Real-life effectiveness of omalizumab in severe allergic asthma above the recommended dosing range criteria

M. Hew*, A. Gillman, M. Sutherland, P. Wark, J. Bowden, M. Guo, H. K. Reddel, C. Jenkins, G. B. Marks, F. Thien, J. Rimmer, G. P. Katsoulotos, M. Cook, I. Yang, C. Katelaris, S. Bowler, D. Langton, C. Wright, M. Bint, V. YozghatlianS. Burgess, P. Sivakumaran, K. Y. Yan, V. Kritikos, M. Peters, M. Baraket, A. Aminazad, P. Robinson, A. Jaffe, H. Powell, J. W. Upham, V. M. McDonald, P. G. Gibson

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

29 Citations (Scopus)


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 (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.

Original languageEnglish
Pages (from-to)1407-1415
Number of pages9
JournalClinical and Experimental Allergy
Issue number11
Publication statusPublished - 1 Nov 2016
Externally publishedYes


  • asthma
  • dosing range
  • omalizumab


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