• 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 Yozghatlian, S 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, and P G Gibson.
• The Alfred Hospital & Monash University, Melbourne, Vic., Australia. m.hew@alfred.org.au.
• Clin. Exp. Allergy. 2016 Nov 1; 46 (11): 1407-1415.

BackgroundOmalizumab (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).ObjectivesTo determine whether AXR participants above the recommended dosing ranges benefit from omalizumab and to compare their response to within-range participants.MethodsData 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).ResultsData 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 RelevancePatients 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.© 2016 John Wiley & Sons Ltd.

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