Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma
(2024) In Annals of Allergy, Asthma and Immunology- Abstract
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... (More)
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).
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- author
- organization
- publishing date
- 2024
- type
- Contribution to journal
- publication status
- epub
- subject
- in
- Annals of Allergy, Asthma and Immunology
- publisher
- Elsevier
- external identifiers
-
- pmid:38151100
- scopus:85183534197
- ISSN
- 1081-1206
- DOI
- 10.1016/j.anai.2023.12.023
- language
- English
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- yes
- id
- 28e2f84f-c58d-4926-9707-c5d230b4bd31
- date added to LUP
- 2024-02-26 12:52:51
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- 2024-04-25 20:52:48
@article{28e2f84f-c58d-4926-9707-c5d230b4bd31,
abstract = {{<p>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 [ppFEV<sub>1</sub>]: <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 ppFEV<sub>1</sub>. 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 ppFEV<sub>1</sub> 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).</p>}},
author = {{Perez-de-Llano, Luis and Scelo, Ghislaine and Canonica, G. Walter and Chen, Wenjia and Henley, William and Larenas-Linnemann, Désirée and Peters, Matthew J. and Pfeffer, Paul E. and Tran, Trung N. and Ulrik, Charlotte Suppli and Popov, Todor A. and Sadatsafavi, Mohsen and Hew, Mark and Máspero, Jorge and Gibson, Peter G. and Christoff, George C. and Fitzgerald, J. Mark and Torres-Duque, Carlos A. and Porsbjerg, Celeste M. and Papadopoulos, Nikolaos G and Papaioannou, Andriana I. and Heffler, Enrico and Iwanaga, Takashi and Al-Ahmad, Mona and Kuna, Piotr and Fonseca, João A. and Al-Lehebi, Riyad and Rhee, Chin Kook and Koh, Mariko Siyue and Cosio, Borja G. and Perng (Steve), Diahn Warng and Mahboub, Bassam and Menzies-Gow, Andrew N. and Jackson, David J. and Busby, John and Heaney, Liam G. and Patel, Pujan H. and Wang, Eileen and Wechsler, Michael E. and Altraja, Alan and Lehtimäki, Lauri and Bourdin, Arnaud and Bjermer, Leif and Bulathsinhala, Lakmini and Carter, Victoria and Murray, Ruth and Beastall, Aaron and Denton, Eve and Price, David B.}},
issn = {{1081-1206}},
language = {{eng}},
publisher = {{Elsevier}},
series = {{Annals of Allergy, Asthma and Immunology}},
title = {{Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma}},
url = {{http://dx.doi.org/10.1016/j.anai.2023.12.023}},
doi = {{10.1016/j.anai.2023.12.023}},
year = {{2024}},
}