Omalizumab: An effective anti-IgE treatment for allergic asthma and rhinitis

Drugs of Today

Volumn 40, Issue 4, 2004, Pages 367-376

  Casale, Thomas B ^a,b  

^a CREIGHTON UNIVERSITY   (United States)

^b Medical Information Department   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

BECLOMETASONE; BETA ADRENERGIC RECEPTOR STIMULATING AGENT; CORTICOSTEROID; FLUTICASONE; IMMUNOGLOBULIN E; IMMUNOGLOBULIN E ANTIBODY; OMALIZUMAB;

ALLERGIC ASTHMA; ALLERGIC DISEASE; ALLERGIC RHINITIS; ANAPHYLAXIS; BLEEDING; CLINICAL TRIAL; DISEASE SEVERITY; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INHIBITION; DRUG MECHANISM; DRUG RECEPTOR BINDING; DRUG SAFETY; FEVER; FLU LIKE SYNDROME; HEADACHE; HUMAN; IMMUNOGLOBULIN BLOOD LEVEL; IMMUNOMODULATION; INJECTION PAIN; INJECTION SITE; MALIGNANT NEOPLASTIC DISEASE; META ANALYSIS; PATHOPHYSIOLOGY; PHARYNGITIS; QUALITY OF LIFE; RASH; REVIEW; SERUM SICKNESS; SIDE EFFECT; SINUSITIS; SKIN INDURATION; SYSTEMATIC REVIEW; UPPER RESPIRATORY TRACT INFECTION; URTICARIA; VIRUS INFECTION;

ANTI-ALLERGIC AGENTS; ANTI-ASTHMATIC AGENTS; ANTIBODIES, MONOCLONAL; ASTHMA; CLINICAL TRIALS; DRUG APPROVAL; HUMANS; IMMUNOGLOBULIN E; QUALITY OF LIFE; RHINITIS, ALLERGIC, PERENNIAL; RHINITIS, ALLERGIC, SEASONAL;

EID: 2642580241     PISSN: 16993993     EISSN: 16994019     Source Type: Journal    
DOI: 10.1358/dot.2004.40.4.820082     Document Type: Review

References (45)

1. National Institutes of Health, National Heart, Lung, and Blood Institute. Guidelines for the diagnosis and management of asthma expert panel report 2. National Institutes of Health, Bethesda, MD, NIH publication 1997, 97-4051.
2. Weiss, K.B., Sullivan, S.D. The health economics of asthma and rhinitis 1. Assessing the economic impact. J Allergy Clin Immunol 2001, 107: 3-8.
3. Barnes, P.J. Anti-IgE therapy in asthma: Rationale and therapeutic potential. Int Arch Allergy Immunol 2000, 123: 196-204.
4. Burrows, B., Martínez, F.D., Halonen, M., Barbee, R.A., Cline, M.G. Association of asthma with serum IgE levels and skin-test reactivity to allergens. N Engl J Med 1989, 320: 271-7.
5. Oettgen, H.C., Geha, R.S. IgE regulation and roles in asthma pathogenesis. J Allergy Clin Immunol 2001, 107: 429-41.
6. Xolair®. Omalizumab for subcutaneous use. Summary of Product Characteristics, Genentech Inc.
7. Presta, L.G., Lahr, S.J., Shields, R.L. et al. Humanization of an antibody directed against IgE. J Immunol 1993, 151: 2623-32.
8. Johansson, S.G.O., Gupta, N., Van As, A. Omalizumab, an anti-immunoglobulin E antibody, is not associated with an increased risk of immunological reactions. Eur Respir J 2002, 20 (Suppl. 38): Abst. P741.
9. MacGlashen, D.W.J., Bochner, B.S., Adelman, D.C. et al. Down regulation of FcεR1 expression on human basophils during in vivo treatment of atopic patients with anti-IgE antibody. J Immunol 1997, 158: 1438-45.
10. Lin, H., Boesel, K.M., Griffith, D.T. et al. Omalizumab rapidly decreases nasal allergic response and FcεR1 on basophils. J Allergy Clin Immunol 2004, 113: 297-302.
11. Prussin, C., Griffith, D.T., Boesel, K.M. et al. Omalizumab treatment downregulates dendritic cell FcεR1 expression. J Allergy Clin Pharmacol 2003, 112: 1147-54.
12. Djukanovic, R. et al. Omalizumab, an anti-IgE antibody, suppresses airway inflammation in mild allergic asthma via a reduction in mast cell surface-associated interleukin-4. World Allergy Organ Congr (Sept 7-Sept 12, Vancouver) 2003, Abst. O-17-3.
13. Silkoff, P.E., Romero, F., Tran, Z.V. et al. Exhaled NO in children on a recombinant humanized monoclonal antibody, rhuMAb-E25 (omalizumab), during with drawal of corticosteroids. Am J Respir Crit Care Med 2001, 163 (5, Suppl.): A858.
14. Noga, O., Hanf, G., Kirchhof, E., Buettner, C., Kunkel, G. Treatment with omalizumab (rhuMAbE25), a monoclonal anti-IgE antibody induces effective changes in subjects with allergic asthma. Eur Respir J 2001, 18 (Suppl. 33): Abst. P345.
15. Fahy, J.V., Fleming, H.E., Wong, H.H. et al. The effect of an anti-IgE monoclonal antibody on the early-and late-phase responses to allergen inhalation in asthmatic subjects. Am J Respir Crit Care Med 1997; 155: 1828-34.
16. Togias, A., Corren, J., Shapiro, G. et al. Anti-IgE treatment reduces skin test (ST) reactivity. J Allergy Clin Immunol 1998, 101: S171.
17. Fox, J.A., Hotaling, T.E., Struble, C. Tissue distribution and complex formation with IgE on anti-IgE Ab after IV administration in cynomolgus monkeys. J Pharmacol Exp Ther 1996, 279: 1000-8.
18. Marian, M., Sun, Y.N., Sinclair, D., et al. Clinical pharmacokinetics (PK) and IgE pharmacodynamics (PD) of omalizumab, a recombinant humanized monoclonal antibody to IgE. Clin Pharmacol Ther 2001, 69: Abst. PI-23.
19. Howes, T. et al. Omalizumab, an anti-IgE antibody, decreases exacerbations in patients with poorly controlled allergic asthma. 99th Int Conf Am Thorac Soc (May 16-May 21, Seattle) 2003, A767.
20. Chipps, B., Kim, K., Korenblat, P., Deniz, Y., Zheng, B., Carroll, A. Effect of omalizumab on healthcare utilization in patients with moderate to severe allergic asthma. J Allergy Clin Immunol 2003, 111 (2, Part. 2): Abst. 301.
21. Milgrom, H., Fick, R.B. Jr., Su, J.Q. et al. Treatment of allergic asthma with monoclonal anti-IgE antibody. New Engl J Med 1999, 341: 1966-73.
22. Busse, W., Corren, J., Lanier, B.Q. et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol 2001, 108: 184-90.
23. Soler, M., Matz, J., Townley, R., et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J 2001, 18: 254-61.
24. Milgrom, H., Berger, W., Nayak, A. et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics 2001, 108: E36.
25. Tillinghast, J., Lanier, B.Q., Busse, W., et al. Omalizumab significantly increases time to first asthma exacerbation compared with placebo. Allergy 2001, 56 (Suppl. 68): Abst. 283.
26. Finn, A. et al. Omalizumab improves asthma-related quality of life in patients with severe allergic asthma. J Allergy Clin Immunol 2003, 111: 278-84.
27. Lemanske, R.F., Nayak, A., McAlary, M., Everhand, F., Fowler-Taylor, A., Gupta, N. Omalizumab improves asthma-related quality of life in children with allergic asthma. Pediatrics 2002, 110: e55.
28. Lanier, B.Q., Corren, J., Lumry, W. et al. Omalizumab is effective in the long-term control of severe allergic asthma. Ann Allergy Asthma Immunol 2003, 91: 154-9.
29. Buhl, R., Soler, M., Matz, J. et al. Omalizumab provides long-term control in patients with moderate-to-severe allergic asthma. Eur Respir J 2002, 20: 73-8.
30. Berger, W. et al. Evaluation of long-term safety of the anti-IgE antibody, omalizumab, in children with allergic asthma. Ann Allergy Asthma Immunol 2003, 91: 182-8.
31. Corren, J., Casale, T., Deniz, Y., Ashby, M. Omalizumab, a recombinant humanized anti-IgE antibody, reduces asthma-related emergency room visits and hospitalizations in patients with allergic asthma. J Allergy Clin Immunol 2003, 111: 87-90.
32. Holgate, S., Bousquet, J., Wenzel, S., Fox, H., Liu, J., Castellsague, J. Efficacy of omalizumab, an anti-immunoglobulin E antibody, in patients with allergic asthma at high risk of serious asthma-related morbidity and mortality. Curr Med Res Opin 2001, 17: 233-40.
33. Holgate, S., Chuchalin, A., Herbert, J. et al. Omalizumab, a novel therapy for severe allergic asthma. Eur Respir J 2001, 18 (Suppl. 33): Abst. P346.
34. Holgate, S., Chung, K.F., Bousquet, J., Fox, H., Surrey, K. Greatest benefit from omalizumab treatment in patients with more severe asthma. 21st Congr Eur Acad Allergol Clin Immunol (June 1-5, Naples) 2002, Abst. 24.
35. Holgate, S., Chuchalin, A., Herbert, J. et al. Omalizumab improves asthma-specific quality of life in patients with severe allergic asthma. Eur Respir J 2001, 18 (Suppl. 33): Abst. P348.
36. Adelroth, E., Rak, S., Haahtela, T. et al. Recombinant humanized MAb-E25, an anti-IgE MAb, in birch pollen-induced seasonal allergic rhinitis. J Allergy Clin Immunol 2000, 106: 253-9.
37. Casale, T.B., Condemi, J., LaForce, C. et al. Effect of omalizumab on symptoms of seasonal allergic rhinitis. A randomized controlled trial. JAMA 2001, 286: 2956-67.
38. Casale, T.B., Bernstein, I.L., Busse, W.W. et al. Use of an anti-IgE humanized monoclonal antibody in ragweed-induced allergic rhinitis. J Allergy Clin Immunol 1997, 100: 110-21.
39. Kuehr, J., Brauburger, J., Zielen, S. et al. Efficacy of combination treatment with anti-IgE plus specific immunotherapy in polysensitized children and adolescents with seasonal allergic rhinitis. J Allergy Clin Immunol 2002, 109: 274-80.
40. Kopp, M.V., Mayatepek, E., Engels, E. et al. Urinary leukotriene E4 levels in children with allergic rhinitis treated with specific immunotherapy and anti-IgE (omalizumab). Pediatr Allergy Immunol 2003, 14: 401-4.
41. Chervinsky, P., Casale, T., Townley, R. et al. Omalizumab, an anti-IgE antibody, in the treatment of adults and adolescents with perennial allergic rhinitis. Ann Allergy Asthma Immunol 2003, 91: 160-7.
42. Boulet, L.P. et al. Omalizumab, an anti-IgE antibody, provides parallel improvements in symptoms of allergic asthma and perennial allergic rhinitis in patients with both diseases: The SOLAR study. Chest [69th Annu Meet Amer Coll Chest Phys (ACCP) (Oct 25-30, Orlando)] 2003, 124 (4, Suppl.): 105S.
43. Schoenwetter, W., Gupta, N., Liu, J. et al. Omalizumab, an anti-immunoglobulin E antibody, is well tolerated in patients with allergic diseases of the airways. Chest 2002, 122 (4, Suppl.): Abst. P118.
44. Nayak, A., Casale, T., Miller, D. et al. Tolerability of retreatment with omalizumab, a recombinant humanized monoclonal anti-IgE antibody, during a second ragweed pollen season in patients with seasonal allergic rhinitis. Allergy Asthma Proc 2003, 24: 323-9.
45. Prous Science Integrity: Omalzimab. Available from URL:http://integrity.prous.com. Accessed Nov 10, 2003.