Omalizumab Effectively Controls Chronic Idiopathic or Spontaneous Urticaria

Summary and Comment |
March 1, 2013

Omalizumab Effectively Controls Chronic Idiopathic or Spontaneous Urticaria

  1. Jeffrey P. Callen, MD

Omalizumab diminished clinical symptoms and signs in treatment-resistant CIU.

  1. Jeffrey P. Callen, MD

Treatment of chronic idiopathic urticaria (CIU; also called spontaneous urticaria) is frustrating. Standard treatments — diet therapy, H1 or H2 antihistamines, even the immunosuppressive agents cyclosporin, methotrexate, and mycophenolate — are often ineffective or poorly tolerated. The biologic agent omalizumab, approved for asthma therapy, blocks the binding of IgE to its high-affinity receptor, reducing the release of histamine and other inflammatory mediators from basophils and mast cells. Earlier findings suggested that repeated use produced better efficacy although optimal dosing and frequency were unknown.

In this phase 3, multicenter, double-blind, manufacturer-funded study, 323 patients with moderate-to-severe CIU who remained symptomatic despite H1-antihistamine therapy were randomized to receive one of three doses of omalizumab (75 mg, 150 mg, or 300 mg) or placebo every 4 weeks. The primary outcome measure was itch-severity score at week 12; the mean change from baseline was –5.1 with placebo, –5.9 with 75 mg, –8.1 with 150 mg (significant), and –9.8 with 300 mg (significant). Most secondary outcomes (e.g., urticaria count and Dermatology Life Quality Index) showed similar dose-dependent effects at week 12. Ten percent of placebo recipients and 18%, 23%, and 53% of 75-mg, 150-mg, and 300-mg recipients, respectively, were urticaria free; 5%, 16%, 22%, and 44%, respectively, were free of both hives and itching. Response onset was significantly shorter and response duration significantly longer with the higher doses; some patients avoided relapse. Adverse events occurred similarly in all groups; the rate of serious events was low; 6% with 300 mg, 3% with placebo, and 1% in 75-mg and 150-mg recipients.


Chronic idiopathic urticaria responded well to omalizumab. The mechanism has not been fully elucidated, but the effects are more likely to involve basophils than mast cells, as effects on the high-affinity IgE receptors of mast cells do not occur until roughly 8 weeks after omalizumab administration, much later than the effects seen here. Omalizumab is not yet approved for treating CIU; monitoring for anaphylaxis is important. Unless the labeling is changed, it is unlikely that there will be much use in dermatology offices.


Reader Comments (2)

John Gallo

I have had I Urticuria for about 25 years and it's very frustrating because prednisone is the only thing that will relieve the swelling,which can be severe at times..I can't use an epi pen because an A Fib situation that occurs infrequently..THis article is encouraging.. Are there side affects from Omalizumab..

Competing interests: None declared

r crane

What difference does the labeling make?

Competing interests: None declared

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