Real-world omalizumab and mepolizumab treated difficult asthma phenotypes and their clinical outcomes
Real-world omalizumab and mepolizumab treated difficult asthma phenotypes and their clinical outcomes
BACKGROUND: Omalizumab and Mepolizumab are biologic drugs with proven efficacy in clinical trials. However, a better understanding of their real-world effectiveness in severe asthma management is needed.
OBJECTIVES: To better understand the real-world effectiveness of Omalizumab and Mepolizumab, elucidate the clinical phenotypes of patients treated with these drugs, identify baseline characteristics associated with biologic response and assess the spectrum of responses to these medications.
METHODS: Using real-world clinical data, we retrospectively phenotyped biologic naïve patients from the Wessex AsThma CoHort of difficult asthma (N=478) commenced on Omalizumab (N=105) or Mepolizumab (N=62) compared to severe asthma patients not receiving biologics (SNB, N=178). We also assessed multiple clinical endpoints and identified features associated with response.
RESULTS: Compared to SNB, Omalizumab patients were younger, diagnosed with asthma earlier, and more likely to have rhinitis. Conversely, compared to SNB, Mepolizumab patients were predominantly older males, diagnosed with asthma later, and more likely to have nasal polyposis but less dysfunctional breathing. Both treatments reduced exacerbations, Acute Healthcare Encounters [AHE] (emergency department or hospital admissions), maintenance oral corticosteroid dose, and improved Asthma Control Questionnaire 6 (ACQ6) scores. Omalizumab response was independently associated with more baseline exacerbations (P=0.024) but fewer AHE (P=0.050) and absence of anxiety (P=0.008). Lower baseline ACQ6 was independently associated with Mepolizumab response (P=0.007). A composite group of non-responders demonstrated significantly more psychopathologies and worse baseline subjective disease compared to responder groups.
CONCLUSIONS AND CLINICAL RELEVANCE: In a difficult asthma cohort, Omalizumab and Mepolizumab were used in distinct clinical phenotypes but were both multidimensionally efficacious. Certain baseline clinical characteristics were associated with poorer biologic responses, such as psychological co-morbidity, which may assist clinicians in biologic selection. These characteristics also emphasize the need for comprehensive approaches to support these patients.
1019-1032
Fong, Wei Chern Gavin
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Azim, Adnan
87c31e0e-c9bf-4258-9ae9-889e2382e7ba
Knight, Deborah
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Mistry, Heena
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Freeman, Anna
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Felongco, Mae
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Kyyaly, Aref
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Harvey, Matthew
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Dennison, Patrick
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Zhang, Hongmei
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Howarth, Peter
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Arshad, S Hasan
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Kurukulaaratchy, Ramesh J
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Kyyaly, Mohammed Aref
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August 2021
Fong, Wei Chern Gavin
dde77f6c-3b15-4d09-aadd-89985eaa3491
Azim, Adnan
87c31e0e-c9bf-4258-9ae9-889e2382e7ba
Knight, Deborah
4f44f912-5106-4fb5-9cf2-b4f86440523c
Mistry, Heena
216f0018-b071-406c-9b66-0e025ca959a7
Freeman, Anna
b5f45a0d-f9e4-4a91-9af0-40efb6730787
Felongco, Mae
adab824f-492d-4e55-ac7c-c26d8c552b99
Kyyaly, Aref
f5feeaaa-5ca6-4c03-b230-7d649d3b7701
Harvey, Matthew
d34fdc10-eecc-45be-aa7b-e2cd70318617
Dennison, Patrick
30c232e3-c218-4dd8-979f-061ac70513d5
Zhang, Hongmei
9f774048-54d6-4321-a252-3887b2c76db0
Howarth, Peter
ff19c8c4-86b0-4a88-8f76-b3d87f142a21
Arshad, S Hasan
795d8599-b77d-44e5-bb9c-67db78822057
Kurukulaaratchy, Ramesh J
9c7b8105-2892-49f2-8775-54d4961e3e74
Kyyaly, Mohammed Aref
7bd69b33-fec8-405c-9f40-b7157f0242f0
Fong, Wei Chern Gavin, Azim, Adnan, Knight, Deborah, Mistry, Heena, Freeman, Anna, Felongco, Mae, Kyyaly, Aref, Harvey, Matthew, Dennison, Patrick, Zhang, Hongmei, Howarth, Peter, Arshad, S Hasan, Kurukulaaratchy, Ramesh J and Kyyaly, Mohammed Aref
(2021)
Real-world omalizumab and mepolizumab treated difficult asthma phenotypes and their clinical outcomes.
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 51 (8), .
(doi:10.1111/cea.13882).
Abstract
BACKGROUND: Omalizumab and Mepolizumab are biologic drugs with proven efficacy in clinical trials. However, a better understanding of their real-world effectiveness in severe asthma management is needed.
OBJECTIVES: To better understand the real-world effectiveness of Omalizumab and Mepolizumab, elucidate the clinical phenotypes of patients treated with these drugs, identify baseline characteristics associated with biologic response and assess the spectrum of responses to these medications.
METHODS: Using real-world clinical data, we retrospectively phenotyped biologic naïve patients from the Wessex AsThma CoHort of difficult asthma (N=478) commenced on Omalizumab (N=105) or Mepolizumab (N=62) compared to severe asthma patients not receiving biologics (SNB, N=178). We also assessed multiple clinical endpoints and identified features associated with response.
RESULTS: Compared to SNB, Omalizumab patients were younger, diagnosed with asthma earlier, and more likely to have rhinitis. Conversely, compared to SNB, Mepolizumab patients were predominantly older males, diagnosed with asthma later, and more likely to have nasal polyposis but less dysfunctional breathing. Both treatments reduced exacerbations, Acute Healthcare Encounters [AHE] (emergency department or hospital admissions), maintenance oral corticosteroid dose, and improved Asthma Control Questionnaire 6 (ACQ6) scores. Omalizumab response was independently associated with more baseline exacerbations (P=0.024) but fewer AHE (P=0.050) and absence of anxiety (P=0.008). Lower baseline ACQ6 was independently associated with Mepolizumab response (P=0.007). A composite group of non-responders demonstrated significantly more psychopathologies and worse baseline subjective disease compared to responder groups.
CONCLUSIONS AND CLINICAL RELEVANCE: In a difficult asthma cohort, Omalizumab and Mepolizumab were used in distinct clinical phenotypes but were both multidimensionally efficacious. Certain baseline clinical characteristics were associated with poorer biologic responses, such as psychological co-morbidity, which may assist clinicians in biologic selection. These characteristics also emphasize the need for comprehensive approaches to support these patients.
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WATCH Biologics Paper manuscript CEA
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WATCH Biologics Paper Supplementary Data
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e-pub ahead of print date: 18 April 2021
Published date: August 2021
Additional Information:
Funding Information:
The authors thank the WATCH participants and the WATCH study team who conducted this study. They also acknowledge the support of the National Institute for Health Research (NIHR) Southampton Biomedical Research Centre and NIHR Clinical Research Facility, which are funded by NIHR and are a partnership between the University of Southampton and University Hospital Southampton NHS Foundation Trust.
Funding Information:
The WATCH study received a non-promotional grant from Novartis (?35,000) and initial assistance through a charitable grant (?3,500) for relevant patient costs (e.g. parking) from the Asthma, Allergy & Inflammation Research Charity. The WATCH study itself is not externally funded The authors thank the WATCH participants and the WATCH study team who conducted this study. They also acknowledge the support of the National Institute for Health Research (NIHR) Southampton Biomedical Research Centre and NIHR Clinical Research Facility, which are funded by NIHR and are a partnership between the University of Southampton and University Hospital Southampton NHS Foundation Trust.
Funding Information:
PD received a non‐promotional grant from Novartis for the WATCH study for data entry clerk funding. PH is an employee of GlaxoSmithKline. No conflicts exist for WCGF, AA, DK, HM, AF, MF, AK, MH, HZ, SHA and RJK.
Publisher Copyright:
© 2021 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd.
Identifiers
Local EPrints ID: 448797
URI: http://eprints.soton.ac.uk/id/eprint/448797
ISSN: 0954-7894
PURE UUID: b0a44033-99dd-41cd-b62d-8911588bbbb6
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Date deposited: 06 May 2021 16:30
Last modified: 17 Mar 2024 06:31
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Contributors
Author:
Wei Chern Gavin Fong
Author:
Adnan Azim
Author:
Deborah Knight
Author:
Heena Mistry
Author:
Anna Freeman
Author:
Mae Felongco
Author:
Aref Kyyaly
Author:
Matthew Harvey
Author:
Patrick Dennison
Author:
Hongmei Zhang
Author:
S Hasan Arshad
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