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Multicenter Study
. 2024 Dec 18;11(1):e002702.
doi: 10.1136/bmjresp-2024-002702.

What is the true target population for biologics in real-life COPD or asthma-COPD overlap patients?

Maéva Zysman  1   2 , Fanchon Herman  3 , Léo Grassion  4 , Camille Taillé  5 , Jesus Gonzalez-Bermejo  6   7 , Marina Guecamburu  8 , Nicolas Roche  9 , Arthur Pavot  2 , Pierre-Olivier Girodet  10 , Arnaud Bourdin  11 , Nicolas Molinari  11 , Patrick Berger  12   13 ; COBRA Study Group
Affiliations
Multicenter Study

What is the true target population for biologics in real-life COPD or asthma-COPD overlap patients?

Maéva Zysman et al. BMJ Open Respir Res. .

Abstract

Introduction: Biologics provide significant benefits in asthma, reducing exacerbations and symptoms. Some biologics have shown promising results in small subgroups of patients with chronic obstructive pulmonary disease (COPD) and frequent exacerbations. Nevertheless, real-life data on the size of the COPD target population remain scarce.

Methods: We analysed the characteristics of COPD and coexisting asthma and COPD patients included in the prospective multicentre, French COhort of BRonchial obstruction and Asthma, between 2008 and 2023 and evaluated the number of patients who could correspond to the inclusion criteria of randomised controlled trials evaluating various biologics targeting interleukin 33 (IL-33) (-receptor), IL-5 (-receptor), IL-4Rα or TSLP, in routine clinical practice.

Results: Among 434 COPD patients, only 21.7% met inclusion criteria for at least one biologic. Among patients with asthma, 54 (3.5%) had coexisting features of COPD in terms of age, smoking status and airflow obstruction and met inclusion criteria for at least one biologic. Notably, these patients were predominantly female, with worse lung function. Globally, the target chronic airway diseases population of the eagerly awaited biologics remains limited to a small part (ie, 1.3%-8%, depending on the biologic).

Conclusion: In a real-life COPD and asthma population (including asthmatic patients with features of COPD), the proportion of patients satisfying selection criteria applied in randomised controlled trials assessing the efficacy of biologics remains limited to less than 10% of the whole population.

Keywords: Asthma Pharmacology; Asthma in primary care; COPD Pharmacology; Eosinophil Biology.

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Conflict of interest statement

Competing interests: MZ reports grants and personal fees from Menarini, personal fees from Sanofi, personal fees from Chiesi, personal fees from AstraZeneca, personal fees from CSLBehring and personal fees from GSK outside the submitted work, grants from AVAD, grants from FRM. FH has no conflict of interest to declare related to the present work. LG has no conflict of interest to declare related to the present work. He received grants from AADAIRC. He received speaker or advisory board fees from GSK, ASTEN, Air Liquide Medical System, Sanofi Genzyme, SOS Oxygene, AstraZeneca, ASV, Boerhinger, VIVISOL and RESMED. CT has no conflict of interest to declare related to the present work. She received grants from GSK to INSERM UMR 1152. She received speaker or advisory board fees from AstraZeneca, GSK, Novartis, Sanofi, Stallergenes, Leo Pharma outside the submitted work. JG-B has no conflict of interest to declare related to the present work. MG has no conflicts of interest to disclose. NR has no conflict of interest to declare related to the present work. He received grants from Boehringer Ingelheim, Novartis, GSK and Pfizer to Institution. He received speaker or advisory board fees from Boehringer Ingelheim, AstraZeneca, GSK, Novartis, Sanofi, Chiesi, Pfizer, Novartis, Teva, Bayer, Austral, Biosency, Zambon, MSD, Menarini outside the submitted work. AP has no conflict of interest to declare related to the present work. P-OG has no conflict of interest to declare related to the present work. He received grants from AstraZeneca. He received speaker or advisory board fees from AstraZeneca, GSK, Sanofi, Chiesi, outside the submitted work. AB has no conflict of interest to declare related to the present work. NM has no conflict of interest to declare related to the present work. PB reports grants and personal fees from AstraZeneca, Menarini, personal fees from Sanofi, personal fees from Chiesi, grants from AVAD, grants from FRM, grants from AstraZeneca.

Figures

Figure 1
Figure 1. Flow chart for COPD patients from COhort of BRonchial obstruction and Asthma and Venn diagram corresponding to the inclusion criteria of studies evaluating the following biologics: astegolimab (anti-IL-33 receptor ST2, clinical trial NCT05037929), benralizumab (anti IL-5-receptor, NCT04053634), dupilumab (anti-IL-4Rα, NCT03930732), itepekimab (anti-IL-33, NCT05326412) mepolizumab (anti-IL-5, NCT04133909), tezepelumab (anti-TSLP, NCT04039113), tozorakimab (anti IL-33, NCT05166889 and NCT05158387). COPD, chronic obstructive pulmonary disease; IL, interleukin.
Figure 2
Figure 2. Flow chart for asthma-COPD overlap patients from COhort of BRonchial obstruction and Asthma and Venn diagram corresponding to the inclusion criteria of studies evaluating the following biologics: astegolimab (anti-IL-33 receptor ST2, clinical trial NCT05037929), benralizumab (anti IL-5-receptor, NCT04053634), dupilumab (anti-IL-4Rα, NCT03930732), itepekimab (anti-IL-33, NCT05326412) mepolizumab (anti-IL-5, NCT04133909), tezepelumab (anti-TSLP, NCT04039113), tozorakimab (anti IL-33, NCT05166889 and NCT05158387). COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; IL, interleukin.
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