Omalizumab

Compound Name:OmalizumabMolecular Target:IgEMolecular Structure:humanized IgG1?, recombinantLicensed Indication:moderate to severe IgE-mediated, persistent asthma (US) or severe asthma (EU), in adults and children over 12 years old, inadequately controlled by inhaled corticosteroid treatmentManufacturer and/or Distributor:Genentech & NovartisInitial FDA Approval2003SummaryOmalizumab is a recombinant humanized IgG1κ monoclonal antibody that binds specifically to circulating, but not cell-bound, human IgE. As a result, native IgE is inhibited from binding to the high-affinity IgE receptor (FcεRI) present on mast cells and basophils, reducing the release of allergic mediators. The number of FcεRI on basophils also decreases. It is administered subcutaneously every two to four weeks for asthma treatment and every 4 weeks for chronic urticaria. Omalizumab was licensed in 2003 for the treatment of moderate to severe persistent asthma in patients older than 12, who had a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids. It has been shown to be effective in decreasing corticosteroid use and number of asthma exacerbations experienced. In 2014, the FDA approved its use for chronic idiopathic urticaria. Omalizumab should not be used for the treatment of acute exacerbations. Particular safety concerns are anaphylaxis, heart attacks, serum sickness, and eosinophilic conditions. A five-year safety study found a slightly higher rate of heart and brain blood vessel problems occurred in patients being treated with omalizumab compared to those patients not treated with omalizumab.References

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3. Busse WW, Morgan WJ, Gergen PJ, Mitchell HE, Gern JE, Liu AH, et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. N Engl J Med. 2011 Mar 17;364(11):1005-1015.̈ http://www.ncbi.nlm.nih.gov/entrez/query.fcgi? cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=21410369

4. Cox L, Lieberman P, Wallace D, Simons FE, Finegold I, Platts-Mills T, et al. American Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma & Immunology Omalizumab- Associated Anaphylaxis Joint Task Force follow-up report. J Allergy Clin Immunol. 2011 Jul;128(1):210- 212. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi? cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=21531014̈

5. Rodrigo GJ, Neffen H, Castro-Rodriguez JA. Efficacy and safety of subcutaneous omalizumab vs placebo as add-on therapy to corticosteroids for children and adults with asthma: a systematic review. Chest. 2011 Jan;139(1):28-35. ̈
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7. Chang TW, Chen C, Lin CJ, Metz M, Church MK, Maurer M. The potential pharmacologic mechanisms of omalizumab in patients with chronic spontaneous urticaria. J Allergy Clin Immunol. 2014 Jun 17. pii: S0091-6749(14)00657-5.
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8. Ledford DK. Omalizumab and Allergic Reactions. J Allergy Clin Immunol Pract. 2016 Jan-Feb;4(1):187- 8.
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9. Ann Intern Med. 2011 May 3;154(9):573-82. doi: 10.7326/0003-4819-154-9-201105030-00002. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Hanania NAAlpan OHamilos DLCondemi JJReyes-Rivera IZhu JRosen KEEisner MDWong DABusse W.

10. J Allergy Clin Immunol. 2015 Dec;136(6):1476-85. doi: 10.1016/j.jaci.2015.09.008. Epub 2015 Oct 27. Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations. Teach SJ, Gill MA, Togias ASorkness CAArbes SJ JrCalatroni AWildfire JJGergen PJCohen RTPongracic JAKercsmar CMKhurana Hershey GKGruchalla RSLiu AHZoratti EMKattan MGrindle KAGern JEBusse WWSzefler SJ.

11. Respir Med. 2017 Jan;122:33-42. doi: 10.1016/j.rmed.2016.11.019. Epub 2016 Nov 26. Beneficial effects of Omalizumab therapy in allergic bronchopulmonary aspergillosis: A synthesis review of published literature. Li JXFan LCLi MHCao WJXu JF.

12. Int J Dermatol. 2017 Jan;56(1):18-26. doi: 10.1111/ijd.13353. Epub 2016 Jun 23. Omalizumab for atopic dermatitis: case series and a systematic review of the literature. Holm JGAgner TSand C, Thomsen SF.

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