Q:

12/31/2013
I have reviewed all of the previously asked questions on Xolair and urticaria, but have not found one on treating someone with severe urticaria and atopic dermatitis, with positive anti IgE antibodies but a negative functional Anti FceR test, both done at Viracor-IBT labs. Her total IgE is 5.5 in a lab with a normal mean of 13.2 (Mayo Clinic Lab). She continues with severe hives and pruritis despite Atarax 25 mg tid, Zantac 150 mg bid and Dapsone 25 mg bid. She has negative anti thyroid antibodies, negative HPylori antibodies, a low tryptase level (2.8)and a normal CBC, chem screen, and negative ANA.

We will try to increase her antihistamine dose as tolerated, but is there any experience with using Xolair in someone with a low normal IgE? I think I read a study of trying this in severe asthma with normal IgE levels, but can find nothing about urticaria, normal IgE and Xolair. Is there any potential adverse effect trying this in someone with normal IgE?

A:

Thank you for your inquiry.

You are correct in that omalizumab has been shown to be effective (at least in some studies) in patients with "nonallergic" asthma (see reference copied below). In addition, in patients with chronic idiopathic urticaria, the relief that occurs does not seem to be correlated with IgE levels (see abstract copied below). In the study in asthmatics who did not have elevated IgE, the drug was well tolerated.

Thus, in summary:

1. There is precedent to consider omalizumab therapy in patients with normal IgE levels.

2. There is no evidence that omalizumab given to such patients has a different side effect profile than in patients with elevated IgE.

Thank you again for your inquiry and we hope this response is helpful to you.

J Dermatol Sci. 2014 Jan;73(1):57-62. doi: 10.1016/j.jdermsci.2013.08.011. Epub 2013 Sep 3.
Omalizumab is an effective and rapidly acting therapy in difficult-to-treat chronic urticaria: A retrospective clinical analysis.
Metz M1, Ohanyan T1, Church MK2, Maurer M1.
Author information
Charité - Universitätsmedizin Berlin, Department of Dermatology and Allergy, Berlin, Germany.
Abstract
Background: Omalizumab (anti-IgE) therapy is effective and safe in chronic urticaria (CU) in placebo-controlled clinical trials but real life clinical data are scarce.
Objective: To better understand the effects of omalizumab in CU patients treated outside of clinical trials.
Methods: In this retrospective clinical analysis, we assessed responder rates, optimal dosage, response to up-/downdosing, time to relief of symptoms, rates of return and time of relapse after omalizumab administration, and safety in 51 CU patients, 20 with chronic spontaneous urticaria (CSU) alone, 21 with different forms of chronic inducible urticaria (CindU) and 10 with both.
Results: Omalizumab treatment led to complete remission in 83% of CSU and 70% of CindU patients. When starting with 150mg omalizumab 4 weekly, only 2/15 CSU and 7/17 CindU patients required updosing to achieve complete remission. In CSU, 57% of complete responses occurred within week one, all on the first day. Relapses were 2-8 weeks in all but six patients, where they were <4 months. Omalizumab was safe. Efficacy was not correlated to baseline IgE levels.
Conclusion: Clinical experience from more than 1250 injections in 51 patients over four years indicates that omalizumab is a rapidly acting, highly effective and safe drug in CSU and CindU patients. Our observations in a real life clinical setting support the recommendation of current EAACI/GA(2)LEN/EDF/WAO guideline for the management of urticaria to use omalizumab to treat urticaria patients.

J Allergy Clin Immunol. 2013 Jan;131(1):110-6.e1. doi: 10.1016/j.jaci.2012.07.047. Epub 2012 Sep 27.
Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma.
Gevaert P, Calus L, Van Zele T, Blomme K, De Ruyck N, Bauters W, Hellings P, Brusselle G, De Bacquer D, van Cauwenberge P, Bachert C.

Sincerely,
Phil Lieberman, M.D.

AAAAI - American Academy of Allergy Asthma & Immunology