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Impact of pre-biolo...
Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma
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- Perez-de-Llano, Luis (author)
- University Hospital Lucus Augusti
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- Scelo, Ghislaine (author)
- Observational and Pragmatic Research Institute Pte Ltd
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- Canonica, G. Walter (author)
- Humanitas University,Humanitas Research Hospital
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- Chen, Wenjia (author)
- National University of Singapore
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- Henley, William (author)
- University of Exeter,Observational and Pragmatic Research Institute Pte Ltd
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Larenas-Linnemann, Désirée (author)
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- Peters, Matthew J. (author)
- Macquarie University, Sydney,Concord Repatriation General Hospital
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- Pfeffer, Paul E. (author)
- Barts Health NHS Trust,Queen Mary University
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- Tran, Trung N. (author)
- AstraZeneca, UK
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- Ulrik, Charlotte Suppli (author)
- Hvidovre Hospital
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- Popov, Todor A. (author)
- University Hospital St. Ivan Rilski
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- Sadatsafavi, Mohsen (author)
- University of British Columbia
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- Hew, Mark (author)
- Monash University
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- Máspero, Jorge (author)
- University of Buenos Aires
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- Gibson, Peter G. (author)
- University of Newcastle,Hunter Medical Research Institute, Australia
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- Christoff, George C. (author)
- Medical University of Sofia
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- Fitzgerald, J. Mark (author)
- University of British Columbia
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- Torres-Duque, Carlos A. (author)
- University Of La Sabana
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- Porsbjerg, Celeste M. (author)
- Bispebjerg Hospital
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- Papadopoulos, Nikolaos G (author)
- National and Kapodistrian University of Athens,University of Manchester
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- Papaioannou, Andriana I. (author)
- National and Kapodistrian University of Athens
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- Heffler, Enrico (author)
- Humanitas University,Humanitas Research Hospital
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Iwanaga, Takashi (author)
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- Al-Ahmad, Mona (author)
- Kuwait University
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- Kuna, Piotr (author)
- Medical University of Lodz
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- Fonseca, João A. (author)
- University of Porto
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- Al-Lehebi, Riyad (author)
- Alfaisal University
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Rhee, Chin Kook (author)
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- Koh, Mariko Siyue (author)
- Singapore General Hospital
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- Cosio, Borja G. (author)
- Hospital Universitario Son Espases
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- Perng (Steve), Diahn Warng (author)
- National Yang-Ming University Taiwan,Taipei Veterans General Hospital
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Mahboub, Bassam (author)
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- Menzies-Gow, Andrew N. (author)
- Royal Brompton and Harefield NHS Foundation Trust,AstraZeneca, UK
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- Jackson, David J. (author)
- Guy's Hospital
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Busby, John (author)
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- Heaney, Liam G. (author)
- Queen's University Belfast
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- Patel, Pujan H. (author)
- Royal Brompton Hospital
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- Wang, Eileen (author)
- University of Colorado School of Medicine
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- Wechsler, Michael E. (author)
- National Jewish Health
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- Altraja, Alan (author)
- University of Tartu
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- Lehtimäki, Lauri (author)
- Tampere University Hospital,University of Tampere
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Bourdin, Arnaud (author)
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- Bjermer, Leif (author)
- Lund University,Lunds universitet,Lungmedicin, allergologi och palliativ medicin,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Klinisk lungmedicin,Forskargrupper vid Lunds universitet,Respiratory Medicine, Allergology, and Palliative Medicine,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Clinical Respiratory Medicine,Lund University Research Groups,Skåne University Hospital
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- Bulathsinhala, Lakmini (author)
- Observational and Pragmatic Research Institute Pte Ltd
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- Carter, Victoria (author)
- Observational and Pragmatic Research Institute Pte Ltd
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Murray, Ruth (author)
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- Beastall, Aaron (author)
- Observational and Pragmatic Research Institute Pte Ltd
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- Denton, Eve (author)
- Monash University
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- Price, David B. (author)
- University of Aberdeen,Observational and Pragmatic Research Institute Pte Ltd
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(creator_code:org_t)
- English.
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In: Annals of Allergy, Asthma and Immunology. - 1081-1206.
- Related links:
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http://dx.doi.org/10... (free)
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https://lup.lub.lu.s...
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Abstract
Subject headings
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- Background: There is little agreement on clinically useful criteria for identifying real-world responders to biologic treatments for asthma. Objective: To investigate the impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in adults with severe asthma. Methods: This was a longitudinal, cohort study across 22 countries participating in the International Severe Asthma Registry (https://isaregistries.org/) between May 2017 and January 2023. Change in 4 asthma domains (exacerbation rate, asthma control, long-term oral corticosteroid [LTOCS] dose, and lung function) was assessed from biologic initiation to 1 year post-treatment (minimum 24 weeks). Pre- to post-biologic changes for responders and nonresponders were described along a categorical gradient for each domain derived from pre-biologic distributions (exacerbation rate: 0 to 6+/y; asthma control: well controlled to uncontrolled; LTOCS: 0 to >30 mg/d; percent-predicted forced expiratory volume in 1 second [ppFEV1]: <50% to ≥80%). Results: Percentage of biologic responders (ie, those with a category improvement pre- to post-biologic) varied by domain and increased with greater pre-biologic impairment, increasing from 70.2% to 90.0% for exacerbation rate, 46.3% to 52.3% for asthma control, 31.1% to 58.5% for LTOCS daily dose, and 35.8% to 50.6% for ppFEV1. The proportion of patients having improvement post-biologic tended to be greater for anti–IL-5/5R compared with for anti-IgE for exacerbation, asthma control, and ppFEV1 domains, irrespective of pre-biologic impairment. Conclusion: Our results provide realistic outcome-specific post-biologic expectations for both physicians and patients, will be foundational to inform future work on a multidimensional approach to define and assess biologic responders and response, and may enhance appropriate patient selection for biologic therapies. Trial Registration: The ISAR database has ethical approval from the Anonymous Data Ethics Protocols and Transparency (ADEPT) committee (ADEPT0218) and is registered with the European Union Electronic Register of Post-Authorization studies (ENCEPP/DSPP/23720). The study was designed, implemented, and reported in compliance with the European Network Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP) Code of Conduct (EUPAS38288) and with all applicable local and international laws and regulation, and registered with ENCEPP (https://www.encepp.eu/encepp/viewResource.htm?id=38289). Governance was provided by ADEPT (registration number: ADEPT1220).
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Lungmedicin och allergi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Respiratory Medicine and Allergy (hsv//eng)
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- art (subject category)
- ref (subject category)
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Perez-de-Llano, ...
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Scelo, Ghislaine
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Canonica, G. Wal ...
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Chen, Wenjia
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Henley, William
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Larenas-Linneman ...
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show more...
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Peters, Matthew ...
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Pfeffer, Paul E.
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Tran, Trung N.
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Ulrik, Charlotte ...
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Popov, Todor A.
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Sadatsafavi, Moh ...
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Hew, Mark
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Máspero, Jorge
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Gibson, Peter G.
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Christoff, Georg ...
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Fitzgerald, J. M ...
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Torres-Duque, Ca ...
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Porsbjerg, Celes ...
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Papadopoulos, Ni ...
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Papaioannou, And ...
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Heffler, Enrico
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Iwanaga, Takashi
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Al-Ahmad, Mona
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Kuna, Piotr
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Fonseca, João A.
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Al-Lehebi, Riyad
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Rhee, Chin Kook
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Koh, Mariko Siyu ...
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Cosio, Borja G.
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Perng (Steve), D ...
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Mahboub, Bassam
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Menzies-Gow, And ...
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Jackson, David J ...
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Busby, John
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Heaney, Liam G.
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Patel, Pujan H.
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Wang, Eileen
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Wechsler, Michae ...
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Altraja, Alan
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Lehtimäki, Lauri
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Bourdin, Arnaud
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Bjermer, Leif
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Bulathsinhala, L ...
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Carter, Victoria
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Murray, Ruth
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Beastall, Aaron
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Denton, Eve
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Price, David B.
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Respiratory Medi ...
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Annals of Allerg ...
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Lund University