Portal de investigação
Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma.
Autores da FMUP
Participantes de fora da FMUP
- Perez-de-Llano L
- Scelo G
- Canonica GW
- Chen W
- Henley W
- Larenas-Linnemann D
- Peters MJ
- Pfeffer PE
- Tran TN
- Ulrik CS
- Popov TA
- Sadatsafavi M
- Hew M
- Máspero J
- Gibson PG
- Christoff GC
- Fitzgerald JM
- Torres-Duque CA
- Porsbjerg CM
- Papadopoulos NG
- Papaioannou AI
- Heffler E
- Iwanaga T
- Al-Ahmad M
- Kuna P
- Al-Lehebi R
- Rhee CK
- Koh MS
- Cosio BG
- Perng Steve DW
- Mahboub B
- Menzies-Gow AN
- Jackson DJ
- Busby J
- Heaney LG
- Patel PH
- Wang E
- Wechsler ME
- Altraja A
- Lehtimäki L
- Bourdin A
- Bjermer L
- Bulathsinhala L
- Carter V
- Murray R
- Beastall A
- Denton E
- Price DB
Unidades de investigação
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 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(1)]: <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(1). 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(1) 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).
Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.
Dados da publicação
- ISSN/ISSNe:
- 1534-4436, 1081-1206
- Tipo:
- Article
- Páginas:
- -
ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY American College of Allergy, Asthma and Immunology
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Citar a publicação
Perez L,Scelo G,Canonica GW,Chen W,Henley W,Larenas D,Peters MJ,Pfeffer PE,Tran TN,Ulrik CS,Popov TA,Sadatsafavi M,Hew M,Máspero J,Gibson PG,Christoff GC,Fitzgerald JM,Torres CA,Porsbjerg CM,Papadopoulos NG,Papaioannou AI,Heffler E,Iwanaga T,Al M,Kuna P,Fonseca JA,Al R,Rhee CK,Koh MS,Cosio BG,Perng DW,Mahboub B,Menzies AN,Jackson DJ,Busby J,Heaney LG,Patel PH,Wang E,Wechsler ME,Altraja A,Lehtimäki L,Bourdin A,Bjermer L,Bulathsinhala L,Carter V,Murray R,Beastall A,Denton E,Price DB. Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma. Ann. Allergy Asthma Immunol. 2024. 132. (5):610-622.e7. IF:5,900. (2).
