Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma

Luis Perez-de-Llano; Ghislaine Scelo; G. Walter Canonica; Wenjia Chen; William Henley; Désirée Larenas-Linnemann; Matthesadatw J Peters; Paul E. Pfeffer; Trung N. Tran; Charlotte Suppli Ulrik; Todor A. Popov; Mohsen Sadatsafavi; Mark Hew; Jorge Maspero; Peter G. Gibson; George C. Christoff; J. Mark Fitzgerald; Carlos A. Torres-Duque; Celeste M. Porsbjerg; Nikolaos G. Papadopoulos; Andriana I. Papaioannou; Enrico Heffler; Takashi Iwanaga; Mona Al-Ahmad; Piotr Kuna; João A Fonseca; Riyad Al-Lehebi; Chin Kook Rhee; Mariko Siyue Koh; Borja G. Cosio; Diahn-Warng Perng (Steve); Bassam Mahboub; Andrew N. Menzies-Gow; David J. Jackson; John Busby; Liam G. Heaney; Pujan H Patel; Eileen Wang; Michael E. Wechsler; Alan Altraja; Lauri Lehtimäki; Arnaud Bourdin; Leif Bjermer; Lakmini Bulathsinhala; Victoria Carter; Ruth Murray; Aaron Beastall; Eve Denton; David B. Price

doi:10.1016/j.anai.2023.12.023

Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma

Luis Perez-de-Llano, Ghislaine Scelo, G. Walter Canonica, Wenjia Chen, William Henley, Désirée Larenas-Linnemann, Matthesadatw J Peters, Paul E. Pfeffer, Trung N. Tran, Charlotte Suppli Ulrik, Todor A. Popov, Mohsen Sadatsafavi, Mark Hew, Jorge Maspero, Peter G. Gibson, George C. Christoff, J. Mark Fitzgerald, Carlos A. Torres-Duque, Celeste M. Porsbjerg, Nikolaos G. PapadopoulosAndriana I. Papaioannou, Enrico Heffler, Takashi Iwanaga, Mona Al-Ahmad, Piotr Kuna, João A Fonseca, Riyad Al-Lehebi, Chin Kook Rhee, Mariko Siyue Koh, Borja G. Cosio, Diahn-Warng Perng (Steve), Bassam Mahboub, Andrew N. Menzies-Gow, David J. Jackson, John Busby, Liam G. Heaney, Pujan H Patel, Eileen Wang, Michael E. Wechsler, Alan Altraja, Lauri Lehtimäki, Arnaud Bourdin, Leif Bjermer, Lakmini Bulathsinhala, Victoria Carter, Ruth Murray, Aaron Beastall, Eve Denton, David B. Price^* (Corresponding Author)

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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/) from May 2017 to January 2023. Change in four asthma domains (exacerbation rate, asthma control, long-term oral corticosteroid [LTOCS] dose, and lung function) was assessed from biologic initiation to one year post-treatment (minimum 24 weeks). Pre- to post-biologic changes for responders and non-responders were described along a categorical gradient for each domain derived from pre-biologic distributions (exacerbation rate: 0 to 6+/year; asthma control: well-controlled to uncontrolled; LTOCS: 0 to >30 mg/day; ppFEV1: <50 to ≥80%).
Results: Percentage of biologic responders (i.e., 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 showing improvement post-biologic tended to be greater for anti–IL-5/5R compared to 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 multi-dimensional approach to define and assess biologic responders and response, and may enhance appropriate patient selection for biologic therapies.

Original language	English
Journal	Annals of Allergy, Asthma, and Immunology
Early online date	25 Dec 2023
DOIs	https://doi.org/10.1016/j.anai.2023.12.023
Publication status	E-pub ahead of print - 25 Dec 2023

Bibliographical note

The authors acknowledge Mr Aivaras Cepelis for his contribution during the development of the manuscript. The authors thank Ms Pui Yee Lai (M.A.), of the Observational and Pragmatic Research Institute (OPRI), and Ms Andrea Lim (BSc, Hons) of the Observational Pragmatic Research Institute (OPRI) for their editorial and formatting assistance that supported the development of this publication.

This study was conducted by the Observational and Pragmatic Research Institute Pte Ltd and was partially funded by Optimum Patient Care Global and AstraZeneca Ltd. No funding was received by the Observational & Pragmatic Research Institute Pte Ltd for its contribution.

Open Access via the Elsevier/University of Aberdeen agreement

Data Availability Statement

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).

Supplementary data related to this article can be found at https://doi.org/10.1016/j.anai.2023.12.023.

Keywords

anti-IgE
anti–IL-5
anti–IL-4/13
control
exacerbation
FEV
oral corticosteroid

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https://www.sciencedirect.com/science/article/pii/S1081120623015089

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Perez-de-Llano, L., Scelo, G., Canonica, G. W., Chen, W., Henley, W., Larenas-Linnemann, D., Peters, M. J., Pfeffer, P. E., Tran, T. N., Ulrik, C. S., Popov, T. A., Sadatsafavi, M., Hew, M., Maspero, J., Gibson, P. G., Christoff, G. C., Fitzgerald, J. M., Torres-Duque, C. A., Porsbjerg, C. M., ... Price, D. B. (2023). Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma. Annals of Allergy, Asthma, and Immunology. Advance online publication. https://doi.org/10.1016/j.anai.2023.12.023

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, Maspero, 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, Fonseca, JA, Al-Lehebi, R, Rhee, CK, Koh, MS, Cosio, BG, Perng (Steve), D-W, 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 2023, 'Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma', Annals of Allergy, Asthma, and Immunology. https://doi.org/10.1016/j.anai.2023.12.023

@article{057a013da9db4b51943c278902905eed,

title = "Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma",

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/) from May 2017 to January 2023. Change in four asthma domains (exacerbation rate, asthma control, long-term oral corticosteroid [LTOCS] dose, and lung function) was assessed from biologic initiation to one year post-treatment (minimum 24 weeks). Pre- to post-biologic changes for responders and non-responders were described along a categorical gradient for each domain derived from pre-biologic distributions (exacerbation rate: 0 to 6+/year; asthma control: well-controlled to uncontrolled; LTOCS: 0 to >30 mg/day; ppFEV1: <50 to ≥80%). Results: Percentage of biologic responders (i.e., 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 showing improvement post-biologic tended to be greater for anti–IL-5/5R compared to 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 multi-dimensional approach to define and assess biologic responders and response, and may enhance appropriate patient selection for biologic therapies.",

keywords = "anti-IgE, anti–IL-5, anti–IL-4/13, control, exacerbation, FEV, oral corticosteroid",

author = "Luis Perez-de-Llano and Ghislaine Scelo and Canonica, {G. Walter} and Wenjia Chen and William Henley and D{\'e}sir{\'e}e Larenas-Linnemann and Peters, {Matthesadatw J} and Pfeffer, {Paul E.} and Tran, {Trung N.} and Ulrik, {Charlotte Suppli} and Popov, {Todor A.} and Mohsen Sadatsafavi and Mark Hew and Jorge Maspero 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 Enrico Heffler and Takashi Iwanaga and Mona Al-Ahmad and Piotr Kuna and Fonseca, {Jo{\~a}o A} and Riyad Al-Lehebi and Rhee, {Chin Kook} and Koh, {Mariko Siyue} and Cosio, {Borja G.} and {Perng (Steve)}, Diahn-Warng and Bassam Mahboub and Menzies-Gow, {Andrew N.} and Jackson, {David J.} and John Busby and Heaney, {Liam G.} and Patel, {Pujan H} and Eileen Wang and Wechsler, {Michael E.} and Alan Altraja and Lauri Lehtim{\"a}ki and Arnaud Bourdin and Leif Bjermer and Lakmini Bulathsinhala and Victoria Carter and Ruth Murray and Aaron Beastall and Eve Denton and Price, {David B.}",

note = "The authors acknowledge Mr Aivaras Cepelis for his contribution during the development of the manuscript. The authors thank Ms Pui Yee Lai (M.A.), of the Observational and Pragmatic Research Institute (OPRI), and Ms Andrea Lim (BSc, Hons) of the Observational Pragmatic Research Institute (OPRI) for their editorial and formatting assistance that supported the development of this publication. This study was conducted by the Observational and Pragmatic Research Institute Pte Ltd and was partially funded by Optimum Patient Care Global and AstraZeneca Ltd. No funding was received by the Observational & Pragmatic Research Institute Pte Ltd for its contribution. Open Access via the Elsevier/University of Aberdeen agreement ",

year = "2023",

month = dec,

day = "25",

doi = "10.1016/j.anai.2023.12.023",

language = "English",

journal = "Annals of Allergy, Asthma, and Immunology",

issn = "1081-1206",

publisher = "Elsevier",

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TY - JOUR

T1 - Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma

AU - Perez-de-Llano, Luis

AU - Scelo, Ghislaine

AU - Canonica, G. Walter

AU - Chen, Wenjia

AU - Henley, William

AU - Larenas-Linnemann, Désirée

AU - Peters, Matthesadatw J

AU - Pfeffer, Paul E.

AU - Tran, Trung N.

AU - Ulrik, Charlotte Suppli

AU - Popov, Todor A.

AU - Sadatsafavi, Mohsen

AU - Hew, Mark

AU - Maspero, Jorge

AU - Gibson, Peter G.

AU - Christoff, George C.

AU - Fitzgerald, J. Mark

AU - Torres-Duque, Carlos A.

AU - Porsbjerg, Celeste M.

AU - Papadopoulos, Nikolaos G.

AU - Papaioannou, Andriana I.

AU - Heffler, Enrico

AU - Iwanaga, Takashi

AU - Al-Ahmad, Mona

AU - Kuna, Piotr

AU - Fonseca, João A

AU - Al-Lehebi, Riyad

AU - Rhee, Chin Kook

AU - Koh, Mariko Siyue

AU - Cosio, Borja G.

AU - Perng (Steve), Diahn-Warng

AU - Mahboub, Bassam

AU - Menzies-Gow, Andrew N.

AU - Jackson, David J.

AU - Busby, John

AU - Heaney, Liam G.

AU - Patel, Pujan H

AU - Wang, Eileen

AU - Wechsler, Michael E.

AU - Altraja, Alan

AU - Lehtimäki, Lauri

AU - Bourdin, Arnaud

AU - Bjermer, Leif

AU - Bulathsinhala, Lakmini

AU - Carter, Victoria

AU - Murray, Ruth

AU - Beastall, Aaron

AU - Denton, Eve

AU - Price, David B.

N1 - The authors acknowledge Mr Aivaras Cepelis for his contribution during the development of the manuscript. The authors thank Ms Pui Yee Lai (M.A.), of the Observational and Pragmatic Research Institute (OPRI), and Ms Andrea Lim (BSc, Hons) of the Observational Pragmatic Research Institute (OPRI) for their editorial and formatting assistance that supported the development of this publication. This study was conducted by the Observational and Pragmatic Research Institute Pte Ltd and was partially funded by Optimum Patient Care Global and AstraZeneca Ltd. No funding was received by the Observational & Pragmatic Research Institute Pte Ltd for its contribution. Open Access via the Elsevier/University of Aberdeen agreement

PY - 2023/12/25

Y1 - 2023/12/25

N2 - 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/) from May 2017 to January 2023. Change in four asthma domains (exacerbation rate, asthma control, long-term oral corticosteroid [LTOCS] dose, and lung function) was assessed from biologic initiation to one year post-treatment (minimum 24 weeks). Pre- to post-biologic changes for responders and non-responders were described along a categorical gradient for each domain derived from pre-biologic distributions (exacerbation rate: 0 to 6+/year; asthma control: well-controlled to uncontrolled; LTOCS: 0 to >30 mg/day; ppFEV1: <50 to ≥80%). Results: Percentage of biologic responders (i.e., 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 showing improvement post-biologic tended to be greater for anti–IL-5/5R compared to 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 multi-dimensional approach to define and assess biologic responders and response, and may enhance appropriate patient selection for biologic therapies.

AB - 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/) from May 2017 to January 2023. Change in four asthma domains (exacerbation rate, asthma control, long-term oral corticosteroid [LTOCS] dose, and lung function) was assessed from biologic initiation to one year post-treatment (minimum 24 weeks). Pre- to post-biologic changes for responders and non-responders were described along a categorical gradient for each domain derived from pre-biologic distributions (exacerbation rate: 0 to 6+/year; asthma control: well-controlled to uncontrolled; LTOCS: 0 to >30 mg/day; ppFEV1: <50 to ≥80%). Results: Percentage of biologic responders (i.e., 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 showing improvement post-biologic tended to be greater for anti–IL-5/5R compared to 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 multi-dimensional approach to define and assess biologic responders and response, and may enhance appropriate patient selection for biologic therapies.

KW - anti-IgE

KW - anti–IL-5

KW - anti–IL-4/13

KW - control

KW - exacerbation

KW - FEV

KW - oral corticosteroid

U2 - 10.1016/j.anai.2023.12.023

DO - 10.1016/j.anai.2023.12.023

M3 - Article

C2 - 38151100

SN - 1081-1206

JO - Annals of Allergy, Asthma, and Immunology

JF - Annals of Allergy, Asthma, and Immunology

ER -

Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma

Abstract

Bibliographical note

Data Availability Statement

Keywords

Access to Document

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Cite this