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

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)


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 ( 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 languageEnglish
JournalAnnals of Allergy, Asthma and Immunology
Early online date25 Dec 2023
Publication statusEarly online date - 25 Dec 2023

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Copyright © 2023. Published by Elsevier Inc.


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