimmune profile and can occur rapidly (ie, within a few days).
CONCLUSION: Omalizumab has exceptional efficacy for antihistamine-resistant CSU with an excellent adverse effect profile.
