Omalizumab is a monoclonal antibody that targets IgE. In the treatment of urticaria, it is administered as a subcutaneous injection once every 4 weeks.
Omalizumab can be prescribed on the NHS for severe chronic spontaneous urticaria if a patient has had an inadequate response to H1-antihistamines and leukotriene receptor antagonists. The severity of the condition must be determined objectively (eg. using a weekly urticaria activity score of 28 or more) and omalizumab must be given under the supervision of a specialist in dermatology, immunology or allergy.
NICE technology appraisal TA339
If the condition has not responded by the fourth dose, treatment should be stopped. In patients who are responsive, 6 doses should be given before stopping, and dosing should be restarted only if the condition returns.
Adverse effects of omalizumab include sinusitis, headache, arthralgia, upper respiratory tract infections and injection site reactions.
Approval of omalizumab for NHS use in the treatment of urticaria is contingent on the company providing the drug with the discount agreed in the patient access scheme.
Omalizumab is already approved by NICE as add-on therapy for treating persistent confirmed IgE-mediated asthma.