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Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma

Holgate, S. T.; Chuchalin, A. G.; Hebert, J.; Lotvall, J.; Persson, Bo G LU ; Chung, K. F.; Bousquet, J.; Kerstjens, H. A.; Fox, H. and Thirlwell, J., et al. (2004) In Clinical and Experimental Allergy 34(4). p.632-638
Abstract
Background Patients with severe asthma are often inadequately controlled on existing anti-asthma therapy, constituting an unmet clinical need. Objective This randomized, double-blind, placebo-controlled trial evaluated the ability of omalizumab, a humanized monoclonal anti-IgE antibody, to improve disease control sufficiently to enable inhaled corticosteroid reduction in patients with severe allergic asthma. Methods After a run-in period when an optimized fluticasone dose (greater than or equal to1000 mug/day) was received for 4 weeks, patients were randomized to receive subcutaneous omalizumab [minimum 0.016 mg/kg/IgE (IU/mL) per 4 weeks; n=126] or matching placebo (n=120) at intervals of 2 or 4 weeks. The study comprised a 16-week add-on... (More)
Background Patients with severe asthma are often inadequately controlled on existing anti-asthma therapy, constituting an unmet clinical need. Objective This randomized, double-blind, placebo-controlled trial evaluated the ability of omalizumab, a humanized monoclonal anti-IgE antibody, to improve disease control sufficiently to enable inhaled corticosteroid reduction in patients with severe allergic asthma. Methods After a run-in period when an optimized fluticasone dose (greater than or equal to1000 mug/day) was received for 4 weeks, patients were randomized to receive subcutaneous omalizumab [minimum 0.016 mg/kg/IgE (IU/mL) per 4 weeks; n=126] or matching placebo (n=120) at intervals of 2 or 4 weeks. The study comprised a 16-week add-on phase of treatment followed by a 16-week fluticasone-reduction phase. Short-/long-acting beta(2)-agonists were allowed as needed. Results Median reductions in fluticasone dose were significantly greater with omalizumab than placebo: 60% vs. 50% (P=0.003). Some 73.8% and 50.8% of patients, respectively, achieved a greater than or equal to50% dose reduction (P=0.001). Fluticasone dose reduction to less than or equal to500 mug/day occurred in 60.3% of omalizumab recipients vs. 45.8% of placebo-treated patients (P=0.026). Through both phases, omalizumab reduced rescue medication requirements, improved asthma symptoms and asthma-related quality of life compared to placebo. Conclusion Omalizumab treatment improves asthma control in severely allergic asthmatics, reducing inhaled corticosteroid requirements without worsening of symptom control or increase in rescue medication use. (Less)
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keywords
quality of life, fluticasone, IgE, allergic asthma, omalizumab, monoclonal antibody, POLLEN, RHINITIS, ASTHMA, COMPLEX-FORMATION, CHILDHOOD, QUALITY-OF-LIFE, IGE MONOCLONAL-ANTIBODY
in
Clinical and Experimental Allergy
volume
34
issue
4
pages
632 - 638
publisher
Wiley-Blackwell
external identifiers
  • other:10.1111/j.1365-2222.2004.1916.x
  • scopus:11144356805
ISSN
1365-2222
DOI
10.1111/j.1365-2222.2004.1916.x
language
English
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yes
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68fed794-0da5-4428-8f27-21232bf54724 (old id 1416901)
date added to LUP
2009-06-16 11:31:43
date last changed
2017-12-10 03:43:29
@article{68fed794-0da5-4428-8f27-21232bf54724,
  abstract     = {Background Patients with severe asthma are often inadequately controlled on existing anti-asthma therapy, constituting an unmet clinical need. Objective This randomized, double-blind, placebo-controlled trial evaluated the ability of omalizumab, a humanized monoclonal anti-IgE antibody, to improve disease control sufficiently to enable inhaled corticosteroid reduction in patients with severe allergic asthma. Methods After a run-in period when an optimized fluticasone dose (greater than or equal to1000 mug/day) was received for 4 weeks, patients were randomized to receive subcutaneous omalizumab [minimum 0.016 mg/kg/IgE (IU/mL) per 4 weeks; n=126] or matching placebo (n=120) at intervals of 2 or 4 weeks. The study comprised a 16-week add-on phase of treatment followed by a 16-week fluticasone-reduction phase. Short-/long-acting beta(2)-agonists were allowed as needed. Results Median reductions in fluticasone dose were significantly greater with omalizumab than placebo: 60% vs. 50% (P=0.003). Some 73.8% and 50.8% of patients, respectively, achieved a greater than or equal to50% dose reduction (P=0.001). Fluticasone dose reduction to less than or equal to500 mug/day occurred in 60.3% of omalizumab recipients vs. 45.8% of placebo-treated patients (P=0.026). Through both phases, omalizumab reduced rescue medication requirements, improved asthma symptoms and asthma-related quality of life compared to placebo. Conclusion Omalizumab treatment improves asthma control in severely allergic asthmatics, reducing inhaled corticosteroid requirements without worsening of symptom control or increase in rescue medication use.},
  author       = {Holgate, S. T. and Chuchalin, A. G. and Hebert, J. and Lotvall, J. and Persson, Bo G and Chung, K. F. and Bousquet, J. and Kerstjens, H. A. and Fox, H. and Thirlwell, J. and Della Cioppa, G.},
  issn         = {1365-2222},
  keyword      = {quality of life,fluticasone,IgE,allergic asthma,omalizumab,monoclonal antibody,POLLEN,RHINITIS,ASTHMA,COMPLEX-FORMATION,CHILDHOOD,QUALITY-OF-LIFE,IGE MONOCLONAL-ANTIBODY},
  language     = {eng},
  number       = {4},
  pages        = {632--638},
  publisher    = {Wiley-Blackwell},
  series       = {Clinical and Experimental Allergy},
  title        = {Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma},
  url          = {http://dx.doi.org/10.1111/j.1365-2222.2004.1916.x},
  volume       = {34},
  year         = {2004},
}