1. Real-life effectiveness of omalizumab in severe allergic asthma above the recommended dosing range criteria.
- Author
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Hew, M., Gillman, A., Sutherland, M., Wark, P., Bowden, J., Guo, M., Reddel, H. K., Jenkins, C., Marks, G. B., Thien, F., Rimmer, J., Katsoulotos, G. P., Cook, M., Yang, I., Katelaris, C., Bowler, S., Langton, D., Wright, C., Bint, M., and Yozghatlian, V.
- Subjects
ASTHMA treatment ,ALLERGIES ,IMMUNOGLOBULIN E ,DRUG dosage ,QUALITY of life ,OMALIZUMAB - Abstract
Background Omalizumab (Xolair) dosing in severe allergic asthma is based on serum IgE and bodyweight. In Australia, patients eligible for omalizumab but exceeding recommended ranges for IgE (30-1500 IU/mL) and bodyweight (30-150 kg) may still receive a ceiling dose of 750 mg/4 weeks. About 62% of patients receiving government-subsidized omalizumab are enrolled in the Australian Xolair Registry ( AXR). Objectives To determine whether AXR participants above the recommended dosing ranges benefit from omalizumab and to compare their response to within-range participants. Methods Data were stratified according to dose range status (above-range or within-range). Further sub-analyses were conducted according to the reason for being above the dosing range (IgE only vs. IgE and weight). Results Data for 179 participants were analysed. About 55 (31%) were above recommended dosing criteria; other characteristics were similar to within-range participants. Above-range participants had higher baseline IgE [812 ( IQR 632, 1747) IU/mL vs. 209 ( IQR 134, 306) IU/mL] and received higher doses of omalizumab [750 ( IQR 650, 750) mg] compared to within-range participants [450 ( IQR, 300, 600) mg]. At 6 months, improvements in Juniper 5-item Asthma Control Questionnaire ( ACQ-5, 3.61 down to 2.01 for above-range, 3.47 down to 1.93 for within-range, P < 0.0001 for both) and Asthma Quality of Life Questionnaire ( AQLQ mean score (3.22 up to 4.41 for above-range, 3.71 up to 4.88 for within-range, P < 0.0001) were observed in both groups. Forced expiratory volume in one second ( FEV
1 ) improved among above-range participants. There was no difference in response between above-range and within-range participants. Above-range participants due to either IgE alone or IgE and weight had similar improvements in ACQ-5, AQLQ and FEV1 . Conclusions and Clinical Relevance Patients with severe allergic asthma above recommended dosing criteria for omalizumab have significantly improved symptom control, quality of life and lung function to a similar degree to within-range participants, achieved without dose escalation above 750 mg. [ABSTRACT FROM AUTHOR]- Published
- 2016
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