TY - JOUR
AU - Wright C.
AU - Marks G.
AU - Jenkins C.
AU - Guo M.
AU - Wark P.
AU - Gibson P.
AU - Peters M.
AU - Reddel H.
AU - Upham J.
AU - Hew M.
AU - Gillman A.
AU - Sutherland M.
AU - Bowden J.
AU - Thien F.
AU - Rimmer J.
AU - Katsoulotos G.
AU - Cook M.
AU - Yang I.
AU - Katelaris C.
AU - Bowler S.
AU - Langton D.
AU - Bint M.
AU - Yozghatlian V.
AU - Burgess S.
AU - Sivakumaran P.
AU - Yan K.
AU - Kritikos V.
AU - Baraket M.
AU - Aminazad A.
AU - Robinson P.
AU - Jaffe A.
AU - Powell H.
AU - McDonald V.
AB - <p>
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. 62% of patients receiving government-subsidised omalizumab are enrolled in the Australian Xolair Registry (AXR). OBJECTIVES: To determine if 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 or within-range). Further sub-analyses were conducted according to the reason for being above the dosing range (IgE only versus IgE and weight). RESULTS: Data for 179 participants were analyzed. 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 &lt; 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 &lt; 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 &amp; 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. This article is protected by copyright. All rights reserved.
</p>

AD - The Alfred Hospital & Monash University, Melbourne, VIC 3004.<br/>Austin Hospital, Heidelberg, VIC 3084.<br/>John Hunter Hospital, Hunter Medical Research Institute, University of Newcastle, New Lambton Heights, NSW 2305.<br/>Flinders Medical Centre, Bedford Park, SA 5042.<br/>Woolcock Institute of Medical Research, Glebe, NSW 2037.<br/>Royal Prince Alfred Hospital, Camperdown, NSW 2050.<br/>Concord Hospital, Concord, NSW 2138.<br/>Liverpool Hospital, Liverpool, NSW 2170.<br/>Box Hill Hospital, Box Hill, VIC 3128.<br/>St Vincent's Clinic, Darlinghurst, NSW 2010.<br/>St George Specialist Centre, Kogarah, NSW 2217.<br/>Canberra Hospital, WODEN, ACT 2606.<br/>The Prince Charles Hospital, Chermside, QLD 4032.<br/>Campbelltown Hospital, Campbelltown, NSW 2560.<br/>Mater Adult Hospital, South Brisbane, QLD 4101.<br/>Frankston Hospital, Frankston, VIC 3199.<br/>Nambour Hospital, QLD 4560.<br/>St George Hospital, Kogarah, NSW 2217.<br/>QLD Children's Lung and Sleep Specialists, Woolloongabba, QLD 4102.<br/>Gold Coast District Hospital, Southport, QLD 4215.<br/>Children's Hospital at Westmead, Westmead, NSW 2145.<br/>School of Women's & Children's Health, UNSW Medicine, UNSW Australia, NSW 2031.<br/>Princess Alexandra Hospital, Woolloongabba, QLD 4102.
AN - 27377155
BT - Clin Exp AllergyClinical and Experimental Allergy
CN - [IF]: 5.587
DP - NLM
ET - 2016/07/06
LA - Eng
LB - AUS<br/>RSP<br/>FY17
M1 - 11
N1 - Hew, Mark<br/>Gillman, Andrew<br/>Sutherland, Michael<br/>Wark, Peter<br/>Bowden, Jeff<br/>Guo, Michael<br/>Reddel, Helen K<br/>Jenkins, Christine<br/>Marks, Guy B<br/>Thien, Frank<br/>Rimmer, Janet<br/>Katsoulotos, Gregory P<br/>Cook, Matthew<br/>Yang, Ian<br/>Katelaris, Constance<br/>Bowler, Simon<br/>Langton, David<br/>Wright, Craig<br/>Bint, Michael<br/>Yozghatlian, Veronica<br/>Burgess, Scott<br/>Sivakumaran, Pathmanathan<br/>Yan, Kwok Y<br/>Kritikos, Vicky<br/>Peters, Matthew<br/>Baraket, Melissa<br/>Aminazad, Ali<br/>Robinson, Paul<br/>Jaffe, Adam<br/>Powell, Heather<br/>Upham, John W<br/>McDonald, Vanessa M<br/>Gibson, Peter G<br/>Clin Exp Allergy. 2016 Jul 5. doi: 10.1111/cea.12774.
N2 - <p>
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. 62% of patients receiving government-subsidised omalizumab are enrolled in the Australian Xolair Registry (AXR). OBJECTIVES: To determine if 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 or within-range). Further sub-analyses were conducted according to the reason for being above the dosing range (IgE only versus IgE and weight). RESULTS: Data for 179 participants were analyzed. 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 &lt; 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 &lt; 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 &amp; 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. This article is protected by copyright. All rights reserved.
</p>

PY - 2016
SN - 1365-2222 (Electronic)<br/>0954-7894 (Linking)
SP - 1407
EP - 1415
T2 - Clin Exp AllergyClinical and Experimental Allergy
TI - Real-life effectiveness of omalizumab in severe allergic asthma above the recommended dosing range criteria
VL - 46
Y2 - FY17
ER -