Omalizumab

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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 Approval:2003Summary:Omalizumab 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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1. Busse W, Buhl R, Fernandez Vidaurre C, Blogg M, Zhu J, Eisner MD, et al. Omalizumab and the risk of malignancy: results from a pooled analysis. J Allergy Clin Immunol. 2012 Apr;129(4):983-989 e986. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi? cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=22365654

2. Buhl R, Soler M, Matz J, Townley R, O'Brien J, Noga O, et al. Omalizumab provides long-term control in patients with moderate-to-severe allergic asthma. Eur Respir J. 2002 Jul;20(1):73-78. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi? cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12166585̈

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. ̈ http://www.ncbi.nlm.nih.gov/entrez/query.fcgi? cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=20688929̈

6. Pelaia G, Vatrella A, Maselli R. The potential of biologics for the treatment of asthma. Nat Rev Drug Discov. 2012 Dec;11(12):958-972. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi? cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=23197041

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.  http://www.ncbi.nlm.nih.gov/pubmed/24948369

8. Ledford DK. Omalizumab and Allergic Reactions. J Allergy Clin Immunol Pract. 2016 Jan-Feb;4(1):187- 8.  http://www.ncbi.nlm.nih.gov/pubmed/26772933

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 NA, Alpan O, Hamilos DL, Condemi JJ, Reyes-Rivera I, Zhu J, Rosen KE, Eisner MD, Wong DA, Busse 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 A, Sorkness CA, Arbes SJ Jr, Calatroni A, Wildfire JJ, Gergen PJ, Cohen RT, Pongracic JA, Kercsmar CM, Khurana Hershey GK, Gruchalla RS, Liu AH, Zoratti EM, Kattan M, Grindle KA, Gern JE, Busse WW, Szefler 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 JX, Fan LC, Li MH, Cao WJ, Xu 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 JG, Agner T, Sand C, Thomsen SF.

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