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Peer-reviewedCC BY-NC 4.0Clinical and Experimental Allergy

A Real‐World Controlled Multicentre Study Evaluating the Association Between Benralizumab Therapy and Major Outcomes in Severe Asthma

  • Dennis Thomas1,2
  • Vanessa M. McDonald1,2,3
  • Gijo Thomas1
  • Joy Lee4
  • Li Ping Chung5
  • Matthew Peters6,7
  • Shakti D. Shukla8
  • Yuto Hamada1,2,9
  • Erin S. Harvey1,2,3
  • Michael Fricker1,2
  • Hayley See10,11
  • Rejoy Sabin Thomas1,2
12 more authors
  • Claude S. Farah6,7,12
  • Andrew Gillman13
  • Constance H. Katelaris14,15
  • Gregory P. Katsoulotos16,17,18,19
  • David Langton20,21
  • Peter G. Middleton22,23,24
  • Paul Reynolds25
  • Janet Rimmer26,27
  • Francis Thien28
  • Stephen Vincent29
  • John W. Upham30
  • Peter G. Gibson1,2,3
30 affiliations
  1. 1College of Health, Medicine and Wellbeing University of Newcastle Callaghan New South Wales Australia
  2. 2Centre of Excellence in Treatable Traits, Hunter Medical Research Institute, Asthma and Breathing Programme Newcastle New South Wales Australia
  3. 3Department of Respiratory and Sleep Medicine John Hunter Hospital Newcastle New South Wales Australia
  4. 4Department of Respiratory and Sleep Medicine Austin Health Melbourne Victoria Australia
  5. 5Department of Respiratory Medicine Fiona Stanley Hospital Murdoch Western Australia Australia
  6. 6Department of Thoracic Medicine Concord Hospital Concord Australia
  7. 7Macquarie Medical School, Faculty of Medicine, Health and Human Sciences Macquarie University Sydney New South Wales Australia
  8. 8Graduate School of Health University of Technology Sydney Sydney New South Wales Australia
  9. 9Clinical Research Centre for Allergy and Rheumatology NHO Sagamihara National Hospital Sagamihara Japan
  10. 10School of Medicine and Public Health University of Newcastle Newcastle New South Wales Australia
  11. 11The Thoracic Society of Australia and New Zealand Sydney New South Wales Australia
  12. 12Faculty of Medicine and Health The University of Sydney Sydney New South Wales Australia
  13. 13Allergy, Asthma and Clinical Immunology Alfred Health Melbourne Victoria Australia
  14. 14School of Medicine Western Sydney University Campbelltown New South Wales Australia
  15. 15Immunology and Allergy Unit Campbelltown Hospital Campbelltown New South Wales Australia
  16. 16Woolcock Institute of Medical Research University of Sydney Glebe New South Wales Australia
  17. 17The University of Notre Dame Sydney Western Australia Australia
  18. 18St George Specialist Centre Kogarah New South Wales Australia
  19. 19St Vincent's Clinic Darlinghurst New South Wales Australia
  20. 20Faculty of Medicine, Nursing and Health Sciences Monash University Clayton Victoria Australia
  21. 21Department of Thoracic Medicine Frankston Hospital Frankston Victoria Australia
  22. 22Department of Respiratory and Sleep Medicine Westmead Hospital Sydney New South Wales Australia
  23. 23Ludwig Engel Centre for Respiratory Research The Westmead Institute of Medical Research Sydney New South Wales Australia
  24. 24Westmead Clinical School University of Sydney Sydney New South Wales Australia
  25. 25Lung Research University of Adelaide and Department of Thoracic Medicine, Royal Adelaide Hospital Adelaide Australia
  26. 26Rhinology and Skull Base Research Group, Applied Medical Research Centre University of New South Wales Sydney Australia
  27. 27Faculty of Medicine Notre Dame University Sydney Australia
  28. 28Eastern Health and Monash University Melbourne Victoria Australia
  29. 29Thoracic and Sleep Medicine Cairns and Hinterland Hospital and Health Service Cairns Queensland Australia
  30. 30Faculty of Medicine The University of Queensland Brisbane Queensland Australia
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Abstract

Background: Real‐world data on benralizumab in patients with severe eosinophilic asthma–while controlling for confounding factors–is currently lacking.

Aim: This real‐world controlled multicentre study evaluated asthma outcomes in patients who received benralizumab compared with a severe asthma cohort who did not receive biologic therapy.

Methods: Two years of data from patients with severe eosinophilic asthma in the Australian Benralizumab Registry (ABenRa) and the Australasian Severe Asthma Registry (ASAR) were included in the analysis. Asthma control questionnaire‐5 (ACQ‐5) scores, asthma‐related quality of life (AQLQ) scores, maintenance oral corticosteroid (OCS) dose, annualised exacerbation rate and clinical remission (ACQ‐5 ≤ 1, with no asthma attacks or OCS use for 12 months, assessed at the 24‐month follow‐up) rates were compared between the groups after adjusting for baseline imbalances.

Results: A total of 211 participants from ABenRa (64.5% female; mean age 57.4 ± 14.5 years) and 250 from ASAR (63.1% female; mean age 53.7 ± 14.8 years) were included. ACQ and AQLQ improved significantly in both groups. Participants in the ABenRa showed greater improvements in ACQ at 12‐ (β = −0.5, p = 0.002) and 24‐months (β = −0.5, p = 0.003), as well as in AQLQ at 12‐ (β = 0.6, p < 0.001) and 24‐months (β = 0.4, p = 0.019), compared with the ASAR group, with no difference in maintenance OCS dose or annualised exacerbation rates between groups. At 12‐ and 24‐months, approximately 60% of participants in the ABenRa achieved controlled or partially controlled asthma as per the GINA guidelines. Notably, clinical benefit was evident within 14 days of initiating treatment. A higher proportion of participants in the ABenRa achieved clinical remission (30.9% vs. 20.4%; OR 2.1 (95% CI 1.1, 4.1), p = 0.037).

Conclusion: Benralizumab was associated with significant improvement in asthma outcomes in patients with severe eosinophilic asthma. This benefit persisted when compared with patients who had severe eosinophilic asthma but did not receive any biologic therapy.

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Cite

BibTeXRIS
BibTeX
@article{thomas2026realworld,
  title = {{A Real‐World Controlled Multicentre Study Evaluating the Association Between Benralizumab Therapy and Major Outcomes in Severe Asthma}},
  author = {Dennis Thomas and Vanessa M. McDonald and Gijo Thomas and Joy Lee and Li Ping Chung and Matthew Peters and Shakti D. Shukla and Yuto Hamada and Erin S. Harvey and Michael Fricker and Hayley See and Rejoy Sabin Thomas and Claude S. Farah and Andrew Gillman and Constance H. Katelaris and Gregory P. Katsoulotos and David Langton and Peter G. Middleton and Paul Reynolds and Janet Rimmer and Francis Thien and Stephen Vincent and John W. Upham and Peter G. Gibson},
  journal = {Clinical and Experimental Allergy},
  year = {2026},
  month = may,
  doi = {10.1111/cea.70348},
  url = {https://doi.org/10.1111/cea.70348},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - A Real‐World Controlled Multicentre Study Evaluating the Association Between Benralizumab Therapy and Major Outcomes in Severe Asthma
AU  - Dennis Thomas
AU  - Vanessa M. McDonald
AU  - Gijo Thomas
AU  - Joy Lee
AU  - Li Ping Chung
AU  - Matthew Peters
AU  - Shakti D. Shukla
AU  - Yuto Hamada
AU  - Erin S. Harvey
AU  - Michael Fricker
AU  - Hayley See
AU  - Rejoy Sabin Thomas
AU  - Claude S. Farah
AU  - Andrew Gillman
AU  - Constance H. Katelaris
AU  - Gregory P. Katsoulotos
AU  - David Langton
AU  - Peter G. Middleton
AU  - Paul Reynolds
AU  - Janet Rimmer
AU  - Francis Thien
AU  - Stephen Vincent
AU  - John W. Upham
AU  - Peter G. Gibson
PY  - 2026
DA  - 2026/05/27
JO  - Clinical and Experimental Allergy
DO  - 10.1111/cea.70348
UR  - https://doi.org/10.1111/cea.70348
AB  - Background: Real‐world data on benralizumab in patients with severe eosinophilic asthma–while controlling for confounding factors–is currently lacking.  Aim: This real‐world controlled multicentre study evaluated asthma outcomes in patients who received benralizumab compared with a severe asthma cohort who did not receive biologic therapy.  Methods: Two years of data from patients with severe eosinophilic asthma in the Australian Benralizumab Registry (ABenRa) and the Australasian Severe Asthma Registry (ASAR) were included in the analysis. Asthma control questionnaire‐5 (ACQ‐5) scores, asthma‐related quality of life (AQLQ) scores, maintenance oral corticosteroid (OCS) dose, annualised exacerbation rate and clinical remission (ACQ‐5 ≤ 1, with no asthma attacks or OCS use for 12 months, assessed at the 24‐month follow‐up) rates were compared between the groups after adjusting for baseline imbalances.  Results: A total of 211 participants from ABenRa (64.5% female; mean age 57.4 ± 14.5 years) and 250 from ASAR (63.1% female; mean age 53.7 ± 14.8 years) were included. ACQ and AQLQ improved significantly in both groups. Participants in the ABenRa showed greater improvements in ACQ at 12‐ (β = −0.5, p = 0.002) and 24‐months (β = −0.5, p = 0.003), as well as in AQLQ at 12‐ (β = 0.6, p < 0.001) and 24‐months (β = 0.4, p = 0.019), compared with the ASAR group, with no difference in maintenance OCS dose or annualised exacerbation rates between groups. At 12‐ and 24‐months, approximately 60% of participants in the ABenRa achieved controlled or partially controlled asthma as per the GINA guidelines. Notably, clinical benefit was evident within 14 days of initiating treatment. A higher proportion of participants in the ABenRa achieved clinical remission (30.9% vs. 20.4%; OR 2.1 (95% CI 1.1, 4.1), p = 0.037).  Conclusion: Benralizumab was associated with significant improvement in asthma outcomes in patients with severe eosinophilic asthma. This benefit persisted when compared with patients who had severe eosinophilic asthma but did not receive any biologic therapy.
SN  - 0954-7894
SN  - 1365-2222
ER  -