P G Gibson1, H Reddel2,3, V M McDonald4,5, G Marks6, C Jenkins7, A Gillman8, J Upham9, M Sutherland10, J Rimmer11, F Thien12, G P Katsoulotos13, M Cook14, I Yang15, C Katelaris16, S Bowler17, D Langton18, P Robinson19, C Wright20, V Yozghatlian21, S Burgess22, P Sivakumaran23, A Jaffe24, J Bowden25, P A B Wark4, K Y Yan2, V Kritikos2, M Peters7, M Hew8, A Aminazad12, M Bint20, M Guo26. 1. 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. 2. Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia. 3. University of Sydney, Liverpool Hospital, Sydney, New South Wales, Australia. 4. 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. 5. School of Nursing and Midwifery, University of Newcastle, Newcastle, New South Wales, Australia. 6. Department of Respiratory Medicine, Liverpool Hospital, Sydney, New South Wales, Australia. 7. Department of Thoracic Medicine, Concord Hospital, Sydney, New South Wales, Australia. 8. Department of Allergy, Immunology and Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia. 9. Department of Respiratory Medicine, Princess Alexandra Hospital, Brisbane, Queensland, Australia. 10. Department of Respiratory and Sleep Medicine, Austin Hospital, Melbourne, Victoria, Australia. 11. St Vincent's Clinic, Campbelltown Hospital, Sydney, New South Wales, Australia. 12. Department of Respiratory Medicine, Box Hill Hospital, Melbourne, Victoria, Australia. 13. St George Specialist Centre, Campbelltown Hospital, Sydney, New South Wales, Australia. 14. Department of Immunology, Canberra Hospital, Canberra, Australian Capital Territory, Australia. 15. Department of Thoracic Medicine, The Prince Charles Hospital, Brisbane, Queensland, Australia. 16. Department of Respiratory and Sleep Medicine, Campbelltown Hospital, Sydney, New South Wales, Australia. 17. Department of Respiratory and Sleep Medicine, Mater Adult Hospital, Brisbane, Queensland, Australia. 18. Department of Thoracic Medicine, Frankston Hospital, Melbourne, Victoria, Australia. 19. Department of Respiratory Medicine, Children's Hospital at Westmead, Sydney, New South Wales, Australia. 20. Department of Respiratory Medicine, Nambour Hospital, Nambour, Queensland, Australia. 21. Department of Respiratory and Sleep Medicine, St George Hospital, Sydney, New South Wales, Australia. 22. QLD Children's Lung and Sleep Specialists, Brisbane, Queensland, Australia. 23. Department of Respiratory Medicine, Gold Coast District Hospital, Gold Coast, Queensland, Australia. 24. Department of Respiratory Medicine, Sydney Children's Hospital, Sydney, New South Wales, Australia. 25. Department of Respiratory, Allergy and Sleep Medicine, Flinders Medical Centre, Adelaide, South Australia, Australia. 26. Clinical Management, Woolcock Institute of Medical Research, Sydney, New South Wales, Australia.
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. AIMS: 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). CONCLUSION: 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.
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. AIMS: 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). CONCLUSION: 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: John Blakey; Li Ping Chung; Vanessa M McDonald; Laurence Ruane; John Gornall; Chris Barton; Sinthia Bosnic-Anticevich; John Harrington; Mark Hew; Anne E Holland; Trudy Hopkins; Lata Jayaram; Helen Reddel; John W Upham; Peter G Gibson; Philip Bardin Journal: Respirology Date: 2021-09-29 Impact factor: 6.175
Authors: Celeste Porsbjerg; Charlotte Ulrik; Tina Skjold; Vibeke Backer; Birger Laerum; Sverre Lehman; Crister Janson; Thomas Sandstrøm; Leif Bjermer; Barbro Dahlen; Bo Lundbäck; Dora Ludviksdottir; Unnur Björnsdóttir; Alan Altraja; Lauri Lehtimäki; Paula Kauppi; Jussi Karjalainen; Hannu Kankaanranta Journal: Eur Clin Respir J Date: 2018-03-06
Authors: Regina Maria de Carvalho-Pinto; Rosana Câmara Agondi; Pedro Giavina-Bianchi; Alberto Cukier; Rafael Stelmach Journal: J Bras Pneumol Date: 2017 Nov-Dec Impact factor: 2.624