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dc.contributor.authorHew, M
dc.contributor.authorGillman, A
dc.contributor.authorSutherland, M
dc.contributor.authorWark, P
dc.contributor.authorBowden, J
dc.contributor.authorGuo, M
dc.contributor.authorReddel, HK
dc.contributor.authorJenkins, C
dc.contributor.authorMarks, GB
dc.contributor.authorThien, F
dc.contributor.authorRimmer, J
dc.contributor.authorKatsoulotos, GP
dc.contributor.authorCook, M
dc.contributor.authorSivakumaran, P
dc.contributor.authoret al.
dc.description.abstractBackground: 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 (FEV1) 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.
dc.publisherJohn Wiley & Sons
dc.relation.ispartofjournalClinical & Experimental Allergy
dc.subject.fieldofresearchNutrition and dietetics
dc.subject.fieldofresearchHealth services and systems
dc.subject.fieldofresearchPublic health
dc.subject.keywordsScience & Technology
dc.subject.keywordsLife Sciences & Biomedicine
dc.titleReal-life effectiveness of omalizumab in severe allergic asthma above the recommended dosing range criteria
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationHew, M; Gillman, A; Sutherland, M; Wark, P; Bowden, J; Guo, M; Reddel, HK; Jenkins, C; Marks, GB; Thien, F; Rimmer, J; Katsoulotos, GP; Cook, M; Sivakumaran, P; et al., Real-life effectiveness of omalizumab in severe allergic asthma above the recommended dosing range criteria, Clinical & Experimental Allergy, 2016, 46 (11), pp. 1407-1415
gro.hasfulltextNo Full Text
gro.griffith.authorSivakumaran, Pathmanathan

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