Effectiveness and response predictors of omalizumab in a severe allergic asthma population with a high prevalence of comorbidities

the Australian Xolair Registry

P. G. Gibson, H. K. Reddel, Vanessa M McDonald, Gary Marks, C. Jenkins, A. Gillman, John Upham, M. Sutherland, J. Rimmer, F. Thien, G. P. Katsoulotos, M. Cook, I. Yang, Constance H Katelaris, Simon Bowler, D. Langton, P. Robinson, C. Wright, V. Yozghatlian, S. Burgess & 11 others P. Sivakumaran, Allan Jaffe, J. Bowden, P. A B Wark, K. Y. Yan, Vicky Kritikos, M. Peters, M. Hew, A. Aminazad, M M Fonseka, M. Guo

Research output: Contribution to journalArticleResearchpeer-review

23 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1054-1062
Number of pages9
JournalInternal Medicine Journal
Volume46
Issue number9
DOIs
Publication statusPublished - 1 Sep 2016

Keywords

  • allergy
  • comorbidity
  • omalizumab
  • phenotype
  • registry
  • severe asthma

Cite this

Gibson, P. G. ; Reddel, H. K. ; McDonald, Vanessa M ; Marks, Gary ; Jenkins, C. ; Gillman, A. ; Upham, John ; Sutherland, M. ; Rimmer, J. ; Thien, F. ; Katsoulotos, G. P. ; Cook, M. ; Yang, I. ; Katelaris, Constance H ; Bowler, Simon ; Langton, D. ; Robinson, P. ; Wright, C. ; Yozghatlian, V. ; Burgess, S. ; Sivakumaran, P. ; Jaffe, Allan ; Bowden, J. ; Wark, P. A B ; Yan, K. Y. ; Kritikos, Vicky ; Peters, M. ; Hew, M. ; Aminazad, A. ; Fonseka, M M ; Guo, M. / Effectiveness and response predictors of omalizumab in a severe allergic asthma population with a high prevalence of comorbidities : the Australian Xolair Registry. In: Internal Medicine Journal. 2016 ; Vol. 46, No. 9. pp. 1054-1062.
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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.",
keywords = "allergy, comorbidity, omalizumab, phenotype, registry, severe asthma",
author = "Gibson, {P. G.} and Reddel, {H. K.} and McDonald, {Vanessa M} and Gary Marks and C. Jenkins and A. Gillman and John Upham and M. Sutherland and J. Rimmer and F. Thien and Katsoulotos, {G. P.} and M. Cook and I. Yang and Katelaris, {Constance H} and Simon Bowler and D. Langton and P. Robinson and C. Wright and V. Yozghatlian and S. Burgess and P. Sivakumaran and Allan Jaffe and J. Bowden and Wark, {P. A B} and Yan, {K. Y.} and Vicky Kritikos and M. Peters and M. Hew and A. Aminazad and Fonseka, {M M} and M. Guo",
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Gibson, PG, Reddel, HK, McDonald, VM, Marks, G, Jenkins, C, Gillman, A, Upham, J, Sutherland, M, Rimmer, J, Thien, F, Katsoulotos, GP, Cook, M, Yang, I, Katelaris, CH, Bowler, S, Langton, D, Robinson, P, Wright, C, Yozghatlian, V, Burgess, S, Sivakumaran, P, Jaffe, A, Bowden, J, Wark, PAB, Yan, KY, Kritikos, V, Peters, M, Hew, M, Aminazad, A, Fonseka, MM & Guo, M 2016, 'Effectiveness and response predictors of omalizumab in a severe allergic asthma population with a high prevalence of comorbidities: the Australian Xolair Registry', Internal Medicine Journal, vol. 46, no. 9, pp. 1054-1062. https://doi.org/10.1111/imj.13166

Effectiveness and response predictors of omalizumab in a severe allergic asthma population with a high prevalence of comorbidities : the Australian Xolair Registry. / Gibson, P. G.; Reddel, H. K.; McDonald, Vanessa M; Marks, Gary; Jenkins, C.; Gillman, A.; Upham, John; Sutherland, M.; Rimmer, J.; Thien, F.; Katsoulotos, G. P.; Cook, M.; Yang, I.; Katelaris, Constance H; Bowler, Simon; Langton, D.; Robinson, P.; Wright, C.; Yozghatlian, V.; Burgess, S.; Sivakumaran, P.; Jaffe, Allan; Bowden, J.; Wark, P. A B; Yan, K. Y.; Kritikos, Vicky; Peters, M.; Hew, M.; Aminazad, A.; Fonseka, M M; Guo, M.

In: Internal Medicine Journal, Vol. 46, No. 9, 01.09.2016, p. 1054-1062.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Effectiveness and response predictors of omalizumab in a severe allergic asthma population with a high prevalence of comorbidities

T2 - the Australian Xolair Registry

AU - Gibson, P. G.

AU - Reddel, H. K.

AU - McDonald, Vanessa M

AU - Marks, Gary

AU - Jenkins, C.

AU - Gillman, A.

AU - Upham, John

AU - Sutherland, M.

AU - Rimmer, J.

AU - Thien, F.

AU - Katsoulotos, G. P.

AU - Cook, M.

AU - Yang, I.

AU - Katelaris, Constance H

AU - Bowler, Simon

AU - Langton, D.

AU - Robinson, P.

AU - Wright, C.

AU - Yozghatlian, V.

AU - Burgess, S.

AU - Sivakumaran, P.

AU - Jaffe, Allan

AU - Bowden, J.

AU - Wark, P. A B

AU - Yan, K. Y.

AU - Kritikos, Vicky

AU - Peters, M.

AU - Hew, M.

AU - Aminazad, A.

AU - Fonseka, M M

AU - Guo, M.

PY - 2016/9/1

Y1 - 2016/9/1

N2 - 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.

AB - 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.

KW - allergy

KW - comorbidity

KW - omalizumab

KW - phenotype

KW - registry

KW - severe asthma

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