Abstract
Introduction:
Omalizumab is a novel anti-IgE therapy for patients having inadequately controlled severe persistent allergic asthma with uncontrolled symptoms despite GINA 2002 step 4 therapy (inhaled ICS + LABA∓ additional controller medication as necessary). Omalizumab reduces exacerbations in these patients.
Aims and objectives:
To evaluate its efficacy, we assessed the effects of omalizumab on multiple measures of asthma control.
Subjects and methods:
Data were pooled from seven trials of omalizumab as add-on therapy in allergic asthma patients aged =12 years (93% with severe persistent asthma). Percentages of patients with =200mL increase and =200 mL decrease in forced expiratory volume in one second (FEV1) were determined and net benefit calculated (percentage with improvement minus percentage with worsening). Asthma control was rated as complete, marked improvement, discernable but limited improvement, no appreciable change, or worsening using the physician's overall assessment. Quality of life was assessed using the Asthma Quality of Life Questionnaire (AQLQ).
Results:
FEV1 data were available for 2,443 omalizumab-treated and 1,094 control patients, physician's overall assessments for 1,085 omalizumab-treated and 1,050 control patients, and AQLQ scores for 1,258 omalizumab-treated and 1,030 control patients. FEV1 increased by =200mL in 29.1% of omalizumab recipients and 26.4% of control patients and decreased by =200mL in 17.5% and 26.1%, respectively. Thus, 11.6% of omalizumab recipients had a 200mL net benefit versus 0.3% of control patients (p < 0.0001). Physicians rated omalizumab as more effective than control, with a larger percentage having complete control/marked improvement (61.3% vs 38.7%, p < 0.0001). Significantly more patients had clinically meaningful (=0.5-point) improvements in AQLQ score with omalizumab (66.3%) than control (53.2%, p < 0.0001).
Conclusions:
Omalizumab therapy had significantly greater benefits than placebo for a range of outcomes associated with asthma control in patients with predominantly severe persistent asthma.
Conflict of interest and funding
Supported by Novartis Pharma AG.
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Price, D., Fox, H., Ayre, G. et al. ABS37: Add-on omalizumab improves asthma control across multiple measures of response in patients with severe persistent allergic (IgE-mediated) asthma. Prim Care Respir J 15, 195 (2006). https://doi.org/10.1016/j.pcrj.2006.04.136
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DOI: https://doi.org/10.1016/j.pcrj.2006.04.136