Clinical Reviews in Allergy & Immunology

, Volume 29, Issue 1, pp 3–16 | Cite as

Omalizumab in asthma

Approval and postapproval experience
Article

Abstract

Omalizumab is a humanized mouse monoclonal antibody that binds specificially to the constant region of the immunoglobulin (Ig)E heavy chain. Omalizumab exerts its effects by reducing free serum IgE levels and FcɛRI expression on several cell types. These effects have been shown to result in decreased airway inflammation and clinical improvement. In multiple studies, omalizumab has been shown to be efficacious in the treatment of moderate-to-severe persistent asthma and is currently approved by the US Food and Drug Administration for the treatment of moderate-to-severe allergic asthma in patients age 12 yr and older. Moreover, omalizumab has been demonstrated to be effective in the treatment of children and adults with seasonal and perennial allergic rhinitis. Postmarketing surveillance has shown omalizumab to be a relatively safe and well-tolerated medication.

Index Entries

Omalizumab anti-IgE asthma rhinitis allergies 

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References

  1. 1.
    Ishizaka, K., Ishizaka, T., and Terry, W. D. (1967), J. Immunol. 99, 849–858.PubMedGoogle Scholar
  2. 2.
    Sutton, B. J. and Gould, H. J. (1993), Nature 366, 421–428.PubMedCrossRefGoogle Scholar
  3. 3.
    Hamelmann, E., Rolinck-Wernighaus, C., and Wahn, U. (2002), Allergy 57, 983–994.PubMedCrossRefGoogle Scholar
  4. 4.
    MacGlashan, D., Lichtenstein, L. M., McKenzie-White, J., et al. (1999), J. Allergy Clin. Immunol. 104, 492–498.PubMedCrossRefGoogle Scholar
  5. 5.
    Kisselgof, A. B. and Oettgen, H. C. (1998), Int. Immunol. 10, 1377–1384.PubMedCrossRefGoogle Scholar
  6. 6.
    Tsicopoulos, A. and Joseph, M. (2000), Clin. Exp. Allergy 30, 602.PubMedCrossRefGoogle Scholar
  7. 7.
    Presta, L. G., Lahr, S. J., Shields, R. L., et al. (1993), J. Immunol. 151, 2623–2632.PubMedGoogle Scholar
  8. 8.
    Shields, R. L., Werther, W. R., Zioncheck, K., et al. (1995), Int. Arch. Allergy Immunol. 107, 308–312.PubMedGoogle Scholar
  9. 9.
    Liu, J., Lester, P., Builder, S., and Shire, S. J. (1995), Biochemistry 34(33), 10,474–10,482.CrossRefGoogle Scholar
  10. 10.
    Easthope, S. and Jarvis, B. (2001), Drugs 61, 253–260.PubMedCrossRefGoogle Scholar
  11. 11.
    Omalizumab (Xolair): An anti-IgE antibody for asthma. In: The Medical Letter on Drugs and Therapeutics, The Medical Letter, Inc., New Rochelle, NY 2003;45, 67.Google Scholar
  12. 12.
    MacGlashan, D. W. Jr., Bochner, B. S., Adelman, D. C., et al. (1997), J. Immunol. 158, 1438–1445.PubMedGoogle Scholar
  13. 13.
    Lin, H., Boesel, K. M., Griffith, D. T., et al. (2004), J. Allergy Clin. Immunol. 113, 297–302.PubMedCrossRefGoogle Scholar
  14. 14.
    Prussin, C., Griffith, D. T., Boesel, K. M., et al. (2003), J. Allergy Clin. Immunol. 112, 1147–1154.PubMedCrossRefGoogle Scholar
  15. 15.
    Maurer, D., Fiebiger, E., Reininger, B., et al. (1998), J. Immunol. 161, 2731–2739.PubMedGoogle Scholar
  16. 16.
    Rissoan, M. C., Soumelis, V., Kadowaki, N., et al. (1999), Science 283, 1183–1186.PubMedCrossRefGoogle Scholar
  17. 17.
    Foster, B., Metcalfe, D. D., and Prussin, C. (2003), J. Allergy Clin. Immunol. 112, 1132–1138.PubMedCrossRefGoogle Scholar
  18. 18.
    Beck, L. A., Marcotte, G. V., MacGlashan, D., Togias, A., and Saini, S. (2004), J. Allergy Clin. Immunol. 114, 527–530.PubMedCrossRefGoogle Scholar
  19. 19.
    Ong, Y. E., Menzies-Gow, A., Matthews, J., and Kay, A. B. (2004), J. Allergy Clin. Immunol. 113(Suppl.), S84.Google Scholar
  20. 20.
    Togias, A., Corren, J., Shapiro, G., et al. (1998), J. Allergy Clin. Immunol. 101(Suppl.), S171.Google Scholar
  21. 21.
    Fahy, J. V., Flemin, H. E., Won, H. H., et al. (1997), Am. J. Respir. Crit. Care Med. 155, 1828–1834.PubMedGoogle Scholar
  22. 22.
    Boulet, L. P., Chapman, K. R., Cote, J., et al. (1997), Am. J. Respir. Crit. Care Med. 155, 1835–1840.PubMedGoogle Scholar
  23. 23.
    Noga, O., Hanf, G., and Kunkel, G. (2003), Int. Arch. Allergy Immunol. 131, 46–52.PubMedCrossRefGoogle Scholar
  24. 24.
    Djukanovic, R., Wilson, S. J., Kraft, M., et al. (2004), Am. J. Respir. Crit. Care Med. 170, 583–593.PubMedCrossRefGoogle Scholar
  25. 25.
    Joos, G. F., O’Connor, B., Anderson, S. D., et al. (2003), Eur. Respir. J. 21, 1050–1068.PubMedCrossRefGoogle Scholar
  26. 26.
    Silkoff, P. E., McClean, P. A., Slutsky, A. S., et al. (1998), J. Asthma 35, 473–479.PubMedGoogle Scholar
  27. 27.
    Barnes, P. J. and Kharitonov, S. A. (1996), Thorax 51, 233–237.PubMedGoogle Scholar
  28. 28.
    Silkoff, P. E., Romero, F. A., Gupta, N., Townley, R. G., and Milgrom, H. (2004), Pediatrics 113, 308–312.CrossRefGoogle Scholar
  29. 29.
    Milgrom, H., Fick, R. B., Su, J. Q., et al. (1999), N. Engl. J. Med. 341, 1966–1973.PubMedCrossRefGoogle Scholar
  30. 30.
    Busse, W., Corren, J., Lanier, B. Q., et al. (2001), J. Allergy Clin. Immunol. 108, 184–190.PubMedCrossRefGoogle Scholar
  31. 31.
    Milgrom, H., Berger, W., Nayak, A., et al. (2001), Pediatrics 108, E36.Google Scholar
  32. 32.
    Solér, M., Matz, J., Townley, R., et al. (2001), Eur. Respir. J. 18, 254–261.PubMedCrossRefGoogle Scholar
  33. 33.
    Package insert. Xolair (omalizumab). East Hanover, NJ: Aventis, June 2003.Google Scholar
  34. 34.
    Prescribing information: summary of product characteristics. Available at: http://www.xolair.com. Last accessed: January 2005.Google Scholar
  35. 35.
    Brownell, J. and Casale, T. B. (2004), Immunol. Allergy Clin. N. Am. 24, 551–568.CrossRefGoogle Scholar
  36. 36.
    Corren, J., Casale, T. B., Deniz, Y., et al. (2003), J. Allergy Clin. Immunol. 111, 87–90.PubMedCrossRefGoogle Scholar
  37. 37.
    Bousquet, J., Wenzel, S., Holgate, S., et al. (2004), Chest 125, 1378–1386.PubMedCrossRefGoogle Scholar
  38. 38.
    Holgate, S. T., Chuchalin, A. G., Hebert, J., et al. (2004), Clin. Exp. Allergy 34, 632–638.PubMedCrossRefGoogle Scholar
  39. 39.
    Ayres, J. G., Higgins, B., Chilvers, E. R., Ayre, G., Blogg, M., and Fox, H. (2004), Allergy 59, 701–708.PubMedCrossRefGoogle Scholar
  40. 40.
    Oba, Y. and Salzman, G. A. (2004), J. Allergy Clin. Immunol. 114, 265–269.PubMedCrossRefGoogle Scholar
  41. 41.
    Bousquet, J., Cabrera, P., Berkman, N., et al. (2005), Allergy 60, 302–308.PubMedCrossRefGoogle Scholar
  42. 42.
    Humbert, M., Beasley, R., Ayres, J., et al. (2005), Allergy 60, 309–316.PubMedCrossRefGoogle Scholar
  43. 43.
    Dykewicz, M. S. and Fineman, S. (1998), Ann. Allergy Asthma Immunol. 81, 478–518.PubMedGoogle Scholar
  44. 44.
    Blaiss, M. S. (1999), Ann. Allergy Asthma. Immunol. 83, 449–454.PubMedGoogle Scholar
  45. 45.
    Bousquet, J., van Cauwenberge, P., and Khaltaev, N. (2001), J. Allergy Clin. Immunol. 108, S147-S336.PubMedCrossRefGoogle Scholar
  46. 46.
    Dykewicz, M. S. (2001), Immunol. Allergy Clin. N. Am. 21, 427.CrossRefGoogle Scholar
  47. 47.
    Greenberger, P. A. (2004), Allergy Asthma Proc. 25, 89–93.PubMedGoogle Scholar
  48. 48.
    Corren, J., Manning, B. E., Thompson, S. F., et al. (2004), J. Allergy Clin. Immunol. 113, 415–419.PubMedCrossRefGoogle Scholar
  49. 49.
    Adelroth, E., Rak, S., Haahtela, T., et al. (2000), J. Allergy Clin. Immunol. 106, 253–259.PubMedCrossRefGoogle Scholar
  50. 50.
    Casale, T. B., Condemi, J., LaForce, C., et al. (2001), JAMA 286, 2956–2967.PubMedCrossRefGoogle Scholar
  51. 51.
    Chervinsky, P., Casale, T., Townley, R., et al. (2003), Ann. Allergy Asthma Immunol. 91, 160–167.PubMedGoogle Scholar
  52. 52.
    Hanf, G., Noga, O., O’Connor, A., and Kunkel, G. (2004), Eur. Respir. J. 23, 414–418.PubMedCrossRefGoogle Scholar
  53. 53.
    Vignola, A. M., Humbert, M., Bousquet, J., et al. (2004), Allergy 59, 709–717.PubMedCrossRefGoogle Scholar
  54. 54.
    Schoenwetter, W., Gupta, N., Liu, J., et al. (2002), Eur. Respir. J. 20(Suppl 38), [abstract] P741.Google Scholar
  55. 55.
    Berger, W., Gupta, N., McAlary, M., et al. (2003), Ann. Allergy Asthma Immunol. 91, 182–188.PubMedCrossRefGoogle Scholar
  56. 56.
    Casale, T. B. (2001), J. Allergy Clin. Immunol. 108(2), S84-S88.PubMedCrossRefGoogle Scholar
  57. 57.
    Heusser, C. and Jardieu, P. (1997), Curr. Opin. Immunol. 9, 805–814.PubMedCrossRefGoogle Scholar
  58. 58.
    Shields, R. L., Werther, W. R., Zioncheck, K., et al. (1995), Int. Arch. Allergy Immunol. 107, 412,413.PubMedCrossRefGoogle Scholar
  59. 59.
    Schoenhoff, M., Lin, Y., Froehlich, J., Fick, R., and Bates, D. (1995), Pharm. Res. 12, 411.Google Scholar
  60. 60.
    Fox, J. A., Hotaling, T. E., Struble, C., et al. (1996), J. Pharmacol. Exp. Ther. 279, 1000–1008.PubMedGoogle Scholar
  61. 61.
    Casale, T. B., Kline, J. N., Busse, W. W., et al. (2005), J. Allergy Clin. Immunol. 115(2), S65.Google Scholar
  62. 62.
    Kline, J. N., Casale, T. B., Busse, W. W., et al. (2005), J. Allergy Clin. Immunol. 115(2), S207.Google Scholar

Copyright information

© Humana Press Inc 2005

Authors and Affiliations

  • Dean T. Chiang
    • 1
  • Justin Clark
    • 1
  • Thomas B. Casale
    • 1
  1. 1.Division of Allergy and ImmunologyCreighton University Medical CenterOmaha

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