title: Effectiveness and response predictors of omalizumab in a severe allergic asthma population with a high prevalence of comorbidities: the Australian Xolair Registry.
abstract: BACKGROUND
  Severe asthma is a high impact disease. Omalizumab targets the allergic inflammatory pathway; however, effectiveness data in a population with significant comorbidities are limited.
  
  
  OBJECTIVE
  To describe severe allergic asthma, omalizumab treatment outcomes and predictors of response among the Australian Xolair Registry participants.
  
  
  METHODS
  A web-based post-marketing surveillance registry was established to characterise the use, effectiveness and adverse effects of omalizumab (Xolair) for severe allergic asthma.
  
  
  RESULTS
  Participants (n = 192) (mean age 51 years, 118 female) with severe allergic asthma from 21 clinics in Australia were assessed, and 180 received omalizumab therapy. They had poor asthma control (Asthma Control Questionnaire, ACQ-5, mean score 3.56) and significant quality of life impairment (Asthma-related Quality of Life Questionnaire score 3.57), and 52% were using daily oral corticosteroid (OCS). Overall, 95% had one or more comorbidities (rhinitis 48%, obesity 45%, cardiovascular disease 23%). The omalizumab responder rate, assessed by an improvement of at least 0.5 in ACQ-5, was high at 83%. OCS use was significantly reduced. The response in participants with comorbid obesity and cardiovascular disease was similar to those without these conditions. Baseline ACQ-5 ≥ 2.0 (P = 0.002) and older age (P = 0.05) predicted the magnitude of change in ACQ-5 in response to omalizumab. Drug-related adverse events included anaphylactoid reactions (n = 4), headache (n = 2) and chest pains (n = 1).
  
  
  CONCLUSIONS
  Australian patients with severe allergic asthma report a high disease burden and have extensive comorbidity. Symptomatic response to omalizumab was high despite significant comorbid disease. Omalizumab is an effective targeted therapy for severe allergic asthma with comorbidity in a real-life setting.
authors.affiliation: Centre for Healthy Lungs, Department of Respiratory and Sleep Medicine, John Hunter Hospital, Hunter Medical Research Institute, University of Newcastle, Newcastle, New South Wales, Australia. peter.gibson@hnehealth.nsw.gov.au.
authors.forename: P G
authors.initials: PG
authors.lastname: Gibson
authors.affiliation: Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.|University of Sydney, Liverpool Hospital, Sydney, New South Wales, Australia.
authors.forename: H
authors.initials: H
authors.lastname: Reddel
authors.affiliation: Centre for Healthy Lungs, Department of Respiratory and Sleep Medicine, John Hunter Hospital, Hunter Medical Research Institute, University of Newcastle, Newcastle, New South Wales, Australia.|School of Nursing and Midwifery, University of Newcastle, Newcastle, New South Wales, Australia.
authors.forename: V M
authors.initials: VM
authors.lastname: McDonald
authors.affiliation: Department of Respiratory Medicine, Liverpool Hospital, Sydney, New South Wales, Australia.
authors.forename: G
authors.initials: G
authors.lastname: Marks
authors.affiliation: Department of Thoracic Medicine, Concord Hospital, Sydney, New South Wales, Australia.
authors.forename: C
authors.initials: C
authors.lastname: Jenkins
authors.affiliation: Department of Allergy, Immunology and Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia.
authors.forename: A
authors.initials: A
authors.lastname: Gillman
authors.affiliation: Department of Respiratory Medicine, Princess Alexandra Hospital, Brisbane, Queensland, Australia.
authors.forename: J
authors.initials: J
authors.lastname: Upham
authors.affiliation: Department of Respiratory and Sleep Medicine, Austin Hospital, Melbourne, Victoria, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Sutherland
authors.affiliation: St Vincent's Clinic, Campbelltown Hospital, Sydney, New South Wales, Australia.
authors.forename: J
authors.initials: J
authors.lastname: Rimmer
authors.affiliation: Department of Respiratory Medicine, Box Hill Hospital, Melbourne, Victoria, Australia.
authors.forename: F
authors.initials: F
authors.lastname: Thien
authors.affiliation: St George Specialist Centre, Campbelltown Hospital, Sydney, New South Wales, Australia.
authors.forename: G P
authors.initials: GP
authors.lastname: Katsoulotos
authors.affiliation: Department of Immunology, Canberra Hospital, Canberra, Australian Capital Territory, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Cook
authors.affiliation: Department of Thoracic Medicine, The Prince Charles Hospital, Brisbane, Queensland, Australia.
authors.forename: I
authors.initials: I
authors.lastname: Yang
authors.affiliation: Department of Respiratory and Sleep Medicine, Campbelltown Hospital, Sydney, New South Wales, Australia.
authors.forename: C
authors.initials: C
authors.lastname: Katelaris
authors.affiliation: Department of Respiratory and Sleep Medicine, Mater Adult Hospital, Brisbane, Queensland, Australia.
authors.forename: S
authors.initials: S
authors.lastname: Bowler
authors.affiliation: Department of Thoracic Medicine, Frankston Hospital, Melbourne, Victoria, Australia.
authors.forename: D
authors.initials: D
authors.lastname: Langton
authors.affiliation: Department of Respiratory Medicine, Children's Hospital at Westmead, Sydney, New South Wales, Australia.
authors.forename: P
authors.initials: P
authors.lastname: Robinson
authors.affiliation: Department of Respiratory Medicine, Nambour Hospital, Nambour, Queensland, Australia.
authors.forename: C
authors.initials: C
authors.lastname: Wright
authors.affiliation: Department of Respiratory and Sleep Medicine, St George Hospital, Sydney, New South Wales, Australia.
authors.forename: V
authors.initials: V
authors.lastname: Yozghatlian
authors.affiliation: QLD Children's Lung and Sleep Specialists, Brisbane, Queensland, Australia.
authors.forename: S
authors.initials: S
authors.lastname: Burgess
authors.affiliation: Department of Respiratory Medicine, Gold Coast District Hospital, Gold Coast, Queensland, Australia.
authors.forename: P
authors.initials: P
authors.lastname: Sivakumaran
authors.affiliation: Department of Respiratory Medicine, Sydney Children's Hospital, Sydney, New South Wales, Australia.
authors.forename: A
authors.initials: A
authors.lastname: Jaffe
authors.affiliation: Department of Respiratory, Allergy and Sleep Medicine, Flinders Medical Centre, Adelaide, South Australia, Australia.
authors.forename: J
authors.initials: J
authors.lastname: Bowden
authors.affiliation: Centre for Healthy Lungs, Department of Respiratory and Sleep Medicine, John Hunter Hospital, Hunter Medical Research Institute, University of Newcastle, Newcastle, New South Wales, Australia.
authors.forename: P A B
authors.initials: PA
authors.lastname: Wark
authors.affiliation: Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.
authors.forename: K Y
authors.initials: KY
authors.lastname: Yan
authors.affiliation: Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.
authors.forename: V
authors.initials: V
authors.lastname: Kritikos
authors.affiliation: Department of Thoracic Medicine, Concord Hospital, Sydney, New South Wales, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Peters
authors.affiliation: Department of Allergy, Immunology and Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Hew
authors.affiliation: Department of Respiratory Medicine, Box Hill Hospital, Melbourne, Victoria, Australia.
authors.forename: A
authors.initials: A
authors.lastname: Aminazad
authors.affiliation: Department of Respiratory Medicine, Nambour Hospital, Nambour, Queensland, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Bint
authors.affiliation: Clinical Management, Woolcock Institute of Medical Research, Sydney, New South Wales, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Guo
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000188:drug therapy*; D001315:Australia; D002637:Chest Pain / Q000139:chemically induced; D002648:Child; D015897:Comorbidity; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab / Q000008:administration & dosage* / Q000009:adverse effects; D011358:Product Surveillance, Postmarketing; D011788:Quality of Life; D012042:Registries; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D000069444:Omalizumab
keywords: allergy; comorbidity; omalizumab; phenotype; registry; severe asthma