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

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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
Pages (from-to)	610-622.e7
Journal	Annals of Allergy, Asthma and Immunology
Volume	132
Issue number	5
Early online date	25 Dec 2023
DOIs	https://doi.org/10.1016/j.anai.2023.12.023
Publication status	Published - 01 May 2024

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10.1016/j.anai.2023.12.023Licence: CC BY

Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma
Copyright 2023 the authors. This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
Final published version, 5.02 MBLicence: CC BY

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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. (2024). Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma. Annals of Allergy, Asthma and Immunology, 132(5), 610-622.e7. https://doi.org/10.1016/j.anai.2023.12.023

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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.",

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}",

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

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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 2024, 'Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma', Annals of Allergy, Asthma and Immunology, vol. 132, no. 5, pp. 610-622.e7. https://doi.org/10.1016/j.anai.2023.12.023

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

PY - 2024/5/1

Y1 - 2024/5/1

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.

U2 - 10.1016/j.anai.2023.12.023

DO - 10.1016/j.anai.2023.12.023

M3 - Article

C2 - 38151100

SN - 1081-1206

VL - 132

SP - 610-622.e7

JO - Annals of Allergy, Asthma and Immunology

JF - Annals of Allergy, Asthma and Immunology

IS - 5

ER -

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

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