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Efficacy and safety...
Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma
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Holgate, S. T. (author)
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Chuchalin, A. G. (author)
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Hebert, J. (author)
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- Lötvall, Jan, 1956 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för invärtesmedicin, Avdelningen för lungmedicin och allergologi,Institute of Internal Medicine, Dept of Respiratory Medicine/Allergology
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Persson, G. B. (author)
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Chung, K. F. (author)
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Bousquet, J. (author)
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Kerstjens, H. A. (author)
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Fox, H. (author)
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Thirlwell, J. (author)
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Cioppa, G. D. (author)
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(creator_code:org_t)
- 2004
- 2004
- English.
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In: Clin Exp Allergy. ; 34:4
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https://gup.ub.gu.se...
Abstract
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- 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 (> or =1000 microg/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 > or =50% dose reduction (P=0.001). Fluticasone dose reduction to < or =500 microg/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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Lungmedicin och allergi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Respiratory Medicine and Allergy (hsv//eng)
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- ref (subject category)
- art (subject category)
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- By the author/editor
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Holgate, S. T.
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Chuchalin, A. G.
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Hebert, J.
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Lötvall, Jan, 19 ...
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Persson, G. B.
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Chung, K. F.
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show more...
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Bousquet, J.
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Kerstjens, H. A.
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Fox, H.
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Thirlwell, J.
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Cioppa, G. D.
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Respiratory Medi ...
- Articles in the publication
- Clin Exp Allergy
- By the university
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University of Gothenburg