Pharmacokinetics, pharmacodynamics and clinical efficacy of omalizumab for the treatment of asthma

References

• Masoli M, Fabian D, Holt S, et al. Global Initiative for Asthma (GINA) Program. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy. 2004 May;59(5):469–478.
   PubMed Web of Science ®Google Scholar
• Beasley R. The burden of asthma with specific reference to the United States. J Allergy Clin Immunol. 2002 May;109(5 Suppl):S482–9.
   PubMed Web of Science ®Google Scholar
• Buhl R, Hanf G, Solèr M, et al. The anti-IgE antibody omalizumab improves asthma-related quality of life in patients with allergic asthma. Eur Respir J. 2002 Nov;20(5):1088–1094.
   PubMed Web of Science ®Google Scholar
• Karpel J, Bukstein DA, LoNigro R. The appropriate omalizumab patient. Manag Care Langhorne Pa. 2007 May;16(5):44–50, 56.
   PubMedGoogle Scholar
• Kulus M, Hébert J, Garcia E, et al. Omalizumab in children with inadequately controlled severe allergic (IgE-mediated) asthma. Curr Med Res Opin. 2010 Jun;26(6):1285–1293.
   PubMed Web of Science ®Google Scholar
• Godard P, Chanez P, Siraudin L, et al. Costs of asthma are correlated with severity: a 1-yr prospective study. Eur Respir J. 2002 Jan;19(1):61–67.
   PubMed Web of Science ®Google Scholar
• Antonicelli L, Stagnozzi G, Giuliodoro S, et al. The safety of omalizumab therapy in a patient with severe persistent allergic asthma and hepatitis C. Ann Allergy Asthma Immunol Off Publ Am Coll Allergy Asthma Immunol. 2009 Sep;103(3):269–270.
   PubMed Web of Science ®Google Scholar
• Andersson F, Borg S, Ståhl E. The impact of exacerbations on the asthmatic patient’s preference scores. J Asthma Off J Assoc Care Asthma. 2003 Sep;40(6):615–623.
   PubMed Web of Science ®Google Scholar
• Serra-Batlles J, Plaza V, Morejón E, et al. Costs of asthma according to the degree of severity. Eur Respir J. 1998 Dec;12(6):1322–1326.
   PubMed Web of Science ®Google Scholar
• Normansell R, Walker S, Milan SJ, et al. Omalizumab for asthma in adults and children. In: Cochrane database of systematic reviews [Internet]. John Wiley & Sons; 2014; [cited 2016 Mar 1]. Available from: http://onlinelibrary.wiley.com.gate2.inist.fr/doi/10.1002/14651858.CD003559.pub4/abstract
   Google Scholar
• Humbert M, Beasley R, Ayres J, et al. Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE. Allergy. 2005 Mar;60(3):309–316.
   PubMed Web of Science ®Google Scholar
• Reddel HK, Bateman ED, Becker A, et al. A summary of the new GINA strategy: a roadmap to asthma control. Eur Respir J. 2015 Sep;46(3):622–639.
   PubMed Web of Science ®Google Scholar
• Global Strategy for Asthma Management and Prevention. 2016. Available from: http://ginasthma.org/2016-gina-report-global-strategy-for-asthma-management-and-prevention/
   Google Scholar
• Chang TW, Wu PC, Hsu CL, et al. Anti-IgE antibodies for the treatment of IgE-mediated allergic diseases. Adv Immunol. 2007;93:63–119.
   PubMed Web of Science ®Google Scholar
• MacGlashan DW, Bochner BS, Adelman DC, et al. Down-regulation of Fc(epsilon)RI expression on human basophils during in vivo treatment of atopic patients with anti-IgE antibody. J Immunol Baltim Md 1950. 1997 Feb 1;158(3):1438–1445.
   Google Scholar
• Jung CM, Prinz JC, Rieber EP, et al. A reduction in allergen-induced Fc epsilon R2/CD23 expression on peripheral B cells correlates with successful hyposensitization in grass pollinosis. J Allergy Clin Immunol. 1995 Jan;95(1 Pt 1):77–87.
   PubMed Web of Science ®Google Scholar
• Hibbert RG, Teriete P, Grundy GJ, et al. The structure of human CD23 and its interactions with IgE and CD21. J Exp Med. 2005 Sep 19;202(6):751–760.
   PubMed Web of Science ®Google Scholar
• Domingo C. Omalizumab for severe asthma: efficacy beyond the atopic patient? Drugs. 2014 Apr;74(5):521–533.
   PubMed Web of Science ®Google Scholar
• Noga O, Hanf G, Brachmann I, et al. Effect of omalizumab treatment on peripheral eosinophil and T-lymphocyte function in patients with allergic asthma. J Allergy Clin Immunol. 2006 Jun;117(6):1493–1499.
   PubMed Web of Science ®Google Scholar
• Chan MA, Gigliotti NM, Dotson AL, et al. Omalizumab may decrease IgE synthesis by targeting membrane IgE+ human B cells. Clin Transl Allergy. 2013;3(1):29.
   PubMedGoogle Scholar
• Teach SJ, Gill MA, Togias A, et al. Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations. J Allergy Clin Immunol. 2015 Dec;136(6):1476–1485.
   PubMed Web of Science ®Google Scholar
• Noga O, Hanf G, Kunkel G. Immunological and clinical changes in allergic asthmatics following treatment with omalizumab. Int Arch Allergy Immunol. 2003 May;131(1):46–52.
   PubMed Web of Science ®Google Scholar
• Roth M, Zhao F, Zhong J, et al. Serum IgE induced airway smooth muscle cell remodeling is independent of allergens and is prevented by omalizumab. PloS One. 2015;10(9):e0136549.
   PubMed Web of Science ®Google Scholar
• Riccio AM, Dal Negro RW, Micheletto C, et al. Omalizumab modulates bronchial reticular basement membrane thickness and eosinophil infiltration in severe persistent allergic asthma patients. Int J Immunopathol Pharmacol. 2012 Jun;25(2):475–484.
   PubMed Web of Science ®Google Scholar
• Hoshino M, Ohtawa J. Effects of adding omalizumab, an anti-immunoglobulin E antibody, on airway wall thickening in asthma. Respir Int Rev Thorac Dis. 2012;83(6):520–528.
   Google Scholar
• Hendeles L, Sorkness CA. Anti-immunoglobulin E therapy with omalizumab for asthma. Ann Pharmacother. 2007 Sep;41(9):1397–1410.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Xolair - Product information. 2016. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000606/WC500057298.pdf
   Google Scholar
• Hayashi N, Tsukamoto Y, Sallas WM, et al. A mechanism-based binding model for the population pharmacokinetics and pharmacodynamics of omalizumab. Br J Clin Pharmacol. 2007 May;63(5):548–561.
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration. Xolair Prescribing Information [Internet]. [ cited 2016 Aug 7]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103976s5224lbl.pdf
   Google Scholar
• Fox JA, Reitz B, Hagler K, et al. The pharmacokinetics and clearance mechanisms of anti-lgE:IgE monoclonal and polyclonal complexes. Pharm Res. 1997;14:2175.
   Google Scholar
• Kornmann O, Watz H, Fuhr R, et al. Omalizumab in patients with allergic (IgE-mediated) asthma and IgE/bodyweight combinations above those in the initially approved dosing table. Pulm Pharmacol Ther. 2014 Aug;28(2):149–153.
   PubMed Web of Science ®Google Scholar
• Riviere GJ, Yeh CM, Reynolds CV, et al. Bioequivalence of a novel omalizumab solution for injection compared with the standard lyophilized powder formulation. J Bioequiv Avail. 2011;3:144–150.
   Google Scholar
• Holgate S, Casale T, Wenzel S, et al. The anti-inflammatory effects of omalizumab confirm the central role of IgE in allergic inflammation. J Allergy Clin Immunol. 2005 Mar;115(3):459–465.
   PubMed Web of Science ®Google Scholar
• Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001 Aug;108(2):184–190.
   PubMed Web of Science ®Google Scholar
• Bousquet J, Siergiejko Z, Świebocka E, et al. Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. Allergy. 2011 May 1;66(5):671–678.
   PubMed Web of Science ®Google Scholar
• Hochhaus G, Brookman L, Fox H, et al. Pharmacodynamics of omalizumab: implications for optimised dosing strategies and clinical efficacy in the treatment of allergic asthma. Curr Med Res Opin. 2003;19(6):491–498.
   PubMed Web of Science ®Google Scholar
• Lowe PJ, Tannenbaum S, Gautier A, et al. Relationship between omalizumab pharmacokinetics, IgE pharmacodynamics and symptoms in patients with severe persistent allergic (IgE-mediated) asthma. Br J Clin Pharmacol. 2009 Jul;68(1):61–76.
   PubMed Web of Science ®Google Scholar
• Zielen S, Lieb A, De La Motte S, et al. Omalizumab protects against allergen- induced bronchoconstriction in allergic (immunoglobulin E-mediated) asthma. Int Arch Allergy Immunol. 2013;160(1):102–110.
   PubMed Web of Science ®Google Scholar
• Slavin RG, Ferioli C, Tannenbaum SJ, et al. Asthma symptom re-emergence after omalizumab withdrawal correlates well with increasing IgE and decreasing pharmacokinetic concentrations. J Allergy Clin Immunol. 2009 Jan;123(1):107–13.e3.
   PubMed Web of Science ®Google Scholar
• Milgrom H, Fick RB, Su JQ, et al. Treatment of allergic asthma with monoclonal anti-IgE antibody. rhuMAb-E25 Study Group. N Engl J Med. 1999 Dec 23;341(26):1966–1973.
   PubMed Web of Science ®Google Scholar
• Solèr M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J. 2001 Aug;18(2):254–261.
   PubMed Web of Science ®Google Scholar
• Lanier B, Bridges T, Kulus M, et al. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol. 2009 Dec;124(6):1210–1216.
   PubMed Web of Science ®Google Scholar
• Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics. 2001 Aug;108(2):E36.
   PubMed Web of Science ®Google Scholar
• Busse WW, Morgan WJ, Gergen PJ, 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.
   PubMed Web of Science ®Google Scholar
• Brodlie M, McKean MC, Moss S, et al. The oral corticosteroid-sparing effect of omalizumab in children with severe asthma. Arch Dis Child. 2012 Jul;97(7):604–609.
   PubMed Web of Science ®Google Scholar
• Bousquet J, Rabe K, Humbert M, et al. Predicting and evaluating response to omalizumab in patients with severe allergic asthma. Respir Med. 2007 Jul;101(7):1483–1492.
   PubMed Web of Science ®Google Scholar
• Brusselle G, Michils A, Louis R, et al. “Real-life” effectiveness of omalizumab in patients with severe persistent allergic asthma: The PERSIST study. Respir Med. 2009 Nov;103(11):1633–1642.
   PubMed Web of Science ®Google Scholar
• Vennera MDC, Pérez De Llano L, Bardagí S, et al. Omalizumab therapy in severe asthma: experience from the Spanish registry–some new approaches. J Asthma Off J Assoc Care Asthma. 2012 May;49(4):416–422.
   PubMed Web of Science ®Google Scholar
• Schumann C, Kropf C, Wibmer T, et al. Omalizumab in patients with severe asthma: the XCLUSIVE study. Clin Respir J. 2012 Oct;6(4):215–227.
   PubMed Web of Science ®Google Scholar
• Braunstahl G-J, Chen C-W, Maykut R, et al. The eXpeRience registry: the “real-world” effectiveness of omalizumab in allergic asthma. Respir Med. 2013 Aug;107(8):1141–1151.
   PubMed Web of Science ®Google Scholar
• Tzortzaki EG, Georgiou A, Kampas D, et al. Long-term omalizumab treatment in severe allergic asthma: the South-Eastern Mediterranean “real-life” experience. Pulm Pharmacol Ther. 2012 Feb;25(1):77–82.
   PubMed Web of Science ®Google Scholar
• Molimard M, Mala L, Bourdeix I, et al. Observational study in severe asthmatic patients after discontinuation of omalizumab for good asthma control. Respir Med. 2014 Apr;108(4):571–576.
   PubMed Web of Science ®Google Scholar
• Cazzola M, Camiciottoli G, Bonavia M, et al. Italian real-life experience of omalizumab. Respir Med. 2010 Oct;104(10):1410–1416.
   PubMed Web of Science ®Google Scholar
• Barnes N, Menzies-Gow A, Mansur AH, et al. Effectiveness of omalizumab in severe allergic asthma: a retrospective UK real-world study. J Asthma Off J Assoc Care Asthma. 2013 Jun;50(5):529–536.
   PubMed Web of Science ®Google Scholar
• Tajiri T, Niimi A, Matsumoto H, et al. Comprehensive efficacy of omalizumab for severe refractory asthma: a time-series observational study. Ann Allergy Asthma Immunol Off Publ Am Coll Allergy Asthma Immunol. 2014 Oct;113(4):470–5.e2.
   PubMed Web of Science ®Google Scholar
• Domingo C, Moreno A, José Amengual M, et al. Omalizumab in the management of oral corticosteroid-dependent IGE-mediated asthma patients. Curr Med Res Opin. 2011 Jan;27(1):45–53.
   PubMed Web of Science ®Google Scholar
• Nopp A, Johansson SGO, Adédoyin J, et al. After 6 years with Xolair; a 3-year withdrawal follow-up. Allergy. 2010 Jan 1;65(1):56–60.
   PubMed Web of Science ®Google Scholar
• Grimaldi-Bensouda L, Zureik M, Aubier M, et al. Does omalizumab make a difference to the real-life treatment of asthma exacerbations? results from a large cohort of patients with severe uncontrolled asthma. Chest. 2013 Feb 1;143(2):398–405.
   PubMed Web of Science ®Google Scholar
• Deschildre A, Marguet C, Salleron J, et al. Add-on omalizumab in children with severe allergic asthma: a 1-year real life survey. Eur Respir J. 2013 Nov;42(5):1224–1233.
   PubMed Web of Science ®Google Scholar
• Deschildre A, Marguet C, Langlois C, et al. Real-life long-term omalizumab therapy in children with severe allergic asthma. Eur Respir J. 2015 Sep;46(3):856–859.
   PubMed Web of Science ®Google Scholar
• Nopp A, Johansson SGO, Ankerst J, et al. CD-sens and clinical changes during withdrawal of Xolair after 6 years of treatment. Allergy. 2007 Oct;62(10):1175–1181.
   PubMed Web of Science ®Google Scholar
• Lowe PJ, Renard D. Omalizumab decreases IgE production in patients with allergic (IgE-mediated) asthma; PKPD analysis of a biomarker, total IgE. Br J Clin Pharmacol. 2011 Aug;72(2):306–320.
   PubMed Web of Science ®Google Scholar
• Busse W, Trazskoma B, Omachi T, et al. Evaluating omalizumab persistency of response after long-term therapy (XPORT). Eur Respir J. 2014 Sep 1;44(Suppl 58):P3485.
   Google Scholar
• Chipps BE, Carrigan G, Trzaskoma B, et al. Asthma-related health outcomes over two years among patients discontinuing omalizumab in EXCELS. In: C47 Asthma and COPD: etiology, morbidity, and mortality [Internet]. American Thoracic Society; 2014. p. A4606; [cited 2016 Aug 11]. (American Thoracic Society International Conference Abstracts). Available from: http://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2014.189.1_MeetingAbstracts.A4606
   Google Scholar
• Lanier BQ, Corren J, Lumry W, et al. Omalizumab is effective in the long-term control of severe allergic asthma. Ann Allergy Asthma Immunol Off Publ Am Coll Allergy Asthma Immunol. 2003 Aug;91(2):154–159.
   PubMed Web of Science ®Google Scholar
• Molimard M, de Blay F, Didier A, et al. Effectiveness of omalizumab (Xolair) in the first patients treated in real-life practice in France. Respir Med. 2008 Jan;102(1):71–76.
   PubMed Web of Science ®Google Scholar
• Korn S, Thielen A, Seyfried S, et al. Omalizumab in patients with severe persistent allergic asthma in a real-life setting in Germany. Respir Med. 2009 Nov;103(11):1725–1731.
   PubMed Web of Science ®Google Scholar
• Cox L, Platts-Mills TAE, Finegold I, et al. American Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma and Immunology Joint Task Force Report on omalizumab-associated anaphylaxis. J Allergy Clin Immunol. 2007 Dec;120(6):1373–1377.
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration. Postmarket Drug Safety Information for Patients and Providers - Omalizumab (marketed as Xolair) Information. 2007. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103976s5102lbl.pdf
   Google Scholar
• Haute Autorité de Santé (HAS). Transparency committee - opinion 06/06/2012. 2012. Available from: http://www.has-sante.fr/portail/upload/docs/application/pdf/2012-07/xolair_06062012_avis_ct10947_130712.pdf
   Google Scholar
• Busse W, Buhl R, Vidaurre FC, et al. Omalizumab and the risk of malignancy: results from a pooled analysis. J Allergy Clin Immunol. 2012 Apr;129(4):983–9.e6.
   PubMed Web of Science ®Google Scholar
• Long A, Rahmaoui A, Rothman KJ, et al. Incidence of malignancy in patients with moderate-to-severe asthma treated with or without omalizumab. J Allergy Clin Immunol. 2014 Sep;134(3):560–7.e4.
   PubMed Web of Science ®Google Scholar
• Namazy J, Cabana MD, Scheuerle AE, et al. The Xolair Pregnancy Registry (EXPECT): the safety of omalizumab use during pregnancy. J Allergy Clin Immunol. 2015 Feb;135(2):407–412.
   PubMed Web of Science ®Google Scholar
• Dewilde S, Turk F, Tambour M, et al. The economic value of anti-IgE in severe persistent, IgE-mediated (allergic) asthma patients: adaptation of INNOVATE to Sweden. Curr Med Res Opin. 2006 Sep;22(9):1765–1776.
   PubMed Web of Science ®Google Scholar
• Brown R, Turk F, Dale P, et al. Cost-effectiveness of omalizumab in patients with severe persistent allergic asthma. Allergy. 2007 Feb;62(2):149–153.
   PubMed Web of Science ®Google Scholar
• Campbell JD, Spackman DE, Sullivan SD. The costs and consequences of omalizumab in uncontrolled asthma from a USA payer perspective. Allergy. 2010 Sep;65(9):1141–1148.
   PubMed Web of Science ®Google Scholar
• Dal Negro RW, Pradelli L, Tognella S, et al. Cost-utility of add-on omalizumab in difficult-to-treat allergic asthma in Italy. Eur Ann Allergy Clin Immunol. 2011 Mar;43(2):45–53.
   PubMedGoogle Scholar
• Norman G, Faria R, Paton F, et al. Omalizumab for the treatment of severe persistent allergic asthma: a systematic review and economic evaluation. Health Technol Assess Winch Engl. 2013 Nov;17(52):1–342.
   PubMed Web of Science ®Google Scholar
• Garcia G, Magnan A, Chiron R, et al. A proof-of-concept, randomized, controlled trial of omalizumab in patients with severe, difficult-to-control, nonatopic asthma. Chest. 2013 Aug;144(2):411–419.
   PubMed Web of Science ®Google Scholar
• Bousquet J, Wenzel S, Holgate S, et al. Predicting response to omalizumab, an anti-IgE antibody, in patients with allergic asthma. Chest. 2004 Apr;125(4):1378–1386.
   PubMed Web of Science ®Google Scholar
• Hanania NA, Alpan O, Hamilos DL, et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011 May 3;154(9):573–582.
   PubMed Web of Science ®Google Scholar
• Abraham I, Alhossan A, Lee CS, et al. “Real-life” effectiveness studies of omalizumab in adult patients with severe allergic asthma: systematic review. Allergy. 2016 Feb 1;71:593–610.
   PubMed Web of Science ®Google Scholar