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Omalizumab

  • Giuseppe Tridente
Chapter

Abstract

Omalizumab (Xolair®, Genentech) is a recombinant humanized IgG1k monoclonal antibody that selectively binds to human immunoglobulin E (IgE). This monoclonal was first registered by TGA in Australia in June 2002 for the treatment of moderate to severe allergic asthma (AA) resistant to inhaled steroids, and with IgE levels corresponding to the recommended dose range. Following a previous rejection in 2001, FDA granted approval in 2003 for adults and adolescents (≥12 years) with moderate to severe persistent asthma, positive to a perennial aeroallergen, and whose symptoms are inadequately controlled with inhaled corticosteroids. In October 2005, a marketing authorization was granted by EMEA for the treatment of AA in patients (≥12 years) in whom standard treatment had failed. In December 2005, TGA extended the registration to include management of adult and adolescent patients with moderate to severe AA, who are already being treated with inhaled steroids and have IgE levels corresponding to the recommended dose range. In June 2009, EMEA extended the indication as add-on therapy in young patients (6 to <12 years of age) affected by severe persistent AA with positive skin test or in vitro reactivity to a perennial aeroallergen, frequent daytime symptoms or nighttime awakenings, and multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Keywords

Food Allergy Allergic Asthma Chronic Urticaria Seasonal Allergic Rhinitis Systemic Mastocytosis 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Supplementary material

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Supplementary material 1 (XLS 66 kb)

References

  1. 1.
    Omalizumab (Xolair®, Novartis) ADEC Meeting Resolution, Apr 2002 TGA, AustraliaGoogle Scholar
  2. 2.
    Omalizumab (Xolair®, Novartis) Public Summary Document (PBAC), Nov 2010, AustraliaGoogle Scholar
  3. 3.
    Omalizumab (Xolair®, Genentech) BLA STN 103976 Medical Review FDA, June 2003Google Scholar
  4. 4.
    Omalizumab (Xolair®, Genentech) BLA STN 103976 Clinical Safety Review FDA, June 2003Google Scholar
  5. 5.
    Omalizumab (Xolair®, Novartis) WC500057295 Scientific Discussion EMEA, Nov 2005Google Scholar
  6. 6.
    Omalizumab (Xolair®, Novartis) WC500057307 Variation Assessment Report (CHMP) EMEA, June 2009Google Scholar
  7. 7.
    Omalizumab (Xolair®, Novartis) WC500057298 EPAR Annex I EMEA, June 2012Google Scholar
  8. 8.
    Omalizumab (Xolair®, Genentech) Prescribing Information, Genentech, July 2010Google Scholar
  9. 9.
    Vouldoukis J, Mazier D, Moynet D et al (2011) IgE mediates killing of intracellular Toxoplasma gondii by human macrophages trough CD23-dependent, interleukin-10 sensitive pathway. PLoS ONE 6:e18289, 1−11Google Scholar
  10. 10.
    Sutton BJ, Beavil RL, Beavil AJ (2000) Inhibition of IgE-receptor interactions. BMB 56:1004–1018CrossRefGoogle Scholar
  11. 11.
    Untersmayr E, Bises G, Starkl P et al (2010) The high affinity IgE receptor is FCεRI expressed by human intestinal epithelial cells. PLoS ONE 5:e9023, 1−11Google Scholar
  12. 12.
    Vichyanond P (2011) Omalizumab in allergic diseases, a recent review. Asian Pac J Allergy Immunol 29:209–219PubMedGoogle Scholar
  13. 13.
    Dhaliwal B, Yuan D, Pang MOY et al (2012) Crystal structure of IgE bound to its B-cell receptor CD23 reveals a mechanism of reciprocal allosteric inhibition with high affinity receptor FcεRI. PNAS 109:12686–12691PubMedCrossRefGoogle Scholar
  14. 14.
    Busse W, Buhl R, Vidaurre CF et al (2012) Omalizumab and the risk of malignancy: results from a pooled analysis. J Allergy Clin Immunol 129:983–989PubMedCrossRefGoogle Scholar
  15. 15.
    Aidan AL, James EF, Abdelkader R et al (2009) Baseline characteristics of patients enrolled in EXCELS: a cohort study. Ann Allergy Asthma Immunol 103:212–219CrossRefGoogle Scholar
  16. 16.
    Cruz AA, Lima F, Sarinho E et al (2007) Safety of antiimmunoglobulin E therapy with omalizumab in allergic patients at risk of geohelminth infection. Clin Exp Allergy 37:197–207PubMedCrossRefGoogle Scholar
  17. 17.
    Thomson NC, Chaudhuri R (2012) Omalizumab: clinical use for the management of asthma. Clin Med Insights Circul Respir Pulm Medi 6:27–40CrossRefGoogle Scholar
  18. 18.
    Saini S, Rosen KE, Hsieh H-J et al (2011) A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. J Allergy Clin Immunol 128:567–573PubMedCrossRefGoogle Scholar
  19. 19.
    Maurer M, Altrichter S, Bieber T et al (2011) Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase. J Allergy Clin Immunol 128:202–209PubMedCrossRefGoogle Scholar
  20. 20.
    Metz M, Maurer M (2012) Omalizumab in chronic urticaria. Curr Opin Allergy Clin Immunol 12:406–411PubMedCrossRefGoogle Scholar
  21. 21.
    Nam Y-H, Kim J-H, Jin HJ et al (2012) Effects of omalizumab treatment in patients with refractory chronic urticaria. Allergy Asthma Immunol Res 4:357–361PubMedCrossRefGoogle Scholar
  22. 22.
    Nadeau KC, Kohli A, Iyengar S et al (2012) Oral immunotherapy and anti-IgE antibody-adjunctive treatment for food allergy. Immunol Allergy Clin N Am 32:111–133CrossRefGoogle Scholar
  23. 23.
    Bedoret D, Singh AK, Shaw V et al (2012) Changes in antigen-specific T cell number and function during oral desensitization in cow’s milk allergy enabled with omalizumab. Mucosal Immunol 5:267–276PubMedCrossRefGoogle Scholar
  24. 24.
    Vichyanond P (2011) Omalizumab in allergic diseases, a recent review. Asian Pac J Allergy Immunol 29:209–219PubMedGoogle Scholar
  25. 25.
    Kaya H, Gümüş S, Uçar E et al (2012) Omalizumab as a steroid-sparing agent in chronic eosinophilic pneumonia. Chest 142:513–516PubMedCrossRefGoogle Scholar
  26. 26.
    Cavelti-Weder C, Muggli B, Keller C et al (2012) Successful use of omalizumab in an inadequately controlled Type 2 diabetic patient with severe insulin allergy. Diabetes Care 35:e41PubMedCrossRefGoogle Scholar
  27. 27.
    Bahn HL, Trevoy J, Pabst H et al (2012) Persistent elevation of peripheral blood myeloid cell counts associated with omalizumab therapy. Am J Health-Syst Pharm 69:302–306CrossRefGoogle Scholar
  28. 28.
    Jandus P, Hausmann O, Haeberli G et al (2012) Unpredicted adverse reaction to omalizumab. J Investig Allergol Clin Immunol 21:563–566Google Scholar
  29. 29.
    Stone JH, Zen Y, Deshpande V (2012) IgG4-related diseases. NEJM 366:539–551PubMedCrossRefGoogle Scholar
  30. 30.
    Kim YJ, Prussin C, Martin B et al (2004) Rebound eosinophilia after treatment of hypereosinophilic syndrome and eosinophilic gastroenteritis with monoclonal anti-IL-5 antibody SCH55700. J Allergy Clin Immunol 114:1449–1455PubMedCrossRefGoogle Scholar
  31. 31.
    Wechsler ME, Fulkerson PC, Bochner BS et al (2012) Novel targeted therapies for eosinophilic disorders. J Allergy Clin Immunol 130:563–571PubMedCrossRefGoogle Scholar
  32. 32.
    Lowe P, Renard D (2010) Omalizumab decreases IgE production in patients with allergic (IgE-mediated) asthma; PKPD analysis of a biomarker, total IgE. BJCP 72:306–320Google Scholar

Copyright information

© Springer-Verlag Italia 2014

Authors and Affiliations

  1. 1.University of VeronaVeronaItaly

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