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March 9, 2018
Anti-IgE for Treatment of Anaphylaxis
Question
What is the current role of Anti-IgE antibody for the treatment/prevention of anaphylaxis?
Answer
By WAO Ask the Expert website editors
Omalizumab, the only anti-IgE antibody available in the US, is only FDA-approved for the treatment of asthma and chronic urticaria. Omalizumab has, however, been used off-label for treatment to prevent idiopathic anaphylaxis and administered in conjunction with oral food and conventional subcutaneous allergen immunotherapy (SCIT) to reduce the risk of anaphylaxis (1).
The earliest use of anti-IgE for the prevention of peanut-induced anaphylaxis was a 2003 double-blind placebo-controlled trial involving 84 subjects receiving either placebo or TNX-901 for four monthly doses. At the end of the treatment period, those receiving the 450 mg dose of TNX-901 tolerated a significantly increased oral challenge dose of peanut allergen. However, 25% in this group did not show an increase in the threshold peanut dose (2). An open-label study using Omalizumab in adult peanut allergic patients demonstrated a protective effect which varied significantly from patient to patient (3). Additional clinical trials in patients undergoing oral food allergy immunotherapy have demonstrated that the use of Omalizumab used concurrently with oral immunotherapy resulted in achieving a higher level of tolerance in a more rapid, safe, and effective manner (4) (5). Randomized controlled trials with RUSH SCIT using ragweed and cluster SCIT using dust mite, cat and/or dog allergen has also shown a reduced incidence of anaphylaxis when using Omalizumab (6) (7). Case studies using Omalizumab for insect venom SCIT has also demonstrated a benefit in terms of safety, especially with RUSH immunotherapy.
To date, for the treatment of idiopathic anaphylaxis, there are no published randomized trials using Omalizumab, however, the National Institute of Health is currently conducting such a study at a single center with Dr. Melody Carter as the principal investigator. (for more information see https://clinicaltrials.gov/show/NCT00890162. Case reports have described remarkable success stories in individual patients. (8) (9) (10) (11, 12) (13) When Omalizumab has been used in patients with systemic mastocytosis or mast cell activation syndrome, the results have been mixed and, when effective, may take up to 6 months to show improvement. We certainly need more research demonstrating real improvement in terms of efficacy and quality of life before routinely recommending Omalizumab, a drug costing between $10,000 to $70,000 per patient per year (depending upon dose and frequency of administration), for patients with idiopathic anaphylaxis.
References
1. Lieberman JA, Chehade M. Use of Omalizumab in the Treatment of Food Allergy and Anaphylaxis. Current Allergy and Asthma Reports. 2013;13(1):78-84
2. Leung DYM, Sampson HA, Yunginger JW, Burks AW, Jr., Schneider LC, Wortel CH, et al. Effect of anti-IgE therapy in patients with peanut allergy. New England Journal of Medicine. 2003;348(11):986-93
3. Savage JH, Courneya JP, Sterba PM, Macglashan DW, Saini SS, Wood RA. Kinetics of mast cell, basophil, and oral food challenge responses in omalizumab-treated adults with peanut allergy. J Allergy Clin Immunol. 2012;130(5):1123-9 e2
4. Schneider LC, Rachid R, LeBovidge J, Blood E, Mittal M, Umetsu DT. A pilot study of omalizumab to facilitate rapid oral desensitization in high-risk peanut-allergic patients. J Allergy Clin Immunol. 2013;132(6):1368-74
5. Sicherer SH, Sampson HA. Food allergy: Epidemiology, pathogenesis, diagnosis, and treatment. J Allergy Clin Immunol. 2014;133(2):291-307; quiz 8
6. Casale TB, Busse WW, Kline JN, Ballas ZK, Moss MH, Townley RG, et al. Omalizumab pretreatment decreases acute reactions after rush immunotherapy for ragweed-induced seasonal allergic rhinitis. Journal of Allergy and Clinical Immunology. 2006;117(1):134-40
7. Massanari M, Nelson H, Casale T, Busse W, Kianifard F, Geba GP, et al. Effect of pretreatment with omalizumab on the tolerability of specific immunotherapy in allergic asthma. Journal of Allergy and Clinical Immunology. 2010;125(2):383-9
8. Jones JD, Marney SR, Jr., Fahrenholz JM. Idiopathic anaphylaxis successfully treated with omalizumab. Ann Allergy Asthma Immunol. 2008;101(5):550-1
9. Warrier P, Casale TB. Omalizumab in idiopathic anaphylaxis. Ann Allergy Asthma Immunol. 2009;102(3):257-8
10. Demirturk M, Gelincik A, Colakoglu B, Dal M, Buyukozturk S. Promising option in the prevention of idiopathic anaphylaxis: omalizumab. J Dermatol. 2012;39(6):552-4
11. Lee J. Successful prevention of recurrent anaphylactic events with anti-immunoglobulin E therapy. Asia Pac Allergy. 2014;4(2):126-8
12. Pitt TJ, Cisneros N, Kalicinsky C, Becker AB. Successful treatment of idiopathic anaphylaxis in an adolescent. J Allergy Clin Immunol. 2010;126(2):415-6; author reply 6
13. Bell MC, Jackson DJ. Prevention of anaphylaxis related to mast cell activation syndrome with omalizumab. Ann Allergy Asthma Immunol. 2012;108(5):383-4
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