title: Real-life effectiveness of omalizumab in severe allergic asthma above the recommended dosing range criteria.
abstract: 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).
  
  
  
  To determine whether AXR participants above the recommended dosing ranges benefit from omalizumab and to compare their response to within-range participants.
  
  
  
  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).
  
  
  
  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.
  
  
  
  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.
authors.affiliation: The Alfred Hospital & Monash University, Melbourne, Vic., Australia. m.hew@alfred.org.au.
authors.forename: M
authors.initials: M
authors.lastname: Hew
authors.affiliation: The Alfred Hospital & Monash University, Melbourne, Vic., Australia.
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authors.lastname: Gillman
authors.affiliation: Austin Hospital, Heidelberg, Vic., Australia.
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authors.lastname: Sutherland
authors.affiliation: Hunter Medical Research Institute, John Hunter Hospital, University of Newcastle, New Lambton Heights, NSW, Australia.
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authors.affiliation: Flinders Medical Centre, Bedford Park, SA, Australia.
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authors.affiliation: Woolcock Institute of Medical Research, Glebe, University of Sydney NSW, Australia.
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authors.lastname: Guo
authors.affiliation: Royal Prince Alfred Hospital, Camperdown, NSW, Australia.
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authors.initials: HK
authors.lastname: Reddel
authors.affiliation: Concord Hospital, Concord, NSW, Australia.
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authors.lastname: Jenkins
authors.affiliation: Liverpool Hospital, Liverpool, NSW, Australia.
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authors.affiliation: Box Hill Hospital, Box Hill, Vic., Australia.
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authors.affiliation: St Vincent's Clinic, Darlinghurst, NSW, Australia.
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authors.lastname: Rimmer
authors.affiliation: St George Specialist Centre, Kogarah, NSW, Australia.
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authors.initials: GP
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authors.affiliation: Canberra Hospital, Woden, ACT, Australia.
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authors.affiliation: The Prince Charles Hospital, Chermside, Qld, Australia.
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authors.affiliation: Campbelltown Hospital, Campbelltown, NSW, Australia.
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authors.affiliation: Mater Adult Hospital, South Brisbane, Qld, Australia.
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authors.lastname: Bowler
authors.affiliation: Frankston Hospital, Frankston, Vic., Australia.
authors.forename: D
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authors.lastname: Langton
authors.affiliation: Nambour Hospital, Nambour, Qld, Australia.
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authors.affiliation: Nambour Hospital, Nambour, Qld, Australia.
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authors.lastname: Bint
authors.affiliation: St George Hospital, Kogarah, NSW, Australia.
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authors.lastname: Yozghatlian
authors.affiliation: QLD Children's Lung and Sleep Specialists, Woolloongabba, Qld, Australia.
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authors.lastname: Burgess
authors.affiliation: Gold Coast District Hospital, Southport, Qld, Australia.
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authors.lastname: Sivakumaran
authors.affiliation: Royal Prince Alfred Hospital, Camperdown, NSW, Australia.
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authors.initials: KY
authors.lastname: Yan
authors.affiliation: Royal Prince Alfred Hospital, Camperdown, NSW, Australia.
authors.forename: V
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authors.lastname: Kritikos
authors.affiliation: Concord Hospital, Concord, NSW, Australia.
authors.forename: M
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authors.lastname: Peters
authors.affiliation: Liverpool Hospital, Liverpool, NSW, Australia.
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authors.lastname: Baraket
authors.affiliation: St Vincent's Clinic, Darlinghurst, NSW, Australia.
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authors.lastname: Aminazad
authors.affiliation: Children's Hospital at Westmead, Westmead, NSW, Australia.
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authors.lastname: Robinson
authors.affiliation: School of Women's & Children's Health, UNSW Medicine, Randwick, NSW, Australia.
authors.forename: A
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authors.lastname: Jaffe
authors.affiliation: Hunter Medical Research Institute, John Hunter Hospital, University of Newcastle, New Lambton Heights, NSW, Australia.
authors.forename: H
authors.initials: H
authors.lastname: Powell
authors.affiliation: Princess Alexandra Hospital, Woolloongabba, Qld, Australia.
authors.forename: J W
authors.initials: JW
authors.lastname: Upham
authors.affiliation: Hunter Medical Research Institute, John Hunter Hospital, University of Newcastle, New Lambton Heights, NSW, Australia.
authors.forename: V M
authors.initials: VM
authors.lastname: McDonald
authors.affiliation: Hunter Medical Research Institute, John Hunter Hospital, University of Newcastle, New Lambton Heights, NSW, Australia.
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mesh_terms: D000328:Adult; D000368:Aged; D000485:Allergens / Q000276:immunology; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab / Q000008:administration & dosage*; D012129:Respiratory Function Tests; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000485:Allergens; D018927:Anti-Asthmatic Agents; D000069444:Omalizumab; D007073:Immunoglobulin E
keywords: asthma; dosing range; omalizumab